A-334-98
President and Fellows of Harvard College (Appellant)
v.
Commissioner of Patents (Respondent)
and
Canadian Environmental Law Association (Intervener)
Indexed as: President and Fellows of Harvard Collegev. Canada (Commissioner of Patents) (C.A.)
Court of Appeal, Linden, Isaac and Rothstein JJ.A.-- Ottawa, December 9, 1999 and August 3, 2000.
Patents -- Patentability of genetically altered non-human
mammals for use in carcinogenicity studies -- Commissioner of Patents
rejecting claims 1 to 12 in patent application as outside definition of
"invention" in Patent Act, s. 2 but allowing claims 13 to 26 -- Appeal
to F.C.T.D. dismissed -- Object of Patent Act to promote development of
inventions for benefit of inventor, public -- Invention must be new,
useful, unobvious -- As Act silent regarding biotechnological
inventions, new life forms, claims in relation thereto decided according
to traditional patent requirements -- Oncomouse unobvious, new, useful
"composition of matter", therefore "invention" within meaning of Act, s.
2 -- Patent Act not excluding living organisms, e.g. non-human mammals,
from definition of "invention" -- Product herein result of human
ingenuity at genetic level, laws of nature, therefore patentable --
Complex life forms within parameters of Patent Act -- Provisions of Act
cast in broad terms to fulfil Parliament's objective to promote
invention -- Human beings not patentable but Parliament or courts will
have to decide as to human genes, products at genetic level.
Animals -- Appellant seeking patent for production of
animals with susceptibility to cancer for carcinogenicity studies --
Product of claims 1 to 12 in patent application referred to as
transgenic non-human mammal or oncomouse -- Whether patentable in
accordance with interpretation of Patent Act -- Oncomouse unobvious,
new, useful composition of matter, therefore "invention" within Act, s. 2
-- Not merely product of laws of nature, rather result of both
ingenuity, laws of nature, therefore patentable -- Test for usefulness
of product mouse produced with all of cells affected by oncogene --
Control, reproducibility tests met -- No common understanding patent law
not extending to living organisms -- Definition of "invention" not
excluding from patentability higher life forms such as oncomouse.
Administrative law -- Judicial review -- Certiorari --
Commissioner of Patents denying patent with respect to claims 1 to 12
in patent application covering forms of transgenic non-human mammals --
Refusal upheld by F.C.T.D. -- F.C.A. holding decisions of Patent
Commissioner warranting more deferential approach by reviewing courts
when made within area of expertise -- Even when reviewed on more
deferential reasonableness simpliciter standard, Commissioner's decision
could not stand -- Patent Commissioner, F.C.T.D. Judge committed
numerous errors in reasoning, conclusions -- Commissioner applied overly
broad control test, not implied by usefulness requirement -- Erred in
splitting invention into phases, relying upon F.C.A. decision in Pioneer
Hi-Bred Ltd. which was distinguishable.
This was an appeal from a Trial Division decision upholding the
refusal by the Commissioner of Patents to grant a patent covering claims
1 to 12 in a patent application in relation to forms of transgenic
non-human mammals. The objective of the appellant is to produce animals
with a susceptibility to cancer for purposes of animal carcinogenicity
studies by using an activated oncogene sequence. A plasmid containing
the oncogene is injected into a fertilized mouse egg which is then
transferred into a female "host" mouse and allowed to develop to term.
If the resulting mouse is found to have all of its cells affected by the
oncogene, it is called a "founder mouse". The founder mouse is then
mated with an uninjected mouse. The Commissioner of Patents confirmed
the decision by the Patent Examiner to reject claims 1 to 12 as being
outside the definition of "invention" in section 2 of the Patent Act. The Trial Judge considered four indicia
in interpreting section 2: (1) the inventor's degree of control over
the creation of the invention; (2) the distinction between human
intervention and the laws of nature in the creation of the oncomouse;
(3) the relevance of the test of reproducibility and (4) the
appropriateness of making distinctions between higher and lower life
forms. On the basis of those indicia, the Trial Judge upheld the
Commissioner of Patents' decision. On appeal, the issue was the
patentability of genetically altered non-human mammals for use in
carcinogenicity studies.
Held (Isaac J.A. dissenting), the appeal should be allowed.
Per Rothstein J.A.: A patent protects an invention. The object of the Patent Act
is to promote the development of inventions in a manner that benefits
both the inventor and the public. An invention may be any new and useful
process or product or a new or useful improvement to a process or
product. Under section 28.3 of the Patent Act, the subject-matter
of a patent claim must not have been obvious to persons skilled in the
art or science. The Commissioner's duty is not discretionary: when a
process or a product satisfies the requirements of the Act, an
application for a patent must be granted. To the extent that this appeal
gives rise to policy questions, they are to be addressed by Parliament
and not by the Court. Because the Patent Act contains no
provision relating to biotechnological inventions and new forms of life
in particular, the type of claims at issue will be patentable if they
are within the scope of existing legislation and meet the traditional
conditions and requirements for a patent.
The issue was whether claims 1 to 12 amount to an "invention" within the meaning of section 2 of the Patent Act.
The oncomouse is both unobvious and a new and useful "composition of
matter"; therefore it is an "invention" within the meaning of section 2
of the Act. The language of patent law is broad and general and is to be
given wide scope because inventions are, necessarily, unanticipated and
unforeseeable. The Court must respect Parliament's use of such language
and not adopt a narrow approach that would conflict with its obvious
intention. The Patent Act does not exclude living organisms, that
is non-human mammals, from the definition of "invention". Patentability
requires a non-naturally occurring "composition of matter" arising from
the application of inventiveness or ingenuity. The oncomouse must be
considered to be the result of both ingenuity and the laws of nature:
ingenuity in the initial genetic engineering involving the assembly of
the oncogene, incorporating it into the plasmid and injecting the
plasmid into the zygote; and the laws of nature, with the oncogene then
affecting all the cells of the oncomouse in the course of gestation, the
subsequent mating of an oncomouse and an uninjected mouse, and the
reliance on Mendelian laws of inheritance to obtain offspring oncomice.
The ingenuity in this case relates not only to the introduction of
genetic material into the mouse by artificial means, but extends to the
makeup of the critical oncogene itself. The oncomouse described in the
patent claims would not exist in nature; rather, it is the result of
both human ingenuity at the genetic level and the laws of nature. Having
regard to section 40 of the Patent Act, on a straightforward
interpretation of the term "composition of matter" and taking into
account the roles of ingenuity and the laws of nature, there is no
reason in law why the product, in this case the oncomouse, is not
patentable.
The Commissioner of Patents and the Trial Judge made a number of
errors in their reasonings and conclusions. First, the Trial Judge
expressed his preference for the minority view in a decision of the
Supreme Court of the United States, Diamond v. Chakrabarty, in
which, by a 5-4 majority, a bacterium which could break down crude oil
was found to be patentable. While American patent decisions are not
binding on Canadian courts, where the statutory language which is being
interpreted is similar in both countries and where the reasoning
underlying the United States Court's interpretation of the language is
persuasive, there is no reason why Canadian courts should ignore the
American case law. Significant reliance should be placed on the majority
opinion in Chakrabarty in concluding that the definition of
"invention" does not exclude from patentability higher life forms such
as the oncomouse. There is no "common understanding" that patent law
does not extend to living organisms. Second, the Commissioner of Patents
refused to grant a patent for claims 1 to 12 mainly because the
inventors did not have full control over all characteristics of the
resulting oncomouse. The Trial Judge agreed with that conclusion.
Control is implied in the requirement that an invention be useful. If
there is insufficient control over a product such that it would not be
practically useful, the usefulness requirement of the definition of
"invention" would not be met. The Commissioner of Patents and the Trial
Judge applied a far broader control test, not implied by the usefulness
requirement for an invention. They read into the definition of
"invention" words not expressed by Parliament, or implied by the
language used by Parliament, and in doing so, erred in law. Usefulness
is necessary for patentability and implies control in the sense that the
desired result will be achieved when the product is used or produced.
The desired result herein is an oncomouse with susceptibility to cancer
for use in carcinogenicity studies. Once that has been achieved, control
over other characteristics of the mouse is irrelevant. If the product
is a composition of matter that is new, useful and unobvious, it is a
patentable "invention". Third, the Trial Judge found that "for an
invention to be patentable, it must be reproducible". In his view, the
oncomouse was not reproducible. By using the methods described in the
specification of the patent application, an oncomouse is producible with
all of its cells affected by the oncogene. Such a mouse is reproducible
and is useful. The reproducibility requirement, in the context of
usefulness, has been satisfied. Fourth, the Commissioner of Patents
split the invention into two phases. Once it was conceded that most
inventions involve the use of some of the laws of nature, there could be
no valid basis for splitting an invention between the portion that is
the result of inventive ingenuity and the portion that is not. Splitting
the invention into phases was not legally justified. It denied to the
inventors a patent on a product which was the result of a combination of
inventive ingenuity and the laws of nature both of which were central
to the invention. Fifth, the Trial Judge erred in finding that complex
life forms were not within the parameters of the Patent Act.
There may be policy reasons against patentability of higher life forms.
However, such arguments are for Parliament, not for courts. Sixth, the
Trial Judge erred in concluding that the patentability of the oncomouse
would provide the inventor with no additional protection beyond that
provided by patenting claims 13 to 26. A patent provides legal
protection against the world, that is others who might come into
possession of an oncomouse and reproduce it. Finally, the Trial Judge
and the Commissioner of Patents erred in putting too much emphasis on
the Federal Court of Appeal's decision in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents).
The findings in that case with respect to cross-breeding of soybeans
are not applicable to the case at bar which involves inventive ingenuity
and intervention at the genetic level and the creation of a specific
new life form.
As to the standard of review, the decision of the Trial Judge is
reviewable on a correctness standard. On the other hand, the expertise
of the Commissioner of Patents warrants a more deferential approach by
reviewing courts on decisions made by him within his area of expertise.
Even on the more deferential reasonableness simpliciter standard,
the Commissioner's decision is properly reviewable by the Court. The
Commissioner was wrong notably in applying control and reproducibility
tests that are not expressed in or implied by the Patent Act and in splitting the invention into phases without legal justification.
A final issue raised was the obvious concern as to whether a
finding that "invention" includes living organisms could be extended to
human beings. The Patent Act cannot be extended to cover human
beings. Patenting is a form of ownership of property which cannot be
extended to human beings. A further ground for so concluding was Charter
section 7, which protects the liberty of the person. Even so, as
scientific research advances, Parliament or the courts will have to
decide whether human genes or products at the genetic level are
patentable.
Per Isaac J.A. (dissenting): The first question
that a Court must ask, when hearing an appeal from an administrative
tribunal, is what is the standard of review. The Trial Judge failed to
do so. The Commissioner's decision was not protected by a privative
clause. However, it is beyond doubt that the Commissioner of Patents has
expertise on the issue of patentability of inventions; he is an expert
tribunal. Since the nature of the question (the patentability of the
oncomouse) is squarely within his area of expertise, his decision should
be accorded deference on the reasonableness simpliciter standard. The purpose of the Patent Act
also weighs in favour of greater deference to decisions of the
Commissioner. The Act recognizes that the Commissioner must always be
aware of, and take into account, the public interest in granting a
patent. In a morally divisive case such as this, the Court should defer
to the Commissioner's decisions where they are informed by
considerations of public policy. The Commissioner's decision was
reasonable because it took a cautious approach to patenting new life
forms. The Trial Judge was right to dismiss the appeal even though he
did not appreciate the need for a standard of review analysis. Under
section 40 of the Act, the Commissioner must be satisfied that an
applicant is legally entitled to a patent. It is not sufficient to
conclude that a patent must be granted once the requirements of the Act
have been met. The grant or refusal of a patent is not a matter of
discretion but this does not mean that an applicant is not required to
satisfy the Commissioner and his officials that he is by law entitled to
the grant.
The issue was whether the decision of the Commissioner was
reasonable. What was done in other jurisdictions is irrelevant to the
resolution of that issue. The decision on this appeal should not be
affected by the fact that the oncomouse has been patented in the United
States of America and Europe. The Commissioner's decision was
reasonable. Absent evidence to the contrary, the Court is bound to
accord appropriate respect for his finding. In all the circumstances of
this case, including the serious moral and ethical implications of this
subject-matter, it seems that Parliament is the most appropriate forum
for the resolution of the issues in dispute here.
| statutes and regulations judicially considered |
| Canadian Charter of Rights and Freedoms, being Part I of the Constitution Act, 1982, Schedule B, Canada Act 1982, 1982, c. 11 (U.K.) [R.S.C., 1985, Appendix II, No. 44], s. 7. |
| Customs Tariff, S.C. 1997, c. 36. |
| Federal Court Act, R.S.C., 1985, c. F-7 , s. 24(1) (as am. by S.C. 1990, c. 8, s. 6). |
| Patent Act, R.S.C. 1970, c. P-4 , ss. 2, 36(1), 42, 44. |
| Patent Act,
R.S.C., 1985, c. P-4 , ss. 2 "invention" (as am. by S.C. 1993, c. 2, s.
2), 10 (as am. by S.C. 1993, c. 15, s. 28), 17, 27 (as am. idem, s. 31), 28.3 (as enacted idem, s. 33), 35(1) (as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 12), 40, 41 (as am. idem, s. 16), 42 (as am. idem), 46 (as am. idem; S.C. 1993, c. 15, s. 43). |
| Patent Act, 35 U.S.C. § 101 (1988). |
| Patent Rules, SOR/96-423, RR. 30(6), 40, 45(2), 46, 47(2),(5). |
| Patents Act 1977 (U.K.), 1977, c. 37. |
| Plant Breeders' Rights Act, S.C. 1990, c. 20. |
| Plant Patent Act (The), 35 U.S.C. § 161 (1930). |
| Plant Variety Protection Act (The), 7 U.S.C. § 2402(a) (1970). |
| Trade-marks Act, R.S.C., 1985, c. T-13. |
| cases judicially considered |
| Monsanto Company v. Commissioner of Patents, [1979] 2 S.C.R. 1108; (1979), 100 D.L.R. (3d) 385; 42 C.P.R. (2d) 161; 28 N.R. 181; Pushpanathan v. Canada (Minister of Citizenship and Immigration),
[1998] 1 S.C.R. 982; (1998), 160 D.L.R. (4th) 193; 11 Admin. L.R. (3d)
1; 43 Imm. L.R. (2d) 117; 226 N.R. 201; amended reasons [1998] 1 S.C.R.
1222; (1998), 11 Admin. L.R. (3d) 130; Canada (Director of Investigation and Research) v. Southam Inc., [1997] 1 S.C.R. 748; (1997), 144 D.L.R. (4th) 1; 50 Admin. L.R. (2d) 199; 71 C.P.R. (3d) 417; 209 N.R. 20; Diamond v. Chakrabarty, 447 U.S. 303 (1980); Application No. 003,389 of N.V. Organon, Re (1973), 15 C.P.R. (2d) 253 (Pat. App. Bd.). |
| Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1987] 3 F.C. 8; (1987), 11 C.I.P.R. 158; 14 C.P.R. (3d) 491; 77 N.R. 137 (C.A.); Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623; (1989), 60 D.L.R. (4th) 223; 25 C.I.P.R. 3; 25 C.P.R. (3d) 257; 97 N.R. 185. |
| Cadbury Schweppes Inc. v. FBI Foods Ltd.,
[1999] 1 S.C.R. 142; (1999), 167 D.L.R. (4th) 577; [1999] 5 W.W.R. 751;
59 B.C.L.R. (3d) 1; 117 B.C.A.C. 161; 42 B.L.R. (2d) 159; 83 C.P.R.
(3d) 289; Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; (1963), 41 C.P.R. 9; 25 Fox Pat C. 99; Electric Fireproofing Co. of Canada v. Electric Fireproofing Co. (1910), 43 S.C.R. 182; affg (1909), 34 Que. S.C. 388; Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111; (1972), 33 D.L.R. (3d) 459; 8 C.P.R. (2d) 202; Perka et al. v. The Queen,
[1984] 2 S.C.R. 232; (1984), 13 D.L.R. (4th) 1; [1984] 6 W.W.R. 289; 28
B.C.L.R. (2d) 205; 14 C.C.C. (3d) 385; 42 C.R. (3d) 113; 55 N.R. 1; Molson Breweries, a Partnership v. John Labatt Ltd. (2000), 5 C.P.R. (4th) 180; 252 N.R. 91 (F.C.A.); X v. Commissioner of Patents (1981), 59 C.P.R. (2d) 7; 46 N.R. 407 (F.C.A.); British Columbia Telephone Co. v. Shaw Cable Systems (B.C.) Ltd., [1995] 2 S.C.R. 739; (1995), 125 D.L.R. (4th) 443; 31 Admin. L.R. (2d) 169; 183 N.R. 184; International Longshoremen's and Warehousemen's Union, Ship and Dock Foremen, Local 514 v. Prince Rupert Grain Ltd., [1996] 2 S.C.R. 432; (1996), 135 D.L.R. (4th) 385; 40 Admin. L.R. (2d) 1; 96 CLLC 210-037; 198 N.R. 99; Application of Abitibi Co., Re (1982), 62 C.P.R. (2d) 81 (Pat. App. Bd.); Rice v. Christiani, [1931] A.C. 770 (P.C.). |
| Diversified Products Corp. v. Tye-Sil Corp. (1991), 35 C.P.R. (3d) 350; 125 N.R. 218 (F.C.A.); Vanity Fair Silk Mills v. Commissioner of Patents, [1939] S.C.R. 245; [1938] 4 D.L.R. 657; Lawson v. Canada (Commissioner of Patents) (1970), 62 C.P.R. 101 (Ex. Ct.); Consolboard Inc. v. MacMillan Bloedel (Sask.), [1981] 1 S.C.R. 504; (1981), 122 D.L.R. (3d) 203; 56 C.P.R. (2d) 145; 35 N.R. 390; Pezim v. British Columbia (Superintendent of Brokers),
[1994] 2 S.C.R. 557; (1994), 114 D.L.R. (4th) 385; [1994] 7 W.W.R. 1;
92 B.C.L.R. (2d) 145; 22 Admin. L.R. (2d) 1; 14 B.L.R. (2d) 217; 4
C.C.L.S. 117; Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. & Int. 1985); Application No. 016,962 (Patent No. 947,179), Re (1973), 17; C.P.R. (2d) 177 (Pat. App. Bd.); Application No. 880,719 (Patent No. 944,693), Re (1973), 18 C.P.R. (2d) 114 (Pat. App. Bd.); Application
for Patent Containing Claims that Read on Mental Steps Performed by a
Human Operator in Deciding to Transmit a Signal, Re (1972), 23 C.P.R. (2d) 93 (Comm. Pat.). |
| Canada. Patent Office. Manual of Patent Office Practice. Ottawa: The Office, 1998. |
| Canada. Royal Commission on New Reproductive Technologies. Proceed with Care: Final Report of the Royal Commission on New Reproductive Technologies. Ottawa: Minister of Government Services, 1993. |
| Fox, Harold G. The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed. Toronto: Carswell, 1969. |
| Hayhurst, William L. "Exclusive Rights in Relation to Living Things" (1991), 6 I.P.J. 171. |
| Hoffmaster, Barry. "The Ethics of Patenting Higher Life Forms" (1989), 4 I.P.J. I. |
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| New Oxford Dictionary of English. Oxford: Clarendon Press, 1998 "transgenic". |
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APPEAL from a Trial Division decision ([1998] 3 F.C. 510;
(1998), 79 C.P.R. (3d) 98; 146 F.T.R. 279) dismissing an appeal from a
refusal by the Commissioner of Patents to grant a patent of invention
for claims 1 to 12 of the appellant's application regarding genetically
altered non-human mammals for use in carcinogenicity studies. Appeal
allowed.
| A. David Morrow and Steven B. Garland for appellant. |
| Frederick. B. Woyiwada for respondent. |
| Paul Muldoon, Theresa A. McClenaghan and Michelle Swenarchuk for intervener. |
| Smart & Biggar, Ottawa, for appellant. |
| Deputy Attorney General of Canada for respondent. |
| Canadian Environmental Law Association, Toronto, for intervener. |
The following are the reasons for judgment rendered in English by
[1]Isaac J.A. (dissenting): I have had the privilege of
reading, in draft, the reasons which Mr. Justice Rothstein proposes to
deliver in this appeal. I am unable to subscribe to them or to his
proposed disposition of the appeal. Since I have reached a different
conclusion respecting the disposition of the appeal, I must state the
reasons which impel me to do so.
[2]The appeal is from a judgment of the Trial Division which
dismissed an appeal by the appellant, pursuant to section 41 of the Patent Act,1 and subsection 24(1) of the Federal Court Act,2
from a refusal by the Commissioner of Patents (hereinafter the
Commissioner) to grant a patent of invention for claims 1 to 12 of the
appellant's application. The reasons for judgment are reported in [1998]
3 F.C. 510.
[3]Section 41 of the Act reads:3
41. Every person who has failed to obtain a patent by
reason of a refusal of the Commissioner to grant it may, at any time
within six months after notice as provided for in section 40 has been
mailed, appeal from the decision of the Commissioner to the Federal
Court and that Court has exclusive jurisdiction to hear and determine
the appeal.
[4]Subsection 24(1) of the Federal Court Act reads:
24. (1) Except as otherwise provided in this Act or any
other Act of Parliament, the Trial Division has exclusive original
jurisdiction to hear and determine all appeals that under any Act of
Parliament may be taken to the Court.
[5]The Commissioner's authority to refuse to grant a patent of invention is found in section 40 of the Act. That section reads:4
40. Whenever the Commissioner is satisfied that an
applicant is not by law entitled to be granted a patent, he shall
refuse the application and, by registered letter addressed to the
applicant or his registered agent, notify the applicant of the refusal
and of the ground or reason therefor. [Emphasis added.]
THE FACTS
[6]The facts upon which the learned Judge proceeded are found in
paragraphs 3 and 4 [pages 514-515] of the reported reasons. There is,
therefore, no reason to repeat them here.
PROCEDURAL HISTORY
[7]It would be helpful to recite the procedural history of the
appellant's application for the patent from the commencement of the
process to the present proceeding, because, in my respectful view, that
is the only way for this Court to assess the reasonableness of the
Commissioner's conclusions and the reasons for them. As I will show
later, this is the assessment that the Judge in the Trial Division
should have made; but, did not make.
[8]On 21 June 1985, the appellant filed a petition for the grant
of a patent of invention respecting transgenic animals described and
claimed in the specifications.5
[9]On 9 April 1987, the Commissioner notified the appellant, pursuant to subsection 45(2) of the Patent Rules,6
of an action by an Examiner in relation to the application. The action
by the Examiner consisted of a request, pursuant to rule 40, for
particulars of the prior art.7
[10]On 23 June 1987, the appellant replied.8
[11]On 21 February 1990, the Commissioner notified the appellant
of a further action taken by the Examiner pursuant to Rule 46 of the Patent Rules
in the public interest. The Examiner stated that the appellant's
application had been examined and that of the 24 claims in the
application, 18 had been rejected--claim 14 was rejected because the
subject- matter lacked inventive ingenuity; claims 1 to 12 and 15 to 17
were rejected as being directed to non-statutory subject-matter and as
being outside the definition of invention as given in section 2 [as am.
by S.C. 1993, c. 2, s. 2] of the Act; and claims 18 and 19 were rejected
as being directed to a method of medical treatment which is outside the
definition of invention in section 2 of the Act. The Examiner stated
that an amendment of the application was required in light of the action
taken.9
[12]By letter dated 21 June 1990, the solicitors for the
appellant asked for a two-month extension to reply to the "Office
Action".10
[13]By letter dated 6 July 1990, the Commissioner granted the extension to 21 August 1990.11
[14]By letter dated 16 August 1990, the solicitors for the
appellant replied in language that found favour with Mr. Justice
Rothstein, as evidenced by his reasons, and asked for favourable
reconsideration of the application.12
[15]By letters dated 11 September and 5 October 1990, respectively, the solicitors for the appellant submitted further material.13
[16]By letter dated 14 January 1992, Examiner S. Kemdirim
notified the appellant of a further action that was taken pursuant to
"Rule 46 of the Patent Rules in the public interest." The letter continued:
This application has been examined pursuant to applicant's
correspondence dated August 16, 1990; September 11, 1990 and October 5,
1990.
The number of claims in this application is 24.
Applicant's arguments presented in his amendment of August 16,
1990 have been considered. However, it has been decided that these
arguments do not overcome the objections set forth in the last Official
Action. The objections to claims 1-12, 14 to 19 are maintained.14
[17]Reasons were given for the rejection of each claim.
Particularly instructive, were the reasons given for the rejection of
claims 1-12 and 15-17. They read:
Claims 1 to 12 and 15-17 are rejected as being directed to
non-statutory subject matter. Subject matter directed to plants or
animals is held to be outside the definition of invention as given in
Section 2 of the Patent Act. Any further modification of said matter
does not confer patentability thereto if it remains in a living or
viable state.
Applicant made reference to Section 2 of the Patent Act and
Section 12.03.01 of the Manual of Patent Office Practice and argued that
Section 2 and Manual of Patent Office Practice Section 12.03.01(a) do
not exclude all animals from patentability.
Section 2 of the Patent Act defines a patentable invention:
| "invention"
means any new and useful art, process, machine, manufacture or
composition of matter, or any new and useful improvement in any art,
process, machine, manufacture or composition of matter; |
Section 2 sets forth the criteria for patentability of a
manufacture or a composition of matter. It must possess novelty and
utility. While Section 2 is silent with respect to patentability of
animals per se, a limiting interpretation should be given to the
language embodied in the definition of the word "invention". Thus,
applicant's alleged invention of claims 1 to 12 and 15-17 do not qualify
as a "manufacture" within the definition of invention as defined in
Section 2 of the Patent Act.
Moreover, given that animals were in existence when the Patent
Act was enacted, had it been the intention of Parliament to include
animals as a patentable subject matter, then words such as "animals" or
"higher life forms" would have appeared in the definition of "invention"
as given in Section 2 of the Patent Act.
Contrary to applicant's statement, the Manual of Patent Office
Practice (M.O.P.O.P.) Section 12.03.01(a) does exclude all animals from
patentability:
| "Plants
and animals are not patentable subject matter" M.O.P.O.P. Section
12.03.01(a), as amended January 1990. For guidance only. |
Applicant made reference to the Supreme Court decision in the
Pioneer Hi-Bred case. Applicant argued that his instant alleged
invention was essentially microbiological and involved human
manipulation of genetic material. This, applicant stated, should be
contrasted with the natural process of crossbreeding process described
in Pioneer Hi-Bred. It must also be remarked that the crossbreeding
process described in Pioneer Hi-Bred was not reproducible.
Although the process of claims 15-17 involves human manipulation
of genetic material, the process is not reproducible, as was the case
with the Pioneer Hi-Bred crossbreeding process. This is because the
injected activated oncogene is randomly incorporated into the chromosome
of the embryo. One can not predict with any certainty the locus in
which it will be integrated. Consequently, different scientists
following the teachings of instant specification will not obtain the
same results, in that different genetically distinct lines of transgenic
mice will be obtained.
In view of the foregoing, claims 1 to 12 and 15-17 are rejected.15
[18]By letter dated 13 April 1992, the solicitors for the
appellant wrote to the Commissioner requesting an extension of time to
reply to the official action.16
[19]By letter dated 27 April 1992, the Commissioner replied, extending the time for reply to the Examiner's action.17
[20]By letter dated 14 July 1992, the solicitors for the
appellant replied to the official action of 14 January 1992. The reply,
consisting of some ten pages with a five-page attachment, reads, in
part:
This letter is filed in response to the official action of January 14th, 1992.
Please replace the claim pages on file with new claim pages containing claims 1 to 26 submitted herewith in duplicate.
Please replace disclosure pages 1 and 2 with new disclosure pages submitted herewith.
R E M A R K S
Claim 1 has been amended by restricting the subject matter to a mammal. Similar amendments have been made in claims 2 to 15. Claim 14 has been restricted
similarly and steps in the method included. Claims 18 and 19 have been
amended to be in "use" format. Claims 25 and 26 have been added to this
application. Claim 25 finds support on pages 5 and 6 and 17 of the
disclosure and claim 26 finds support on page 5 of the disclosure.
In view of the amendments to the claims, various minor
amendments have been made to pages 1 and 2. The amendments to page 1
have been made to improve support for claim 1 and the amendments to page
2 have been made to improve support for claims 15, 14 and 3,
respectively.18 [Emphasis added.]
[21]What emerges from this response, clearly, in my view, is the
vigorous debate between the solicitors for the appellant and the
Examiner, respecting the patentability of the subject-matter of the
application. One should notice, too, that in the give and take of this
debate, each party accepts or rejects the positions taken by the other.
The excerpts quoted in paragraphs 22 and 23, infra, demonstrate the nature and quality of the debate.
[22]I excerpt below from the solicitors reply at pages 122-123:
The balance of the official action relates to an objection to
claims 1 to 12 and 15 to 17 as being directed to non-statutory subject
matter. As the Examiner correctly observes Section 2 is silent with
respect to patentability of animals per se. However, the Examiner
interprets the silence of this section of the Patent Act as indicating
that a limiting interpretation should be put on the language embodied in
the definition of the word "invention". Applicant respectfully
disagrees. Applicant understands that in a common law jurisdiction such
as Canada, if there is no express prohibition of an activity, such as
patenting a new, useful and unobvious animal, then applicant is free to
obtain such protection. Applicant also respectfully disagrees with the
Examiner's statement that the subject matter of claims 1 to 12 does not
qualify as a "manufacture". New genetic material, new arrangements of
old genetic material combinations of new and old genetic material are
commonly accepted as patentable. Vectors containing such genetic
material are patentable. Cells containing such material are patentable.
However, the Patent Office appears to draw a line between cells and
differentiated aggregations of cells in the form of a mammal. Whether
or not the cells are differentiated, the subject matter of the claims
has required human intervention and, it is respectfully submitted, does
quality as "manufacture".19 [Emphasis added.]
[23]The Examiner's final action is dated 24 March 1993.
Examiner, M. Gillen, informed the appellant that the refusal of claims 1
to 12 was maintained but that claims 13 to 26 were allowable. I
reproduce, in part, the reasons given for maintaining the refusal of
claims 1 to 12:
Claims 1-12 are directed to a transgenic non-human mammal. Said
claims are rejected as being directed to non-statutory subject matter.
It is held that a higher life form, like an animal, is outside the
definition of invention as given in Section 2 of the Patent Act.
Applicant has argued "that in a common law jurisdiction such as
Canada, if there is no express prohibition of an activity, such as
patenting a new, useful and unobvious animal, then applicant is free to
obtain such protection". The implication of this statement is that if
something is not expressly prohibited by the Patent Act, and provided it
is new, useful and unobvious, then it is patentable. This is clearly
not the case in Canada and the Commissioner's right to both interpret
Section 2 of the Patent Act and to reject certain subject matter and
activities as being directed to non-patentable subject matter has been
confirmed by the Courts.
In Commissioner of Patents v Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning
(1964) S.C.R. at 56 Judson J. said, ". . . in Canada the Patent Office,
supervised by the Court, does examine as to inventiveness, and an
applicant may appeal to the highest court. Moreover, in the
particular class of case with which we are here concerned dealing with
drugs and medicines, there is considerable public interest at stake, and
the Commissioner should most carefully scrutinize the application to
see if it merits the grant of monopoly privileges and to determine the
scope of the monopoly available." Judson J. affirmed the
Commissioner's right to consider the public interest in interpreting
Section 2 of the Act. [Emphasis added.]
In Lawson v Commissioner of Patents (1970) 62 C.P.R. 101,
at 109 Cattanach J. states "I take it as well settled that all new and
useful arts and manufactures are not necessarily included in s. 2(d) of
the Patent Act." In Lawson v Commissioner of Patents the Exchequer Court upheld the Commissioner's refusal to grant a patent for subdivided land in the shape of a champagne glass.
In Tennessee Eastman v Commissioner of Patents (1974)
S.C.R. 111, at 119 Pigeon J. said, "Having come to the conclusion that
methods of medical treatment are not contemplated in the definition of
`invention' as a kind of `process', the same must, on the same basis, be
true of a method of surgical treatment." In this case the Court upheld
the Commissioner's interpretation of "invention" to exclude methods of
medical or surgical treatment.
In Pioneer Hi-Bred Ltd. v Commissioner of Patents (1987),
3 F.C. 8, 77 N.R. 137, the Federal Court of Appeal upheld the refusal
of the Commissioner of Patents to grant a patent for a new plant
variety, where claims to the plant and its seed were rejected as being
directed to non-statutory subject matter. The Commissioner based his
objection on an interpretation of the definition of "invention" as given
in Section 2 of the Patent Act.
The foregoing clearly demonstrates that not everything which is new, useful and inventive is a priori patentable
subject matter. The Commissioner of Patents has both a right and an
obligation to consider the public interest in the granting of a patent. [Emphasis added.]
Applicant has argued that "patenting of higher life forms (plants and animals) is clearly comtemplated [sic] in decisions of the Patent Appeal Board and the Courts". However, on the question of the patentability of higher
life forms, neither the Patent Appeal Board nor the Courts have
expressly stated that these life forms constitute patentable subject
matter.
In the Abitibi case (Re application of Abitibi Co. (1982), 62 C.P.R. (2d) 81)
the Commissioner concurred with the recommendation of the Patent Appeal
Board that microorganisms be considered as patentable subject matter.
The Commissioner's decision made a distinction between lower life forms
like animals. The Abitibi decision established the patentability
of lower life forms "produced en masse as chemical compounds are
prepared" and "formed in such large numbers that any measurable quantity
will possess uniform properties and characteristics." As for higher
life forms, like plants and animals, the Commissioner's decision
concluded, regarding the question of patentable subject matter, "Whether
it reaches up to higher life forms--plants (in the popular sense) or
animals--is more debatable". [Emphasis in original.]
The issue of higher life forms as patentable subject matter was dealt with subsequent to the Abitibi decision in an application for patent protection for a plant and its seed, submitted by Pioneer Hi-Bred Ltd.
A Commissioner's decision upheld by the Federal Court of Appeal
(referenced above) rejected claims to a soybean plant and its seed.
Marceau J. in his summary stated: "speaking of the intention of
Parliament, given that plant breeding was well established when the Act
was passed, it seems to me that the inclusion of plants within the
purview of the legislation would have led first, to a definition of
invention in which words such as `strain', `variety' or `hybrid' would
have appeared, and second to the enactment of special provisions capable
of better adapting the whole scheme to a subject matter, the essential
characteristics of which is that it reproduces itself as a necessary
result of its growth and maturity."
While the issue of the patentability of higher life forms was "more debatable" in the Abitibi decision, the Commissioner concluded in the Pioneer Hi-Bred
case that one type of higher life form, i.e. plants, was outside the
definition of invention as given in Section 2 of the Patent Act. While
the Supreme Court did not make a ruling on the Commissioner's rejection
of claims to a plant and its seed under Section 2 of the Act, the
Federal Court of Appeal upheld the Commissioner's rejection of these claims under this section of the Act.
If one accepts that an animal, in this case a mammal, is a more
complex and higher life form than a plant, it seems logical to conclude
that if a plant is held to be non-patentable subject matter, then the
same must be said for animals.
In rejecting claims 1-12, directed to a transgenic non-human
mammal, the examiner is guided by the Commissioner's decision in the Abitibi case and bound by the Federal Court of Appeal decision in the Pioneer Hi-Bred
case. Claims 1-12 are rejected as being directed to a form of living
matter which is outside the definition of invention as given in Section 2
of the Patent Act.20
[24]By letter dated 24 September 1993, the appellant's
solicitors responded to the Examiner's final action. Their position,
summarized at page 9 of the letter was that:
1) There is no statutory basis for excluding higher life forms from patent protection;
2) There is no legal precedent that prohibits patenting of
higher life forms created by significant technical intervention of man;
and
3) It is in the interest of the Canadian public to allow patents for higher life forms.
In view of the foregoing, we respectfully request that the Commissioner of Patents allow claims 1-12 of the present application.21
[25]In the letter, the solicitors also asked the Commissioner to
review the Examiner's final action and for an oral hearing before the
Patent Appeal Board as provided in subsections 47(2) and (5),
respectively, of the Patent Rules.
[26]By letter dated 22 June 1994, the Chairman of the Patent Appeal Board informed the appellant's solicitors, inter alia, that an oral hearing had been fixed for 28 July 1994.22
[27]The oral hearing was held on 28 July 1994. On 14 August
1995, the Chairman of the Patent Appeal Board informed the appellant's
solicitors of the Commissioner's decision refusing to grant a patent
containing claims 1-12 of the application and informing them of their
client's statutory right of appeal.23
[28]On 2 February 1996, the appellant filed, in the Trial
Division, a notice of appeal from the decision of the Commissioner
rejecting claims 1-12 of the application.24 No particular grounds of error are alleged in the notice.
[29]On 21 April 1998, the Trial Division issued judgment
dismissing the appeal. It is from that judgment that this appeal is
taken.
DECISION OF THE COMMISSIONER
[30]Although Mr. Justice Rothstein has dealt with the
Commissioner's decision in his reasons, I find it necessary to highlight
certain portions of it for purposes of these reasons.
[31]I note, first, the final statement in the first paragraph of the Commissioner's reasons:
. . . I have subsequently reviewed the prosecution of the application and discussed the rejection with the Board before rendering my decision.25 [Emphasis added.]
[32]Secondly, the Commissioner's description of the subject-matter of the application should be noticed here:
The application is directed to a transgenic mammal, in
particular a transgenic mouse which can be used as a test vehicle for
substances suspected of being carcinogenic or for substances thought to
confer protection against the development of neoplasms.26
[33]Thirdly, he noticed that this Court, in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents)27
unanimously refused to accept the definition of "manufacture" and
"composition of matter" that the Supreme Court of the United States had
relied upon in Diamond v. Chakrabarty,28 the decision that Mr. Justice Rothstein urges us to accept guidance from.
[34]Fourthly, he agreed with counsel for the appellant that, because the Supreme Court of Canada, did not decide Pioneer Hi-Bred on the merits, the Examiner was wrong to say in the final action that he was bound by the decision of this Court in Pioneer Hi-Bred. He did allow, however, that the decision of this Court in Pioneer Hi-Bred was of high persuasive value.29
[35]Fifthly, he observed that in Application of Abitibi Co., Re,30
a decision of the Patent Appeal Board, on whose recommendation the
Commissioner's decision was based, was reluctant to consider claims to
higher life forms to be patentable.
[36]Sixthly, after rejecting the argument by counsel for the
appellant that he should interpret the words "manufacture" and
"composition of matter" found in section 2 of Act, according to U.S.
practice, he stated:
. . . I do not however consider that much weight can be given to United States practice in interpreting Canadian legislation.
In my view the words "manufacture" and "composition of matter"
as found in Section 2 apply to something that has been made under the
control of the inventor. In the case of "manufacture" it is the
production of articles for use from starting materials, prepared by
giving these materials new forms, qualities, properties or combinations
whether by hand labour or machinery. As to the term "composition of
matter" I would construe the term broadly to include not only the result
of chemical union or mechanical admixture but also microbiological, or
genetic engineering techniques so long as they are performed and
controlled by the human hand. At the same time the resulting product
must be reproducible in a consistent manner.31 [Emphasis added.]
[37]Finally, he concluded his analysis as follows:
Since the plasmids and the transgenic unicellular material are
produced under the full control of the inventor and are reproducible, I
am satisfied that they are a "manufacture" or a "composition of matter"
under Section 2 of the Act. I note that no objections, based on Section
2, were raised against such claims in the instant application.
However I cannot extend the meaning of "manufacture" or
"composition of matter" to include a non-human mammal. On the plain and
ordinary meaning of the words, and here I am strongly influenced by the
Federal Court of Appeal decision in Pioneer Hi-Bred, I do not
find that a non-human mammal like a mouse falls within the definition of
"invention". The inventors do not have full control over all the
characteristics of the resulting mouse since the intervention of man
ensures that reproducibility extends only as far as the cancer forming
gene.32
[38]He, therefore, refused to grant a patent concerning claims 1-12.33
REASONS OF THE TRIAL DIVISION
[39]The Judge of the Trial Division treated the appeal as one that came to him to be heard as an appeal de plano.
No doubt, rising to the submissions made to him by counsel, he accepted
that [at page 516] "this is the first time the Court has been faced
with the question of whether a higher life form, a mammal, is
patentable." In my respectful view, the Judge was misled by counsel into
believing that he was doing something more than sitting to review the
decision of a specialized tribunal. It is true that the appellant was
given a right of appeal by statute. However, since Pezim v. British Columbia (Superintendent of Brokers),34
the first question that a Court must ask, when hearing an appeal from
an administrative tribunal, like the present one, is what is the
standard of review. This is so, notwithstanding the existence of a
statutory right of appeal and the fact that the constitutive statute of
the tribunal does not contain a privative clause.
[40]This approach was affirmed to Pushpanathan v. Canada (Minister of Citizenship and Immigration),35 where Bastarache J., for the majority stated:
One of the elements necessary for the disposition of an
application for judicial review is the standard of review of the
decision of the administrative tribunal whose decision is being
reviewed, and that question is clearly in issue in this case. Reluctant as this Court is to decide issues not fully argued before it, determining the standard of review is a prerequisite to the disposition of this case. [Emphasis added.]
[41]The principle laid down in that case respecting the need to
decide what the standard of review in judicial review proceedings apply
with equal force, in my respectful view, to statutory appeals since the
judgment of the Supreme Court in Pezim.
[42]As I have already said, that is the first question the Court
below should have asked. It did not. It is a question that I must now
ask and answer because, in my respectful view, the answer is "a
prerequisite to the disposition of this case."36 With great
respect to those who are of a contrary opinion, it is my view that the
failure of counsel for the parties to raise the issue of standard of
review does not relieve reviewing courts of their obligation to do a
standard of review analysis.
STANDARD OF REVIEW
[43]In a number of recent decisions, the Court has addressed the
standard of review of the decisions of the Registrar of Trade Marks, a
tribunal established under the Trade-marks Act,37 a statute in pari materia. The latest decision is Molson Breweries, a Partnership v. John Labatt Ltd.38 There, Mr. Justice Rothstein writing for a majority of the Court, stated the standard as follows at paragraph 29 [page 196]:
I think the approach in Benson & Hedges v. St. Regis and in McDonald v. Silcorp are consistent with the modern approach to standard of review. Even though there is an express appeal provision in the Trade-marks Act to the Federal Court, expertise on the part of the Registrar has been recognized as requiring some deference. Having
regard to the Registrar's expertise, in the absence of additional
evidence adduced in the Trial Division, I am of the opinion that
decisions of the Registrar, whether of fact, law or discretion, within
this area of expertise, are to be reviewed on a standard of
reasonableness simpliciter. [Emphasis added.]
[44]The Supreme Court in Pushpanathan enumerated four
factors to consider in applying the pragmatic and functional test to
determine the appropriate standard of review: the presence or absence of
a privative clause; the expertise of the decision-maker; the purpose of
the provision in particular and the Act as a whole; and the nature of
the problem in question.
[45]There is no privative clause in this case; however, as the Supreme Court recognized in Pezim,39
this does not end the inquiry. Tribunals whose decisions are reviewed
by way of appeal may still warrant some deference when the other factors
so indicate.
[46]In my respectful view, that the Commissioner has expertise on the issue of patentability of inventions is not open to doubt.
[47]X v. Commissioner of Patents40 was an
appeal under section 44 [R.S.C. 1970, c. P-4] (now section 40) of the
Act from a decision of the Commissioner which had approved the
recommendation of the Patent Appeal Board and refused the appellant's
application for a patent for an alleged invention. The appellant alleged
that the Commissioner erred in finding that the patent was inoperable.
Thurlow C.J., for an unanimous court, concluded that the Commissioner
was an expert tribunal and that "the Court would be bound to accord
appropriate respect" to his decision. This is how he expressed it at
page 10 of his reasons:
On the material in the record, consisting of the specification
and the communications between the appellant and the Patent Office, and in the absence of evidence on the point,
it does not appear to me that the Court is in any position to form an
opinion that differs from that of the Board as to whether or not a
device of the kind described in the specification could be constructed
and made to work. Even if the Court were inclined to take a view
differing from that of the Commissioner and his advisers, the Court
would be bound to accord appropriate respect for their finding on the
same material, having regard to the technical expertise such officials
are presumed to have and exercise. [Emphasis added.]
[48]Thurlow C.J. wrote those reasons, more than a decade before the Supreme Court of Canada decided British Columbia Telephone Co. v. Shaw Cable Systems (B.C.) Ltd. where L'Heureux-Dubé J., writing for the Court that was unanimous on this point, stated at paragraph 30:
The case at hand concerns a specialized administrative tribunal,
the CRTC, which possesses considerable expertise over the subject
matter of its jurisdiction. However, despite the expertise of the CRTC,
its decision in the case at hand is not protected by a privative clause
and is, in fact, subject to an express statutory right of appeal.
Nonetheless, it was clearly established in both Pezim, supra, and Bell Canada v. Canada (Canadian Radio-television and Telecommunications Commission),
[1989] 1 S.C.R. 1722, that a specialized tribunal such as the CRTC,
acting within its area of expertise and jurisdiction, is entitled to
curial deference, even in the absence of a privative clause and the
presence of a statutory right of appeal.41
Curiously the approaches to the review of decisions of expert
tribunals, which these two decisions contain, do not differ in any
significant respect from that which Mr. Justice Rothstein stated in John Labatt Ltd.
[49]It is clear from my statement of the points raised by the
various examiners in my recitation of the procedural history of this
case that they are persons with technical expertise.42
Furthermore, at the request of the applicant, the Examiner's final
action was referred to the Patent Appeal Board--another body with patent
expertise--to hold hearings pursuant to subsection 30(6) of the Patent Rules.43
It should be noticed that, in his decision, the Commissioner indicated
that he had discussed the Examiner's refusal with the members of the
Patent Appeal Board before rendering his decision.44 For these reasons, it is my respectful view that the Commissioner is an expert tribunal.
[50]Since the nature of the question (the patentability of the
oncomouse) is squarely within the Commissioner's area of expertise, it
is my opinion that his decision should be accorded deference on the
reasonableness simpliciter standard, as stated by Mr. Justice Rothstein in John Labatt Ltd.
[51]The purpose of the Act also weighs in favour of greater deference for the Commissioner. Judson J., for a unanimous Court in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning,
stated that "there is considerable public interest at stake" in patents
relating to drugs and medicines, and therefore "the Commissioner should
most carefully scrutinize the application to see if it merits the grant
of monopoly privileges, and to determine the scope of the monopoly
available."45 There is no question in my mind that the public interest is engaged in applications of the kind in issue here.
[52]That the public interest is paramount in patent cases is
also exemplified by section 10 [as am. by S.C. 1993, c. 15, s. 28] of
the Act which, subject to certain safeguards for patent applicants,46
allows the general public to inspect all patents and documents filed in
connection with patents. If patent applications resulted merely in
bilateral disputes between the patent examiners and the applicant, there
would be no need for the public to have access to patent documents. The
Act thus recognizes that the Commissioner must be aware of and consult
the public interest in all patent cases.
[53]Finally, as Binnie J. stated in Cadbury Schweppes Inc. v. FBI Foods Ltd.:
. . . at least one of the policy objectives underlying the
statutory remedies available to a patent owner is to make disclosure
more attractive, and thus hasten the availability of useful knowledge in
the public sphere in the public interest.47
[54]It is, thus, clear to me that one of the purposes of the Act
is that the Commissioner must always be aware of, and take into
account, the public interest in granting a patent. In a morally divisive
case such as this,48 this Court should defer to the Commissioner's decisions where they are informed by considerations of public policy.
[55]I therefore conclude that the Commissioner's decision should have been reviewed on the standard of reasonableness simpliciter, i.e., in the words of Iacobucci J. in Canada (Director of Investigation and Research) v. Southam Inc.49 at paragraph 56:
An unreasonable decision is one that, in the main, is not
supported by any reasons that can stand up to a somewhat probing
examination. Accordingly, a court reviewing a conclusion on the
reasonableness standard must look to see whether any reasons support it.
The defect, if there is one, could presumably be in the evidentiary
foundation itself or in the logical process by which conclusions are
sought to be drawn from it. An example of the former kind of defect
would be an assumption that had no basis in the evidence, or that was
contrary to the overwhelming weight of the evidence. An example of the
latter kind of defect would be a contradiction in the premises or an
invalid inference.
[56]In my respectful view, if the Judge below had adopted this
approach, he would certainly have reached the conclusion that he should
have given deference to the Commissioner's decision, since the issue
within his jurisdiction and his decision was reasonable. In his erudite
exposition, the learned Judge concluded that it was correct. In the
absence of any contrary evidence on the point, I must infer that it was
also reasonable in the sense in which Iacobucci J. defined it in Southam.
[57]The Commissioner's decision was also reasonable because it
took a cautious approach to patenting new life forms. As William L.
Hayhurst, Q.C. has stated: "if Canada's past performance in intellectual
property matters is any indication, one thing is clear: Canada will
move cautiously."50 The need for this cautious approach to new technologies was emphasized in the Final Report of the Royal Commission on New Reproductive Technologies, which reported that:
. . . although public attitudes of 40 years ago--captured in the
phrase "better living through modern technology"--are still prevalent,
there are also increasing concerns about scientists "playing God" and
technologies "tampering with nature." There is a growing unease on the
part of some that the "genie has been let out of the bottle," and
technology will never be "contained" again.51
[58]Applying the foregoing approach to this case, it is my
respectful view that the Judge below was right to dismiss the
appellant's appeal even though, as I have said, he did not appreciate
the need for a standard of review analysis.
[59]This conclusion is sufficient to enable me to dismiss this
appeal. However, in view of the way in which the appeal was argued
before us and in deference to counsel, I consider it helpful to address
some of the issues raised and dealt with by Mr. Justice Rothstein in his
reasons.
[60]I deal, first, with the twin issues of whether the
Commissioner has any discretion to issue or to refuse the patent and
whether policy considerations are relevant. This leads to a discussion
of section 40 of the Act.
[61]I repeat that section here for ease of reference:
40. Whenever the Commissioner is satisfied that an
applicant is not by law entitled to be granted a patent, he shall
refuse the application and, by registered letter addressed to the
applicant or his registered agent, notify the applicant of the refusal
and of the ground or reason therefor. [Emphasis added.]
[62]Mr. Justice Rothstein's conclusion based on a quotation taken from Monsanto Company v. Commissioner of Patents52 is that [infra, paragraph 109] "[i]t is apparent that when a process or a product satisfies the requirements of the Patent Act,
an application for a patent must be granted." This statement, in my
respectful view, overlooks the clear provision in section 40 that it is
the Commissioner who must be satisfied that an applicant is
legally entitled to a patent. It is not sufficient, in my view, to
conclude that a patent must be granted once the requirements of the Act
have been met. I agree that discretion is not involved in the grant or
refusal of a patent. However, that is not to say that an applicant must
not satisfy the Commissioner and his officials that, by law, he or she
is entitled to a patent.
[63]Furthermore, in my respectful view, the quotation in Monsanto
does not support Mr. Justice Rothstein's conclusion. In that case,
Pigeon J. made the statement in response to a complaint made in the
following circumstances: the applicant for a patent had tendered
affidavit evidence based on scientific principles. The Commissioner and
his officials did not take issue with those principles, but simply said
"[w]e are not satisfied that this is adequate." Pigeon J., writing for
the Court stated that this response was insufficient because "if
accepted, it makes the right of appeal illusory."53 He then
went on to quote section 42 (now section 40) of the Act and indicated as
Mr. Justice Rothstein has said that the grant or refusal of a patent is
not a matter of discretion. I am in respectful agreement with Pigeon J.
that the grant or refusal of a patent is not a matter of discretion,
but, as I have already said, this does not mean that an applicant is not
required to satisfy the Commissioner and his officials that he is by
law entitled to the grant.
PIONEER HI-BRED AND CHAKRABARTY
[64]In Pioneer Hi-Bred, this Court was concerned with the
patentability of varieties of cross-bred soybean. One of the issues in
the appeal was whether the cross-bred soybean varieties were
"manufacture" or a "composition of matter" within the meaning of section
2 of the Act. As happened in this case, the Commissioner refused to
issue the patent and the appellant in that case contended that the
Commissioner erred in determining that a strain of naturally born plant
derived by artificial cross-breeding was not an invention within the
meaning of section 2 of the Act.
[65]Counsel for the appellant, citing the decision of the United States Supreme Court in Chakrabarty and the decision of the United States Board of Appeals and Patent Interferences in Ex parte Hibberd54
urged the Court to conclude, on the basis of these decisions, that the
subject-matter of their application was a "manufacture" or a
"composition of matter". The decision of the (Canadian) Patent Appeal
Board in Abitibi was also cited. In Pioneer Hi-Bred,
Marceau J.A. wrote reasons in which Pratte and Lacombe JJ.A. concurred.
After reviewing the arguments based on these decisions, he rejected the
definitions of "manufacture" and "composition of matter" relied upon by
the United States Supreme Court in Chakrabarty, stating:
Even if those definitions were held to be applicable to a
micro-organism obtained as a result of a laboratory process, I am unable
to go further and accept that they can also adapt to a plant variety
produced by cross-breeding. Such a plant cannot really be said, other
than on the most metaphorical level, to have been produced from raw
materials or to be a combination of two or more substances united by
chemical or mechanical means. It seems to me that the common ordinary
meaning of the words "manufacture" and "composition of matter" would be
distorted if a unique but simple variety of soybean were to be included
within their scope.55
[66]Pratte J.A., in separate reasons, added, as a further ground
for dismissing the appeal, the fact that the applicant had not complied
with the disclosure requirements of subsection 36(1) of the Act.
[67]The appellant appealed the judgment of this Court to the
Supreme Court of Canada. That Court dismissed the appeal for the
additional reason given by Pratte J.A., and without expressing any
opinion on the views expressed by Marceau J.A.
[68]Given the reliance placed on Chakrabarty in this
Court, it is not unreasonable to assume that the appellant in that case
did rely upon it in the Supreme Court of Canada. The decision is not
mentioned in the reasons of Lamer J. [as he then was] who wrote for the
Court; but, it is reasonable to assume that by implication at least,
that Court refused to adopt the definitions of "manufacture" and
"composition of matter" which the United States Supreme Court accepted
in that case.
[69]What then is the precedential value of the reasons of this Court in Pioneer Hi-Bred
as expressed by Marceau J.A. in light of the decision of the Supreme
Court of Canada? Based on decisions of the Court of Appeal of England,
the Commissioner concluded that it was not binding on him, but was of
high persuasive value only. I agree. Although we are not bound by it, it
is my respectful view that judicial comity requires us to pay
considerable deference to it. For that reason alone, I would reject the
reasoning of the majority of the Supreme Court in Chakrabarty and the United States Board of Appeals and Patent Interferences in Ex parte Hibberd.
[70]It is plain, from his reasons, that Mr. Justice Rothstein
has placed great reliance on the decision of the United States Supreme
Court in Chakrabarty. Indeed, at paragraph 147 of his reasons, he states that he places "significant reliance" on Chakrabarty without any acknowledgement whatsoever that the arguments advanced in Pioneer Hi-Bred based on Chakrabarty had been considered by this Court and unanimously rejected by it and probably by a unanimous Supreme Court of Canada.
WHETHER OUR DECISION SHOULD BE INFLUENCED BY THE FACT THAT THE ONCOMOUSE HAS BEEN PATENTED IN THE UNITED STATES AND EUROPE
[71]At paragraph 110 of Mr. Justice Rothstein's reasons, he
stated that "[i]t is arguable on policy grounds that there is merit to
uniformity" between Canada and the United States and Europe. In my
respectful view, to take this into account is clearly to introduce
policy consideration into our decision-making. In my respectful view, if
Mr. Justice Rothstein is right that we are faced here with a simple
problem of statutory interpretation, then we should construe the words
"manufacture" and "composition of matter" in their ordinary meaning and
in their total legislative context. The practice in other countries is
certainly not part of the legislative context of the definition of those
terms in the Act. Where Parliament decides that such matters are
relevant, it says so.56
[72]Furthermore, there is no evidence before us of the nature of
the material that was presented to the authorities in those
jurisdictions to persuade them to grant the patent, what their
legislative regimes were, or what criteria they used. These are all
facts that the appellant would have had to prove to the requisite degree
before they could have been admitted and considered, if relevant. They
were not.
[73]The issue for us in this case is whether the decision of the
Commissioner was reasonable. What was done in other jurisdictions is
quite irrelevant to a resolution of that issue.
[74]I conclude then that our decision on this appeal should not
be affected in any way by the fact that the oncomouse has been patented
in the United States of America and Europe.
[75]The Commissioner, the authority in which Parliament has
confided the responsibility to decide such matters, is of the view that
it cannot be patented here for the reasons that he gave. His decision
was reasonable. Like Thurlow C.J. in X v. Commissioner of Patents, supra,
it is my respectful view that, absent evidence to the contrary, and
there was none in the record presented to us, "this Court is bound to
accord appropriate respect for their finding".
[76]I wish to emphasize why, in my view, it is necessary to pay
deference to the findings of the Commissioner by referring to some
observations that Cory J., for a unanimous Court, made in International Longshoremen's and Warehousemen's Union, Ship and Dock Foremen, Local 514 v. Prince Rubert Grain Ltd.57
There the Court reversed a decision of this Court that the Canada
Labour Relations Board did not have jurisdiction to determine the
composition of a bargaining unit for collective bargaining purposes and
for certification under the Canada Labour Code. In giving his reasons
for doing so, Cory J. took the opportunity to warn of the approach
courts should take in assessing the decisions of administrative
tribunals generally and of labour relations boards in particular. He
made the following observations at paragraph 20 [page 445]:
At the outset it should be stated, once again, that it would be
all too easy for courts to find that empowering provisions of statutes
creating administrative tribunals are jurisdictional in nature, thereby
increasing the likelihood that their jurisdiction will be unnecessarily
limited. The result of adopting such an approach would be that a great
many decisions of the tribunals would be required to be correct in the
eyes of the courts. There have been very salutary warnings sounded
against the courts taking such a position.
After citing from three authorities, he continued at paragraphs 23-24 (pages 446 and 447), as follows:
If these warnings are not heeded, the operation and indeed the
whole concept of administrative tribunals may be jeopardized. These
tribunals are often set up to operate in areas where specific expertise,
experience, and sensitivity to the particular problems involved are
essential to their resolution. Administrative tribunals are designed to
function expeditiously, inexpensively, and with less formality than
courts. There is little doubt either of the need for these tribunals or
of the very important role they fulfil in Canadian society.
It has often been very properly recognized that labour relations
boards exemplify a highly specialized type of administrative tribunal.
Their members are experts in administrating comprehensive labour
statutes which regulate the difficult and often volatile field of labour
relations. Through their constant work in this sensitive area, labour
boards develop the special experience, skill and understanding needed to
resolve the complex problems of labour relations. There were very sound
reasons for the establishment of labour boards and the protection of
their decisions by broad privative clauses. Parliament and provincial
legislatures have clearly indicated that decisions of these boards on
matters within their jurisdiction should be final and binding. The
courts could all too easily usurp the role of these boards by
characterizing the empowering legislation according them authority as
jurisdiction limiting provisions which would require their decisions to
be correct in the opinion of the court. Quite simply, courts should
exercise deferential caution in their assessment of the jurisdiction of
labour boards and be slow to find an absence or excess of jurisdiction.
[77]Although those observations were made in relation to the
approach to decisions on jurisdiction, nevertheless they appear to be
equally applicable to the decisions of expert tribunals such as the
Commissioner whose decisions call for the exercise of experience, skill,
and expertise in resolving complex problems with which courts are not
equipped to deal. It is not sufficient, in my respectful view, to assess
the decision on the standard of correctness and then, as an after
thought, to lay it on a procrustean bed and charaterize it as
unreasonable.
[78]Following the refusal of the Supreme Court in Pioneer Hi-Bred
to accommodate cross-bred soya bean varieties within the definition of
"invention" in section 2 of the Act, Parliament enacted the Plant Breeders' Rights Act,58
within eleven months after the Supreme Court had dismissed the appeal.
In all the circumstances of this case, including the limited role that
our jurisprudence has assigned to the courts in this area and the
serious moral and ethical implications of this subject-matter, it seems
to me that Parliament is the most appropriate forum for the resolution
of the issues in dispute here.
[79]I do not find it necessary to deal with the other points which Mr. Justice Rothstein raised in his reasons.
CONCLUSION
[80]For all these reasons, then, I am of the view that the
appeal should be dismissed with costs to the respondent. There will be
no costs to the intervener.
* * *
The following are the reasons for judgment rendered in English by
Rothstein J.A.:
OVERVIEW
[81]The issue in this appeal is the patentability of genetically
altered non-human mammals for use in carcinogenicity studies. Claims 1
to 12 in patent application 484723 (the 723 patent) (set out in Appendix
A) cover forms of transgenic non-human mammals. The Commissioner of
Patents found that the appellant was not entitled to be granted a patent
covering these claims.59 Claims 13 to 26 in the patent
application (set out in Appendix B) are for methods for the production
of transgenic non-human mammals or transgenic cell cultures, for using
transgenic non-human mammals, methods of testing materials suspected of
being carcinogens using transgenic non-human mammals, and various
plasmids and somatic cell cultures. Claims 13 to 26 were found to be
patentable.60
[82]An appeal to the Federal Court Trial Division from the
Patent Commissioner's refusal to grant a patent in respect of claims 1
to 12 was dismissed.61 This is an appeal from the decision of the Federal Court Trial Division.
OBJECTIVES OF PATENT CLAIMS 1 TO 12
[83]The "Summary of the Invention" in the patent application
provides a description of what is intended by the inventors. The
objective of the appellant is to produce animals with a susceptibility
to cancer for purposes of animal carcinogenicity studies. The animals
can be used to test a material suspected of being a carcinogen by
exposing the animals to the material and seeing if cancerous tumours
develop. Because of the propensity of the animals to develop tumours,
amounts of materials tested can be smaller, more closely approximating
the amounts to which humans are exposed. The animals will be expected to
develop tumours much sooner because they already have that propensity.
The animals can also be used to test materials thought to confer
protection against the development of cancer. The result is that
carcinogenicity studies can be carried out more effectively and with
closer comparability to the effect of test materials on humans than
would be possible without the transgenic mammals.
[84]The technology by which a cancer-prone mouse is produced is
described in the Commissioner's decision. An activated oncogene sequence
(oncogene) is a gene which makes a mouse more susceptible to cancer.62
A plasmid (a carrier) is constructed containing the oncogene. The
plasmid is injected into a fertilized mouse egg (preferably while it is
at the one-cell (zygote) stage and generally not later than the
eight-cell stage). The injected egg is then transferred into a female
"host" mouse and allowed to develop to term. The reason for injecting
the oncogene preferably into the zygote is to ensure, to the extent the
oncogene is taken up, that it will affect all the cells of the mouse
which develops from the zygote. If the resulting mouse is found to have
all of its cells63 affected by the oncogene, it is called a "founder mouse".64
The founder mouse is then mated with an uninjected mouse. In accordance
with Mendelian inheritance of single loci, 50% of the offspring will be
found to have all their cells affected by the oncogene.
[85]The appellant seeks to protect the product of this process,
that is, the founder mammal and the offspring whose cells are affected
by the oncogene. In this decision, for ease of reference, the product of
claims 1 to 12 will be referred to as a transgenic non-human mammal or
an oncomouse.
JUDICIAL HISTORY
[86]The 723 patent application was filed on June 21, 1985 for an
invention entitled "Transgenic Animals". The invention had been
assigned by the inventors, Leder and Stewart, to the appellant,
President and Fellows of Harvard College.
[87]On March 24, 1993, by Examiner's final action, the Examiner
rejected claims 1 to 12 as being outside the definition of "invention"
in section 2 of the Patent Act but allowed claims 13 to 26.
[88]On August 4, 1995, after review by the Commissioner of
Patents and a hearing before the Patent Appeal Board, the refusal to
grant a patent for claims 1 to 12 was confirmed by the Commissioner.
| 1. Decision of the Patent Commissioner |
[89]In his decision, having regard to section 40 of the Patent Act,65
the Commissioner determined that to reject an application as
unpatentable subject-matter, he must be satisfied that, by law, the
appellant is not entitled to a patent and must give reasons based on an
interpretation of the Patent Act and any applicable jurisprudence.
[90]The Commissioner reviewed decisions of the Patent
Commissioner, Federal Court of Appeal and Supreme Court of Canada. He
then observed that on April 12, 1988, a patent had been granted in the
United States for transgenic non-human mammals. Although the definitions
of the term "invention" in the United States and Canadian legislation
are similar, the Commissioner was of the view that in interpreting
Canadian legislation, not much weight could be given to the U.S.
practice. In considering the words "manufacture" and "composition of
matter" in the definition of "invention" in section 2 of the Patent Act,
the Commissioner found that they required something to be made under
the control of the inventor and that the resulting product be
reproducible in a consistent manner.
[91]With respect to the application in this case, the
Commissioner found there were two distinct phases involved: "firstly,
the preparation of the genetically engineered plasmid and secondly the
development of a genetically engineered mouse in the uterus of the host
mouse".66 In the first phase human intervention is involved.
The Commissioner was satisfied that the plasmids and the transgenic
unicellular material were produced under the full control of the
inventor and were reproducible and were therefore a "manufacture" or a
"composition of matter" under the definition of "invention" in section 2
of the Patent Act. In the second phase, he found that the laws
of nature take over. Being "strongly influenced" by the Federal Court of
Appeal's decision in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents),67
he would not include a non-human mammal as being patentable. His reason
was that "[t]he inventors do not have full control over all the
characteristics of the resulting mouse since the intervention of man
ensures that reproducibility extends only as far as the cancer forming
gene".68
[92]In distinguishing Application of Abitibi Co., Re69 (Abitibi)
in which the Commissioner's predecessor had been satisfied that
micro-organisms such as yeast, mould, fungi, bacteria, actinomycetes,
unicellular algae, virus or protozoa could be the subject of patent
protection, the Commissioner found that "different considerations"
(which he did not identify) applied as between claims to lower life
forms as in Abitibi and higher life forms as in this case.
[93]Accordingly, he refused to grant a patent covering claims 1 to 12.
| 2. Decision of the Federal Court Trial Division |
[94]The appellant appealed to the Federal Court Trial Division.
The Trial Division Judge first determined that as there were no special
provisions in the Patent Act regarding biotechnology, it was
necessary to apply the ordinary tests of patentability. To be
patentable, the subject-matter must be an "invention" according to the
definition in section 2 of the Patent Act and must be new, useful and unobvious. In his opinion:70
There is no dispute here that the oncomouse is new, useful and
unobvious. The question is whether this is an "invention" to which the Patent Act . . . applies.
[95]He then considered a decision of the Supreme Court of the United States, Diamond v. Chakrabarty,71
in which, by a 5-4 majority, a bacterium which could break down crude
oil was found to be patentable. The five member majority found that the
proper question to be addressed was not whether the subject-matter of
the patent application was animate or inanimate, but rather, whether it
was made by a person as opposed to being something naturally occurring.
They found it was the product of human ingenuity and was patentable. The
four member dissenting minority held that the United States patent
system did not encompass living organisms. The learned Trial Division
Judge expressed his preference for the minority view.
[96]He then turned to the Canadian legislation and concluded
that the issue was whether claims 1 to 12 related to patentable
subject-matter according to the definition of "invention" in section 2
of the Patent Act. He considered four indicia in interpreting section 2.
[97]The first was the inventor's degree of control over the
creation of the invention. He found that a mouse was a complex life
form, in which none of the features except the presence of the oncogene
were under the control of the inventor. Although in his view it was not
necessary for the inventor to control all aspects of the natural process
leading to the creation of the end product, in this case, he found the
end product was completely unknown and unknowable. He concluded that
once the oncogene was introduced, everything else about the oncomouse
was independent of human intervention and that the inventors lacked
sufficient control over the oncomouse to meet the control requirement.
[98]The second issue was the distinction between human
intervention and the laws of nature in the creation of the oncomouse.
The learned Judge found that the creation of the oncomouse is a marriage
between nature and human intervention. While he found that oncomice do
not occur naturally, "[w]hat will result from the gestation process is
infinitely variable and, in its detail, unknown".72
[99]The third issue was reproducibility. The learned Judge found
that for an invention to be patentable, it must be reproducible. He
found that "although the gene will be present in some mice, at some
place, with some characteristics, the precise mouse, the precise
location, and the precise quality of the gene are unreproducible".73 He added that "[t]he variations of the gene are created and controlled completely by the laws of nature and are infinite".74 Because the oncomouse cannot be reproduced at will, except for the oncogene, the test for reproducibility had not been met.
[100]The fourth issue was whether a distinction was to be made
for patentability purposes between higher and lower life forms. In his
view, a complex life form was not patentable.
A complex life form does not fit within the current parameters .
. . without stretching the meaning of the words to the breaking point,
which I am not prepared to do.75
[101]As a final point, he expressed the view that to stretch the
definition of invention to include the oncomouse would not enhance the
protection already accorded the appellant by the patenting of claims 13
to 26.
[102]For all these reasons he dismissed the appeal.
[103]The learned Judge, in his reasons, did not address the
issue of the standard of review of the decision of the Patent
Commissioner. It appears that it was either not argued before him or
perhaps he thought it unnecessary to deal with the issue in view of his
conclusion to uphold the decision of the Patent Commissioner.
ANALYSIS
| (a) Object and purpose of the Patent Act |
[104]Some insight into the appropriate approach to interpreting the Patent Act may be derived from a consideration of the object and purpose of the legislation.
[105]A patent protects an invention. When a patent for an
invention is granted, the patentee is given the "exclusive right,
privilege and liberty of making, constructing and using the invention
and selling it to others to be used"76 for a period specified in the Patent Act:
17 years from the date on which the patent is issued for patent
applications filed before October 1, 1989, as in this case, or 20 years
from the date of the filing of a patent application filed on or after
October 1, 1989.77 The 17 or 20 year terms are intended to
enable the inventor to exploit the invention free from competition for
that period. The purpose is to permit the recovery of research and
development investment necessary to produce the invention and a return
on that investment to the inventor, commensurate with the value
purchasers place on the invention. The intention is to provide an
incentive for the creation of processes or products which are new,
useful and unobvious. Without patent protection, as soon as a product
implementing a new idea is marketed, others could copy it and compete
with the original inventor without having to have made the initial
research and development investment. Competitors who did not have to
cover such costs could drive prices down to such a level that the
original inventor could not recoup the research and development
investment made, let alone a return on that investment, thereby
discouraging the creation of inventions.78
[106]In return for the 17- or 20-year period of protection from
competition, the patentee is required to make full disclosure of the
invention. In its recent decision in Cadbury Schweppes Inc. v. FBI Foods Ltd.,79 the Supreme Court of Canada described the "bargain that lies at the heart of patent protection":
A patent is a statutory monopoly which is given in exchange for a
full and complete disclosure by the patentee of his or her invention . .
. . Accordingly, at least one of the policy objectives underlying the
statutory remedies available to a patent owner is to make disclosure
more attractive, and thus hasten the availability of useful knowledge in
the public sphere in the public interest.
Thus, the object of the Patent Act is to promote the development of inventions in a manner that benefits both the inventor and the public.
| (b) The requirement that an invention be new, useful and unobvious |
[107]An invention may be any new and useful process or product
or a new or useful improvement to a process or product. "Invention" is
defined in section 2 of the Patent Act:
2. In this Act, except as otherwise provided,
| "invention" means any new and
useful art, process, machine, manufacture or composition of matter, or
any new and useful improvement in any art, process, machine, manufacture
or composition of matter. |
[108]Under section 28.3 of the Patent Act the subject-matter of a patent claim must not have been obvious to persons skilled in the art or science. Section 28.380 provides:
28.3 The subject-matter defined by a claim in an
application for a patent in Canada must be subject-matter that would not
have been obvious on the claim date to a person skilled in the art or
science to which it pertains, having regard to
| (a)
information disclosed more than one year before the filing date by the
applicant, or by a person who obtained knowledge, directly or
indirectly, from the applicant in such a manner that the information
became available to the public in Canada or elsewhere; and |
| (b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere. |
The requirement that to be patentable, the subject-matter would
not have been obvious, was a common law principle affirmed by the
Supreme Court of Canada81 and applied in patent jurisprudence of this Court82
before the enactment of section 28.3 in 1993. It was said that
inventiveness or ingenuity, without which an advance was considered to
be obvious and therefore unpatentable, was implied in the term
"invention" in section 2.83
| (c) Non-discretionary nature of patentability decision |
[109]By reason of section 40 of the Patent Act, an
application for a patent is to be refused where it is determined that an
applicant is not, by law, entitled to be granted a patent. Section 40
states:
40. Whenever the Commissioner is satisfied that an
applicant is not by law entitled to be granted a patent, he shall refuse
the application and, by registered letter addressed to the applicant or
his registered agent, notify the applicant of the refusal and of the
ground or reason therefor.
The non-discretionary nature of the Commissioner's duty is highlighted in Monsanto Company v. Commissioner of Patents.84 At pages 1119-1120, after citing section 40 (then section 42) of the Patent Act, the majority judgment of Pigeon J. stated:
I have underlined by law [in section 42] to stress that
this is not a matter of discretion: the Commissioner has to justify any
refusal. As Duff C.J. said in Vanity Fair Silk Mills v. Commissioner of Patents,85 (at p. 246):
| No doubt
the Commissioner of Patents ought not to refuse an application for a
patent unless it is clearly without substantial foundation . . . . |
It is apparent that when a process or a product satisfies the requirements of the Patent Act, an application for a patent must be granted.
| (d) Policy considerations |
[110]There was considerable fanfare in this appeal that
significant policy questions are at stake. The evidence is that the
oncomouse has been patented in the United States and Europe. It is
arguable on policy grounds that there is merit to uniformity and that
Canada should follow suit. On the other side, there were arguments made
against patenting the oncomouse based on human health, environmental and
other concerns. However, all that is at issue in this appeal is the
interpretation of the Patent Act and the determination of
whether, on the basis of the evidence, the appellant's product is
patentable in accordance with that interpretation. It is the duty of the
Court to take the statute as it finds it, neither expanding its
interpretation beyond Parliament's intention as expressed by the
language in the statute, nor limiting that interpretation by reading
words of limitation into the statute not placed there by Parliament. To
the extent that the appeal gives rise to policy questions, they are to
be addressed by Parliament and not the Court.
| (e) Supreme Court observations on patentability of life forms |
[111]The Supreme Court of Canada has instructed that because the Patent Act
contains no provision relating to biotechnological inventions and new
forms of life in particular, the type of claims at issue here will only
be patentable if they are within the scope of existing legislation and
if they meet the traditional conditions and requirements for a patent.
At page 1642 of Pioneer Hi-Bred, supra, Lamer J. (as he then was), referring to the cross-breeding of soybean varieties, stated:
It is true that most countries give the producers of new plant
varieties special protection; even in Canada, several legislative
proposals for this purpose have appeared over the years. Though this
kind of legislation might act as a catalyst in the development of
scientific research in Canada, I consider that this Court does not
have the right to stretch the scope of patent protection beyond the
limits of existing legislation. Accordingly, since the Patent Act contains
no provisions relating directly to biotechnological inventions and new
forms of life in particular, this new soybean variety will only be
patentable if it meets the traditional conditions and requirements for a
patent. [Emphasis added.]
[112]The Supreme Court also has instructed that where the issue
is the patentability of a form of life involving new technology, a
cautious approach to the scope of pronouncements by the courts must be
adopted. At page 1632 of Pioneer Hi-Bred Lamer J. stated:
The real issue in this appeal is the patentability of a form of
life. This is in fact a claim for a new product developed in the field
of biotechnology, an area of activity taking in all types of techniques
having a common purpose, "the application of scientific and engineering
principles to the processing of materials by biological agents to
provide goods and services" . . . . This is regarded by many as the
latest technological system to be developed in the 20th century and the
harbinger of a new era, and we must therefore be very cautious regarding
the scope of our pronouncements. [Emphasis added.]
I do not take the words of Lamer J. to mean that the courts must adopt a restrictive approach to interpreting the Patent Act
whenever a living organism is at issue. Rather, when called upon to
make a legal determination in respect of living matter under the Patent Act, the courts must be particularly careful and mindful of the need for precision in their pronouncements.
| 2. Patentability of the oncomouse |
[113]The issue is whether claims 1 to 12 amount to an "invention" within the meaning of that term in section 2 of the Patent Act.
The learned Trial Division Judge found that the oncomouse was new,
useful and unobvious. There is no dispute on this appeal with respect to
these findings. Because the oncomouse is not "art" or a "process" or a
"machine", the controversy is only whether it may be considered to be a
"manufacture" or "composition of matter".
[114]I conclude that the oncomouse is both unobvious and a new
and useful "composition of matter". Therefore it is an "invention"
within the meaning of that term in section 2 of the Patent Act.
As I conclude that the oncomouse is a "composition of matter", it is not
necessary for me to consider whether it is also a "manufacture".
[115]In Chakrabarty, supra, in dealing with the term
"composition of matter" Chief Justice Burger, speaking for the five
member majority, stated at page 308:
. . . "composition of matter" has been construed consistent with
its common usage to include "all compositions of two or more substances
and . . . all composite articles, whether they be the results of
chemical union, or of mechanical mixture, or whether they be gases,
fluids, powders, or solids."
[116]Burger C.J. noted that the terms "manufacture" and
"composition of matter", as modified by the comprehensive "any" in the
definition of "invention" in the United States patent statute, were
expansive, and "Congress plainly contemplated that the patent laws would
be given wide scope".86 At page 316, the Chief Justice
observed that Congress employed broad general language because
inventions are often unforeseeable.
This is especially true in the field of patent law. A rule that
unanticipated inventions are without protection would conflict with the
core concept of the patent law that anticipation undermines
patentability . . . . Mr. Justice Douglas reminded that the inventions
most benefiting mankind are those that "push back the frontiers of
chemistry, physics, and the like." . . . Congress employed broad general
language in drafting § 101 precisely because such inventions are often
unforeseeable. [Citations omitted.]
The majority's approach is clear. The language of patent law is
broad and general and is to be given wide scope because inventions are,
necessarily, unanticipated and unforeseeable.
[117]I find this reasoning persuasive. I see no reason why it
would not be applicable in interpreting the definition of "invention" in
section 2 of the Patent Act. Parliament has used the same broad
and general language as the United States Congress. The Court must
respect Parliament's use of such language and not adopt a narrow
approach that would conflict with Parliament's obvious intention.
[118]In this case, the question is whether the oncomouse is a
"composition of matter". What is an "oncomouse" for the purposes of the
analysis is to be understood by reference to patent claim 1. It includes
both the founder oncomouse, which has had the oncogene introduced at
its zygote stage, and subsequent generations of offspring oncomice which
will have inherited the oncogene from a parent.
[119]Using the definition applied in Chakrabarty, I am of the view that the oncomouse is a "composition of matter".
[120]The process here involves injecting a plasmid containing
the oncogene into a fertilized mouse egg. The oncogene is comprised of
DNA. Kreuzer and Massey87 define DNA as:
. . . (deoxyribonucleic acid) The chemical molecule that
is the basic genetic material found in all cells . . . DNA belongs to a
class of biological molecules called nucleic acids.
DNA is a physical substance and is therefore matter. The
fertilized mouse egg is a form of biological matter. The combination of
these two forms of matter by the process described in the specification
is thus a "composition of matter". This conclusion is consistent with
the Patent Commissioner's finding that the "transgenic unicellular
material" (the oncogene injected fertilized mouse egg) was a
"manufacture" or a "composition of matter".88
[121]What the Commissioner described as "transgenic unicellular
material" is transferred to a host mouse and is allowed to develop to
term. The resulting founder oncomouse is the product of that
"composition of matter". The genetic alteration which has been performed
at the single cell stage is permanent and is reproduced in all cells of
the oncomouse. Although the natural gestation process is required to
allow the fertilized mouse egg to develop, this does not mean the
organism ceases to become a "composition of matter" as it develops from
the single-cell stage into an oncomouse. The founder oncomouse is
therefore itself a composition of matter.
[122]Similarly, offspring oncomice are the product, in
accordance with the Mendelian inheritance ratio of single loci, of the
mating of a male mouse and a female mouse, one of which is an oncomouse.
One might argue this simply involves the natural processes of mouse
reproduction. However, such a view ignores the fact that an offspring
oncomouse has the artificial oncogene sequence by virtue of its
introduction into the genome of the initial founder oncomouse. The
offspring oncomouse has a particular genetic trait which would not occur
in nature. Offspring oncomice are therefore linked to the transgenic
unicellular material which was found to be a composition of matter by
the Patent Commissioner. Once that is recognized, it follows that an
offspring oncomouse is a "composition of matter", notwithstanding the
fact it possesses the oncogene through genetic inheritance, as opposed
to through the initial injection process.
[123]While what is at issue are living organisms and in
particular higher life forms, i.e. non-human mammals, nothing in the
term "composition of matter" suggests that living things are excluded
from the definition. Indeed, in the Federal Court of Appeal decision in Pioneer Hi-Bred, supra, Marceau J.A. stated at page 12:
I am prepared to accept that the Canadian patent legislation
does not support the assumption that life forms are definitely not
patentable.
At the Supreme Court of Canada in Pioneer Hi-Bred, Lamer
J., at page 1627 noted that Marceau J.A. was of the opinion that
Canadian patent legislation did not expressly exclude living organisms
from patentability and did not take exception with this view. In fact,
at page 1643, Lamer J. observed that the Patent Act contains no
provision relating to new forms of life and therefore a new soybean
variety in that case would only be patentable if it met the traditional
conditions and requirements for a patent. It is apparent that Lamer J.
was not excluding life forms from patentability. In Abitibi, supra,
the Patent Commissioner found that microbial cultures and other lower
life forms could constitute inventions for purposes of the Patent Act. Abitibi was cited before the Supreme Court of Canada in Pioneer Hi-Bred and there was no disapproval expressed of that finding. For these reasons, I am satisfied that the Patent Act does not exclude living organisms, i.e. non-human mammals, from the definition of "invention".
[124]That is not to say that the term "composition of matter"
has no limits. In both Canada and the United States, natural phenomena,
scientific principles and abstract theorems are not patentable. In
Canada, subsection 27(8) [as am. by S.C. 1993, c. 15, s. 31] of the Patent Act excludes scientific principles and abstract theorems from patentability.
27. . . .
(8) No patent shall be granted for any mere scientific principle or abstract theorem.
[125]In Chakrabarty, Burger C.J. stated at pages 303-304:
This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena and abstract ideas have been held not patentable . . . .
Thus, a new mineral discovered in the earth or a new plant found in the
wild is not patentable subject matter. Likewise, Einstein could not
patent his celebrated law that E=mc2; nor could Newton have
patented the law of gravity. Such discoveries are "manifestations of . .
. nature, free to all men and reserved exclusively to none . . . ."
Judged in this light, respondent's micro-organism plainly qualifies as patentable subject-matter. His
claim is not to a hitherto unknown natural phenomenon, but to a
nonnaturally occurring manufacture or composition of matter--a product
of human ingenuity "having a distinctive name, character [and] use. [Citations omitted; underlining added.]
In Pioneer Hi-Bred, Lamer J. expressed a similar view in the following words at page 1634:
The intervention made by Hi-Bred does not in any way appear to
alter the soybean reproductive process, which occurs in accordance with
the laws of nature. Earlier decisions have never allowed such a method
to be the basis for a patent. The courts have regarded creations
following the laws of nature as being mere discoveries the existence of
which man has simply uncovered without thereby being able to claim he
has invented them. [Emphasis added.]
[126]The definition of "invention" in the Patent Act does
not expressly exclude discoveries that follow the laws of nature. It
would thus appear that the reason creations or discoveries that only
follow the laws of nature do not meet the requirements of patentability
is because they are not considered new and unobvious. Rather, such
creations or discoveries are considered to have existed and only to have
been uncovered by man. Something more is required for patentability,
namely, a non-naturally occurring "composition of matter" arising from
the application of inventiveness or ingenuity.
[127]The question then is whether the oncomouse is merely a
discovery of a natural phenomenon or involves the application of
inventive ingenuity. What is sought to be patented is a mouse with a
genetic structure different from what it would have been without human
intervention at the genetic level. The learned Trial Division Judge
found that the oncomouse was new and accepted that "Oncomice do not
occur naturally".89 Such findings, which are not in dispute
on this appeal and which I accept, are sufficient to satisfy the test
that the oncomouse is not merely the product of the laws of nature and
is therefore patentable.
[128]Further support for this view is found in the decision of
the Patent Examiner which determined that claims 13 to 26 were
patentable. The oncomouse is the creation of the process described in
claims 14 and 15. Claims 14 and 15 provide:
| 14. A method of producing a transgenic cell culture comprising: |
|
a) introducing
an activated oncogene sequence into pluripotent cells of a mammalian
embryo; |
|
b) allowing
said embryo to develop into an adult animal; and, |
| c) culturing somatic cells of said animal.90 |
| 15. A
method of producing a transgenic mammal having an increased probability
of developing neoplasms, said method comprising introducing into a
mammal embryo an activated oncogene sequence. |
If the process for producing the product is patentable, it is
because it must be considered to involve ingenuity and not merely the
discovery of the operation of a law of nature or the existence of a
naturally occurring phenomenon. It must logically follow that the
product of that process must also be considered to involve that same
ingenuity and be patentable.
[129]In my opinion, the oncomouse must be considered to be the
result of both ingenuity and the laws of nature--ingenuity in the
initial genetic engineering involving the assembly of the oncogene,
incorporating it into the plasmid and injecting the plasmid into the
zygote; and the laws of nature, with the oncogene then affecting all the
cells of the oncomouse in the course of gestation, the subsequent
mating of an oncomouse and an uninjected mouse, and the reliance on
Mendelian laws of inheritance to obtain offspring oncomice. However, the
use of the laws of nature by inventors does not disqualify a product
from being an invention, provided inventiveness or ingenuity is also
involved. As Professor Vaver has explained:
Patents can, of course, be granted for a new practical
application of the theory of gravity--for example, on an improved
gravity pump.91
[130]Indeed, substantially more is involved here than merely the
operation of the laws of nature. By definition, transgenic organisms
come into being through human manipulation at the genetic or molecular
level. The New Oxford Dictionary of English defines "transgenic" as:
. . . of, relating to, or denoting an organism that contains
genetic material into which DNA from an unrelated organism has been
artificially introduced.
In this case, we are dealing with a transgenic mouse, all of
whose cells contain a foreign oncogene which was assembled and
artificially incorporated into the genome of the mouse as a result of
human intervention. The genetic material which has been introduced is
itself an artificial composition. Thus, the ingenuity in this case
relates not only to the introduction of genetic material into the mouse
by artificial means, but extends to the makeup of the critical oncogene
itself.
[131]While one might argue that nature already produces some
mice with a genetic predisposition to develop cancer, it would be wrong
to say that the appellant has simply "discovered" or merely "recreated"
something which naturally occurs (or might naturally occur). When trying
to objectively determine whether the creation of the oncomouse involves
human ingenuity or only the laws of nature, this Court ought not equate
the reason why the oncomouse is useful, i.e. its predisposition to
develop cancer, with what has actually been produced. The question is
not whether cancer prone mice exist in nature. Rather, the question is
whether the oncomouse described in the patent claims would exist in
nature. Clearly it would not.
[132]It is true that the laws of nature must be employed in the
gestation of the oncogene injected zygote in the uterus of the host
mouse and the resulting production of a founder mouse and the subsequent
mating of the founder mouse to produce offspring mice affected with the
oncogene. If only the laws of nature were involved, the
oncomouse would not be patentable. However, here, the product is the
result of both human ingenuity at the genetic level and the laws of
nature.
[133]Having regard to section 40 of the Patent Act, supra,
on a straightforward interpretation of the term "composition of matter"
and taking into account the roles of ingenuity and the laws of nature,
there is no reason in law why the product, in this case the oncomouse,
is not patentable.
| 3. Errors in the reasoning in the decisions below |
[134]I now explain, with reference to their reasons, why I
differ with the reasoning and conclusions of the Patent Commissioner and
the learned Trial Division Judge.
| (a) Reliance on the majority decision in Chakrabarty |
[135]There is no authoritative Canadian jurisprudential
interpretation of the term "composition of matter" as it appears in the
definition of "invention" in the Patent Act. In the Supreme Court decision in Electric Fireproofing Co. of Canada v. Electric Fireproofing Co.,92 Idington J. adopted the position of the Court below93
in stating that "the composition need not be a chemical, but may be a
mechanical one". However, a statement to the effect that a "composition
of matter" may be either the result of a chemical reaction which
produces a new chemical compound, or a mere mechanical mixture of
substances, does not advance the analysis very far in determining the
scope of the term "composition of matter".
[136]In coming to my conclusion, I have placed considerable
reliance on the majority opinion of the United States Supreme Court in Chakrabarty
and, in doing so, differ from the approach of both the Patent
Commissioner and the learned Trial Division Judge. The Commissioner was
of the view that not much weight should be accorded to the practice of
the United States Patent and Trademark Office to not refuse to grant
patents for non-human multicellular living organisms, including animals.94 As the Patent and Trademark Office granted a patent for transgenic non-human mammals on April 12, 1988 on the authority of Chakrabarty,
inferentially the Patent Commissioner was not according much weight to
the interpretation of the definition of "invention" by the Supreme Court
of the United States in that case. The Commissioner did not cite
authority for this view. However, there would seem to be some support
for it in the older jurisprudence. In Rice v. Christiani,95 Lord Tomlin stated:
It may be true that the framers of the earlier Canadian statutes
relating to patents looked for a model towards the American law rather
than towards the English law, but there are marked differences between
the American and Canadian statutes, and an examination of the
development of American patent law is not of assistance in construing
the language of the statute now under consideration.
At page 6 of his text,96 Mr. Fox observes that the
origin of patent law is grounded in the common law of England and
specifically the royal prerogative to grant monopolies for new
inventions that dates back hundreds of years. Accordingly, the law of
the United Kingdom is often accepted as authoritative in interpreting
Canadian patent law.
[137]However, it is doubtful that UK decisions are helpful for
the specific purpose of construing the definition of "invention" in the
Canadian Patent Act. The view had been expressed97
that the terms in the definition of "invention" in the Canadian statute
should be interpreted co-extensively with the terminology ("any manner
of manufacture") used in the British Patents Act.98 After canvassing a number of English cases, Professor Fox stated at pages 19-20 of his text:
An examination of these decisions will demonstrate that included within the word "manufacture" [in the context of the U.K. Patents Act]
are arts, machines, manufactures, compositions of matter, and
processes, and that, as early as 1835, the word "manufacture" was taken
to be almost synonymous with invention. It may, therefore, be accepted
in principle that the requirements with regard to subject-matter are
co-extensive under the British and Canadian statutes, and that the
jurisprudence established on this point by the courts of the United
Kingdom is authoritative in this country. [Citations omitted.]
[138]This approach has been questioned by the Supreme Court of Canada. In Tennessee Eastman Co. et al. v. Commissioner of Patents,99 Pigeon J. stated for the Court that:
. . . I would first observe that I doubt whether decisions
dealing with the patentability of inventions under the U.K. Act are
entitled in Canada to the weight which authors such as Fox (Canadian
Patent Law and Practice, 4th ed. p. 19) seem to think they should have.
There are substantial differences between the British and Canadian
statutes which need not be enumerated.
[139]However, the Canadian Patent Act, first enacted in
1869, was modelled on the United States patent statute of 1836. In their
material aspects, the respective definitions of "invention" continue to
be almost identical. For comparison purposes, I repeat section 2 of the
Canadian Patent Act:
2. In this Act, except as otherwise provided,
| "invention" means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter. [Emphasis added.] |
The United States patent statute100 provides:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter,
or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.
[Emphasis added.]
Where Canadian and U.S. statutory provisions are similar, Mr.
Fox indicates that United States decisions are "treated with respect"
but do not operate as stare decisis.101
. . . that United States decisions are accepted only on very
particular points where the relevant statutes make similar provision.
They are treated with respect, as is proper, but they do not operate as stare decisis or constitute an estoppel. [Citations omitted.]
[140]I agree with Mr. Fox that while United States patent
decisions are obviously not binding on Canadian courts, where the
statutory language which is being interpreted is similar in both
countries and where the reasoning underlying the United States Court's
interpretation of the language is persuasive, there is no reason why
Canadian courts should ignore the U.S. jurisprudence.
[141]In Chakrabarty, supra, the issue was whether
human-made micro-organisms were patentable. The inventors had discovered
a process by which four different plasmids capable of degrading four
different oil components could be transferred and maintained stably in a
single pseudomonas bacterium which itself had no capacity for degrading
oil. The majority of the Court:
(1) approached the matter bearing in mind the
principle that the Court should not read into patent laws, limitations
and conditions which the legislature has not expressed;
(2) construed the terms "manufacture" and
"composition of matter" broadly in view of the expansiveness of these
terms particularly as modified by the comprehensive "any"; and
(3) recognized that laws of nature, physical phenomena and abstract ideas had been held to be nonpatentable.
Having regard to these principles, the majority found that the
inventors had produced a new bacterium which, with markedly different
characteristics from any found in nature and having significant utility,
was patentable.
[142]I see no reason why the analysis of the United States
Supreme Court does not provide useful guidance for the purposes of
construing the same words in Canadian Patent Act. Canadian courts
must not read into legislation conditions and limitations not expressed
by Parliament. The broad language of the definition reflects the fact
that inventions are unforeseeable. As Burger C.J. pointed out, in the
field of patent law, the statute cannot be confined to the particular
applications contemplated when the legislation was enacted.102
A rule that unanticipated inventions are without protection
would conflict with the core concept of the patent law that anticipation
undermines patentability.
The same principle is applicable to Canadian patent law.
[143]In Canada, the products of the operation of the laws of
nature are not patentable and it will only be creations that also
involve ingenuity that will be.
[144]For these reasons, I disagree with the Patent Commissioner's inference that the Chakrabarty
case deserves not much weight. I agree with the learned Trial Division
Judge that the case is relevant and helpful. However, with respect to
the learned Trial Division Judge, for the reasons that follow, I think
that the majority view in Chakrabarty is to be preferred over that of the minority to which he subscribed.
[145]In coming to the conclusion that United States patent law
did not cover living organisms, the minority observed that where there
is an absence of legislative direction [at page 319]:
. . . the courts should leave to Congress the decisions whether
and how far to extend the patent privilege into areas where the common
understanding has been that patents are not available [i.e. to cover
living organisms].103
On this fundamental issue of whether there is a "common
understanding" that patent legislation does not extend to living
organisms, I do not find the minority view compelling. I have difficulty
reconciling the proposition that there is a "common understanding" that
patents are not available to cover living organisms with the object and
purpose of patent legislation--to promote inventions. The "common
understanding" cannot mean that there are limitations on the areas of
research and innovation that may result in patentable inventions. Here, I
think the logic of the majority is more persuasive, that the
distinction as to what is and is not patentable is not between animate
and inanimate things, but between discoveries resulting from the laws of
nature, whether living or not, and human made inventions.104
[146]In Canada, there is no "common understanding" that patent
law does not extend to living organisms. As I have already noted, the
decision of the Patent Commissioner to grant a patent to cover yeast,
moulds and other lower life forms in the Abitibi patent application in 1982 suggests the opposite.105 And in Pioneer Hi-Bred, the Supreme Court of Canada has accepted that the Canadian Patent Act does not necessarily exclude living things from patent protection.106
[147]I am, therefore, of the view that the majority opinion of the United States Supreme Court in Chakrabarty provides useful guidance in interpreting the definition of "invention" in the Canadian Patent Act,
and in the preceding analysis (paragraphs 113 to 125), I have placed
significant reliance on it in concluding that the definition of
"invention" does not exclude from patentability, higher life forms such
as the oncomouse.
[148]A major reason why the Commissioner of Patents refused to
grant a patent for claims 1 to 12 was that the inventors did not have
full control over all characteristics of the resulting oncomouse. At
page 7 of his decision, he stated:
The inventors do not have full control over all the
characteristics of the resulting mouse since the intervention of man
ensures that reproducibility extends only as far as the cancer forming
gene.
The learned Trial Division Judge agreed with this conclusion.
While he allowed that not all characteristics need be under the direct
control of the inventor, he was of the view that an element of control
was essential and that, apart from the presence of the transgene:
. . . everything else about the mouse is present completely independently of human intervention.107
[149]Counsel before us did not indicate the source of the
control test as a requirement for patentability. No prior Federal Court
or Supreme Court of Canada jurisprudence was cited on this point.
[150]However, there is reference in the Canadian Patent Office Manual of Patent Office Practice to a control test.
In assessing whether subject matter falls within the meaning of
the definition of a patentable invention under Section 2 of the Patent
Act, the prerequisites established by Canadian jurisprudence and
legislation that must be satisfied are, inter alia:
. . .
| (b) whether
the subject matter is operable, controllable and reproducible by the
means described by the inventor so that the desired result inevitably
follows whenever it is worked. |
The reference in the Manual appears to be based upon a line of Patent Appeal Board decisions108
which applied "control" and "reproducibility" tests to establish
whether something claimed as an "art or process" was "useful" as
required by the definition of "invention" in section 2 of the Patent Act. The words in the Patent Office Manual appear to be taken from the Patent Appeal Board decision in Organon, at pages 257-258:
The other factor to be decided is whether the "art" in terms
of the present process satisfies the prerequisites of being a "useful"
art or process within the meaning of s. 2(d), which may be conveniently stated, inter alia,
as to: whether the subject-matter is useful in a "manual or productive
art" (as distinct from a fine art such as that in which novelty is
solely the exercise of professional skills, or that having intellectual
meaning or aesthetic appeal alone), whether the subject-matter is
controllable and reproducible by the means disclosed so that the desired
result inevitably follows whenever it is worked, and whether the
subject-matter has utility in practical affairs (as that in relation to
trade, commerce or industry) which is beneficial to the public.
[Emphasis added.]
[151]From the Organon decision it is apparent that the
control (and reproducibility) test is considered to be implicit in the
statutory requirement that an "invention" be "useful". In Organon,
the Patent Appeal Board spoke of an art or process being "useful" as
distinct from a "fine art" having "intellectual meaning or aesthetic
appeal alone".
[152]I agree with the Patent Appeal Board in Organon that control is implied in the requirement that an invention be useful. However, the words in the Organon
decision apply only to art or a process and not a product. I am
prepared to accept, without deciding, that the control test set out in Organon
is also applicable to products. It follows that if there is
insufficient control over a product such that it would not be
practically useful, the usefulness requirement of the definition of
"invention" would not be met.
[153]However, in this case, the Patent Commissioner and the
learned Trial Division Judge applied a far broader control test, not
implied by the usefulness requirement for an invention. In doing so, I
am of the respectful view that they read into the definition of
"invention" words not expressed by Parliament, or implied by the
language used by Parliament, and in doing so, clearly erred in law.
[154]The learned Trial Division Judge accepted that the presence
of the oncogene in the oncomouse was under the control of the
inventors. His concern was that the "myriad" of other characteristics of
the mouse were not under their control. As he pointed out:
. . . it may be that there is a logical place at which one can
draw a line and say definitively that a certain percentage of
characteristics must be controlled before one can claim the entire life
form as an invention. However, that line was not shown to me in the
present case and the complexities of the issue make it unlikely that the
Court is the forum in which to decide where the line should be drawn.109
I think his comments demonstrate that once a control test is
extended beyond what is necessarily implied by the statutory language,
i.e. control in the context of usefulness, trying to decide how much and
what type of control is sufficient introduces virtually imponderable
considerations. There is no doubt that the inventors do not have, or
claim to have, control over the length of the oncomouse's tail, the
colour of its eyes or the texture of its fur. The difficulty with a
broad control test is that nothing in the Patent Act or in the
common law jurisprudence provides any guideline or methodology that
might provide any clue as to what degree or type of control would be
"sufficient".
[155]The point is that control over the length of a tail, colour
of eyes or texture of fur is irrelevant to the usefulness of the
invention. No reason has been disclosed which would explain why, in the
abstract, some degree or type of control of features not necessary for
usefulness is a requirement for patentability. I do not see it as
relevant that the myriad of other characteristics which are influenced
by the genetic makeup of the oncomouse are not under the control of the
inventors. All that is important for the usefulness of the product (the
use of the oncomouse in carcinogenicity studies) is that, using the
methods described by the inventors, a mouse is produced with all of its
cells affected by the oncogene. That the other genes of the mouse are
not under the control of the inventors does not detract from the
usefulness of the invention.
[156]The learned Trial Division Judge recognized that the
genetic makeup of the oncomouse, except for the presence of the
oncogene, was irrelevant for purposes of the invention. However, he
concluded that everything except the presence of the oncogene was
independent of human intervention, and the control test was, therefore,
not met. With respect, I am of the opinion that the learned Judge erred
in imposing a control test in respect of characteristics of the
oncomouse that were irrelevant to establishing that it was useful.
[157]As indicated in note 64, in the "Production of Transgenic
Mice" section of the patent application, the inventors disclosed that of
28 mice analyzed, 2 males (7%) were found to have retained the oncogene
and both subsequently transmitted the oncogene sequence through the
germ line in a ratio consistent with the Mendelian inheritance of single
loci, i.e. 50%. The Patent Commissioner and the learned Trial Division
Judge did not base their lack of sufficient control conclusion on the
relatively low percentage of founder mice derived from the process
described by the inventors. In my view, they were correct in not doing
so for two reasons. The first is that the process was found to be
patentable by the Patent Examiner and this finding was not challenged.
The second is that a low rate of founder oncomice production is not
evidence that the inventors do not have control over the process or the
product. The reason for the low percentage is not explained, although
the record indicates that after the filing of the patent application,
"many transgenic animals within the claims have successfully been made".110
As long as the process produces some founder oncomice and offspring
oncomice in accordance with Mendelian inheritance, a useful product has
been created. The relevant control test is therefore satisfied.
[158]In sum, usefulness is necessary for patentability and
implies control in the sense that the desired result will be achieved
when the product is used or produced. That desired result in this case
is an oncomouse with susceptibility to cancer for use in carcinogenicity
studies. Once that has been achieved, control over other
characteristics of the mouse is not necessary or relevant. Such
"additional" control has nothing to do with the desired result. If the
product is a composition of matter that is new, useful and unobvious, it
is a patentable "invention". These conditions have been met in this
case.
[159]In his reasons, the learned Trial Division Judge found that "for an invention to be patentable, it must be reproducible".111
In his view (and in the view of the Patent Commissioner) the oncomouse
was not reproducible. The Patent Commissioner did not cite authority for
his reference to reproducibility. The learned Trial Division Judge
referred to paragraph 27(3)(b) [as am. by S.C. 1993, c. 15, s. 31] of the Patent Act as authority for the reproducibility requirement.
[160]Paragraph 27(3)(b) provides:
27. . . .
(3) The specification of an invention must
. . .
| (b)
set out clearly the various steps in a process, or the method of
constructing, making, compounding or using a machine, manufacture or
composition of matter, in such full, clear, concise and exact terms as
to enable any person skilled in the art or science to which it pertains,
or with which it is most closely connected, to make, construct,
compound or use it; |
[161]As I read paragraph 27(3)(b), it requires the
specification of an invention to set out clearly the steps of the
process or the method of compounding or using a composition of matter in
such terms as to enable a person skilled in the science to compound or
use it.
[162]Compliance with paragraph 27(3)(b) is not a
condition precedent to an invention. The provision is only concerned
with sufficiency of disclosure by the inventor. Provided disclosure is
sufficient to enable another person skilled in the science to make and
use the product, its requirements have been met.112
[163]There is no dispute here that the specification contained sufficient disclosure to comply with paragraph 27(3)(b).
Indeed, claims 13 to 26 were found to be patentable and it is therefore
implicit that there has been compliance with paragraph 27(3)(b). If the process claims are not disqualified by reason of paragraph 27(3)(b), it follows that neither should the product claims that derive from the patentable process claims.
[164]The discussion of reproducibility in the reasons of the
learned Trial Division Judge appear to relate closely to the issue of
control which I have already addressed. Indeed, the reproducibility test
also appears to originate from the Organon decision which
asserts both control and reproducibility tests in the context of the
usefulness requirement for an art or process (and arguably a product) to
be an invention. By using the methods described in the specification of
the patent application, an oncomouse is producible with all of its
cells affected by the oncogene. Such a mouse is reproducible and is
useful. The fact that other characteristics of the oncomouse are not
reproducible at will by the inventor or person skilled in the science is
irrelevant because they are not necessary for the usefulness of the
oncomouse.
[165]Other than the requirement for sufficient disclosure of an invention in paragraph 27(3)(b), about which there is no dispute on this appeal, I see nothing in the Patent Act
pertaining to a reproducibility requirement which the inventors can be
said to have failed to meet. The reproducibility requirement derived
from Organon, supra, in the context of usefulness, has been satisfied in this case.
| (d) Splitting the process in phases |
[166]The Patent Commissioner split what the inventors did into
two phases. Phase one, engineering the plasmid and the transgenic
unicellular material, involved human intervention and was found to be
patentable. Phase two, developing a genetically engineered oncomouse in
the uterus of a host mouse was found not to be patentable. The learned
Trial Division Judge accepted that distinction.
[167]With respect, I am unable to agree with the Commissioner's
distinction. The Trial Division Judge correctly accepted that most
inventions involve the use of some of the laws of nature. It seems to me
that once this is conceded, there can be no valid basis for splitting
an invention between the portion that is the result of inventive
ingenuity and the portion that is not. I agree that one could view the
creation of the oncomouse as involving two phases (or perhaps more).
However, this does not justify splitting them. The oncomouse is the
product of both. If the laws of nature may be employed together with
human ingenuity in developing an invention, it should not matter whether
the laws of nature are employed at the beginning, during or at the end
of the process or whether the steps of the process can or cannot easily
be separated into phases.
[168]Splitting what the inventors did into phases also results in a curious inconsistency in this case. Claim 25 provides:
A somatic cell culture derived from a transgenic mammal wherein
the cells of said cell culture contain an activated oncogene sequence
integrated into a chromosome.
Claim 25 was found to be patentable. However, the somatic cell
culture is only derived once a transgenic mammal has been brought into
existence. It has not been explained why the somatic cell culture would
be considered patentable when the transgenic mammal from which it is
derived is not. What we are left with from the phasing approach is the
patentability of the somatic cell culture derived from a non-patentable
transgenic mammal which in turn is derived from patentable transgenic
unicellular material. I think the discontinuity that has occurred here
points out the incongruous results from an approach which provides for
the splitting into phases of what the inventors have done.
[169]In my respectful view, splitting the invention into phases
was not legally justified. It denied to the inventors a patent on a
product which was the result of a combination of inventive ingenuity and
the laws of nature both of which were central to the invention.
| (e) Lower and higher life forms |
[170]The learned Trial Division Judge found that a complex life
form such as the oncomouse does not fit within the current parameters of
the Patent Act. Contrary to the decision of the Patent Appeal Board in Abitibi,
the learned Judge was of the view that a distinction between the
patentability of lower and higher life forms was appropriate on the
grounds of policy. In coming to this conclusion, he also relied on the
minority opinion in Chakrabarty that life forms were not patentable at all.
[171]As has already been pointed out, the majority of the United
States Supreme Court had found that there was no limitation in the
United States patent statute against patenting living organisms. Having
so found, Burger C.J. for the majority observed at page 317 that policy
concerns that might justify a limitation on patenting life forms were
not matters for the courts.
What is more important is that we are without competence to
entertain these arguments--either to brush them aside as fantasies
generated by fear of the unknown, or to act on them. The choice we are
urged to make is a matter of high policy for resolution within the
legislative process after the kind of investigation, examination, and
study that legislative bodies can provide and courts cannot. That
process involves the balancing of competing values and interests, which
in our democratic system is the business of elected representatives.
Whatever their validity, the contentions now pressed on us should be
addressed to the political branches of the Government, the Congress and
the Executive, and not to the courts.
[172]I agree. It is not up to the Court, for policy reasons, to
place limits on the scope of legislation not supported by the words.
That is the role of the legislative branch of Government. In Abitibi,
lower living organisms such as yeast, were found to be patentable.
There may be policy reasons against the patentability of higher life
forms (or lower life forms for that matter). However, such arguments are
for Parliament and not the courts. For the reasons already given, the
words of the definition of "invention" in the Patent Act do not
exclude living organisms and the Court may not impose such a limitation
on policy grounds. I must conclude that the learned Trial Division Judge
erred in finding that complex life forms were not within the parameters
of the Patent Act.
| (f) Protection afforded by patenting the oncomouse |
[173]The learned Trial Division Judge concluded that to patent
the oncomouse would provide the inventor with no additional protection
beyond that provided by patenting claims 13 to 26. Again, I must
respectfully disagree. If patent protection ends there, the inventors
have no practical patent protection over the product of their ingenuity.
As was stated by William L. Hayhurst, Q.C.:113
Some patents for processes may be of little practical value. To
discover that a competitor is carrying out the process may be difficult.
If a process produces a living organism that reproduces itself, the
process may have to be carried out only once: competitors who are able
to get their hands on the organism need not repeat the process of
producing it. What is needed is a patent on the organism . . . .
Anyone can purchase a founder mouse or offspring having the
oncogene in its cells, and breed it. While the inventors or their
assignees or licensees might impose a condition on the sale of an
oncomouse that it not be bred, such a contractual condition is only
effective against the purchaser. A patent provides legal protection
against the world, that is, others who might come into possession of an
oncomouse and reproduce it. In contrast to the protection afforded by a
patent, Professor Vaver has pointed out weaknesses in the common law
alternatives:
. . . common law protection is volatile. It can disappear
despite the owner's best efforts. Someone may learn of the secret
independently or may reverse-engineer it or the product that contains
it; innocent buyers from an industrial spy may profit from their
purchase and can end up destroying its value as a trade secret by
publicizing it. Departing employees can also use information that has
become part of their general skills and knowledge.114
In my opinion, the patentability of the oncomouse does provide
protection not provided by the patenting of claims 13 to 26, or by
non-statutory alternatives such as the law of contract.
[174]Certain comments of Marceau J.A. in Pioneer Hi-Bred
appear to have had significant influence on the findings of the Patent
Commissioner and the Trial Division Judge. These comments are found at
pages 13-14 [supra, note 67] of the Federal Court of Appeal judgment in Pioneer Hi-Bred:
I have not been convinced. Even if those definitions [definitions of "manufacture" and "composition of matter" taken from Chakrabarty]
were held to be applicable to a micro-organism obtained as a result of a
laboratory process, I am unable to go further and accept that they can
also adapt to a plant variety produced by cross-breeding. Such a plant
cannot really be said, other than on the most metaphorical level, to
have been produced from raw materials or to be a combination of two or
more substances united by chemical or mechanical means. It seems to me
that the common ordinary meaning of the words "manufacture" and
"composition of matter" would be distorted if a unique but simple
variety of soybean were to be included within their scope.
. . .
In sum, relying both on the common meaning of the words of the
definition for "invention" as it appears in the Act and on the
legislative context in which they are found, insofar as the intention of
Parliament may be derived therefrom, I am satisfied that the soybean
variety developed by the appellant cannot be the subject matter of a
patent of invention.
[175]What was at issue in Pioneer Hi-Bred was the cross-breeding of soybeans. There was no human intervention at the molecular or genetic level as in the case at bar.
[176]In the present case, there has been a sophisticated genetic
alteration performed. This is quite different from cross-breeding
plants as in Pioneer Hi-Bred and constitutes what Lamer J. noted
in the Supreme Court decision was the "second type" of genetic
engineering. At page 1633 he stated:
This procedure [cross-breeding of plants] differs from the
second type of genetic engineering, which requires a change in the
genetic material--an alteration of the genetic code affecting all the
hereditary material--since in the latter case the intervention occurs
inside the gene itself. The change made is thus a molecular one and the
"new" gene is thus ultimately the result of a chemical reaction, which
will in due course lead to a change in the trait controlled by the gene.
While the first method implies an evolution based strictly on heredity
and Mendelian principles, the second also employs a sharp and permanent
alteration of hereditary traits by a change in the quality of the genes.
In this second type of genetic engineering that is involved in
the case at bar, there is intervention at the genetic level and a sharp
and permanent alteration of an hereditary trait by insertion of a
non-naturally occurring activated oncogene sequence into the fertilized
mouse egg and its presence in all the cells of the oncomouse. A mouse
zygote is altered in this case by implanting a specific non-naturally
occurring activated oncogene sequence with a known function into it,
thus producing a specific life form that did not exist in nature.
[177]Indeed, the Patent Examiner, in allowing a patent for
claims 14 and 15, found that the process for the production of the
oncomouse was patentable and no objection was taken to this
determination on the basis of the comments of Marceau J.A. in Pioneer Hi-Bred
by the Patent Commissioner or the learned Trial Division Judge. If the
process for the production of the oncomouse was not disqualified from
patentability on this ground, it follows that the oncomouse itself
cannot be disqualified.
[178]The findings of Marceau J.A. in Pioneer Hi-Bred with
respect to cross-breeding of soybeans are not applicable to the case at
bar which involves inventive ingenuity and intervention at the genetic
level and the creation of a specific new life form.
STANDARD OF REVIEW
[179]The dissenting reasons of Isaac J.A. appear to be largely
based on deferring to the decision of the Patent Commissioner by
application of the reasonableness simpliciter standard of review.
[180]There is no question that the decision of the Trial
Division Judge, which was the subject of this appeal, is reviewable on a
correctness standard. None of the indicia, e.g. expertise, privative clauses, which would suggest a more deferential standard of review is applicable.
[181]On the other hand, the decision of the Patent Commissioner
may be entitled to some deference. I say "may" because the issue of
standard of review was not dealt with by the Trial Division Judge, nor
was it raised by the respondent on this appeal and we have not had the
benefit of prior consideration or argument on it.
[182]There is no privative clause in respect of decisions of the
Patent Commissioner. Rather, there is a statutory right of appeal from
the decision of the Patent Commissioner to the Federal Court Trial
Division.115 The issue involves the interpretation of the Patent Act.
The issue is a fundamental one and in respect of which a decision will
have important precedential value--whether higher life forms come within
the definition of "invention" in the Patent Act. In Pioneer Hi-Bred, supra,
the Supreme Court of Canada did not suggest there was any deference
owed to the Patent Commissioner on the interpretation of the definition
of "invention" in the Patent Act. These considerations suggest a higher standard of scrutiny of the Patent Commissioner's decision in this case.
[183]On the other hand, there is no doubt that the expertise of
the Patent Commissioner warrants a more deferential approach by
reviewing courts on decisions made by the Commissioner within his area
of expertise.116 However, the broader the proposition and the
further the implications of a decision stray from the core expertise of
the Commissioner as in this case, less deference is warranted.
[184]Having regard to the functional and pragmatic approach to
determining the standard of review reiterated and further explained by
Bastarache J. in Pushpanathan v. Canada (Minister of Citizenship and Immigration),
[1998] 1 S.C.R. 982, the generality of the proposition at issue here
suggests that the question in this case is one that Parliament intended
be left to the courts. At paragraph 38 [pages 1011-1012] of Pushpanathan, Bastarache J. stated:
Keeping in mind that all the factors discussed here must be
taken together to come to a view of the proper standard of review, the
generality of the proposition decided will be a factor in favour of the
imposition of a correctness standard. This factor necessarily intersects
with the criteria described above, which may contradict such a
presumption, as the majority of this Court found to be the case in Pasiechnyk, supra.
In the usual case, however, the broader the propositions asserted, and
the further the implications of such decisions stray from the core
expertise of the tribunal, the less likelihood that deference will be
shown. Without an implied or express legislative intent to the contrary
as manifested in the criteria above, legislatures should be assumed to
have left highly generalized propositions of law to courts.
[185]While I am of the view, on a functional and pragmatic
basis, that the Patent Commissioner's decision in this case is likely
reviewable on the less deferential standard of correctness, I am also
satisfied that even on the more deferential reasonableness simpliciter standard, the decision is properly reviewable by the Court.
[186]The seminal case which established the reasonableness simpliciter standard is Canada (Director of Investigation and Research) v. Southam Inc., [1997] 1 S.C.R. 748. Iacobucci J. stated at page 776 [paragraph 56]:
An unreasonable decision is one that, in the main, is not
supported by any reasons that can stand up to a somewhat probing
examination. Accordingly, a court reviewing a conclusion on the
reasonableness standard must look to see whether any reasons support it.
At page 778 [paragraphs 59-60], he stated:
The standard of reasonable simpliciter is also closely
akin to the standard that this Court has said should be applied in
reviewing findings of fact by trial judges. In Stein v. "Kathy Kay" (The Ship), [1976] 2 S.C.R. 802, at p. 806, Ritchie J. described the standard in the following terms:
| . . .
the accepted approach of a court of appeal is to test the findings (of
fact) made at trial on the basis of whether or not they were clearly wrong rather than whether they accorded with that court's view of the balance of probability. (Emphasis in original.) |
Even as a matter of semantics, the closeness of the "clearly wrong" test to the standard of reasonableness simpliciter
is obvious. It is true that many things are wrong that are not
unreasonable; but when "clearly" is added to "wrong", the meaning is
brought much nearer to that of "unreasonable".
Applying the approach of Iacobucci J. in Southam, supra,
to the appeal at bar, I am satisfied that the decision of the Patent
Commissioner is clearly wrong. The Commissioner applied control and
reproducibility tests that are not expressed in or implied by the Patent Act. He split the invention into phases without legal justification. He relied on the decision of the Federal Court of Appeal in Pioneer Hi-Bred
in arriving at his conclusion when that decision is clearly
distinguishable. And there are significant and unexplained
inconsistencies between what was found to be patentable and what was
not. In short, the reasons of the Patent Commissioner do not support his
conclusion. Even on a reasonableness simpliciter standard, the decision of the Patent Commissioner is properly the subject of review by the Trial Division and this Court.
THE INTERVENER'S SUBMISSIONS
[187]The Canadian Environmental Law Association was granted
intervener status in this appeal. The intervener supports the
respondent's position. The intervener makes submissions in relation to
the interpretation of the Patent Act and public interest considerations.
[188]In so far as statutory interpretation is concerned, the
intervener raised two arguments not put forward by the respondent. The
first is the doctrine of contemporanea expositio--that the
meaning of words in an enactment will be understood in the sense which
they bore when the enactment was passed. The intervener argued that the
definition of "invention" in the Patent Act is in all material respects unchanged from the way in which it appeared when the first Patent Act
was enacted in 1869. The intervener says that at that time it could not
have been contemplated that higher life forms were included within the
definition of "invention" when such inclusion would give rise to serious
ethical issues.
[189]The doctrine of contemporanea expositio does not apply to the definition of "invention" in the Patent Act. As I have already noted, this argument was addressed by the majority of the Supreme Court of the United States in Chakrabarty
when it found that a rule that would deny patent protection because an
invention was unknown when the Act was passed would conflict with the
core concept of patent law, that anticipation undermines patentability,
and that broad general language was employed because inventions are
often unforeseeable.
[190]In Canada, it has been recognized that the doctrine of contemporanea expositio does not apply to all statutes. In Perka et al. v. The Queen,117 Dickson J. (as he then was) stated:
This does not mean, of course, that all terms in all statutes
must always be confined to their original meanings. Broad statutory
categories are often held to include things unknown when the statute was
enacted. In Gambart v. Ball (1863), 32 L.J.C.P. 166, for example, it was held that the Engraving Copyright Act
of 1735, which prohibited unauthorized engraving or "in any other
manner" copying prints and engravings, applied to photographic
reproduction--a process invented more than one hundred years after the
Act was passed. (See also Maxwell, supra, at pp. 102 and 243-44.)
This kind of interpretive approach is most likely to be taken, however,
with legislative language that is broad or "open textured". It is
appropriate, as the judgments of Viscount Sankey in Edwards v. Attorney-General for Canada, [1930] A.C. 124, and Viscount Jowitt in Attorney-General for Ontario v. Attorney-General for Canada (the Privy Council Appeals Reference),
[1947] A.C. 127, indicate, to the interpretation of the words in
constitutional documents, whose meaning must be capable of growth and
development to meet changing circumstances. [Emphasis added.]
[191]The inclusion of things unknown must be applicable to the definition of "invention" in the Patent Act.
The words of the definition are broad and open-textured. Inventions
are, by definition, "new". With respect to the definition of "invention"
in the Patent Act, this argument of the intervener is misplaced.
[192]The intervener then relies on the enactment of the Plant Breeders' Rights Act118
which provides a form of property protection for plant breeders. The
intervener says that this enactment demonstrates that the products of
plant breeding were not protected under the Patent Act and by implication, that other life forms which are the product of genetic engineering are similarly not patentable under the Patent Act.
[193]The type of protection offered by the Plant Breeders' Rights Act is broader than under the Patent Act
because it covers the product of cross-breeding resulting solely from
the application of the laws of nature. However, there is no necessary
implication from this enactment that the definition of "invention" in
the Patent Act excludes living organisms resulting from
application of human ingenuity. The same argument was made before the
Supreme Court of the United States in Chakrabarty respecting plant breeders legislation in that country and was rejected. Similarly, there is nothing in the Canadian Plant Breeders' Rights Act that implies that living things are excluded from the definition of "invention" in the Patent Act provided they are the result of human ingenuity and are not solely a product of the laws of nature.
[194]The intervener then makes a number of public interest arguments which are summarized in its factum as follows:
The public interest implications include issues of equitable
access to the benefits of biodiversity; the environmental and human
health hazards arising from products of this technology; and issues
relating to animal welfare; and commodification and objectification of
life; and the public interest in rapid dissemination of scientific
research results.
[195]These considerations are not appropriate for the Court to take into account for two reasons.
[196]The first is that, as the appellant points out, they raise
factual questions on which evidence could be lead on both sides of the
issues. There is no opportunity on appeal to do so. In the absence of
evidence, the Court cannot entertain arguments on these issues.
[197]The second and more fundamental point is that as already
explained, such arguments are properly addressed to Parliament and not
the Court. In this type of case, the Court is not the forum for a public
policy debate. Moreover, what is at issue here is not whether the
oncomouse or any other living organisms should be created. A patent does
not give a positive right to develop or use an invention, but rather
only a right to exclude others from using or reproducing the invention
for a limited period of time. Thus, even if the oncomouse were found not
to be patentable, such a decision would not prevent inventors from
developing the product or indeed, other genetically engineered living
organisms.
[198]I have already indicated that, in my respectful view, the words of the Patent Act
do not exclude living things. It is Parliament and not the Court that
defines the limits of patentability. The provisions of the Patent Act
have been cast in broad terms to fulfil Parliament's objective--to
promote invention. If anyone is of the opinion that the scope of
patentability should be narrowed, it is open to that person to ask
Parliament to do so.
SCOPE OF CLAIMS
[199]The appellant has applied its technology to produce mice
with a genetic predisposition to develop cancerous tumours using the
c-myc oncogene, but claims that the process can be applied to non-human
mammalian life forms generally and that the technology is identical for
all oncogenes. The appellant's claim covers all transgenic
non-human mammals and all oncogenes. The rationale for claiming all
non-human mammals and all oncogenes is that if the claims were
restricted to mice or to the c-myc gene, the appellant's technology
could be easily appropriated by a competitor by following the methods in
the patent claims using other mammals such as rats or sheep or other
oncogenes.119
[200]On appeal before this Court, there was no argument to limit
the patentability of the claims to mice or to the c-myc gene. However,
these restrictions had been raised by the Patent Examiner in respect of
claims 1 and 15.120 Although claim 1 had been rejected by the
Patent Examiner, claim 15 was found to be patentable. The appellant
appears to have satisfied the Patent Examiner that claim 15 should not
be restricted to mice or to the c-myc oncogene. Indeed, the Patent
Examiner allowed claim 17 which explicitly provided for a method of
producing a transgenic mammal with an activated oncogene sequence
comprised of a DNA sequence from one of 33 oncogene sequences that were
identified. This is a sufficient basis for this Court to accept the
claims as drawn, that is, covering all non-human mammals and all
oncogenes.
[201]The legal principles on the issue of overbreadth of patent claims relevant to this case are discussed in Monsanto.121 In Monsanto,
the Commissioner of Patents rejected patent claims of the applicant in
respect of 126 chemical compounds as being too broad on the basis that
the applicant disclosed details of the preparation of only three of
them. At page 1117, Pigeon J. held that there could be:
. . . just two possible reasons for rejecting claims such as those in issue.
| 1. There is evidence of lack of utility in respect of some of the area covered; |
| 2. It is not a sound prediction. |
[202]If the Patent Commissioner decides to reject patent claims
as being overbroad for either of these reasons, section 42 (now section
40) of the Act places an onus upon him to justify any such refusal. In
ruling that the Patent Appeal Board improperly rejected Monsanto's
claims on the basis of overbreadth, Pigeon J. held at page 1121:
In the instant case, the Board, in spite of a complete absence of any evidence of unsoundness of the prediction, deny [sic] the claims and would in the end limit them to the area of proved utility instead of allowing them to the extent of predicted utility. In my view this is contrary to s. 42 [now section 40] of the Patent Act.
[203]A patent specification is addressed to a person skilled in
the art or science. Although the various steps are disclosed only for a
mouse and the c-myc gene, the same steps are involved for other
non-human mammals and other oncogenes and any person skilled in the
science would know that similar results should be expected.
[204]The only basis for rejecting the claims as overbroad would
be if there was evidence of lack of utility in respect of some of the
area covered or if what is disclosed in the specification is not a sound
prediction. There was no finding by the Patent Examiner that any of the
claims did not have utility or that the specification did not contain
sound predictions. There is therefore no basis for this Court to
restrict the claims.
THE IMPLICATION FOR HUMAN BEINGS
[205]A final question is whether the Patent Act could be
extended to cover human beings. In other words, could a finding that
"invention" includes living organisms extend to human beings? For
example, on a theoretical level, could a person whose genome has been
modified by the addition of an engineered gene in order to eliminate or
suppress a genetic predisposition to a disease be the subject-matter of a
patent?
[206]Strictly, the question does not arise here, because the
patent claims are restricted to non-human mammals. However, the
potential extension to human beings is an obvious concern.
[207]The answer is clearly that the Patent Act cannot be
extended to cover human beings. Patenting is a form of ownership of
property. Ownership concepts cannot be extended to human beings. There
are undoubtedly other bases for so concluding, but one is surely section
7 of the Canadian Charter of Rights and Freedoms [being Part I of the Constitution Act, 1982, Schedule B, Canada Act 1982,
1982, c. 11 (U.K.) [R.S.C., 1985, Appendix II, No. 44]] which protects
liberty. There is, therefore, no concern by including non-human mammals
under the definition of "invention" in the Patent Act, that there is any implication that a human being would be patentable in the way that the oncomouse is.
[208]In saying this, I make no finding or observation on the
patentability of human genes or products or processes at the genetic
level. As scientific research advances, these and other related matters
will require determination by the courts or by Parliament.
CONCLUSION
[209]The appeal will be allowed with costs in this Court and in
the Trial Division. The decisions of the learned Trial Division Judge
and the Commissioner of Patents are quashed and the matter will be
remitted to the Commissioner of Patents with the direction to grant a
patent covering claims 1 to 12 of the patent application.
Linden J.A.: I agree.
1 R.S.C., 1985, c. P-4 [as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 16] (hereinafter the Act).
2 R.S.C., 1985, c. F-7 [as am. by S.C. 1990, c. 8, s. 6].
3 Supra, note 1, s. 41.
4 Supra, note 1, s. 40.
5 Appeal Book, at pp. 39-64.
6 SOR/96-423.
7 Supra, note 5, at p. 65.
8 Ibid., at pp. 66-69.
9 Ibid., at pp. 70-71.
10 Ibid., at pp. 72-74.
11 Ibid., at p. 75.
12 Ibid., at pp. 76-83.
13 Ibid., at pp. 84-111.
14 Ibid., at p. 112.
15 Ibid., at pp. 113-114.
16 Ibid., at pp. 115-116.
17 Ibid., at p. 117.
18 Ibid., at pp. 118-133.
19 Ibid., at pp. 122-123.
20 Ibid., at pp. 134-136.
21 Ibid., at p. 146.
22 Ibid., at p. 137.
23 Ibid., at p. 158.
24 Ibid., at pp. 36-38.
25 Ibid., at p. 160.
26 Ibid.
27 [1987] 3 F.C. 8 (C.A.); affd [1989] 1 S.C.R. 1623 (hereinafter Pioneer Hi-Bred).
28 447 U.S. 303 (1980) (hereinafter Chakrabarty).
29 Appeal Book, at p. 164.
30 (1982), 62 C.P.R. (2d) 81 (Pat. App. Bd.) (hereinafter Abitibi).
31 Appeal Book, at p. 165.
32 Ibid., at p. 166.
33 Ibid., at pp. 159-166.
34 [1994] 2 S.C.R. 557 (hereinafter Pezim).
35 [1998] 1 S.C.R. 982, at p. 1004 (hereinafter Pushpanathan).
36 Ibid. See also, Lamer J., as he then was, in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, at p. 1635.
37 R.S.C., 1985, c. T-13.
38 (2000), 5 C.P.R. (4th) 180 (F.C.A.) (hereinafter John Labatt Ltd.).
39 Supra, note 34.
40 (1981), 59 C.P.R. (2d) 7 (F.C.A.).
41 [1995] 2 S.C.R. 739, at p. 757.
42 They are also required by statute to be
"competent" which is further evidence of their expertise. See s. 35 (1)
[as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 12] of the Act, which
reads as follows:
| 35.
(1) The Commissioner shall, on the request of any person made in such
manner as may be prescribed and on payment of a prescribed fee, cause an
application for a patent to be examined by competent examiners to be employed in the Patent Office for that purpose. [Emphasis added.] |
43 R. 30(6) reads: "Where the rejection is not
withdrawn pursuant to subsection (5), the rejection shall be reviewed by
the Commissioner and the applicant shall be given an opportunity to be
heard." The Patent Appeal Board is a non-statutory body created pursuant
to the Canadian Patent Office Manual of Patent Office Practice
(March 1998), which reads: "the Patent Appeal Board (PAB) consists of
one or more senior members of the CPO who have not participated in the
examination of the application under review. The Board reviews the
grounds for rejection in final actions and hold hearings under s. 30(6)
of the Patent Rules when requested by applications and advises the Commissioner on these matters." [Emphasis added.]
44 Supra, note 25.
45 [1964] S.C.R. 49, at p. 56.
46 The safeguards are an 18 month confidentiality
provision and no examination for patents withdrawn within 18 months of
filing the application.
47 [1999] 1 S.C.R. 142, at para. 46 [p. 172].
48 See, for ex., Barry Hoffmaster, "The Ethics of Patenting Higher Life Forms" (1989), 4 I.P.J.
1, at p. 2. Professor Hoffmaster describes how an announcement by the
U.S. Patent and Trademark Office that non-human multicellular living
organisms are a patentable subject matter "provoked a moral maelstrom."
49 [1997] 1 S.C.R. 748, at pp. 776-777 (hereinafter Southam).
50 W. L. Hayhurst, "Exclusive Rights in Relation to Living Things" (1991), 6 I.P.J. 171, at p. 196.
51 Canada. Proceed with Care: Final Report of the Royal Commission on New Reproductive Technologies (Ottawa: Minister of Government Services, 1993), at p. 24.
52 [1979] 2 S.C.R. 1108 (hereinafter Monsanto).
53 Ibid., at p. 1119.
54 227 U.S.P.Q. 443 (Bd. Pat. App. & Int. 1985).
55 Supra, note 27, at pp. 13-14.
56 See for ex., the Customs Tariff, S.C. 1997,
c. 36, where Parliament has said clearly that in interpreting the
customs tariff, the ordinary rules of statutory interpretation are
superseded by interpretative tools written by an international
organization.
57 [1996] 2 S.C.R. 432, at p. 445.
58 S.C. 1990, c. 20, Royal Assent was given on 19 June 1990.
59 Decision of Commissioner of Patents, dated August 4, 1995.
60 Decision of the Patent Examiner, dated March 24, 1993.
61 [1998] 3 F.C. 510 (T.D.).
62 The inventors have constructed an "activated
oncogene sequence" which contains DNA from an oncogene which harbours
the genetic code, or blueprint, for the production of protein specific
to that oncogene in cells of the non-human mammal. This protein plays a
role in the growth and division of cells. Elevated levels of the protein
in cells cause the predisposition in the mammal to develop cancerous
tumours. In order to "activate" the oncogene to direct the increased
levels of protein, the inventors have fused a "promoter sequence" of DNA
from a different source to the oncogene. The combined effect of the
oncogene code and the promoter sequence is to produce a mammal which is
susceptible to cancerous tumour growth.
63 Patent claim 1 provides:
| 1. A
transgenic non-human mammal whose germ cells and somatic cells contain
an activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage. |
"Germ cells" are reproductive cells, and "somatic cells" are all
other cells of the organism other than reproductive cells. It is
understood that the transgenic non-human mammals which are sought to be
patented will have the oncogene present in all reproductive and somatic
cells.
64 Of 28 mice analyzed by the inventors, 2 males or about 7% were found to have retained the oncogene.
65 R.S.C., 1985, c. P-4.
66 Decision of Commissioner of Patents, supra, note 59, at p. 6.
67 [1987] 3 F.C. 8 (T.D.); affd by [1989] 1 S.C.R. 1623.
68 Decision of Commissioner of Patents, supra, note 59, at p. 7.
69 (1982), 62 C.P.R. (2d) 81 (Pat. App. Bd.).
70 Supra, note 61, at para. 12 [p. 521].
71 447 U.S. 303 (1980).
72 Supra, note 61, at para. 30 [p. 530].
73 Ibid., at para 32 [p. 531].
74 Ibid.
75 Ibid., at para 35 [p. 532].
76 S. 42 [as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 16] of the Patent Act provides:
42. Every patent granted under
this Act shall contain the title or name of the invention, with a
reference to the specification, and shall, subject to this Act, grant to
the patentee and the patentee's legal representatives for the term of
the patent, from the granting of the patent, the exclusive right,
privilege and liberty of making, constructing and using the invention
and selling it to others to be used, subject to adjudication in respect
thereof before any court of competent jurisdiction.
77 R.S.C., 1985, c. P-4 , s. 46 (as am. idem; S.C. 1993, c. 15. s. 43).
78 See the introduction to chapter three, "Patents" in David Vaver, Intellectual Property Law: Copyright, Patents, Trade-Marks, (Toronto: Irwin Law, 1997), at pp. 113-114.
79 [1999] 1 S.C.R. 142, at pp. 171-172 [para. 46].
Although it was not a patent case, the Court described the essence of
patent law in order to distinguish it from the law of breach of
confidence in the context of trade secrets.
80 As enacted by S.C. 1993, c. 15, s. 33.
81 Inventiveness was affirmed as "an essential attribute of patentability" by the Supreme Court of Canada in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49, at p. 56.
82 See for ex., Diversified Products Corp. v. Tye-Sil Corp. (1991), 35 C.P.R. (3d) 350 (F.C.A.). At p. 365 Décary J.A. stated: "There is no specific section in the Patent Act
relating to the requirement for inventiveness or inventive ingenuity,
but it has been held and is no longer questioned that by use of the
words `invention' and `inventor' throughout the Act, inventiveness or
inventive ingenuity is required to obtain a valid patent."
83 Vaver, supra, note 78, at p. 126.
84 [1979] 2 S.C.R. 1108.
85 [1939] S.C.R. 245.
86 At p. 308.
87 Helen Kreuzer and Adrianne Massey. Recombinant DNA and Biotechnology: A Guide for Teachers, (Washington, D.C.: ASM Press, 1996), at p. 537.
88 Supra, note 59, at p. 7.
89 Supra, note 61, at para. 29 [p. 530].
90 Although claim 14 is for a transgenic cell culture, the cell culture requires the prior development of the oncomouse.
91 Supra, note 78, at p. 128.
92 (1910), 43 S.C.R. 182, at p. 186.
93 (1909), 34 Que. S.C. 388, at p. 401 (per Archibald J.).
94 "United States Patent and Trademark Office, Animals--Patentability", 1077 Official Gazette U.S. Patent & Trademark Office 8 (April 21, 1987)
95 [1931] A.C. 770 (P.C.), at p. 779.
96 Fox, H. G. The Canadian Law and Practice Relating to Letters Patent for Invention, 4th ed. Toronto: Carswell, 1969.
97 As stated by Fox, supra, note 96, at p. 19. One example of this approach being applied in Canada is the judgment of Cattanach J. in Lawson v. Canada (Commissioner of Patents)
(1970), 62 C.P.R. 101 (Ex. Ct.) where he stated at page 111:
"Therefore, it is accepted in principle that the requirements with
regard to subject-matter of a patent are co-extensive under the British
and Canadian statutes and that the jurisprudence established by the
Courts of the United Kingdom is authoritative in Canada."
98 Patents Act 1977 (U.K.), 1977, c. 37.
99 [1974] S.C.R. 111, at p. 120. Similar doubts have previously been expressed by the Supreme Court. In Electric Fireproofing Co. of Canada v. Electric Fireproofing Co., supra,
note 92, at pp. 185-186, Idington J. stated: "Our statute defines what
is patentable. I am not clear that the ground it covers is identical
with that portion of the Royal Prerogative reserved and preserved by
statute as the foundation in England for grants of the like kind of
rights."
100 35 U.S.C. § 101 (1988).
101 Supra, note 96, at p. 6.
102 Chakrabarty, supra, note 71, at p. 316.
103 The minority went even further and found there was no absence of legislative direction in the Chakrabarty case. They found that Congress had passed legislation extending patent or patent-like protection to new plant varieties (The Plant Patent Act, 35 U.S.C. § 161 (1930), and The Plant Variety Protection Act,
7 U.S.C. § 2402(a) (1970)). In these circumstances, the minority held
that the United States patent statute must have been enacted by
Congress in the belief that the definition of "invention" in the statute
did not cover living organisms. It is neither necessary nor appropriate
for this Court to be concerned with the implications of other United
States legislation on the scope of the United States patent statute.
104 Chakrabarty, supra, note 71, at p. 315.
105 In Abitibi, supra, note 69, at pp. 84-88,
the Patent Commissioner traces English, American and Canadian decisions
on the issue of whether life forms are subject to patentability. The
modern view in all countries and in Canada in particular since Abitibi in 1982, is that the "common understanding" is that patent law does extend to living organisms.
106 See paragraph 123 above.
107 Supra, note 61, at para. 24 [p. 527].
108 Application No. 003,389 of N.V. Organon, Re (1973), 15 C.P.R. (2d) 253 (Pat. App. Bd.); Application No. 016,962 (Patent No. 947,179), Re (1973), 17 C.P.R. (2d) (Pat. App. Bd.); Application No. 880,719 (Patent No. 944,693), Re (1973), 18 C.P.R. (2d) 114 (Pat. App. Bd.); Application for Patent Containing Claims that Read on Mental Steps Performed by a Human Operator in Deciding to Transmit a Signal, Re (1972), 23 C.P.R. (2d) 93 (Comm. of Pat.).
109 Supra, note 61, at para. 23 [pp. 526-527].
110 In correspondence from the appellant to the Commissioner of Patents, dated July 14, 1992, at p. 4.
111 Supra, note 61, at para. 31 [p. 530].
112 See Consolboard Inc. v. MacMillan Bloedel (Sask.), [1981] 1 S.C.R. 504, at p. 527, per Dickson J. [as he then was].
113 "Exclusive Rights in Relation to Living Things" (1991), 6 I.P.J. 171, at p. 177.
114 Supra, note 78, at p. 114.
115 As per ss. 41 and 17 of the Patent Act.
116 See by analogy to the Commissioner of Trade-marks Molson Breweries v. John Labatt Ltd. (2000), 5 C.P.R. (4th) 180 (F.C.A.), at paras. 45-51 [pp. 202-204].
117 [1984] 2 S.C.R. 232, at p. 265.
118 S.C. 1990, c. 20.
119 Supra, note 110, at p. 2.
120 In the "Notice of Official Action" from the Patent Examiner, dated January 14, 1992.
121 Supra, note 84, at pp. 1114-1119.
Appendix "A"
Claims found to be non-patentable
| 1. A
transgenic non-human mammal whose germ cells and somatic cells contain
an activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage. |
| 2. The
mammal of claim 1, a chromosome of said mammal including an endogenous
coding sequence substantially the same as a coding sequence of said
oncogene sequence. |
| 3. The
mammal of claim 2, said oncogene sequence being integrated into a
chromosome of said mammal at a site different from the location of said
endogenous coding sequence. |
| 4. The
mammal of claim 2 wherein transcription of said oncogene sequence is
under the control of a promoter sequence different from the promoter
sequence controlling the transcription of said endogenous coding
sequence. |
| 5. The
mammal of claim 4 wherein said promoter sequence controlling
transcription of said oncogene sequence is inducible. |
| 6. The mammal of claim 1 wherein said oncogene sequence comprises a coding sequence of a c-myc gene. |
| 7. The
mammal of claim 1 wherein transcription of said oncogene sequence is
under the control of a viral promoter sequence. |
| 8. The mammal of claim 7 wherein said viral promoter sequence comprises a sequence of an MMTV promoter. |
| 9. The mammal of claim 7 wherein said viral promoter sequence comprises a sequence of an RSV promoter. |
| 10. The
mammal of claim 1 wherein transcription of said oncogene sequence is
under the control of a synthetic promoter sequence. |
| 11. The mammal of claim 1, said mammal being a rodent. |
| 12. The mammal of claim 11, said mammal being a mouse. |
Appendix "B"
Claims Found to be Patentable
| 13. A
method of testing a material suspected of being a carcinogen comprising
exposing the mammal of claim 1 to said material and detecting neoplasms
as an indication of carcinogenicity. |
| 14. A method of producing a transgenic cell culture comprising: |
|
a) introducing an
activated oncogene sequence into pluripotent cells of a mammalian
embryo; |
| b) allowing said embryo to develop into an adult animal; and, |
| c) culturing somatic cells of said animal. |
| 15. A
method of producing a transgenic mammal having an increased probability
of developing neoplasms, said method comprising introducing into a
mammal embryo an activated oncogene sequence. |
| 16. The
method of claim 15 wherein an activated oncogene sequence comprises a
fused gene comprising an oncogene sequence fused to an activating viral
or synthetic promoter sequence. |
| 17. The
method of claim 15 wherein said activated oncogene sequence comprises a
DNA sequence from one of the oncogene sequences src, yes, fps, abl, ros,
fgr, erbB, fms, mos, raf, Ha-ras-1, Ki-ras 2, Ki-ras 1, myc, myb, fos,
ski, rel, sis, N-myc, N-ras, Blym, mam, neu, erbA1, ra-ras, mht-myc,
myc, myb-ets, raf-2, raf-1, Ha-ras-2, erB. |
| 18. Use
of the transgenic mammal of claim 1 in a method of testing a material
suspected of altering neoplastic development, said method comprising
treating said mammal with said material and detecting a reduced or
increased incidence of development of neoplasms, compared to an
untreated mammal of claim 1, as an indication of said alteration. |
| 19. The
use of claim 18, further comprising exposing said treated and untreated
mammals to a carcinogen prior to, after, or simultaneously with treating
said mammal with said material. |
| 20. Plasmid having ATCC Accession No. 39745. |
| 21. Plasmid having ATCC Accession No. 39746. |
| 22. Plasmid having ATCC Accession No. 39747. |
| 23. Plasmid having ATCC Accession No. 39748. |
| 24. Plasmid having ATCC Accession No. 39749. |
| 25. A
somatic cell culture derived from a transgenic mammal wherein the cells
of said cell culture contain an activated oncogene sequence integrated
into a chromosome. |
| 26. Use
of a transgenic mammal according to any one of claims 1 to 12 to test a
material suspected of altering neoplastic development in a mammal. |
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