Date: 20091208
Docket: T-1761-08
Citation: 2009 FC 1249
Ottawa, Ontario, December
8, 2009
PRESENT: The Honourable Mr. Justice Boivin
BETWEEN:
BAYER
SCHERING PHARMA AKTIENGESELLSCHAFT
Applicant
and
THE
ATTORNEY GENERAL OF CANADA
Respondent
PUBLIC REASONS FOR JUDGMENT
AND JUDGMENT
[1]
This
is an application by way of an appeal pursuant to section 41 of the Patent
Act, R.S. 1985, c. P-4, by the Applicant, Bayer Schering Pharma Aktiengesellschaft,
of a decision of the Commissioner of Patents dated May 21, 2008, in which the
Commissioner refused to grant a patent on Patent Application No. 508,336 (the
Application).
The Factual Background
[2]
[…]
[3]
The
Application claims divisional status from […] the “Parent Application” which […]
is now […] the “Parent Patent” […]. Two of the claims in the Parent Patent are
relevant in the case at hand: Claim [L] claimed a process for preparing a
particular product, for which the chemical structure was described in detail.
Claim [B] claimed the product described in claim [L] when produced by the
process described in claim [L].
[4]
Before
1989, the Patent Act did not permit patents for foods or medicines
produced by chemical methods, except when prepared by a described and claimed
process. These were generally known as “process-dependent” claims (see
subsection 41(1) of the Patent Act below, as it read at that time). The
Application, and therefore this appeal, are governed by the Patent Act
as it read immediately before October 1, 1989:
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41.
(1) In the case of inventions relating to substances prepared or produced by
chemical processes and intended for food or medicine, the specification shall
not include any claim for the substance itself, except when prepared by the
methods or processes of manufacture particularly described and claimed or by
their obvious chemical equivalents.
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41.
(1) Lorsqu’il s’agit d’inventions couvrant des substances préparées ou
produites par des procédés chimiques et destinées à l’alimentation ou à la
médication, le mémoire descriptif ne doit pas comprendre les revendications
pour la substance même, excepté lorsque la substance est préparée ou produite
par les modes ou procédés de fabrication décrits en détail et revendiqués, ou
par leurs équivalents chimiques manifestes.
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[5]
[…]
[6]
[…]
[7]
The
Application contains [a number of claims] and each claim is dependent in some
way or another upon claim [L], which claims a particular compound. There is no
material difference between the compound described in that claim and the
compound described in claim [B] (and claim [L]) of the Parent Patent. The only
difference material to this proceeding is that the Parent Patent claims the
product only when produced by a process (as was then required by the
legislation), while the Application purports to claim the product itself (as
would now generally be permitted by the legislation).
The Impugned Decision
[8]
In
her decision, the Commissioner of Patents rejected claims [L] to [R] on a
number of grounds but particularly on the ground of “obviousness double patenting”.
The Parent Patent and the Application did not claim the same invention, so that
form of double patenting did not apply. However, the Commissioner held that the
claims of the Application displayed no “inventive ingenuity” in comparison with
the claims of the Parent Patent, as they were not “patentably distinct”. Since
none of the claims patently distinguished over the claims of the Parent Patent,
the patent was refused.
[9]
The
Commissioner also found that the Application is not a proper divisional application,
but the Application was not refused on that basis. The Commissioner simply held
that “the Applicant must remove all reference to divisional status from the
instant application”.
[10]
The
Commissioner also rejected claims [N] to [R] as being indefinite and ambiguous
because the processes upon which the compounds of these claims are based are
defined in exclusionary terms, such as excluding the processes of the Parent
Patent. The Commissioner also rejected claims [N] to [R] as unsupported by the
disclosure of the Application […].
The Issues
[11]
This
application raises the following questions:
1.
What is the appropriate standard of review of the decision of the
Commissioner?
2. Did
the Commissioner err in rejecting claims [L] to [R] on the ground of obviousness
double patenting?
3.
Did the Commissioner err in concluding that the Application is not a
proper divisional application?
4.
Did the Commissioner err in concluding that claims [N] to [R] are
indefinite and ambiguous and are not supported in the disclosure?
The Relevant Legislation
[12]
Subsections
4(2), 36(1) and sections 40 and 41 of the Act provide as follows :
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4.(2) The Commissioner shall receive all
applications, fees, papers, documents and models for patents, shall perform
and do all acts and things requisite for the granting and issuing of patents
of invention, shall have the charge and custody of the books, records,
papers, models, machines and other things belonging to the Patent Office and
shall have, for the purposes of this Act, all the powers that are or may be
given by the Inquiries Act to a commissioner appointed under Part II of that
Act.
36. (1) A patent shall be
granted for one invention only but in an action or other proceeding a patent
shall not be deemed to be invalid by reason only that it has been granted for
more than one invention.
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.
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.
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4.(2) Le commissaire reçoit les demandes,
taxes, pièces écrites, documents et modèles pour brevets, fait et exécute
tous les actes et choses nécessaires pour la concession et la délivrance des
brevets; il assure la direction et la garde des livres, archives, pièces
écrites, modèles, machines et autres choses appartenant au Bureau des
brevets, et, pour l’application de la présente loi, est revêtu de tous les
pouvoirs conférés ou qui peuvent être conférés par la Loi sur les enquêtes à
un commissaire nommé en vertu de la partie II de cette loi.
36. (1)
Un brevet ne peut être accordé que pour une seule invention, mais dans une
instance ou autre procédure, un brevet ne peut être tenu pour invalide du
seul fait qu’il a été accordé pour plus d’une invention.
40. Chaque
fois que le commissaire s’est assuré que le demandeur n’est pas fondé en
droit à obtenir la concession d’un brevet, il rejette la demande et, par
courrier recommandé adressé au demandeur ou à son agent enregistré, notifie à
ce demandeur le rejet de la demande, ainsi que les motifs ou raisons du
rejet.
41. Dans les six mois suivant
la mise à la poste de l’avis, celui qui n’a pas réussi à obtenir un brevet en
raison du refus ou de l’opposition du commissaire peut interjeter appel de la
décision du commissaire à la Cour fédérale qui, à l’exclusion de toute autre
juridiction, peut s’en saisir et en décider.
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The Analysis
1. What is the
appropriate standard of review of the decision of the Commissioner?
[13]
The
parties do not agree on the standard of review that applies.
[14]
The
Applicant submits that all the issues are questions of law and the standard of
review is therefore correctness (Belzberg v. Canada
(Commissioner of Patents), 2009 FC 657 and Pioneer Hi-Bred Ltd. v.
Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623, 97 N.R. 185). The
consideration and interpretation of the jurisprudence pertaining to double
patenting is a clear question of law and the Commissioner does not possess
expertise in the analysis of these cases.
[15]
The
Respondent submits the issues are not necessarily all questions of law. Furthermore,
the fact that an issue is a question of law does not automatically lead to the
conclusion that the appropriate standard of review is correctness.
[16]
In
light of recent jurisprudence, even with respect to a question of law, the
Respondent further argues that the Court must still conduct a standard of
review analysis to determine whether deference to the decision-maker may be
warranted.
[17]
Although
correctness has been recognized as the standard of review for questions in
relation with the interpretation of the Patent Act (Harvard College v. Canada
(Commissioner of Patents), 2002 SCC 76, [2002] 4 S.C.R. 45), the Court is
of the view that in the case at bar the standard of review is reasonableness
for the following reasons.
[18]
In
Dunsmuir v. New-Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190 at paragraphs
55-56, the Supreme Court of Canada recently summarized various factors to be
considered in the standard of review analysis of a question of law:
A consideration of the following factors
will lead to the conclusion that the decision maker should be given deference
and a reasonableness test applied:
- A privative clause: this is a statutory
direction from Parliament or a legislature indicating the need for deference.
- A discrete and special administrative
regime in which the decision maker has special expertise (labour relations for
instance).
- The nature of the question of law. A
question of law that is of “central importance to the legal system … and
outside the … specialized area of expertise” of the administrative decision
maker will always attract a correctness standard (Toronto (City) v. C.U.P.E. [2003] 3 S.C.R. 77, at para.
62). On the other hand, a question of law that does not rise to this level may
be compatible with a reasonableness standard where the two above factors so
indicate.
[19]
In
the more recent decision in Canada (Minister of
Citizenship and Immigration) v. Khosa, 2009 SCC 12, [2009] 1
S.C.R. 339, the Supreme Court reinforced the principles enunciated in Dunsmuir
more particularly as they relate to two issues: respect for the legislators’
designation of a non-judicial decision-maker (particularly one with special
expertise) and respect for the decision-maker’s interpretation of a question of
law. The Supreme Court also reiterated that a Court should not substitute its
own judgment for that of a tribunal where the tribunal’s decision falls within
a range of possible and acceptable outcomes.
[20]
Although
there is no privative clause in the case at bar, the Supreme Court in Khosa
clearly indicated that a measure of deference can nonetheless be appropriate:
Dunsmuir recognized that with or without a
privative clause, a measure of deference has come to be accepted as appropriate
where a particular decision had been allocated to an administrative decision
maker rather than to the courts […] A policy of deference “recognizes the
reality that, in many instances, those working day to day in the implementation
of frequently complex administrative schemes have or will develop a
considerable degree of expertise or field sensitivity to the imperatives and
nuances of the legislative regime.
[21]
The
Court is also in agreement with the Respondent that Parliament designated the
Commissioner of Patents in the Patent Act to “do all acts and things
requisite for the granting and issuing of patents of invention”, and to refuse
a patent application where the Commissioner “is satisfied that an applicant is
not by law entitled to be granted a patent” (subsection 4(2) and section 40 of
the current Patent Act). It is clear that these decisions were thus
assigned to the Commissioner to decide, in light of her and her staff’s
specialized expertise, and not to Parliament (see Genencor International
Inc. v. Commissioner of Patents and Attorney General of Canada, 2008 FC
608, [2009] 1 F.C.R. 361).
[22]
In
applying these principles to the case at hand, it is quite difficult to
dispute, in light of the provisions of the Patent Act, that the
Commissioner of Patents does not operate with a recognized and considerable expertise
in the patent area.
[23]
The
Court remains of the view that each claim and patent must be analyzed
individually and the issue must be decided on a case by case basis but also
recognizes that questions involving obviousness, which preceded Dunsmuir
and Khosa, have been decided to be questions of mixed fact and law (Halford
v. Seed Hawk Inc., 2006 FCA 275, 353 N.R. 60 at paragraphs 39-40).
[24]
The
Applicant also argued at hearing that the case at bar was not a judicial review
but an appeal under the Patent Act and, for that reason, the
standard of review weighs towards correctness.
[25]
The
Court disagrees and it is noteworthy to refer to Harvard College as the
decision dealt with the standard of review applicable to a decision on the
Patent Commissioner. In that case, Justice Bastarache wrote for the majority
and indicated that “the fact that the Patent Act contains no privative
clause and gives applicants a broad right of appeal from the decision of the
Commissioner is relevant and suggests a more searching standard of review”. However,
he also provided the following comment two paragraphs later:
“The above in no way implies that
decisions of the Commissioner will always be reviewed according to a
correctness standard. If, for example, the question to be decided was
whether or not a particular life form such as a fungus should be classified as
a higher life form or as a lower life form, the Commissioner’s decision would
likely be accorded deference. As noted, s. 40 of the Act states that it is the
Commissioner who must be “satisfied” that a patent should not be issued. In
such an instance, the Commissioner’s scientific expertise suggests that the
courts defer to his decision in respect to whether he is satisfied that the
life form falls within a category of patentable subject matter.” (Harvard College at paragraph 151)
(Emphasis is ours)
[26]
Further,
the Court refers to the Federal Court of Appeal decision in Scott Paper Ltd.
v. Canada (Attorney General), 2008 FCA 129, 377 N.R. 173 at paragraph 11
where it applied Dunsmuir. Although the case involved the Trade-marks
Act, R.S., 1985, c. T-13 rather than the Patent Act, the Federal Court
of Appeal noted that some legal questions are subject to a standard of
reasonableness, even where there is a right of appeal:
While there is a right of appeal of the
Hearing Officer’s decision, the subject matter is one in which the Registrar
and his delegated hearing officers have special expertise, and the legal
questions involved are squarely within that area of expertise: see Dunsmuir,
at paragraph 55.
(Emphasis is ours)
[27]
For
these reasons, the Court is of the view that the Commissioner’s conclusion will
not be reversed in the absence of palpable and overriding error.
2.
Did the Commissioner err in rejecting claims [L] to [R] on the ground
of obviousness double patenting?
The Applicant’s
Arguments
[28]
While
the Application was pending, the former Patent Act was amended and the
requirement to only claim medicines in process-dependent form was lifted. The
Applicant took advantage of this amendment by asserting claims to the medicine
in non-process-dependent form. The Applicant did this in a divisional
application because the Parent Patent had already been issued. The Commissioner
did not dispute the Applicant’s right to make the amendments which led to the
present claims.
[29]
The
sole basis of the Commissioner’s rejection of claims [L] to [P] was double
patenting. The Applicant does not dispute that these claims claim the same subject
matter as the product claims of the Parent Patent, except […] [for one
difference] in claims [L] to [P] of the Application […] [and the fact that] claims
[L] to [P] are not process-dependent. The only issue in relation to double
patenting is therefore whether or not claims [L] to [P] are properly the
subject of an obviousness double patenting objection based on the fact that
they claim the same product as the Parent Patent, but not in process-dependent
form.
[30]
There
is no dispute in the present case that the claims of the Application and the
Parent Patent are not identical or conterminous and that “same invention”
double patenting cannot apply. The Applicant accepts the principle of
obviousness double patenting as enunciated by the Supreme Court of Canada exists
but argues that it does not apply to the facts of this case. The Applicant
submits that in Aventis Pharma Inc. v. Mayne Pharma (Canada) Inc., 2005 FC
1183, 142 A.C.W.S. (3d) 325, this Court was comparing a product patent with a
product-by-process patent, with the products being identical, which is the same
situation in relation to claims [L] to [P] of the Application and that the
Commissioner did not dispute this. As noted in Aventis v. Mayne at
paragraph 74:
Once a patent is obtained for a substance
per se, no additional protection may be obtained for the same substance.
However, it is nevertheless possible to obtain a patent for the process by
which the substance is made independently of the patent on the substance per se.
This type of patent is a valid patent and does not extend the statutory monopoly
of the patent on the substance per se.
[31]
The
Applicant adds that inherent to a claim to a compound in per se form is
the notion that all conceivable processes are contemplated, even those which
are not known.
[32]
The
Commissioner distinguished the Aventis v. Mayne case on the sole ground
that, in that case, “obviousness double patenting was not alleged” and that “As
a result, the Court did not consider obviousness double patenting and whether
the claims of the second patent exhibited “novelty or ingenuity” over the
claims of the first patent” (Commissioner’s decision at p. 8). The Applicant
submits the Commissioner’s characterization of the Aventis v. Mayne case
was wrong.
[33]
In
Aventis v. Mayne, the notice of allegation before the court referred to “double
patenting” in broad terms, and was not limited to “same invention” double
patenting. The Applicant argues it could not have been so limited since product
claims are obviously not identical to or conterminous with product-by-process
claims. The Court in Aventis v. Mayne was aware of and considered the
Supreme Court’s decision in Camco and the Applicant argues it is not
possible to read Camco without being aware of the doctrine of
obviousness double patenting. Moreover, at the hearing, the Applicant emphasized
that the use of the word “obvious” by the Court in Aventis v. Mayne makes
it clear that the Court had both branches of the doctrine of double patenting
in mind. Further, in the Aventis v. Mayne case, as in the present case,
“same invention” double patenting obviously could not have applied. The
Applicant submits there was no sound basis for the Commissioner to conclude
that the Court in Aventis v. Mayne did not have obviousness double
patenting in mind.
[34]
The
Applicant submits the decision in Aventis v. Mayne, as it related to
double patenting, has been cited with approval by the Federal Court of Appeal
in Pfizer Canada Inc. v. Canada (Minister of Health), 2008 FCA 108, 377
N.R. 9 and has thus become authoritative.
[35]
The
same principle was recently endorsed by the Supreme Court of Canada in Apotex
Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265 at
paragraph 102, where the relevant patent was attacked on the basis of double
patenting in relation to a previous patent for a genus that included the claims
of the subject patent. The Supreme Court specifically found that certain
process claims and a product-by-process claim in the genus patent did not have
to be considered at all in relation to double patenting because there was no
identity between those claims and the product claims of the subject patent. The
Court found that the only comparison which must be considered was between the
respective product claims of the two patents. The Supreme Court did not refer
to either the Aventis v. Mayne or Pfizer decisions, but the
Applicant argues it is clear that the Supreme Court was of the view that double
patenting does not apply when comparing a product-by-process claim with a
product claim.
[36]
According
to the Applicant, the Federal Court of Appeal and the Supreme Court of Canada
have thus made it clear that double patenting has no application when comparing
a product claim with an earlier product-by-process claim and the Applicant
submits the rejection of claims [L] to [R] on the ground of double patenting
must therefore be reversed on this basis alone.
[37]
The
Applicant adds that double patenting should not even have been considered in
the particular circumstances of this case. In Consolboard Inc. v. MacMillan
Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R.
504, 35 N.R. 390, a divisional application was filed as a result of a
restriction requirement by the Patent Office, as in the present case. The
Supreme Court held that such a divisional patent should not be deemed invalid
or open to attack solely “by reason only of the grant of the original patent”.
[38]
The
Commissioner considered the Consolboard case but distinguished it on the
basis that “the claims currently in the instant application were not removed
from the patent application because of a lack of unity objection by the
Examiner”. The Commissioner’s observation is factually correct, but the
Applicant argues it is not a legally valid distinction from the principles of
the Consolboard case. The present application is a divisional
application which resulted from a restriction requirement by the Patent Office,
which was lawfully amended in order to take advantage of a change in the law.
The Applicant submits it is a fundamental right of any person to claim the
benefit of a change in the law of Canada favourable to such person (see section
12 and subsection 44(c) of the Interpretation Act, R.S. 1985, c. I-21)
and the Applicant is entitled to a fair, large and liberal interpretation of
the provisions of the Patent Act which govern the Application. The
Applicant may claim the benefit of a change in the law, whether in a divisional
application or otherwise (Burton Parsons Chemicals Inc. v. Hewlett-Packard
(Canada) Ltd., [1976] 1 S.C.R. 555, 3 N.R. 553) and the Commissioner should
not have considered double patenting at all in the present circumstances.
The Respondent’s
Arguments
[39]
The
Respondent submits that no invention is entitled to more than one patent and before
anything can be patented, it must demonstrate “inventive ingenuity” in
comparison with anything that has come before. Thus, if in comparison with
something that has already been patented, a subsequent purported invention is
either the same or does not show inventive ingenuity, a patent cannot be
granted for it. Otherwise, the rule against “double patenting” would be
violated.
[40]
In
the present case, the Applicant had a patent for a product as produced by a
specified process and it later sought a patent for the product itself. However,
the Respondent submits the product claimed in the second application displayed
no inventive ingenuity in comparison with the claims of the earlier patent, as
it was not “patentably distinct”. Accordingly, the Commissioner of Patents
properly refused to grant the patent sought.
[41]
Where
double patenting is an issue, the question arises as to how “identical” the
claims must be for a first patent to invalidate a second. Where the patents are
“precisely conterminous”, the second claim will be said to violate the rule
against “same invention” double patenting. The Respondent admits this form of
double patenting is not in issue in the present case. However, another form of
double patenting, “obviousness” double patenting, has also been recognized (see
Camco at paragraphs 66-67) and the notion that a patent must not violate
the rule against “obviousness double patenting” has long been recognized (Camco
at paragraphs 37 and 63).
[42]
According
to the Respondent, in a situation of potential double patenting, unless the
later claim exhibits novelty or ingenuity in comparison to the earlier claim,
the two will not be “patentably distinct” and the issuance of the second patent
will be prohibited (Pfizer Canada Inc. v. Canada (Minister of Health),
2006 FC 1471, 303 F.T.R. 284 at paragraphs 99-102; Bayer AG v. Novopharm
Ltd., 2006 FC 379, 289 F.T.R. 263 at paragraphs 41, 42, 56 and 57; Apotex
v. Sanofi-Synthelabo, above at paragraphs 111-113; Pharmascience Inc. v.
Sanofi-Aventis Canada Inc., 2006 FCA 229, [2007] 2 F.C.R. 103 at paragraphs 67-68).
[43]
This
principle is particularly demonstrated when process-dependent claims are
considered. The Courts have long recognized that only when the process and the
product both exhibit inventive ingenuity is each considered a separate
patentable invention. Otherwise, they are aspects of the same thing and are not
separate inventions (Merck & Co. v. Apotex Inc., 2006 FCA 323,
[2007] 3 F.C.R. 588 at paragraph 32, referring to CIBA-Geigy AG v. (Canada) Commissioner
of Patents, (1982), 42 N.R. 587, 15 A.C.W.S. (2d) 218 (F.C.A.); Hoffmann-LaRoche
& Co. v. Canada (Commissioner of Patents), [1955] S.C.R. 414, 23 C.P.R.
1).
[44]
In
the present case, the Respondent submits the claims in the Application
demonstrate no inventive ingenuity in comparison to the Parent Patent. With the
exception of an immaterial difference, the product described in the
Application’s claims is precisely the same as the product described in the
claims of the Parent Patent.
[45]
The
Commissioner’s decision is correct and reasonable and the Applicant even
acknowledges there is no material difference between the compound described in
the claims of the Application and the compound described in claim [B] (and
claim [L]) of the Parent Patent. Accordingly, the claims in the Application
demonstrate no inventive ingenuity or novelty in comparison with the claims of
the Parent Patent. The Respondent argues they are not patentably distinct and
issuing a patent for them would offend the rule against “obviousness” double
patenting, especially because all claims in the Application are dependent on
claim [L].
[46]
The
Applicant cites Aventis v. Mayne, Pfizer and Sanofi-Synthelabo
and argues that the law has changed, such that a product claim must not display
inventive ingenuity in comparison to a process-dependent claim for the same
product. However, the Respondent argues the emphasis which the Applicant puts on
these decisions is misplaced as this jurisprudence pertains only to “same
invention” double patenting. If the Applicant’s arguments were retained, this
would get rid of the concept of obviousness double patenting.
[47]
In
Aventis v. Mayne, the Court was being called upon in an application
under section 6 of the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, to decide whether the generic drug manufacturer’s allegation of
invalidity was justified. In that case, the validity of the patent was in
issue, not the decision of the Commissioner. No allegation of “obviousness”
double patenting was made and the Court made no mention of it, and the question
of whether the claims of the second patent showed novelty or ingenuity in
comparison to the first patent was not discussed. According to the Respondent,
it was clear that only “same invention” double patenting was considered (Aventis
v. Mayne at paragraph 76).
[48]
The
Federal Court of Appeal has ruled that in order to be taken into consideration,
a specific allegation of “obviousness” double patenting is required (Bayer
AG v. Apotex Inc., 2001 FCA 263, 278 N.R. 178 at paragraph 14). Similarly,
in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. 2008 SCC 61, [2008] 3
S.C.R. 265, only “same invention” double patenting was considered and the
Supreme Court stated at par. 102: “…it is apparent, for double patenting
purposes, that there is no identity between the product claims 1 and 5 of the
‘777 patent and claims 1, 8 and 15 of the ‘875 patent…”. The concept of
“identity” is relevant only to the prohibition against “same invention” double
patenting and the Respondent submits the Court would not have eliminated the
requirement for “inventive ingenuity” in obviousness double patenting without
discussing it.
[49]
Finally,
the Respondent submits that the Applicant appears to rely on something similar
to a fairness argument which has no application, as the Commissioner is bound
to refuse a patent where he or she is satisfied that an applicant is not by law
entitled to it. The Respondent argues that if the Commissioner granted the
patent sought in the present case, this would create the type of undue
extension of the statutory monopoly, known as the “evergreening” of a patent that
the Courts have vigorously warned against. The Commissioner’s decision was
therefore correct and the Court should not interfere with it.
The Analysis
[50]
The
leading case on double patenting is the decision of the Supreme Court of Canada
in Whirlpool Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 (Camco),
which concerned a patent governed by the Patent Act as it read before
1989, as in the present appeal. In Camco, the Supreme Court accepted
that there is an inherent prohibition against double patenting in the Patent
Act. The Court held further that there are two branches of the prohibition
on double patenting, namely “same invention” double patenting, whereby the
claims must be “identical or conterminous” and the “obviousness” branch, which
has to do with claims that are not “patentably distinct” from those of the
earlier patent.
[51]
There
can only be one patent for an invention (Camco, at paragraph 63) and
once a patent has been granted for an invention, a subsequent patent shall not
issue for the same invention, since that would, in effect, allow an unlawful
extension of the monopoly granted by the first (Canada (Commr. of Patents)
v. Farbwerke Hoechst A/G Vormals Meister Lucius Bruning, [1964] S.C.R. 49
at 53, 41 C.P.R. 9; Consolboard, above at 536-537. A second patent could
not be justified unless the claims exhibited “novelty or ingenuity” (Farbwerke
Hoechst, above; Consolboard, above). As noted by both parties at the
hearing, it is possible to obtain a patent for a product and a patent for a
process to produce that product.
[52]
The
scope of the exclusive right is determined by the claims of the patent. The
claim is what describes the element of the invention and defines the monopoly
the patentee seeks in the application. A comparison between the claims of the
two patents is critical to assessing the allegation of obviousness double
patenting (Bayer v. Novopharm at paragraph 42).
[53]
As
noted by the Respondent, the prohibition against double patenting relates back
to the “evergreen” problem. An inventor is only entitled to a patent for each
invention (subsection 36(1) of the Patent Act). If a subsequent patent
issues with identical claims, there is an improper extension of the monopoly.
[54]
The
prohibition against double patenting involves a comparison of the claims rather
than the disclosure, because the claims define the monopoly. There are two
approaches as to determining whether there has been a double patenting: one is
to consider whether the claims are identical or conterminous, an approach which
is sometimes called the “same invention”; a second branch of the test is to
consider whether the second patent is “obvious” or not “particularly distinct”
from the first, based on the common knowledge of an ordinary workman as of the
date of publication of the patent (Camco, paragraphs 63-75; Apotex v.
Sanofi at paragraphs 94 to 115; Bayer AG v. Novopharm Ltd. at
paragraphs 40-63; Eli Lilly Canada Inc. v. Apotex Inc., 2007 FC 455, [2008]
2 F.C.R. 636 at paragraph 359; Bristol-Myers Squibb Canada Co. v. Apotex
Inc., 2009 FC 137, 74 C.P.R. (4th) 85 at paragraph 175).
[55]
It
is trite law that different types of claims exist in the pharmaceutical
industry, namely product claims and process claims. Once a patent is obtained
for a substance per se, no additional protection may be obtained for the
same substance. However, as noted in Aventis v. Mayne at paragraph 76,
it is possible to obtain a patent for the process by which the substance is
made, independently of the patent on the substance per se. This type of
patent is a valid patent and does not extend the statutory monopoly of the
patent on the substance per se.
[56]
The
undisputed test for obviousness is whether at the date of the invention, an
unimaginative skilled technician, in light of his general knowledge and the
literature and information on the subject available to him on that date, would
have been led directly and without difficulty to the invention (Proctor
& Gamble Co. v. Beecham Canada Ltd. (1982), 40 N.R. 313, 12 A.C.W.S.
(3d) 491 (F.C.A.)).
[57]
In
the case at bar, the Court finds that claims [L] to [P] in the Application are not
inventive. Although claim [L] claims the same compound as claim [B] of the
Parent Patent, it is not process-dependent like claim [B] of the Parent Patent,
and although claims [F] and [P] cover the same subject matter as claim [L], […]
[there is one difference]. As noted in the Commissioner’s decision at issue:
Claims [L] to [P] of the instant
application claim the same compounds as are claimed in the [Parent Patent],
with the only difference being that the compounds are claimed in process dependent
form in the patent while there is no reference to a process in claims [L] to [P]
of the application.
The compounds recited in claims [L] to [P]
are the same compounds that are claimed in the claims of the patent. Further,
they are the same compounds produced by the processes recited in the remaining
claims of the patent, such as the process recited in claim [L] of the [Parent
Patent].
[58]
The
Parent Patent claims a process for a particular compound as well as a compound produced
by a particular process, also known as a process-dependent compound, as
required by the Patent Act at that time. All claims in the present
Application depend on claim [L], which is a claim for a particular compound.
There is no material difference between the compound in claim [L] of the
Application and the compound in claims [L] and [B] of the Parent Patent. As
such, the critical requirement of inventive ingenuity is not found here. The
jurisprudence is clear that novelty and ingenuity are required to set aside an
allegation of obviousness double patenting.
[59]
Furthermore,
the Parent Patent and the Application possess the same basic molecular
structure. Given that the Parent Patent has been granted, claim [L] in the
Application is not patentably distinct because the same compound is described
in the Parent Patent […].
[60]
The
Court is therefore of the opinion that it was obvious to claim these processes
and subject matter and these claims do not exhibit “novelty or ingenuity” as
stated in Camco, above. As a result, I find that double patenting
exists. For these reasons, the appeal is dismissed.
[61]
Given
the Court’s conclusion with respect to this issue, there is no need to address
issues (3) and (4).
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that the appeal be
dismissed.
“Richard Boivin”
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-1761-08
STYLE OF CAUSE: BAYER
SCHERING PHARMA AKTIENGESELLSCHAFT v.
THE
ATTORNEY GENERAL OF CANADA
PLACE OF
HEARING: Ottawa, Ontario
DATE OF
HEARING: October
15, 2009
REASONS FOR JUDGMENT: BOIVIN
J.
DATED: December
8, 2009
APPEARANCES:
|
Mr. Gunars
A.Gaikis
Mr. Jeremy E.
Want
|
FOR THE APPLICANT
|
|
Mr. F.B.
(Rick) Woyiwada
|
FOR THE RESPONDENT
|
SOLICITORS
OF RECORD:
|
Smart &
Biggar
Barristers and
Solicitors
|
FOR THE APPLICANT
|
|
Mr. John H.
Sims, Q.C.
Deputy
Attorney General of Canada
|
FOR THE RESPONDENT
|