Apotex Inc. v. ADIR

Apotex Inc. v. ADIR
Court (s) Database
Federal Court of Appeal Decisions
Date
2009-06-30
Neutral citation
2009 FCA 222
File numbers
A-393-08
Decision Content
Federal Court of Appeal
CANADA
Cour d'appel fédérale
Date: 20090630
Docket: A-393-08
Citation: 2009 FCA 222
CORAM: LINDEN J.A.
EVANS J.A.
LAYDEN-STEVENSON J.A.
BETWEEN:
APOTEX INC.
and
APOTEX PHARMACHEM INC.
Appellants
and
ADIR and
SERVIER CANADA INC.
Respondents
Heard at Toronto, Ontario, on June 1-2, 2009.
Judgment delivered at Ottawa, Ontario, on June 30, 2009.
REASONS FOR JUDGMENT BY: LAYDEN-STEVENSON J.A.
CONCURRED IN BY: LINDEN J.A.
EVANS J.A.
Federal Court of Appeal
Cour d'appel fédérale
Date: 20090630
Docket: A-393-08
Citation: 2009 FCA 222
CORAM: LINDEN J.A.
EVANS J.A.
LAYDEN-STEVENSON J.A.
BETWEEN:
APOTEX INC.
and
APOTEX PHARMACHEM INC.
Appellants
and
ADIR and
SERVIER CANADA INC.
Respondents
REASONS FOR JUDGMENT
LAYDEN-STEVENSON J.A.
[1] This is an appeal by Apotex Inc. and Apotex Pharmachem Inc. (collectively Apotex) from the judgment of Justice Snider dated July 2, 2008, in an action for infringement of Canadian Patent No. 1,341,196 (the '196 Patent).
[2] The respondents, ADIR and Servier Canada Inc. (referred to throughout these reasons interchangeably as ADIR or Servier), commenced an action against Apotex alleging that it infringed ADIR’s '196 Patent. Apotex defended the action on several fronts. Among other things, it asserted: the '196 Patent is invalid because it is not inventive in light of prior disclosures and the common general knowledge; ADIR was not the first inventor; the patent lacks utility; and, there was no basis for sound prediction on the Canadian filing date. By counterclaim, Apotex claimed damages under section 36 of the Competition Act, R.S.C., 1985, c. C-34 (the Competition Act) on the basis that ADIR obtained the '196 Patent in breach of section 45 of the Competition Act.
[3] Justice Snider concluded, among other things, that claims 1, 2, 3 and 5 of the '196 Patent are valid and have been infringed by Apotex. She dismissed Apotex’s counterclaim. Although Apotex advances several grounds of appeal and alleges many errors on the part of the trial judge, no issue is taken with respect to her determination on infringement (if her conclusion on validity is sustained) or remedies (if Apotex is unsuccessful on this appeal).
[4] For the reasons that follow, I conclude that Apotex’s allegations of error largely relate to factual determinations made by the trial judge for which Apotex has not demonstrated palpable and overriding error. I also conclude that, to the extent that Apotex’s arguments relate to questions of law, the trial judge did not err as alleged. Consequently, I would dismiss the appeal.
BACKGROUND
[5] ADIR is an innovator pharmaceutical company. It owns the '196 Patent. Servier exploits the patent rights in Canada. The application for the '196 Patent was filed on October 1, 1981. Consequently, the pre-October 1, 1989 version of the Patent Act, R.S.C. 1985, c. P-4 (the Patent Act) applies. References to the Patent Act in these reasons, unless otherwise specified, are references to the pre-October 1989 Patent Act.
[6] The patent claims priority from two patent applications filed in France on October 2, 1980 and April 7, 1981. This proceeding concerns claims 1, 2, 3 and 5, which read:
1. Composés répondant à la formule générale
dans laquelle :
R1 représente un atome d'hydrogène ou un groupe alkyle de 1à 4 atomes de carbone
R2 représente un groupe alkyle linéaire de 1 à 6 atomes de carbone et leurs sels d'addition pharmaceutiquement acceptables.
2. Un composé selon la revendication 1 où R2 est un alkyle de 3 ou 4 atomes de carbone et leurs sels pharmaceutiquement acceptables.
3. Un composé selon la revendication 1 où R2 est un n-propyle et ses sels pharmaceutiquement acceptables.
5. Le composé selon la revendication 1 qui est le {N - [(1,S) éthoxycarbonyl - 1 butyle] (S) - alanyle} - 1 carboxy – 2(S) (3aS,7aS) perhydroindole et ses sels pharmaceutiquement acceptables.
[7] The '196 Patent was issued following lengthy conflict proceedings involving applications filed by Schering Corporation (Schering) and Hoechst Aktiengesellschaft (Hoechst). The proceedings were ultimately resolved by order of the Federal Court, on consent, dated December 12, 2000. Claims 1-3 of the '196 Patent were issued on March 6, 2001 and expire on March 6, 2018. Claim 5 of the '196 Patent was twice corrected and was issued, in its present form, on May 14, 2001. It expires on May 14, 2018.
[8] At issue in this case is the development of angiotensin-converting enzyme (ACE) inhibiting compounds. ACE is an enzyme that can bind with the angiotensin I protein to produce angiotensin II, which increases blood pressure by constricting blood vessels. ACE inhibitors bind with ACE to prevent the conversion of angiotensin I to angiotensin II, thereby lowering blood pressure. The first orally effective ACE inhibitor, captopril, was invented by Bristol-Myers Squibb (Squibb) around 1977.
[9] Following the invention of captopril, other pharmaceutical companies began working to develop ACE inhibitor research programs. In response to the serious side effects experienced by some users of captopril, Merck & Co. (Merck) developed a new ACE inhibitor, enalapril, which it presented at a conference in Troy, New York (“the Troy conference”) on June 18, 1980. Enalapril has an N-carboxyalkyl moiety in place of captopril’s problematic sulfhydryl methylene group. Both captopril and enalapril contain the same proline unit.
[10] Both Schering and ADIR had been working with ACE inhibitors before the Troy conference. Following this disclosure, Schering and ADIR, among others, turned their attention to building upon the enalapril molecule.
[11] Schering’s research focused on the use of various bicyclic rings in place of proline on an enalapril-like molecule. One of the Schering compounds created through this work contained molecules with a perhydroindole ring structure in place of the proline unit. Schering applied for a patent on October 20, 1981, and was eventually granted Canadian Patent No. 1,341,206 (the '206 Patent). The '206 Patent covers the ramipril molecule, an ACE-inhibiting compound. Schering and its licensees have marketed ramipril to great commercial success.
[12] ADIR’s work also focused on the use of bicyclic rings in place of proline on the Merck backbone. In 1981, Dr. Vincent, an ADIR scientist, created a molecule with a perhydroindole ring on the proline end of an enalapril-like molecule (also referred to as the C-terminus), but also used a propyl on the side chain at the other end (also referred to as the N-terminus). On September 1, 1981, ADIR tested an enatiomerically-pure (S) salt of this compound, know as perindopril. It filed Canadian Patent Application No. 387,093 (the '093 Application) in respect of this work.
[13] Schering and Hoechst had also filed patent applications in respect of various ACE-inhibiting compounds. The Commissioner of Patents (the Commissioner) placed the '093 Application, Patent Application 388,336 (Schering), Patent Application 384,787 (Hoechst), and Patent Application 418,453 (Hoechst) into conflict as provided for in the Patent Act.
[14] The Commissioner made determinations pursuant to subsection 43(7) of the Patent Act on August 8, 1996. None of the applicants were satisfied with the results and six proceedings were commenced in the Federal Court pursuant to subsection 43(8). These proceedings were later consolidated into Court File Number T-228-97 pursuant to an order of Mr. Justice Joyal (the Joyal order).
[15] ADIR, Hoechst, and Schering ultimately settled this proceeding. On December 12, 2000, Justice Nadon, then of the Federal Court, granted an order, on consent, allocating the claims among the parties (the Nadon order). The '196 Patent covers the claims awarded to ADIR.
[16] Servier is a licensee of ADIR and manufactures perindopril for sale in Canada. Perindopril is one of a family of compounds. It is an ACE inhibitor and is useful in the treatment of hypertension and cardiac insufficiency. Perindopril is the active ingredient in the medicine Servier sells in Canada under the trade-mark COVERSYL. Since at least 2006, Apotex, a generic company, has manufactured perindopril products in Canada and exported them internationally to affiliates and others.
THE TRIAL DECISION
[17] After 30 days of trial, Justice Snider determined that the '196 Patent is valid and Apotex had infringed it. As noted previously, she dismissed the Apotex counterclaim under the Competition Act. A summary of Justice Snider’s conclusions follows.
Standing
[18] The trial judge held that only ADIR and Servier Canada had standing as plaintiffs. The evidence was not persuasive enough to support a finding that the non-ADIR foreign plaintiffs held a license to use the '196 Patent in Canada or could otherwise claim under the patentee, ADIR.
Claims Construction
[19] The construction of claims 1, 2, 3 and 5 of the '196 Patent was not contentious. Justice Snider performed a purposive construction of the claims. She identified the person skilled in the art (the skilled person) as an individual having at least a few years’ experience in academia or industry in the respective field and holding a Master or Doctoral degree in synthetic organic chemistry, medicinal chemistry, pharmacology or biochemistry, or, a medical doctor having several years experience treating hypertension or cardiac insufficiency in humans.
[20] Justice Snider found that a skilled person would construe the claims at issue as follows:
Claim 1 corresponds to a subset of compounds falling under General Formula I where R1 is defined as a hydrogen atom or an alkyl group with one to four atoms, and R2 is a linear alkyl group with one to six carbon atoms, and their pharmaceutically acceptable salts. Claim 1 has five chiral centres but does not specify any particular stereochemical designation for any of the stereocentres. It is an essential element that each compound of the claim contains both a bicyclic 6,5 perhydroindole moiety on the C-terminus and a linear alkyl group with one to six atoms on the N-terminus.
Claims 2, 3 and 5 are dependent on claim 1. As dependent claims they are necessarily more limiting than claim 1 and must be construed consistently with the larger claim.
Claim 2 corresponds to a subset of compounds falling under claim 1 wherein R2 is restricted to n-propyl or n-butyl, and their pharmaceutically acceptable salts. Claim 2 has five chiral centres but does not specify any particular stereochemical designation for any of the stereocentres.
Claim 3 corresponds to a still narrower set of compounds falling under claim 1 where R2 is limited to n-propyl, and their pharmaceutically acceptable salts. As with claims 1 and 2, claim 3 has five chiral centres but does not specify any particular stereochemical designation for any of the stereocentres. Because there are five chiral centres or stereocentres, claim 3 encompasses 32 (25) different compounds.
Finally, claim 5 (as it stands today) corresponds to a single stereoisomer where each of the 5 chiral centres is designated as (S). It is undisputed that claim 5 encompasses perindopril as well as its pharmaceutically acceptable salts. Although worded as a dependent claim (« Le composé selon la revendication 1 »), the claim is to a single compound. The words that indicate dependency are unnecessary to the construction of claim 5.
Nature of the Invention
[21] The debate between the parties was whether, in light of the description, the claims should be construed as being examples of one alleged invention or class of compounds encompassing all of General Formula I, or whether the claims should stand on their own. Justice Snider concluded that claims 1, 2, 3 and 5 form one or more inventions that are distinct from the larger class of compounds of General Formula I in the description. The invention claimed by the patent, on a purposive construction of the claims at issue, is that disclosed by claims 1, 2, 3 and 5.
Direct Infringement
[22] Justice Snider found there was ample evidence of direct infringement by Apotex. By its manufacture and sale of perindopril products under the trade name Apo-Perindopril, Apotex made, constructed, used, offered for sale and sold perindopril products that are included in claims 1, 2, 3 and 5 of the '196 Patent.
Inducement
[23] Justice Snider applied the test for inducement set out in Warner Lambert v. Wilkinson Sword Canada Inc. (1988), 19 F.T.R. 198, 19 C.P.R. (3d) 402 (F.C.T.D.) (Warner Lambert). She concluded that the first branch of the Warner Lambert test was not met and found there was no inducement.
Exemptions from Liability
[24] Justice Snider found that Apotex is not liable for the identified quantities of perindopril which fit within the regulatory and experimental use exemption of section 55.2 of the Patent Act (post October 1, 1989). Apotex is liable for its export sales. The infringement by Apotex involves, in part, the manufacture of perindopril for export. To that extent, Apotex infringed the '196 Patent and is liable to Servier Canada and ADIR.
Corrections to Claim 5
[25] Justice Snider rejected Apotex’s claim of non-infringement of claim 5 on the basis that the Commissioner of Patents twice improperly corrected the claim.
Judicial Review
[26] In reaching this conclusion, the trial judge was not persuaded by Servier’s argument that Apotex was required to proceed by way of judicial review. She found that sections 59 and subsections 60(1) and 60(2) of the Patent Act permit Apotex to make claims of invalidity based on unlawful actions of the Commissioner as a defense to infringement.
Standard of Review
[27] Justice Snider applied Dunsmuir v. New Brunswick, [2008] 1 S.C.R. 190 (Dunsmuir). She concluded the applicable standard of review was reasonableness and applied that standard.
Reasonableness of Decision
[28] The trial judge held that the decisions reached by the Commissioner to correct claim 5 under section 8 of the Patent Act were reasonable. She also concluded that the corrections were clerical errors.
Obviousness
C-terminus
[29] Justice Snider relied on the test for obviousness and the framework for applying the test set out in Janssen-Ortho Inc. v. Novopharm Ltd., 2007 FCA 217, 59 C.P.R. (4th) 116 (F.C.A.), leave to appeal dismissed, [2007] S.C.C.A. No. 442 (Janssen-Ortho). She was not persuaded that the addition of the 6,5 perhydroindole bicyclic ring was obvious.
Invention
[30] The trial judge found the invention to be a bicyclic 6,5 moiety on the C-terminus of the compound and a linear alkyl group with 1 to 6 carbon atoms on the N-terminus.
Person of Ordinary Skill
[31] As noted earlier, Justice Snider determined that the hypothetical skilled person includes a number of skilled individuals with experience in work or academia, holding a Master, Doctoral, or medical degree.
Body of Knowledge
[32] Justice Snider outlined the evidence forming the state of the art. She did not include the art outside the field of ACE inhibition cited by Apotex because Apotex had not established that a skilled person would look beyond the field at issue.
Climate in the Field
[33] Justice Snider found that the general trend in the prior art was that the S2 prime subsite of ACE was capable of accepting a wide variety of moieties, some of which were larger than perhydroindole. Further, the trial judge acknowledged there were two moieties taught in the prior art, tryptophan and THIQ, which contained bicyclics. She accepted that a medicinal chemist would have the skill to use SAR methodology to manipulate chemical compounds. However, she found that Apotex had not established how the skilled person, without inventiveness or ingenuity, could collate the prior art on ACE inhibitors (and even some sources outside the ACE inhibition field), make some fundamental assumptions and combine this knowledge to come up with a perindopril molecule. The trial judge accepted expert evidence that small changes in structure can have unpredictable pharmacological effects.
Motivation
[34] Justice Snider found there was recognition after the Troy conference of a specific problem to solve, namely, to come up with a better ACE inhibitor than that developed by Merck. The evidence suggested the existence of a general motivation in the industry to build upon, and not merely work around, the Merck disclosure at the Troy conference. The evidence also suggested that inventive ingenuity was employed.
Time and Effort
[35] While it was uncontested that ADIR, Hoechst, Warner-Lambert and Schering developed compounds incorporating bicyclic ring modifications after Merck’s disclosure at the Troy conference, the trial judge was not satisfied on the record that any of the other chemists discovered perindopril with its 6,5 bicyclic ring and a linear alkyl group. Further, there was no evidence that any of the other compounds were developed by persons of ordinary skill. Rather, Doctors Smith and Vincent were inventive and ingenious, not persons of ordinary skill.
Commercial Success
[36] It was not contested that Servier achieved commercial success with sales of perindopril.
N-terminus
[37] In addition to her conclusions regarding the C-terminus, Justice Snider observed that it was immaterial that there was no language in the description of the '196 Patent to limit the invention to a linear alkyl sidechain since the invention was not General Formula I. Further, although there was disclosure of substituents with linear alkyl sidechains, there was no evidence that a person of ordinary skill in the art would be expected to select this class of substituents from the numerous others recorded, without difficulty.
Utility
[38] Justice Snider found that Apotex had not satisfied its burden to show that the compounds of claims 1, 2 and 3 of the '196 Patent lack utility.
Promise of the '196 Patent
[39] Based on the patent’s disclosure, Justice Snider held that the promise of the '196 Patent is that all of the compounds claimed will have some level of ACE inhibition when measured in vitro and that some of the compounds will have sufficient activity to treat hypertension and cardiac insufficiency.
The 1992 Vincent Article
[40] Justice Snider held that the 1992 Vincent Article does not, on a balance of probabilities, either expressly or by inference, demonstrate that any of the compounds of claim 3 of the '196 Patent lack utility. She accepted Dr. Vincent’s explanation that the purpose of the article was not to describe absolute activity or inactivity. She noted that the underlying test data showed that none of the compounds had a zero activity level. She concluded that the “admission” of Dr. Laubie on this point was ambiguous in regard to whether there was zero activity in vitro or in vivo.
The Gavras Report
[41] Justice Snider determined that the Gavras Report did not establish a lack of utility for the compounds of claim 3. Since she already had found that a “therapeutic anti-hypertensive effect” is not the promise of the patent, she considered that the testing results were irrelevant. In any event, Justice Snider found that the testing methodology of Dr. Gavras was so seriously flawed she could give little weight to his results.
Sound Prediction
[42] Justice Snider applied the three-part test for sound prediction set out in Apotex Inc. v. Wellcome Foundation Ltd. (2002), 21 C.P.R. (4th) 499 (S.C.C.) (Wellcome) and concluded that Apotex had not met the burden of demonstrating the skilled person, as of the filing date, could not soundly predict that the trans compounds of claims 1, 2 and 3 would have utility.
The (R,R,R) Compounds
[43] The trial judge was not persuaded that Servier did not have a sound basis for predicting that compounds with the (R,R,R) configuration on the backbone of the molecule would possess the promised ACE-inhibitory utility of the '196 Patent. She held that the prior art, most notably Merck’s European Patent Application 0 012 401 A1 (the '401 Application) and Patchett, A. A. et al., “A new class of Angiotensin-converting enzyme inhibitors” 288 Nature 280 (the Nature paper), form a factual basis and sound line of reasoning for predicting that there would be some level of ACE inhibition, even if low.
The Trans Compounds
[44] Justice Snider rejected Apotex’s allegations that Servier could not have soundly predicted the utility of the compounds in claims 1, 2 and 3 containing trans configuration of the two asymmetrical carbon atoms on the fused 6,5 bicyclic ring at the time of the Canadian filing date since a skilled person would not, as of the relevant date, have known how to synthesize such compounds.
Inventorship
[45] Apotex failed with respect to its argument that the ADIR scientists were not the first inventors of the compounds patented under the '196 Patent. Justice Snider interpreted subsection 61(1) of the Patent Act as applying only where there had been a “missed conflict.” In considering the object of the Patent Act with respect to first inventorship and predictability, she found that Parliament provided that a patent issued pursuant to the conflict process is protected from further attacks on the question of inventorship, except in the circumstances contemplated by the Patent Act, specifically, paragraph 61(1)(b). As such, these proceedings were intended to be final on the issue of inventorship. Apotex’s interpretation that inventorship could be raised whether or not conflict proceedings had occurred would have the effect of rendering meaningless the words “on which conflict proceedings should have been directed” in paragraph 61(1)(b).
[46] Justice Snider held that Apotex was precluded from challenging the validity of the '196 Patent on the grounds of inventorship because the claims involved in the conflict proceedings were ones on which conflict proceedings had been directed.
[47] The trial judge also concluded that Apotex had failed to satisfy its evidentiary burden to demonstrate that Schering scientist, Dr. Smith, was the first to know or use the invention of the '196 Patent. Although she accepted that Schering had made at least one compound with ACE inhibition activity that falls within General Formula I before the ADIR scientists made and tested their two compounds, as previously stated, she found that the invention of the '196 Patent was contained in the claims and not General Formula I.
Competition Act
[48] Justice Snider dismissed Apotex’s counterclaim seeking damages pursuant to section 36 of the Competition Act. She concluded the law is settled that without “something more”, the mere assertion of patent rights cannot be a violation under section 45 of Competition Act. Each step in the conflict proceedings and issuance of the '196 Patent was in accordance with the Patent Act or Federal Courts Rules. On the facts before her, she held that the requisite “something more” was not present. Thus, the '196 Patent could not give rise to a violation of section 45 of the Competition Act. Prior to the issuance of the '196 Patent, there could be no impairment of competition. Following the issuance of the patent, Servier had only as much market power as was inherent in the ‘196 Patent. ADIR was merely exercising its rights under the Patent Act.
[49] In the alternative, Justice Snider held that the two-year limitation period set out in subsection 36(4) of the Competition Act had expired. She found that since there was no ongoing collusion, the limitation period ran from the date of the settlement agreement or, at latest, the issuance of the patent. She further held that the discoverability principle did not apply since subsection 36(4) of the Competition Act expressly defines a specific date on which the limitation period begins, independent of knowledge of a cause of action. Even if the discoverability period did apply, Justice Snider held Apotex became aware of and received a copy of the Settlement Agreement in April 2003. As such, the latest date from which the two-year limitation period could run (based on discoverability) would be April 2003. She therefore found that Apotex was well beyond the two-year limitation contained in subsection 36(4) of the Competition Act.
[50] On the issue of whether ADIR’s allegedly anti-competitive actions serve to disentitle Servier to equitable relief, Justice Snider held that in entering into the Settlement Agreement, Servier (or ADIR) was exercising its rights under the Patent Act. As such, the trial judge found that Apotex failed to show that there was conduct that would disentitle Servier to any of the equitable remedies that it may seek.
Remedies
[51] Justice Snider found that Servier Canada and ADIR are entitled to:
A declaration of the validity of the '196 Patent;
A permanent injunction, subject to the right of Apotex to sell its perindopril products for a further 30 days from the date of the judgment;
Damages to be quantified subsequent to judgment (as a result of an Order dated March 14, 2007, in which Prothonotary Aronovitch provided for a bifurcation of the trial of this action so as to leave the calculation as to quantum of damage or profits to a later time); and
Pre and post-judgment interest.
Issues
[52] Apotex alleges various errors on the part of the trial judge. Many of its arguments are largely a reiteration of those made to the trial judge. The alleged errors are subsumed under the titles identified below. Where distinct subsidiary issues arise with respect to a specific topic, they are so indicated.
(a) Nature of the Invention
(b) Obviousness
(1) the trial judge applied the wrong test;
(2) the trial judge tested as of the wrong date;
(3) the trial judge erred in unduly narrowing the field of relevant art;
(4) the trial judge erred in applying the standard.
(c) First Inventorship
(d) Utility
(e) Sound Prediction
(f) Claim 5 Corrections
(g) Competition Act
The Relevant Statutory Provisions
[53] The text of the statutory provisions referred to in these reasons is attached as Appendix “A”.
Nature of the Invention
[54] Apotex asserts that the trial judge erred in ascertaining the invention of the '196 Patent. Distilled, its arguments are that the trial judge asked herself the wrong question, erred in failing to follow May & Baker Limited et al. v. Boots Pure Drug Company Limited (1950), 67 R.P.C. 23 (H.L.) (May & Baker) and in concluding that the specific compounds claimed in the '196 Patent constitute separate inventions rather than various aspects of the same invention. At the end of the day, these allegations amount to a single complaint: Justice Snider did not agree with Apotex that the invention of the patent is the larger class of compounds of General Formula I and nothing more.
[55] The question identified by Apotex as central to its argument is: “what did [the alleged inventor] invent?” It argues that the trial judge erroneously concluded, contrary to May & Baker and subsection 36(1) of the Patent Act (which states that a patent shall only be granted for one invention), that claims, 1, 2, 3 and 5 of the '196 Patent disclose one or more inventions distinct from the larger class of compounds encompassed by General Formula I described in the specification. Such a conclusion, according to Apotex, “cannot be right as a matter of law” because it conflates the concepts of invention and monopoly.
[56] Apotex maintains May & Baker stands for the proposition that an invention cannot be found to exist in two specifically exemplified compounds distinct from the disclosed invention of a general class. Noting that there was no issue regarding the construction of the claims per se, Apotex contends that the general formula found in the disclosure constitutes the invention. In relying on C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201, aff’d., [1963] S.C.R. 410 (Boehringer) and Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co., [1965] 1 Ex. C.R. 710, aff’d., [1966] S.C.R. 189 (Hoechst) to conclude otherwise, Apotex asserts that the trial judge erred because questions of construction and ascertainment of the invention disclosed by a patent are not matters of binding jurisprudential precedence.
[57] For a variety of reasons, I am not persuaded that Justice Snider erred as alleged. Paragraph 34(a) of the Patent Act requires an applicant to correctly and fully describe the invention and its operation or use as contemplated by the inventor. Paragraph (e) of the same section requires the applicant to particularly indicate and distinctly claim the part, improvement, or combination that he claims as his invention.
[58] Whirlpool Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 (Whirlpool) decides that claims construction is antecedent to issues of both infringement and validity. It also stands for the proposition that purposive construction requires a court to have regard to the whole of the patent (including the claims and the disclosure) when ascertaining the nature of the invention. Indeed, several of the authorities cited in Apotex’s memorandum of fact and law illustrate the application of these principles. More recent authority indicates that the inventive concept need not be readily discernable from the claims, even in circumstances where construction of the claims is not in issue. A bare chemical formula may require recourse to the specification to determine the inventive concept of the claims: Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265 (Sanofi).
[59] The trial judge proceeded precisely in accordance with the holdings of the above-noted jurisprudence. She examined the patent as a whole to ascertain its invention in circumstances where there was really no debate as to the construction of the claims. When confronted with competing positions as to the nature of the invention, she turned to relevant jurisprudence where a broad class of compounds was described in the disclosure and narrower claims to compounds were stated in the claims. To assist in her analysis, she referred to Boehringer, Hoechst and the decision of this Court in Merck & Co. Inc. v. Apotex Inc., 2006 FCA 323, [2007] 3 F.C.R. 588, leave to appeal refused, [2006] S.C.C.A. No. 507 (Merck lisinopril).
[60] The trial judge determined that the circumstances before her were consistent with those in Boehringer, Hoechst and Merck lisinopril. That being the case, she found that General Formula I did not constitute the invention of the patent as urged by Apotex. Rather, she concluded that claims 1, 2, 3 and 5 of the '196 Patent are for one or more inventions that are distinct from the larger class of compounds in General Formula I in the description.
[61] May & Baker was distinguished from circumstances where, as in Boehringer, Hoechst and Merck lisinopril, the class of compounds described by a general formula is disclosed in the specification, but the claims are limited to a compound and a small genus around the compound. In May & Baker, the issue was whether an amendment to disclaim a genus and add a claim to two compounds produces a substantially different invention. The Court held that to permit the amendment of the specification would claim an invention substantially different from that claimed in its original form. This Court, in Merck lisinopril, at paragraph 38, noted that in May & Baker, the two substances were not specifically named in any claims but were only named as examples as part of a broader class. Hence, they were there considered as examples of a broad inventive class. That was not the situation in Merck lisinopril and it is not the situation here.
[62] To bolster its position, Apotex refers to cases dealing with double patenting. Those authorities are of no assistance. Double patenting prohibits more than one patent being issued with respect to the same invention. The authorities do not stand for the principle for which they are cited.
[63] Contrary to Apotex’s submission, Justice Snider did not suggest that the Boehringer, Hoechst and Merck lisinopril authorities stand for the proposition that each claim discloses a separate invention. Rather, she concluded that this case is one where reading the claims in light of the specification results in more than one invention. Notably, subsection 36(1) of the Patent Act contemplates the possibility of a patent containing more than one invention.
[64] More significantly, the issue in the present proceeding is the same as that considered and decided against Apotex in Merck lisinopril. In its written submissions, Apotex did not address Merck lisinopril except by way of footnote where it alleged that Justice Snider wrongly interpreted the case (an observation that I have rejected). No argument was tendered with respect to Miller v. Canada (Attorney General), 2002 FCA 370, 220 D.L.R. (4th) 149. There, Justice Rothstein, then of this Court, discussed the test to be met in order for the Court to overrule its own decisions. Simply put, the test is one of manifest error. Apotex made no such allegation in regard to Merck lisinopril.
[65] At the hearing of this appeal, and despite its candid acknowledgement that it had made the same arguments in Merck lisinopril, Apotex continued to rely on May & Baker and insisted that it applied, rather than Merck lisinopril. This submission was primarily based on the allegation that perindopril had not been disclosed in the '093 Application. The short answer to that allegation is that claim 8 of the '093 Application claimed perindopril and its stereoisomers.
[66] Moreover, after hearing extensive evidence and argument and reviewing the patent in its totality, the trial judge concluded otherwise. As previously stated, she determined the circumstances before her were consistent with those in Boehringer, Hoechst and Merck lisinopril. That conclusion was open to her on the record and I can detect no reviewable error in this respect. Consequently, this ground of appeal fails.
Obviousness
[67] The question of obviousness is largely a factual inquiry. The trial judge applied the framework articulated in Janssen-Ortho. Subsequently, the Supreme Court of Canada issued its decision in Sanofi. The Janssen-Ortho framework is not inconsistent with that described in Sanofi. Therefore, the trial judge’s factual determinations are equally relevant to the Sanofi analysis. To the extent that a specific Sanofi factor may not have been analysed, it will be necessary to determine whether the trial judge’s factual conclusions are sufficient to respond to the Supreme Court’s Sanofi analysis. I will return to that issue later in these reasons.
(1) The trial judge applied the wrong test
[68] Apotex submits Justice Snider erred by directing the obviousness inquiry to the claims of the '196 Patent. In so doing, it argues that the trial judge specifically and erroneously rejected as relevant what the disclosure taught about inventiveness. Had she construed the entire specification, she would have concluded that the invention was the class of compounds described in General Formula I.
[69] This submission, in my view, constitutes a second kick at the can regarding Apotex’s first argument with respect to the nature of the invention. I endorse and adopt the reference from Angiotech Pharmaceuticals Inc. v. Conor Medsystems Inc., [2008] UKHL 49 (Angiotech) at paragraph 19 relied upon by Servier in this regard. In Angiotech, Lord Hoffman stated that “the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description.” This is consistent with the observation of this Court in Janssen-Ortho that “what is in issue is the patent claim as construed by the Court” (paragraph 25). It is also consistent with Sanofi where, in describing the appropriate framework for an obviousness inquiry, Justice Rothstein stated, at paragraph 67, that the second step is the need to “identify the inventive concept of the claim in question or if that cannot readily be done, construe it.” No error has been established in this respect.
(2) The trial judge tested as of the wrong date
[70] Apotex claims that Justice Snider erred by choosing the filing date of the '093 application (October 1, 1981) rather than the filing date of the priority application (October 2, 1980). Perindopril had not been synthesized or tested until September 1, 1981. No reason is advanced as to why the choice of the earlier date would assist its obviousness argument. Indeed, choosing the latter date had the effect of encompassing more prior art that could be relied upon by Apotex (for example, the Nature paper published on November 20, 1980).
[71] At the hearing of this appeal, Apotex’s counsel was questioned regarding paragraph 55 of Merck lisinopril where this Court stated that where a Canadian application contains material relating to subject-matter invented after the priority date, that subject-matter cannot benefit from that date. Such a defect in the priority claim will not invalidate the entire patent, but will simply result in the application bearing the Canadian filing date. Counsel’s response was that its point is not a major one.
[72] Apotex has not demonstrated that the trial judge erred in choosing October 1, 1981 as the date of invention. I agree with Servier that since Justice Snider found that claims 1, 2, 3 and 5 of the '196 Patent were not obvious as of October 1, 1981, she undoubtedly would have made the same finding based on the earlier date when less prior art would have been available to the skilled person.
(3) The trial judge erred in unduly narrowing the field of relevant art
[73] Obviousness is considered with reference to the prior art that a skilled person would look to in order to solve the problem addressed by the patent. This is ordinarily referred to as the general common knowledge. Justice Snider concluded that it cannot be presumed that a skilled person would look to prior art outside the field of ACE inhibition, absent evidence to that effect. On the basis of the evidence before her, she was not persuaded that the skilled person would look outside this field. This is a factual finding.
[74] Apotex contends, because the trial judge defined the skilled person as a composite, including a medical doctor with experience treating hypertension or cardiac insufficiency, it was unreasonable to suppose that a doctor treating such conditions would not have regard to other possible treatments for those conditions. However, Doctors Gavras and Brunner, Apotex’s expert medical doctors, provided no evidence that non-ACE inhibition prior art was relevant. I fail to see how the trial judge can be faulted.
[75] Apotex has not demonstrated reviewable error in Justice Snider’s assessment of the evidence regarding whether the skilled person would look outside the field of ACE inhibition. On the record, it was open to the trial judge to make the finding that she made.
(4) The trial judge erred in applying the standard
[76] Apotex identifies this allegation as its “most important argument” in relation to obviousness. Notably, the arguments made before this Court are largely a reiteration of those made in the first instance before Justice Snider. Additionally, Apotex’s argument, in part, constitutes a rehashing of its thesis regarding the nature of the invention. Its position in this respect was rejected by the trial judge, with whom I agree. It bears repeating that the onus is on Apotex to establish, on a balance of probabilities, that a claim is obvious: Whirlpool; Sanofi.
[77] Justice Snider concluded that the essential elements of the claims in issue are the use of both a 6,5 perhydroindole moiety and a linear alkyl group with one to six atoms on either end of the molecule. She determined that the prior art taught the use of