Date: 20050928
Docket: T-1133-02
Citation: 2005 FC 1332
BETWEEN:
ABBOTT LABORATORIES and
ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR ORDER
PHELAN J.
A. INTRODUCTION
[1]
This
is an application by Abbott Laboratories (“Abbott”) for an order prohibiting
the Minister of Health from issuing a Notice of Compliance (“NOC”) to Apotex
Inc. (“Apotex”) in respect of Apotex’s brand of 250 mg. and 500 mg. clarithromycine
tablets known as Apo-Clarithromycine until the expiry of Canadian Patent
2,261,732 (the “'732
patent”). The active medicinal ingredient in these tablets is
6-0-methylerythromycin A Form II (also referred to as Clarithromycine Form II).
[2]
This
proceeding was commenced under the Patented Medicine (Notice of Compliance)
Regulations, SOR/93-133 (the “NOC Regulations”). The issue in this proceeding
is whether Abbott has successfully rebutted Apotex’s allegation that the patent
is not valid. The issue of infringement is not directly raised in this
proceeding, other than that there is no infringement because the patent is invalid.
[3]
The
nature of the NOC proceedings has been summarized by Layden-Stevenson J. in Fournier
Pharma Inc. v. Canada (Minister of Health) 2004 FC
1718:
6. As
noted, this proceeding is brought under the Regulations. The history and
scheme of the Regulations have been delineated in various decisions of the
Federal Court of Appeal and need not be repeated here. See: Merck Frosst
Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55
C.P.R. (3d) 302 (F.C.A.); AB Hassle v. Canada (Minister of
National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.);
Novartis AG et al. v. Abbott Laboratories Ltd. et al (2000), 7 C.P.R. (4th)
264 (F.C.A.). Basically, issues of non-infringement and validity between the
patent holder (first person) and the person seeking a NOC from the Minister
(second person) originate with a NOA, served on the first person by the second
person, setting out the second person’s allegations, including the legal and
factual basis in support. The first person may disagree and apply to the court
for an order prohibiting the Minister from issuing a NOC to the second person
until after expiration of the patent.
8. Section
6 proceedings are not to be likened to actions for determining validity or
infringement. They are proceedings in judicial review, to be held
expeditiously, whose aim is to determine whether the Minister is free to issue
the requested NOC. Their scope is confined to administrative purposes: Apotex
Inc. v. Canada (Minister of National Health and Welfare) (1997), 76
C.P.R. (3d) 1 (F.C.A.). The determination must turn on whether there are
allegations by the second person sufficiently substantiated to support a
conclusion for administrative purposes (the issuance of a NOC) that an
applicant’s patent would not be infringed if the second person’s product is put
on the market: Pharmacia Inc. v. Canada (Minister of National Health and
Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.).
9. By
merely commencing the proceeding, the applicant obtains what is tantamount to
an interlocutory injunction without having satisfied any of the criteria a
court would require before enjoining issuance of a NOC: Merck Frosst Canada
Inc. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R.
(3d) 368 (S.C.C.); Bristol-Myers Squibb Canada Inc. v. Canada (Attorney
General) (2001), 11 C.P.R. (4th) 539 (F.C.A.). The Regulations
allow a court to determine summarily, on the basis of the evidence adduced,
whether the allegations are justified. Section 6 proceedings are not
adjudicative and cannot be treated as res judicata. The patentee is in
no way deprived of all the recourses normally available to enable it to enforce
its rights. If a full trial of validity or infringement issues is required,
this can be obtained in the usual way by commencing an action: Pfizer Canada
Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th) 245 (F.C.A.); SmithKline
Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76
(F.C.T.D.) aff’d (2002), 21 C.P.R. (4th) 129 (F.C.A.); Novartis
A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450 (F.C.A.).
B. THE PATENT – NOTICE OF
ALLEGATION
[4]
The
'732 patent is
attached as Appendix A to these Reasons. The claims in issue are 1, 2, (3 and
9 are no longer in issue), 13, 15 and 16 to 21.
[5]
Apotex
alleged that Claims 16 to 21 of the '732 patent are invalid because they claim
an admittedly old product (i.e. Form II Clarithromycine). Claims 16 to 21 are
set out below:
16. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 2.
17. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 3.
18. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 9.
19. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 13.
20. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 15.
21. 6-0-methylerythromycin
A crystal Form II prepared according to the process of Claim 1.
[6]
Apotex
says that a product by process claim cannot be valid if the compound itself is
old.
[7]
Apotex
further alleges that claims 16-21 are invalid because the claims upon which
they depend (claims 1, 2, 13 and 15 – set out below) are invalid because each
claim is beyond the processes actually invented and disclosed. It is said that
the processes were never tested and their utility was not soundly predicted;
the processes do not work to make Form II; the processes were obvious and anticipated.
[8]
There
is a significant issue as to the interpretation of the dependent claims as
alternative claims. It is useful to set those claims out as well. The
relevant claims are:
1.
A
method of preparing 6-0-methylerythromycin A crystal Form II comprising:
(a)
converting
erythromycin A to 6-0-methylerythromycin A;
(b)
treating
the 6-0-methylerythromycin A prepared in step a with a solvent selected
from the group consisting of:
(i)
an
alkanol of from 1 to 5 carbon atoms, provided said alkanol is not ethanol or
isopropanol,
(ii)
a
hydrocarbon of from 5 to 12 carbon atoms,
(iii)
a
ketone of from 3 to 12 carbon atoms,
(iv)
a
carboxylic ester of from 3 to 12 carbon atoms, provided said carboxylic esteris
not isopropyl acetate,
(v)
an
ether of from 4 to 10 carbon atoms,
(vi)
benzene,
(vii)
benzene
substituted with one or more substituents selected from the group consisting
of:
alkyl of from
one to four carbon atoms,
alkoxy of
from one to four carbon atoms,
nitro, and
halogen,
(viii)
a
polar aprotic solvent,
(ix)
a
compound having the formula HNR1R2 wherein R1
and R2 are independently selected from hydrogen and alkyl of
one to four carbon atoms, provided that R1 and R2 are not
both hydrogen,
(x)
water
and a water miscrible solvent selected from the group consisting of:
a water
miscible organic solvent, and
a water
miscible alkanol,
(xi)
methanol
and a second solvent selected from the group consisting of:
a hydrocarbon
of from 5 to 12 carbon atoms,
an alkanol of
from 2 to 5 carbon atoms,
a ketone of
from 3 to 12 carbon atoms,
a carboxylic
ester of from 3 to 12 carbon atoms,
an ether of
from 4 to 10 carbon atoms,
benzene, and
benzene
substituted with one or more substituents selected from the group consisting
of:
alkyl
of from one to four carbon atoms,
alkoxy
of from one to four carbon atoms,
nitro,
and
halogen,
and
(xii)
a
hydrocarbon of from 5 to 12 carbon atoms and a second solvent selected from the
group consisting of:
a ketone of
from 3 to 12 carbon atoms,
a carboxylic
ester of from 3 to 12 carbon atoms,
an ether of
from 4 to 10 carbon atoms,
benzene,
benzene
substituted with one or more substituents selected from the group consisting
of:
alkyl
of from one to four carbon atoms,
alkoxy
of from one to four carbon atoms,
nitro,
and
halogen,
and
a polar
aprotic; and
(c)
isolating
the 6-0-methylerythromycin A crystal Form II crystals.
2.
The
process of Claim 1 wherein step (a) comprises
(i)
converting
erythromycin A into an erythromycin A 9-oxime derivative;
(ii)
protecting
the 2' and 4'' hydroxy
groups of the erythromycin A 9-oxime derivative prepared in step (i);
(iii)
reacting
the product of step (ii) with a methylating agent; and
(iv)
deprotecting
and deoximating the product of step (iii) to form 6-0-methylerythromycin
A.
13. A
method according to Claim 2 wherein the solvent comprises a compound of formula
HNR1R2
wherein R1 and R2 are independently selected from
hydrogen and alkyl of from one to four carbon atoms, provided that R1
and R2 are not both hydrogen.
15. A
method according to Claim 2 wherein the solvent is selected from the group
consisting of:
acetone,
heptane,
toluene,
methyl tert-butyl
ether,
N, N-dimethylformamide,
ethyl
acetate,
xylene,
isopropanol-water,
tetrahydrofuran-water,
ethanol-water,
ethyl ether,
arnyl
acetate,
isopropyl
acetate-methanol,
diisopropyl
ether,
isopropyl
butyrate
isopropylamine,
and
methanol-ethanol.
[9]
Apotex
therefore raises the issues of novelty, sound prediction and inutility.
[10]
Abbott
contends that the claims within Claims 1 and 15 are alternate claims for
purposes of section 27(5) of the Patent Act and therefore Apotex must
successfully invalidate all of the claims in Claims 1 and 15. Abbott also says
that Apotex’s experiments are inadmissible; that the allegations against Claims
13 and 15 are not justified; that the allegations of lack of novelty are also
not justified.
[11]
Crystals are solid
materials in which molecules (like Clarithromycine) are arranged in a specific
geometric pattern extending in those dimensions. Where multiple crystal forms
exist, the phenomenon is known as “polymorphism”.
[12]
Clarithromycine
is a chemical compound whose molecules crystallize into at least two shapes;
polymorphs. Clarithromycine is used as an antibiotic, particularly in the
treatment of infections in the upper respiratory tract of both children and
adults.
[13]
Form
I and Form II Clarithromycine are the names given respectively to two
polymorphs of Clarithromycine. Each displays a specific result when subjected
to x-ray powder diffraction, differential scanning calorimetry or infrared
spectrum analysis.
[14]
Form
II is the polymorphic form of the Clarithromycine included in Biaxin tablets
since 1993 and sold by Abbott.
[15]
The
earliest claim date of the '732 patent is July 29, 1996. Claims 1 to 15 of the '732 patent
claim processes to make Form II, and claims 16 to 21 of the patent claim Form
II when made by those processes. (In the patent, Clarithromycine is called
6-0-methylerythromycin A.) Since Claims 1 to 15 are process claims, they are
not eligible claims under the NOC Regulations and cannot be the basis for a
prohibition order.
[16]
It
is not disputed that the “person skilled in the art” of the '732 patent
would have a B.Sc. in chemistry or chemical engineering and two to five years’
experience in pharmaceutical process development. All the experts’
qualifications far exceeded this “person skill” in the art.
C. SUFFICIENCY OF PLEADINGS AND
EVIDENTIARY BURDEN
[17]
Much
has been made about the sufficiency of the pleadings, and the burden and
sufficiency of proof as well as the presumption of validity. Abbott has
challenged the Notice of Allegation (“NOA”) and based its application to this
Court on the grounds that:
·
The
NOA does not comply with the NOC Regulations because it is insufficiently
detailed.
·
Claims
16 to 21 of the '732 are not
dependent on invalid claims.
·
None
of claims 1, 2 (3 and 9 are no longer in issue), 13 and 15 is invalid for being
broader than the invention made or disclosed, being anticipated or obvious,
being claims for an old method, lacking utility or being claims for an old
product.
[18]
Apotex
says that Abbott’s Notice of Application does not challenge the allegation that
claims 16 to 21 claim an old product and that a product by process claim is not
valid if the product is old. Apotex also complains that Abbott’s Notice of
Application does not raise Abbott’s argument regarding s.27(5) of the Patent
Act.
[19]
A
review of the pleadings and the evidence discloses that all of the issues
raised by each party were sufficiently raised to “put the issues in play”, even
if that were the correct legal standard as argued by Abbott. No party was
unduly surprised or prejudiced by the manner in which any issue came before the
Court. The parties had available all the pre-hearing procedural steps to deal
with any deficiencies in the record. The parties were not shy to use these
procedures where they thought necessary.
[20]
The
NOA, particularly paragraph 16, raises the issue of “old product” – lack of
novelty, invalid breadth of claim, anticipation/obviousness, inutility in
respect of Claim 1. Paragraph 17 deals with Claim 2; paragraph 20 deals with
Claim 13, paragraph 21 with Claim 15. Furthermore, paragraph 21, which covers
Claims 16-21, raises all those same issues because these claims are dependent
on the earlier claims (and their alleged deficiencies) including in
subparagraph (iii), the issue of old product.
[21]
The
test for adequacy of pleadings was recently reviewed in Pfizer Canada Inc.
v. Novopharm Ltd. 2005 FCA 270:
14. The
purpose for Novopharm providing the detailed statement of the legal and factual
basis for the non-infringement allegations was to notify the patentee (Pfizer)
of the reasons why its patent would not be infringed or was invalid (see AB
Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R.
(4th) 272 (F.C.A.) at paragraph 16). At paragraph 17 of that
decision Stone J.A. stated:
… the detailed statement
must be such as to make the patentee fully aware of the grounds for claiming
that the issuance of an NOC would not lead to infringement of a listed patent
for, otherwise, the patentee would be unable to decide whether or not to
initiate a section 6 proceeding.
15. Similarly,
in SmithKline Beecham Pharma Inc. v. Apotex Inc., Noël J.A. stated the
following at paragraph 24:
The detailed statement …
is intended to place the patentee in the position of deciding whether to oppose
the issuance of a notice of compliance by instituting a section 6 proceeding or
to stand aside.
16. The
Applications Judge erred in his formulation of the legal test to determine
whether Novopharm’s NOA was deficient when he required Novopharm to ‘put into
play’ all aspects of the non-infringement issue. Whether Novopharm’s NOA was
adequate depends on whether it provided Pfizer with a sufficient understanding
of the case it had to meet (supra at paragraph 4). The legal test of
adequacy does not require Novopharm to anticipate all possible grounds of
infringement, including Pfizer’s speculative theory that the dihydrate could be
used in the process of manufacturing Novopharm’s bulk monohydrate. As noted by
Evans J.A. in AstraZeneca AB v. Apotex Inc. 2005 FCA 183, [2005] F.C.J.
No. 842 (QL) at paragraph 11:
A second person [the
generic] should not be required to anticipate every theory of possible
infringement, however speculative, in the detailed statement supporting its allegations.
[22]
The
adequacy of the NOA is determined by whether it provided Abbott with a
sufficient understanding of the case it had to meet. The NOA clearly meets
that standard.
[23]
In
addition to the allegation of insufficiency of pleadings, the parties have
raised the question of on whom the burden of proof rests. This is a relevant
issue because of the arguments pertaining to the various experts’ testimony.
[24]
Abbott’s
position is that because of the presumption of patent validity, where the NOA
challenges the patent’s validity, the evidentiary burden on Apotex is to put the
allegations of invalidity in play by filing evidence in support of each
allegation of invalidity.
[25]
Unlike
the issue of adequacy of pleadings where the matter of putting “the issues in
play” is not the legal test, in respect of burden of proof, the matter of
putting “the issues in play” does become relevant.
[26]
The
evidentiary burden was also discussed in Pfizer Canada Inc. v. Novopharm
Ltd., supra, at paragraphs 19 and 20:
19. In
Pharmacia Inc. v. Canada (Minister of National
Health and Welfare) (1995), 64 C.P.R. (3d) 450 (F.C.A.), Hugessen
J.A. addressed the evidentiary burden placed on a generic under the
Regulations. He adopted the reasons of the trial judge who described this
burden as follows:
… the grounds
that the patentee has for challenging the generic’s notice of allegation should
be advanced in the originating notice of motion filed pursuant to s. 6(1) of
the Regulations. … The generic may then be informed as to what vexes the patentee
and why a prohibition order barring entry should be issued. Initially, i.e.,
before the Minister, the generic has raised the issue of non-infringement. At
this stage, before the court, the generic now has the opportunity to file
evidence supporting its detailed statement. In essence, this is the evidential
burden on a respondent.
(see Pharmacia
Inc. v. Canada (Minister of National Health and Welfare) (1995), 60
C.P.R. (3d) 328 at 339-40 (F.C.T.D.), per Wetston J.)
20. In
my view, this statement remains good law. Where, as here, the NOA is found to
be adequate, the legal burden remains squarely on Pfizer to prove, on a balance
of probabilities, that the allegations in the NOA are unjustified. Novopharm
has no evidential burden to support the allegations in its NOA and detailed
statement (see AB Hassle v. Canada (Minister of National
Health and Welfare) (2002), 22 C.P.R. (4th) 1 at
paragraph 35). Therefore, Novopharm need only file evidence supporting its
detailed statement to counter evidence, if any, submitted by Pfizer in the
course of the prohibition proceedings.
[27]
Gibson
J. in SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th)
76 (F.C.T.D.) limited the burden of proof to requiring the Applicant to
disprove the allegations in the NOA.
14. Against
the foregoing, I conclude that while an “evidential burden” lies on Apotex to
put each of the issues raised in its Notice of Allegation “in play”, if it is
successful in doing so, the “persuasive burden” or “legal burden” then lies with
SmithKline. Assuming Apotex to be successful in putting the issue of validity
of the '637 Patent “in play”, SmithKline
is entitled to rely on the presumption of validity of the patent created by
subsection 43(2) of the Act.
15. Against
the foregoing, I conclude that while an “evidential burden” lies on Apotex to
put each of the issues raised in its Notice of Allegation “in play”, if it is
successful in doing so, the “persuasive burden” or “legal burden” then lies
with SmithKline. Assuming Apotex to be successful in putting the issue of
validity of the '637 Patent “in play”,
SmithKline is entitled to rely on the presumption of validity of the patent
created by subsection 43(2) of the Act.
16. The “persuasive burden”
or “legal burden” that lies with SmithKline in the circumstances described in
the preceding paragraph is, however, impacted by the nature of the proceeding
here before the Court. In Merck Frosst Canada Inc. v. Canada
(Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), Mr. Justice Hugesson, for the
Court, wrote at pages 319-20:
As I understand the scheme of the regulations, it is
the party moving under s. 6, in this case Merck, which, as the initiator of the
proceedings, has the carriage of the litigation and bears the initial burden of
proof. That burden, as it seems to me, is a difficult one since it must be to
disprove some or all of the allegations in the notice of allegation which, if
left unchallenged, would allow the Minister to issue a notice of compliance.
.....
In this connection, it may be noticed that, while s.
7(2)(b) [of the Regulations] seems to envisage the court making a declaration
of invalidity or non-infringement, it is clear to me that such declaration
could not be given in the course of the s. 6 proceedings themselves. Those
proceedings, after all, are instituted by the patentee and seek a prohibition
against the Minister; since they take the form of a summary application for
judicial review, it is impossible to conceive of them giving rise to a
counterclaim by the respondent seeking such a declaration. Patent invalidity,
like patent infringement, cannot be litigated in this kind of proceeding.
Thus, the burden on SmithKline is only to disprove the
allegations in the notice of allegation, not to justify declarations of
validity and infringement or conversely to negative claims for declarations of
invalidity and non-infringement.
[Justice Gibson’s judgment was affirmed on appeal at (2003),
21 C.P.R. (4th) 129.]
[28]
Given
the summary nature of NOC proceedings and the focus on disproving the
allegations in the NOA, the statutory presumption of validity is not sufficient
defence, in and of itself, to shift the burden of proof to Apotex. The burden
of disproving the allegations in the NOA rests on Abbott and does not shift to
Apotex because of the presumption of validity.
[29]
Therefore,
the issue for this Court is whether Abbott has disproven the allegations made
by Apotex. If Abbott has disproved each of the allegations, a prohibitive
order would issue.
D. EXPERTS
[30]
As
with most NOC proceedings, the parties produce numerous eminently qualified
expert witnesses. The principal witnesses were:
For Abbott:
Dr. Stephen Bryn, a
Ph.D. chemist, and a highly respected scientist and author in the very field of
science in issue. He consults widely in the pharmaceutical industry on the
very questions at issue in this case. Dr. Byrn, says Abbott, “wrote the book”
on Solid State Chemistry of Drugs. He is widely published on the very matters
of the crystal forms of drugs which is the issue in this case.
Dr. Allan Myerson, the
Provost of the Illinois Institute of Technology. He is a Ph.D. chemical
engineer. He also consults to the pharmaceutical industry but on the more
concrete issues of designing processes to crystallize drugs. Dr. Myerson is
also widely published on the process of crystallization in industry and his
leading textbook is in fact called The Handbook of Industrial
Crystallization.
Dr. Jerry Atwood,
Chairman of the Department of Chemistry at the University of
Missouri-Columbia. He is a highly accomplished Ph.D. chemist with broad
expertise in solid-state chemistry.
For Apotex
Dr. Robert McClelland, a
professor of chemistry at the University of Toronto holding both
a B.Sc. (Honours Chemistry) and Ph.D. in Chemistry from that university. His
expertise was in the area of mechanistic organic chemistry, and in the area of
biological and medicinal chemistry. He has been an accepted expert in many
proceedings before this Court.
Dr. Robert Brown, a professor
at Queen’s University, who holds B.Sc. Honours in Chemistry, a M.Sc. Physical
Organic Chemistry and Ph.D. with expertise in mechanistic organic chemistry.
Dr. Michael Cima, a
professor at M.I.T., holds a Ph.D. in chemical engineering with expertise in
material science including the field of polymorphism.
Dr. James B.
Hendrickson, who is a professor at Brandeis University, also has a
Ph.D. with expertise in organic chemistry.
[31]
The
one witness not produced by either party is a person with a B.Sc. in chemistry
or chemical engineering and two to five years experience in pharmaceutical
process development – the “person skilled in the art”. There was a paucity of
evidence about this mythical person. Like the “reasonable man” in tort law,
this person’s knowledge, understanding and actions are described to the Court
through the prism of the battery of experts.
[32]
The
parties engaged in a considerable amount of attack on the respective witnesses,
colloquially, “slagging” their reputations and their findings. Aside from the
rhetoric, these arguments were of little benefit to the parties or the Court.
[33]
I
reject the suggestion that these experts, on both sides, were not qualified and
were not honest in the opinions they held. The fact that some worked for a company
related to one of the parties or that others have been regular expert witnesses
for a particular party was not persuasive in terms of undermining their
credibility.
[34]
What
is important in assessing the evidence is to look at what was said and what was
done and to give the evidence the appropriate weight in the full context of the
record. There is no evidence that any witness deliberately tried to mislead
nor that those who conducted tests did so for the purpose of having the tests
fail.
[35]
On
many key points there was not much direct conflict, discrepancies between
witnesses were generally based on addressing slightly different questions. The
evidence was often carefully nuanced, in part due to equally nuanced questions.
[36]
Dr.
McClelland was singled out for particular attack on his opinions and the
integrity of his evidence. I have found his evidence, both in affidavit form
and under cross-examination, to be clear, cogent and rational. I see no basis
for suggesting that he was anything but forthright.
E. SECTION 27(5) PATENT ACT
[37]
Abbott
defends the patent’s validity, particularly in respect of Claims 1, 15 and
16-21 by arguing that, where a claim is made in the alternative, so long as one
alternative is patentable, the claim is valid. Put another way, Abbott
contends that even if one or more alternatives in the claim includes
unpatentable matter, that fact does not affect the overall validity of that
claim in the patent.
[38]
In
effect, Abbott says that Apotex would have to be able to allege that every
alternative in the '732 patent is not patentable in order to succeed in
this case. Abbott says it would be unfair for it to lose patent protection
just because one small part of a claim was bad.
[39]
Section 27(5) does not speak directly to this
point. The provision reads:
|
27. (5) For greater certainty, where a claim defines the
subject-matter of an invention in the alternative, each alternative is a
separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.
|
27. (5) Il est entendu que, pour l'application des
articles 2, 28.1 à 28.3 et 78.3, si une revendication définit, par variantes,
l'objet de l'invention, chacune d'elles constitue une revendication
distincte.
|
[40]
The starting point of this analysis is the
patent itself and the construction of that patent. The '732 patent
teaches how to obtain Form II by mixing amenes and solvents rather than by
means of heating. The first 15 claims are “method” or “process” claims while
claims 16-21 are compound claims.
[41]
Claim 1 is the broadest claim, Claim 13 relates to
the amenes group and Claim 15 refers to the use of 17 solvents.
[42]
The
principles of patent construction were reviewed by Justice Binnie in Free
World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024 and Whirlpool
Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. The principles were summarized
by Harrington J. in Biovail Pharmaceuticals v. Canada, [2005] F.C.J. No.
7 as follows:
1. A
patent is construed as a bargain between the inventor and the public. In
consideration of disclosing the invention, the inventor is given a temporary
monopoly to exploit it.
2. It
is a statutory requirement that the patent contain a specification and end with
a claim or claims “defining distinctly and in explicit terms the subject-matter
of the invention for which an exclusive privilege or property is claimed”. The
specification must be sufficiently full, clear, concise and exact “as to enable
any person skilled in the art or science to which it pertains, or to which it
is most closely connected, to make, construct, compound or use it”. (Patent
Act, R.S.C. 1985, c. P-4, as amended, s. 27)
3. The
patent is notionally addressed to a person skilled in the art or science of the
subject-matter and is to be read as such a person would have read it when it
first became public. (More will be said about this skilled reader.)
4. The
claims are to be read in an informed and purposive way to permit fairness and
predictability and to define the limits of the monopoly “[I]ngenuity of the
patent lies not in the identification of the desired result but in teaching one
particular means to achieve it. The claims cannot be stretched to allow the
patentee to monopolize anything that achieves the desired result” (Free
World Trust, paras. 31, 32).
5. The
claim portion of the patent specification takes precedence over the disclosure
portion in the sense that the disclosure is read to understand what was meant
by a word in the claims “but not to enlarge or contract the scope of the claim
as written and thus understood” (Whirlpool, para. 52).
6. It
is only such novel features that the inventor claims to be essential that
constitute the “pith and marrow” of the claim. “The key to purposive
construction is therefore the identification by the Court with the assistance
of the skilled reader, of the particular words or phrases in the claims that
describe what the inventor considered to be the “essential” elements of his
invention” (Whirlpool, para. 45).
7. Some
elements of the claimed invention are essential and others are not, based
either on common knowledge when the patent was published or according to the
intent of the inventor, expressed or inferred from the claims. This lies at
the heart of Biovail’s position that Novopharm’s allegation that it will not
infringe the '320 patent is not
justified. Put another way, was it obvious at the time the patent was
published that the substitution of a variant would make a difference?
8. To overclaim
is to lose everything. If the inventor underclaims, the court will not broaden
the monopoly in the interests of the “spirit” thereof. This often, as in this
case, results in layers of claims, each limitation serving as a potential
safety net so that if the broadest claims fail, the monopoly may be saved in
part by the more modest claims.
9. Yet a patent
is not an ordinary writing. It meets the definition of a “regulation” in the Interpretation
Act, and must be read to assure the attainment of its objects. “Claims
construction is a matter of law for the judge, and he was quite entitled to
adopt a construction of the claims that differed from that put forward by the
parties.” (Whirlpool, para. 52)
[43]
The
person skilled in the art has been described by Binnie J. in Free World
Trust v. Électro-Santé Inc. (2000), 9 C.P.R. (4th) 168, at
paragraph 44, as follows:
The courts
have traditionally protected a patentee from the effects of excessive
literalism. The patent is not addressed to an ordinary member of the public,
but to a worker skilled in the art described by Dr. Fox as:
A
hypothetical person possessing the ordinary skill and knowledge of the
particular art to which the invention relates, and a mind willing to understand
a specification that is addressed to him. This hypothetical person has
sometimes been equated with the “reasonable man” used as a standard in negligence
cases. He is assumed to be a man who is going to try to achieve success and
not one who is looking for difficulties or seeking failure. [Fox, H.G. The
Canadian Patent Law and Practice relating to Letters Patent for Inventions 4th
ed Toronto: Carswell
169 at 184]
[44]
Abbott
must establish that there are alternative claims in the relevant claim. This
issue was examined in Abbott Laboratories et al v. The Minister of Health
and Ratiopharm 2005 FC 1095 dealing with this same patent but focused
primarily on non-infringement although issues of validity were also addressed.
The evidentiary base of that case and this instance case are somewhat
different, as were some of the legal arguments.
[45]
Without
reference to any other evidence, I would have immediately adopted the reasoning
of Justice von Finckenstein, principally, that claim 15 uses the exact words
“selected from the group consisting of”, as well as the word “and” instead of
“or” before enumerating the last solvent. That would indicate that the use of
all of the named solvents would produce Form II.
[46]
However,
Dr. Cima, an expert for Apotex, admitted under cross-examination that in
respect of Claim 1, the solvents were claimed as alternatives to each other and
that a person skilled in the art in February of 1998 (the claim date is July
29, 1996) would have understood it to be claimed as alternatives. (Application
Record, Vol. IV (Transcripts), p. 847, Q. 289 and 290)
[47]
Claim
1 and Claim 15 are structured similarly opening with “… a solvent selected from
the group consisting of …” and with “and” as the penultimate word of the claim.
[48]
Dr.
Cima’s answer is the only evidence relied upon by Abbott. Having reviewed his
evidence on this point, it is unclear whether Dr. Cima understood the purport
of the question. His answer flies in the face of the wording of the patent.
There is insufficient evidence, given the multitude of experts who said nothing
about the issue, to say that on the balance of probabilities, there were
alternate claims and the patent would be understood as such. I am not
satisfied that there are alternative claims.
[49]
Even
if Dr. Cima’s answer is to the effect urged by Abbott that there are alternate
claims in Claim 1 and 15, s. 27(5) cannot be interpreted in the manner argued
by Abbott.
[50]
The
specific wording of s. 27(5) limits its application to three sections of the Patent
Act, evidencing a legislative intention to circumscribe the operation of
the section. S. 27(5) did not say something to the effect of “For all
purposes…”.
[51]
The
sections of the Patent Act to which s. 27(5) refers are (a) section 2 –
the definition provision; (b) section 28.1 – the claim date provision; (c)
section 28.2 – the non-prior disclosure provision; (d) section 28.3 – the
non-obvious provision; and (e) section 78.3 – transitional provision related to
s. 43. Therefore, the application of s. 27(5) is very limited within the
operation of the Patent Act itself.
[52]
S.
27(5) is part of the provisions under the heading “Application for Patents”.
The section requires that if there are alternative claims, each alternative
meet the test for patentability – novelty, utility and inventiveness. Failure
to establish that each alternative meets the test for patentability would
result in the alternative being invalid as well as the whole of the claim.
[53]
S.
27(5) does not direct that alternatives in a claim constitute a separate claim
for purposes of either s. 27 and 58. It is particularly significant that s. 58
is not included by reference in s. 27(5) because s. 58 allows a court to sever
an invalid claim from a patent and allow the remainder of the patent to
survive.
[54]
The
conflicting interpretations result in Abbott arguing that so long as one
alternative in a claim is valid, the whole claim is saved and Apotex saying
that if one alternative is proven not to be patentable, the whole claim fails.
[55]
Abbott
makes this argument on the effect of s. 27(5) without reliance on any direct
authority in support. One would have thought that if s. 27(5) had the scope
argued by Abbott, it would have been the subject of at least some learned
writing if not actual decisions of this Court.
[56]
Given
that alternative claims can result in a vast number of claims and the general
adverse consequences of overclaiming, I interpret the application of s. 27(5)
more narrowly than Apotex. It applies only to the named provisions and is
principally an administrative provision for purposes of a patent application.
[57]
Therefore,
even if the claim (1 or 15) is in the alternative, if Apotex establishes that
an alternative is not patentable, the whole claim fails – at least for purposes
of an NOC.
F. NOVELTY
[58]
Apotex
has alleged that Form II is an old product for which Abbott cannot have a valid
patent on the basis of a product by process claim. Hoffman-La Roche &
Co. Ltd. v. Commissioner of Patents (1955), 23 C.P.R. 1 (S.C.C.) is still
good law in Canada; the
principle of novelty is still contained in s. 2 of the Patent Act. I do
not understand Canwell Enviro-Industries Ltd. v. Baker Petrolite Corp. et al
(2002), 17 C.P.R. (4th) 478 to have eliminated the requirement for
novelty. That decision is more relevant to issues of disclosure.
[59]
In
addition, Apotex alleges that Form II has been disclosed prior to the claim
date. For this, it relies most particularly on an article by I.I. Salem
entitled “Clarithromycine found in analytical profiles of drug substances and
excipients” Vol. 24 published by Academic Press Inc. San Diego – 1996.
[60]
Apotex
also relies upon the prior sale and use of the tablets BIAXIN.
Old Product
[61]
As
Dr. Bryn attested, prior to the priority date, Clarithromycine was known
without a numerical reference. It was known to have a melting point of 225°C.
What is now called Form I does not have a melting point, it simply changes its
molecular shape at something beyond 135°C and has now been labelled Form II.
This process of obtaining Clarithromycine through heating was well-known before
the priority date.
[62]
Dr.
Cima confirmed that the '732
patent clearly admitted that the practice at the time of the priority date was to
make Form II (which the '732 patent states to have been in the marketed product
at the time of the priority date of the '732 patent) by thermal conversion at a
temperature greater than 80°C.
[63]
The
evidence of Drs. Hendrickson, Brown and Myerson is all to the same effect -
that Form II was a known product well before the priority date. In essence,
Clarithromycine upon heating moves from Form I, to Form II at 135°C and the
substance melts at 225°C. What Abbott has done is give a name or numerical
designation to each of these forms.
[64]
The
fact that Form II is “old product” was highlighted by five European Patent
Applications dating back as far as 1981 up to 1988 in which solvents were used
to obtain Form II.
[65]
A
similar description of the process was contained in the 1984 Journal of
Antibiotics. To the same effect were articles published in the Journal of
Antibiotics in 1990, 1991 and 1993. The 1980 European Patent Application and
the 1984 Journal of Antibiotics both describe what is Example II in the '732 patent.
[66]
Abbott’s
Dr. Myerson confirmed in cross-examination that the 1980 European Patent
Application describes the same crystallization of Form II using water and
solvents as are described in the '732 patent.
[67]
This
aspect of Apotex’s evidence establishes the allegation in the NOA that Form II
was old product. Abbott has no satisfactory answer to this allegation other
than to say that what was produced, either through heating or the use of
solvents, was not called Form II.
Prior Disclosure/Anticipation
[68]
Apotex
alleged that the invention described in the '732 patent had been anticipated by the Salem article. While the
exact date of publication is not certain, it is certain that the priority date
of the patent was July 29, 1996.
[69]
To
be able to establish anticipation, Apotex must establish that the Salem article was
available to the public in Canada or elsewhere prior to the priority date.
The evidence must satisfy the requirements of subsection 28.2(1)(a) and (b) set
out below:
|
28.2 (1) The subject-matter defined by a claim in an
application for a patent in Canada (the "pending
application") must not have been disclosed
(a) 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 subject-matter became available
to the public in Canada or elsewhere;
(b) before the claim date by a person not mentioned in
paragraph (a) in such a manner that the subject-matter became available to
the public in Canada or elsewhere;
|
28.2 (1) L'objet que définit la revendication d'une
demande de brevet ne doit pas :
a) plus d'un an avant la date de dépôt de celle-ci, avoir
fait, de la part du demandeur ou d'un tiers ayant obtenu de lui l'information
à cet égard de façon directe ou autrement, l'objet d'une communication qui
l'a rendu accessible au public au Canada ou ailleurs;
b) avant la date de la revendication, avoir fait, de la
part d'une autre personne, l'objet d'une communication qui l'a rendu
accessible au public au Canada ou ailleurs;
|
[70]
According
to the affidavit of William Sinden filed on behalf of Apotex, the Salem article was
received in the publisher’s warehouse on July 25, 1996 but was not available
for distribution until August 30, 1996. The U.S. Library of Congress did not
receive its copy until September 5, 1996.
[71]
Holding
a copy of the article in the publisher’s warehouse prior to distribution to
libraries, purchasers and others does not mean that the article “became
available to the public in Canada or elsewhere”. See Canwell
Enviro-Industries Ltd. v. Baker Petrolite Corp. et al, supra.
[72]
There
is no basis for Apotex’s allegation that the article is proof of anticipation.
It does, however, suggest, and purely as a corroborative matter, that Form II
was a known matter. Salem’s secret use of the patented invention is
not itself grounds for invalidating the patent. See Proctor & Gamble
Co. v. Kimberly-Clark of Canada Ltd. (1989), 28 C.P.R. (3d) 226 (reversed
on other grounds, 29 C.P.R. (3d) 545 (C.A.).
[73]
The
second basis for the allegation of anticipation is that there had been prior
sale and use through the tablets BIAXIN which were on the market.
[74]
The
guiding principles respecting subsection 28.2(1)(a) are set out in paragraph 42
of Canwell Enviro-Industries Ltd. v. Baker Petrolite Corp. et al, supra,
in particular paragraph 3:
3. The
prior sale or use of a chemical product will constitute enabling disclosure to
the public if its composition can be discovered through analysis of the
product. The Board of Appeal for the European Patent Office in Fisons PLC
v. Packard Instrument B.V., E.P.O. case number T0952/92-3.4.1, August 17,
1994, stated at p. 21:
… in the
Board’s view it is the fact that direct and unambiguous access to information
concerning the composition or internal structure of a prior used product is
possible, for example by means of analysis, which makes such composition
or internal structure “available to the public” and thus part of the state of
the art for the purpose of Article 54(2) EPC. [emphasis added]
[75]
In
my view, while Hoffman-La Roche, supra, is good law generally
with respect to novelty, it must be applied in a manner consistent with the present
Patent Act. In other words, subsection 28.2 (1)(a) and (b) are to be
applied rather than s. 27(i)(a) of the former Act.
[76]
In
the absence of evidence (such as showing that reverse engineering was feasible)
that BIAXIN could disclose Form II as taught in the '732 patent, Apotex
cannot rely on this allegation of prior disclosure. However, this finding does
not undermine the earlier conclusion that the subject matter of the '732 patent
is “old” product and that Hoffman-La Roche, supra, is still good
law; that one cannot obtain a patent on an old product even by use of a new
process.
[77]
In
addition to the conclusion that Apotex has made out its allegation of “old”
product, the Court must also deal with the allegations of sound prediction,
inutility and insufficiency.
G. SOUND
PREDICTION
[78]
The
basic requirement that the utility for patentability either be demonstrated or
be a sound prediction is laid out in Apotex Inc. v. Wellcome Foundation Ltd.
(2003), 21 C.P.R. (4th) 499 (S.C.C.) (known as the “AZT case”), in
particular at paragraph 69:
69.
With
respect, I think Parliament intended to get something more than speculation in
exchange for the grant of a patent monopoly (a point which is further discussed
below). On the other hand, I do not think, with respect, that the doctrine of
sound prediction is limited to the narrow ambit ascribed to it by the trial
judge. Once it is accepted that in appropriate circumstances utility can be
predicted in advance of complete testing (whether of untested chemical
compounds or otherwise), there seems no reason in principle why the doctrine
should not be applied more generally, depending, of course, on the expert
evidence. There is no doubt that care must be taken that the doctrine is not
abused, and that sound prediction is not diluted to include a lucky guess or
mere speculation. The public is entitled to obtain a solid teaching in
exchange for the patent rights.
[79]
There
are three components to sound prediction:
·
there
must be a factual basis for the prediction;
·
the
inventor must have at the date of the patent application, an articulate and
sound line of reasoning from which the desired result can be inferred from the
factual basis; and
·
there
must be proper disclosure.
[80]
Dr.
McClelland opined that in choosing and using solvents for crystallizing or
recrystallizing, the process is highly unpredictable and highly empirical. Drs.
Brown and Cima’s evidence was to the same effect.
[81]
Abbott’s
Dr. Myerson, in his affidavit evidence, confirmed that the determination of
solvents or solvent compositions which will allow the direct crystallization of
a particular polymorph is a problem which required significant experimentation
and inventiveness.
[82]
Dr.
Myerson reaffirmed this problem of predictability in his cross-examination:
Q: And
that’s because … and the reason for that is that this is pretty delicate work
in the sense that one solvent, ethanol, for example, and alkanol will produce
Form I and yet methanol and alkanol will produce Form II?
A: The
way I would describe it is that a priori, meaning without
experimentation, you cannot predict which solvent will make which form.
[83]
While
Apotex’s Dr. McClelland said that solvents move in unpredictable patterns, Abbott’s
Dr. Myerson acknowledged that at least 2 of the 16 solvents (see Claim 15) in
the '732
patent do not work, others only produce Form I.
[84]
It
is known that in respect of Claim 1, only the benzene and benzene substitutes
work to produce Form II.
[85]
In
my view, given the legal burden imposed in a NOC proceeding for Abbott to meet
Apotex’s NOA, it is not sufficient for Abbott to show that one or two solvents
work and to reap the benefits of patent protection for the whole claim. The
burden is the very opposite.
[86]
The
issue of predictability is further complicated by the vast number of solvent
and solvent combinations which could be used for the crystallization process.
The properties of each solvent affects the process of trying to obtain Form II.
[87]
Abbott’s
theory is that if one solvent of a particular class produces the
“thermodynamically stable form” (Form II), other solvents of that class with
similar properties will do likewise.
[88]
Dr.
McClelland calls that theory into question especially since four common organic
solvents closely related to solvents in the list in Claim 1, along with
unspecified combinations of these four solvents with other common organic
solvents, produce only Form I as stated in the '732 patent.
[89]
In
light of the weight of the evidence indicating unpredictability including the
vast number of substances at issue, I can find insufficient cogent evidence
from Abbott to challenge this allegation in regard to Claim 1. Indeed there
are some admissions by Dr. Myerson which confirm this unpredictability.
[90]
With
respect to Claim 13, Abbott maintains its theory that if one amene works,
others must also work to produce Form II. The theory is similar to that
advanced in respect of solvents in Claim 1.
[91]
As
was pointed out by Apotex’s witnesses, the one example shown to work is the
easiest. The Abbott witnesses’ evidence was general in nature but of little
ultimate assistance. In the face of the evidence on inutility (referred to
further in these Reasons), Abbott must do more than rely on one example which
works when there is evidence that not all examples work.
[92]
Apotex
has made an allegation of unpredictability with the amene group in Claim 13 which
has been supported by the evidence. The unpredictability of amenes is related
to other comments on unpredictability. Abbott has not produced persuasive
evidence through testing to show either that its theory is sustainable or that
Apotex’s allegation has no basis.
[93]
With
respect to Claim 15, Abbott contends that its Claim is not overbroad. It
relies, in part, on Dr. McClelland’s concession that a person skilled in the
art would know from reading the '732 patent that somewhere between 50/50
ethanol-water and 100% ethanol, the combination ratio would stop making Form
II. This is known as the changeover point. The evidence is that it is
implicit in the patent that there is a changeover point.
[94]
A
central criticism of Claim 15 is that the patent discloses no ratios for the
solvents to be used. As stated earlier, there is strong evidence that one
cannot predict which and how the particular solvents would make Form II.
[95]
While
Abbott contends that a person skilled in the art would know the changeover
point, such a person might obtain the information from the disclosure, not from
the claim. There is no evidence as to how such person would know the changeover
point from the claim description.
[96]
In Apotex
Inc. v. AB Hassle et al (2004), 29 C.P.R. (4th) 23 (F.C.A.) at
page 30, the Court of Appeal held that “it is not appropriate
to look to the disclosure to construe the claim and, in particular, to vary the
scope or ambit of the claim”. Abbott cannot rely on the disclosure to cure the
defect in the claim.
[97]
If
the ratios are unnecessary for a person skilled in the art, Abbott failed to
explain why Claim 4 contained a ratio of 1:1. The use of ratios in one part of
the claim suggests that knowledge of ratios is necessary and that it is
necessary to provide the ratios in the claim itself.
[98]
In Halford
v. Seed Hawk Inc. (2004), 31 C.P.R. (4th) 434, Pelletier J. (as
he then was) held that a dependant claim cannot be given a construction which
is inconsistent with the claim on which it depends. Claim 15 is dependent on
Claim 2 which incorporates parts of Claim 1.
[99]
Abbott
has been unable to rebut Apotex’s allegation that Claim 15 is unpredictable.
Abbott would ask the Court to read into Claim 15 a provision which effectively
says that the claim includes those ratios which would be successful in making
Form II. This is an insufficient rebuttal to Apotex’s allegations.
H. INUTILITY
[100] It has been well settled
law that a patent claim which includes inoperable species results in the
entirety of the claim being invalid; see Mineral Separation North America
Corp. v. Noranda Mines Ltd. (1952), 15 C.P.R. (Sec. II) 133; also
see Société des Usines Chimiques Rhone-Poulenc and CIBA, S.A. v. Jules R.
Gilbert Limited et al, [1968] S.C.R. 950.
[101] In my view, s. 27(5) of
the Patent Act has not changed that long-standing proposition of patent
law. Certainly no authority has been cited to me to support the argument that
the law has been changed in such an important way.
[102] In respect of Claim 1,
Apotex argues that this claim includes inoperable species. The evidence
curiously enough establishes not only that some solvents in Claim 1 make Form
I; some make, what is called in another patent, Form III.
[103] International Patent
Application WO 01/402 42 13, December 1, 2000, claims the making of Form 1 and
III through a recrystallization using a solvent claimed in the patent. That same
solvent, acctonitrite (referred to as “polar aprotic”) is claimed in Claim
1(b)(viii) of the '732 patent to make Form II.
[104] Apotex has also established
that the isopropyl acetate and leptane referred to in Claim 1(b)(xii) of the '732
patent is also claimed by Abbott in U.S. Patent 5,858,986 to make Form I.
[105] Abbott has provided no
rebuttal to the documentary and affidavit evidence submitted by Apotex that
Claim 1 of the '732 patent contain inoperable species. Therefore, one can
conclude that Apotex’s submission on this point is correct and that would
conclude the matter on Claim 1.
[106] Furthermore, Apotex ran
a number of experiments on solvents said to be operable to make Form II. The
solvents were methanol, acetone, N, N-dimethylformamide,
ethanol/water (where ethanol is greater than 70% of the mixture),
methanol/water, methanol/isopropyl acetate, and lastly, methanol/ethanol. Each
of these solvents is listed in Claim 1. The experiments did not produce Form
II.
[107] While Abbott criticizes
the experiments – an issue dealt with later – it chose not to file any rebuttal
evidence. Given the nature of NOC proceedings, it was incumbent on Abbott to
rebut Apotex’s allegations, otherwise the allegation stands.
[108] The evidence from these
experiments also calls into question Abbott’s general theory of operability;
that if one solvent produces Form II, all of the listed solvents and solvent
compounds do. The credibility of this thesis is severely undermined by this
evidence and the evidence referred to earlier in these Reasons.
[109] With respect to Claim
13, Apotex again says that it contains inoperable species – that it lacks
utility. The starting point of the evidence is Example 16 of the '732 patent on
which Apotex’s experts performed its test. Example 16 reads:
Example 16
Recrystallization from
Isopropylamine
A clear
solution resulting from addition of 6-0-methylerythromycin A (8.0 g) to
isopropylamine (50 mL) was stirred overnight at ambient temperature. When no
precipitate formed, and additional 10.4 g of 6-0-methylerythromycin A
was added. The clear solution was stirred overnight at ambient temperature
during which time a precipitate formed. The solid was collected by filtration
and dried in the vacuum oven (2-4 in Hg, 45-50°C) to give 6-0-methylerythromycin
A Form II (16.2 g).
[110] The actual tests were
performed by Brantford Chemicals Inc. (“BCI”), a company related to Apotex. Dr.
Allen Rey, the Assistant Manager, Research and Development was asked to carry
out and/or supervise the testing of Example 16.
[111] The actual testing was
done by Dr. Rocha and the test results were reviewed by Dr. Rey. The result
was that no solid (the result of a successful recrystallization) was obtained
on three occasions, June 10, 13 and 17.
[112] In these proceedings,
Dr. McClelland’s evidence was that BCI followed the instructions in Example 16
precisely. His evidence compares the steps in Example 16 with those of BCI –
they are virtually identical except that BCI used half the Clarithromycine and
half the isopropylamine and left the substance overnight at 20-25°C (whereas
Example 16 calls for “ambient temperature”).
[113] In the face of Apotex’s
evidence of the test and the conclusions of both Dr. McClelland and Dr.
Hendrickson, to the effect that the test was done properly, consistent with a
person skilled in the art and showed that there was no basis for sound
prediction or utility, Apotex obtained leave of the Court to file reply test
evidence.
[114] Abbott’s reply test
evidence was submitted by Dr. Chyall, which showed that his test worked. However,
Dr. Chyall was given instructions by counsel on how to conduct the test which
included bubbling with nitrogen to a specific line on the beaker.
[115] Then what followed was a
number of affidavits from each side’s respective experts criticizing the
others’ test procedures. Abbott has added a further objection – the BCI test
results were hearsay because the evidence came from Dr. Rey whereas it was Dr. Rocha
who performed the test.
[116] The criticism of
Apotex’s test includes the allegation that since Example 16 is, in part, an
evaporation process, BCI’s failure to “uncap” the substance and allow for
evaporation is a fatal flaw. If the term “ambient temperature” was meant to
direct evaporation, then BCI’s test would have contained a major flaw.
[117] Apotex counters with the
allegation that Abbott’s test was performed according to a “secret protocol”
from counsel. That protocol was significantly different from what was called
for in Example 16.
[118] For reasons given
earlier, I have rejected the arguments that any of these witnesses attempted to
mislead the Court, that because of relationships with a party, they were
prepared to “skew” the results or their opinion. I also do not accept that
those performing the tests did not approach the task “with a mind willing to
understand”. Certainly there is no evidence that those witnesses approached
their tasks with closed minds.
[119] The argument on this
testing can be distilled to whether a person skilled in the art would know that
Example 16 called for an overnight evaporation. The opinion evidence is, as
one would expect, evenly split. There is nothing in the text of Example 16 to
indicate that evaporation was called for.
[120] Abbott’s position would
be stronger if its test had followed Example 16 precisely (as did Apotex) but
had allowed for overnight evaporation. Instead, Apotex chose to do a quite
different test – a telling comparison between Example 16 and Abbott’s test is
found at page 8 of Dr. McClelland’s reply affidavit.
[121] Given the conflict in
the evidence, I accept Apotex’s test and conclusions because they are most
closely in line with what is described in Example 16. There is insufficient
compelling evidence that a person skilled in the art would have conducted the
test as was done by Abbott’s Dr. Chyall.
[122] Abbott has failed to
make out its challenge to Apotex’s allegation on the issue of inutility of
Claim 13. Apotex’s evidence of inutility is significantly stronger than any
rebuttal evidence.
[123] With regard to Claim 15,
some of the same issues are raised as for Claim 13, most particularly the issue
of hearsay and of insufficiency of disclosure in the patent.
[124] Apotex again used BCI to
conduct experiments on the solvents in Claim 15, specifically methanol,
acetone, N, N-dimethylformamide, ethanol/water where ethanol
greater than 70% of mixture, methanol/water, methanol/isopropyl acetate,
methanol/ethanol. These solvents also appear in Claim 1(b).
[125] The results of those
experiments is that these solvents for the most part produced Form I (some did
not work at all) but never Form II.
[126] As rebuttal, Abbott ran
a test of Example 10. The evidence of the test results came from Dr. Chyall.
[127] In performing the test,
Dr. Chyall chose to do the test in a manner not described in Example 10.
Moreover, Abbott’s Dr. Atwood admitted that with the solvent combinations, one
would have to experiment to find the correct ratios. It was said that a person
skilled could obtain this information relatively easily.
[128] However, what the
experiments do establish is that there is a serious question about the adequacy
or sufficiency of the disclosure in the claim.
[129] Example 16 does not
mention evaporation. Dr. Chyall had to use a “protocol” to do his experiment
and had to follow a method not called for in the patent when doing Example 10.
[130] Given the nature of
these “off” claim procedures, I conclude that Abbott has not shown the
sufficiency of its claim disclosure.
[131] In addition, and as
raised in respect of Claim 13, Abbott asks the Court to reject all of Apotex’s
test evidence on the basis that it is hearsay. This is a narrow basis upon
which to defend an allegation of inutility rather than facing the allegation head
on with other test evidence to establish that the claims actually work.
[132] The courts are less
reluctant to accept hearsay evidence than in the past and even this Court’s
Rules must be read in light of the developing law from the Supreme Court of
Canada. The hearsay evidence will be admissible if it is necessary and
reliable.
[133] In my view, Dr. Rey
would be an appropriate affiant as he had overall supervision and
responsibility for the tests. It is not immediately obvious that each of the
people involved in a test must provide affidavits. It is not necessary that
each person who performed a function related to the test file an affidavit
attesting to their specific function. Dr. Rocha was Dr. Rey’s surrogate in
performing some of the physical functions of the test and recording the
results.
[134] I also conclude that his
evidence is sufficiently reliable. Dr. Rey not only was responsible for the
tests, he supervised and observed the tests. There is no requirement that he
stand by the testing equipment at all times.
[135] The evidence establishes
that the laboratory notes were kept in a proper way consistent with standard operating
protocol.
[136] Even if the test results
were inadmissible through Dr. Rey, other expert witnesses (e.g. Dr. McClelland)
commented on those tests and opined that they were performed correctly. As
expert evidence, it is permissible for the expert to comment on work done by
others. While the weight given to that expert opinion will be affected by the
reliability of the test evidence, the opinion is still admissible.
[137] However, as hearsay
evidence, there may be issues of weight arising from the evidence. Given the
nature of the tests and the absence of compelling evidence which undermines
what was said to have been done, the evidence must be given significant
importance.
[138] Moreover, Abbott had its
opportunity to deal with any alleged infirmities due to the hearsay nature of
Dr. Rey’s evidence. In respect of Example 16 tests, it had an opportunity to
submit rebuttal test evidence, which it did.
[139] With respect to Claim 15
and the hearsay evidence, it brought a motion to strike portions of Apotex’s
expert affidavits. Abbott’s complaint was that Dr. Rey’s evidence was hearsay,
that he did not have sufficient direct knowledge to be able to respond to
cross-examination.
[140] Prothonotary Aronovitch
ordered Apotex to produce a further witness to address Abbott’s complaint.
Apotex offered to produce Dr. Rocha. Abbott did not take up the offer despite
having gone to Court to obtain that very opportunity.
[141] Abbott elected to
challenge the hearsay evidence by requiring Apotex to produce another witness.
It then chose not to cross-examine that witness. It is too late in the day,
too prejudicial to the parties and to the orderly resolution of this case, to
disregard this evidence.
I. CONCLUSION
[142] The record before the
Court contained certain confidential information. To ensure that there is no
inadvertent disclosure of that information, the parties will have 14 days from
the release of these reasons to make submissions on the disclosure in the
public version of these reasons.
[143] Given that Abbott has
failed to disprove Apotex’s allegations in respect of Claims 1, 13 and 15 and,
more particularly, the allegations that the '732 patent claims are neither
novel, nor reasonably predictable, nor that they have utility, this application
for a prohibition will be dismissed with costs to Apotex in accordance with
Column III of this Court’s Tariff.
“Michael
L. Phelan”
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