Court File No. 35562

IN THE (ON APPEAL FROM THE FEDERAL COURT OF APPEAL)

BETWEEN:

APOTEX INC. and APOTEX PHARMACHEM INC.

Appellants (Respondents) -and-

SANOFI-AVENTIS and BRISTOL-MYERS SQUIBB PHARMACEUTICALS HOLDING PARTNERSHIP

Respondents (Appellants)

FEDERATION INTERNATIONALE DES CONSEILS EN PROPRIETE INTELLECTUELLE and CANADA'S RESEARCH-BASED PHARMACEUTICAL COMPANIES and CENTRE FOR INTELLECTUAL PROPERTY POLICY and INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY ("AIPPI") and BIOTECANADA and CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION Interveners

FACTUM OF THE INTERVENER, CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION ("CGPA")

AITKEN KLEE LLP AITKEN KLEE LLP Suite 300, 100 Queen Street Suite 300, 100 Queen Street Ottawa, ON KIP 119 Ottawa, ON K 1P 119

David W. Aitken David W. Aitken Jonathan Stainsby Jonathan Stainsby

Tel: 613-903-5099 Tel: 613-903-5099 647-317-6868 647-317-6868 Fax:613-695-5854 Fax:613-695-5854 E-mail: E-mail: [email protected] [email protected] j [email protected] [email protected]

Solicitors for the Intervener, Agents for the Intervener, Canadian Canadian Generic Pharmaceutical Generic Pharmaceutical Association Association ORIGINAL TO: THE REGISTRAR Supreme Court of Canada 30I Wellington Street .Ottawa ON KIA OJI

COPY TO:

Counsel for the Appellants Agent for the Appellants

GOODMANS LLP NELLIGAN O'BRIEN PAYNE LLP Barristers and Solicitors Barristers and Solicitors Suite 3400, 333 Bay Street Suite I500, 50 O'Connor Street , ON M5H 2S7 Ottawa, ON KIP 6L2

Harry Radomski Dougald E. Brown Richard Naiberg Nando De Luca Tel: 6I3-238-8080 Fax:6I3-238-2098 Tel: 4I6-597-4I42 Email: [email protected] Fax:4I6-979-I234 Email: [email protected] [email protected] [email protected]

AND TO:

Counsel for the Respondents Agent for the Respondents

GOWLING LAFLEUR HENDERSON LLP GOWLING LAFLEUR HENDERSON LLP I 60 Elgin Street I 60 Elgin Street Suite 2600 Suite 2600 Ottawa, Ontario KIP I C3 Ottawa, Ontario KIP I C3

Anthony G. Creber Anthony G. Creber Marc Richard Marc Richard Livia Aumand Livia Aumand

Tel: 613-233-I 78I Tel: 613-233-1781 Fax:613-563-9869 Fax:613-563-9869 Email: [email protected] Email: [email protected] [email protected] [email protected] [email protected] [email protected]

11 AND TO:

Counsel for the Intervener, Federation Agents for the Intervener, Federation internationale des conseils en propriete internationale des conseils en propriete intellectuelle intellectuelle

FASKEN MARTINEAU DUMOULIN LLP FASKEN MARTINEAU DUMOULIN LLP The Stock Exchange Tower, Suite 3700, I300 - 55 Metcalfe St. 800 Victoria Square, P.O. Box 242 Ottawa, Ontario Montreal, Quebec H4Z I E9 KIP 6L5

Julie Desrosiers Gerald L. (Jay) Kerr-Wilson Kang Lee Telephone: (613) 236-3882 Telephone: (5I4) 397-7400 Fax: (613) 230-6423 Fax: (514) 397~7600 E-mail: [email protected] E-mail: [email protected] [email protected]

AND TO:

Counsel for the Intervener, Canada's Agents for the Intervener, Canada's Research-Based Pharmaceutical Companies Research-Based Pharmaceutical Companies

NORTON ROSE FULBRIGHT CANADA NORTON ROSE FULBRIGHT CANADA LLP LLP Royal Bank Plaza, South Tower I 500-45 O'Connor Street Suite 3800, 200 Bay St., PO Box 84 Ottawa, Ontario Toronto, Ontario M5J 2Z4 KIP IA4

Patrick E. Kierans Sally Gomery Kristin Wall Telephone: (6I3) 780-8604 Telephone: (4I6) 2I6-3904 Fax: (613) 230-5459 Fax: (4I6) 2I6-3930 E-mail: E-mail: [email protected] [email protected] kristin. [email protected]

111 AND TO: Counsel for the Intervener, Centre for Agents for the Intervener Centre for Intellectual Property Policy Intellectual Property Policy

JEREMY DE BEER PROFESSIONAL SAMUELSON-GLUSHKO CANADIAN CORPORATION INTERNET POLICY & PUBLIC 676 Roosevelt Avenue INTEREST CLINIC Ottawa, Ontario University of Ottawa, Faculty of Law K2A2A7 57 Louis Pasteur Street, Ottawa, Ontario K 1N 6N5 Jeremy de Beer Tamir Israel Telephone: (613) 263-9155 Fax: (613) 562-5417 Telephone: (613) 562-5800 Ext: 2914 E-mail: [email protected] Fax: (613) 562-5417 E-mail: [email protected]

AND TO:

Counsel for the Intervener, International· Agents for the Intervener, International Association for the Protection of Intellectual Association for the Protection of Intellectual Property (" AIPPI") Property (" AIPPI")

SMART & BIGGAR SMART & BIGGAR 900 - 55 Metcalfe Street 900 - 55 Metcalfe Street P.O. Box 2999, Station D P.O. Box 2999, Station D Ottawa, Ontario Ottawa, Ontario KlP 5Y6 KlP 5Y6

Steven B. Garland Steven B. Garland Colin B. Ingram Colin B. Ingram

Telephone: (613) 232-2486 Telephone: (613) 232-2486 Fax: (613) 232-8440 Fax: (613) 232-8440 E-mail: [email protected] E-mail: [email protected] [email protected] [email protected]

IV AND TO:

Counsel for the Intervener, BIOTECanada Agents for the Intervener, BIOTECanada

BORDEN LADNER GERVAIS LLP BORDEN LADNER GERVAIS LLP World Exchange Plaza World Exchange Plaza 1300-100 Queen Street 100 Queen Street, Suite 1300 Ottawa, Ontario K 1P 1J9 Ottawa, Ontario KIP 1J9

James Eliot Mills Nadia Effendi Chantal Saunders Telephone: (613) 237-5160 Telephone: (613) 369-4782 Fax: (613) 230-8842 Fax: (613) 230-8842 E-mail: [email protected] E-mail: [email protected] [email protected]

v TABLE OF CONTENTS

PART I STATEMENT OF FACTS 1

PART II STATEMENT OF ISSUES 2

PART III STATEMENT OF ARGUMENT 2

Issue 1: AZT is good law 2

Issue 2: The law of "promise" should not be abandoned in 7 the name of harmonization

Issue 3: Obviousness 8

PART IV COSTS 10

PARTV ORDER SOUGHT 10

PART VI TABLE OF AUTHORITIES 11

Part VII TABLE OF STATUTORY PROVISIONS 12

PART VIII TABLE OF OTHER SOURCES 13

VI PART I-STATEMENT OF FACTS 1. The judgment of this Court in AZT1 is the clear and consistent standard by which the validity of patents based on prediction has been assessed for more than a decade. On this appeal, Sanofi argues that this Court should uphold the interpretation of AZT given by the Federal Court of Appeal below. 2 That interpretation is deeply flawed and fundamentally inconsistent with the principles enunciated in and the reasoning that informs AZT. It makes it impossible to ever conclude that a patent based on an unsound prediction is invalid for failure to comply with the disclosure requirements of AZT.

2. The bargain that underlies Canadian patent law balances the interests of the public and those of patentees. The law of sound prediction as articulated by this Court in AZT respects and fosters this delicate balance. The judgment of the FCA departs from that articulation, upsets the balance and injects uncertainty into patent law. As this Court has held, "There is a high economic cost attached to uncertainty and it is the proper policy of patent law to keep it to a minimum. "3

3. Contrary to Sanofi's assertions, the law of sound prediction as stated in AZT is not a newly minted doctrine that places Canada in contravention of international treaties or "out-of­ step" with other jurisdictions. There is no imperative to "harmonize" the Canadian law of utility with the laws of other jurisdictions, nor is there an adequate evidentiary record upon which this Court could engage in a meaningful comparative international law analysis in support of patent law harmonization.

4. The FCA judgment also eviscerates the law of obviousness set forth by this Court in Plavix. 4 Plavix affirmed the principle that in "areas of endeavour where advances are often won by experimentation"5 a patent may be held invalid if the ~xperiment was "obvious-to-try." However, based on a misinterpretation of Plavix, the FCA limited a finding of obviousness to a situation in which the results of the experiment were known before it was conducted. This approach is fundamentally inconsistent with the purpose and intent of the obvious-to-try doctrine.

I Apotex Inc. v. Wei/come Foundation ltd., 2002 sec 77 ("AZT'). 2 Factum of the Respondents, Sanofi-Aventis et al. ("Sanofi Factum") at ~136. The intervener BIOTECanada goes further, arguing ( factum ~29-33) that (I) this Court erred in "creating" the doctrine of sound prediction in AZT and (2) all of the jurisprudence that applies AZT is flawed. AZT has been cited at least 123 times since it was released in 2002. Overturning jurisprudence that has been consistently applied for over a decade can only lead to uncertainty. 3 Free World Trust v. Electro Sante Inc., 2000 sec 66 at ~42. 4 Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 ("Plavix"). 5 Plavix, supra, at ~68. PART II-STATEMENT OF ISSUES 5. The submissions of the CGP A deal with the following issues:

1. The disclosure requirement for patents based on sound prediction laid down by this Court in AZT is good law. This requirement cannot be avoided by "reading down" the promise of the patent to the utility that has been demonstrated; n. The longstanding requirement that the utility of a patent will be assessed against what the patent says the invention will do is good law. The requirement cannot be avoided by characterizing it as a newly minted "promise doctrine" and arguing that it should be rejected on the basis that it is out-of-step with the laws of other jurisdictions; and

111. The "obvious-to-try" test laid down by this Court in Plavix is good law. The test cannot be avoided by limiting it to situations in which experimental results are known in advance. PART III - STATEMENT OF ARGUMENT Issue 1 -AZT is good law 6. For over a decade, AZT has provided a clear and consistent standard by which the validity of patents based on prediction has been assessed. AZT reaffirmed the principle that a patent can validly claim a utility that has not yet been demonstrated, but rather is based on prediction. However, AZT made it clear that the prediction must be sound and the patent must disclose the factual basis and line of reasoning for the prediction. A patent based on unsupported speculation, or one that fails to meet the disclosure requirements, will be held invalid. 6

7. Generic pharmaceutical manufacturers must comply with the requirements of the Patented Medicines (Notice of Compliance) Regulation/ ("PMNOC Regulations") in order to make lower-cost generic versions of marketed drugs available to the Canadian public. The P MNOC Regulations require a generic manufacturer to serve a Notice of Allegation containing a detailed statement of the legal and factual basis for any allegation of patent invalidity. A clear and consistent standard by which to evaluate the validity of patents is essential to the ability of generic pharmaceutical manufacturers to select appropriate drugs for genericization at the earliest possible date. The AZT principles form the basis by which CGPA members assess the validity of pharmaceutical patents that are based on predictions of therapeutic utility.

8. It is not uncommon for patents covering pharmaceuticals to be based on predicted therapeutic utility. Drug development typically includes a preclinical phase, which may include

6 AZT at if70, 83. 7 Patented Medicines (Notice ofCompliance) Regulations, SOR/93-133.

2 testing in animal models. If the preclinical study results are promising, the drug moves to the clinical phase in which it is tested in humans. An inventor need not await the results of clinical trials demonstrating therapeutic efficacy in humans before filing a patent application. Patent applications for drugs are routinely filed on the basis of pre-clinical in vitro and in vivo animal studies. In such a case, therapeutic efficacy in humans is necessarily based on prediction.

9. AZT holds that a patent based on prediction can be validly obtained, so long as the prediction is sound (at the time of patent filing) and the factual basis and line of reasoning for the prediction are disclosed in the patent. 8 If, for example, a patent discloses positive pre-clinical test results in an animal model which can be extrapolated to soundly predict therapeutic efficacy in humans, the patent will not be held invalid for lack of utility (barring evidence of inutility in fact).

10. In the present case, Canadian Patent No. 1,336, 777 (the "777 Patent") was filed on the basis of results of pre-clinical studies in rats. The trial judge held that the 777 Patent promised therapeutic efficacy and because that had not been demonstrated in humans, the patent was based on prediction. The evidence revealed that the results of the rat testing disclosed in the 777 Patent could not be extrapolated to soundly predict therapeutic efficacy in humans. More was required, . including disclosure of the "track record" of internal testing that had allowed Sanofi to predict. 9 The trial judge held the patent invalid as it failed to disclose the factual basis and sound line of reasoning for the prediction of therapeutic efficacy in humans, as required by AZT.

11. The FCA avoided the application of AZT by "reading down" the promised utility to match what the patent disclosed as having been demonstrated (i.e., results of the pre-clinical animal testing). Therapeutic efficacy in humans was interpreted to be merely a "goal" and then discounted on the basis that "a goal is not necessarily a promise." 10 As the promise of utility was held to go no further than what had been demonstrated, the FCA held that the AZT requirements for a patent based on prediction simply did not apply. 11

12. As is evident from the concurring reasons in the Court below, the basis for characterizing therapeutic efficacy in humans as a mere goal (and not a promise of utility) was the inadequacy of the disclosed animal model as a "guarantee" of results in humans:

8 AZT, supra, at ~70. 9 Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486 ("Trial Judgment") at ~573. 10 Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 ("FCA Judgment") atiI67. 11 FCA Judgment, supra, at ~54.

3 [128] I understand the Trial Judge to have found that a person skilled in the art would know at the relevant time that one cannot reasonably predict any useful use of clopidogrel in humans from the properties and-advantages demonstrated in the patent (See, for example, paragraphs 572, 573 & 580 of the Reasons). Thus, the person skilled in the art would recognize that the mechanism and the properties specifically identified in the first part of the statement found on page 21 of the '777 patent ("On account of its interesting inhibitory properties towards platelet aggregation and its interference in the mechanism of formation of arterial and venous thromboses ... ") are insufficient to make the leap to the conclusion that a practical application in humans will indeed be achieved. [129] In this context, it is difficult, if not impossible, in my view, to construe the statement at the end of the sentence at page 21 of the '777 patent as a promise (i.e., effectively, a guarantee) that any specific result will be achieved in humans. 12 13. This manner of construction is deeply flawed. It is based on the proposition that a patent will not be construed to promise a utility beyond that which the patent discloses was actually demonstrated or soundly predicted. 13 This effectively inoculates a patent that makes a claim of utility based on speculation against a finding of invalidity. Rather than holding a patent that makes a speculative promise invalid on the basis of AZT, the promise will be read down to what has been disclosed. Under this approach it is impossible to ever conclude that a patent based on an unsound prediction is invalid for failure to comply with the disclosure requirements of AZT.

14. The impropriety of this approach was clearly articulated by the Federal Court in AstraZeneca v. Apotex: [ 127] The evidence aside, the interpretation advanced by AstraZeneca is unpalatable because it is tautological, promotes perverse incentives for innovators, and fails to appreciate the distinction between disclosure and utility requirements under the Patent Act. [128] First, AstraZeneca's approach to utility is tautological. On a high level, the promise is the yardstick against which utility is measured for the purpose of demonstration. Yet, AstraZeneca proposes a backwards approach that establishes that benchmark based on what can ultimately be demonstrated in the patent. To circumscribe the scope of the promise based on what is demonstrated in the patent makes it impossible to ever conclude that a patent is invalid for lack of utility. No matter how broad a promise (e.g. this drug cures cancer), it would always be read down to a narrower promise based on what was demonstrated. Such an approach would run contrary to the policy objectives of patent law which serve to create consistency and clarity in the bargain struck

12 FCA Judgment, supra, at ifl28-129. 13 This approach was considered and expressly rejected by the trial judge (see '"Sanofi's Matching Principle": Trial Judgment, supra, at 1f 176-181 ).

4 between innovators and the public. Instead, unequivocal promises in patents could in no way be relied upon and would be subordinate to more complex questions of demonstration within the patent. 14 15. The Federal Court expressly rejected this approach in AstraZeneca v. Apotex, holding that it "would perversely encourage patentees to over-promise. . . . [T]hat overbroad promise would present no concern with respect to invalidity based on inutility because any promise that cannot be demonstrated will be read down to what can be demonstrated." 15

16. Sanofi argues that a promise should invalidate a claim "only if it is false, in fact. " 16 This is clearly contrary to AZT which expressly rejected the so-called after-the-fact validation theory: [80] In my view, with respect, Glaxo/Wellcome's proposition is consistent neither with the Act (which does not postpone the requirement of utility to the vagaries of when such proof might actually be demanded) nor with patent policy (which does not encourage the stockpiling of useless or misleading patent disclosures). Were the law to be otherwise, major pharmaceutical corporations could (subject to cost considerations) patent whole stables of chemical compounds for all sorts of desirable but unrealized purposes in a shot-gun approach hoping that, as in a lottery, a certain percentage of compounds will serendipitously turn out to be useful for the purposes claimed. Such a patent system would reward deep pockets and the ingenuity of patent agents rather than the ingenuity of true inventors. 17 17. The prohibition on patenting mere speculation is intended to preserve the delicate balance that underpins the notional patent bargain. If the factual basis and line of reasoning for a prediction is not disclosed in the patent, the patentee will have given nothing in exchange for the monopoly (no "hard coinage"}, and the patentee's side of the bargain would be unmet. 18

18. In its concurring reasons, the FCA cautioned that one must be careful not to treat a statement of practical purpose as a promise on the basis that the reason for such a statement may "have little to do with an intent to promise a result within the meaning of Consolboard." One alternative reason the FCA suggests is compliance with foreign patent practice. 19

19. The proposition that a statement of utility cannot be read as a promise until one first determines the reason for its inclusion is unworkable from a practical point of view. The public

14 AstraZeneca Canada Inc v. Apotex Inc., 2014 FC 638 at~l27-128. 15 Ibid., at ~129. 16 Sanofi Factum at ~94. 17 AZT, supra, at ~80; see also ~37. 18 Eli lilly and Company v. Teva Canada limited, 2011 FCA 220 ("Atomoxetine '')at ~51. 19 FCA Judgment, supra, at ~125.

5 is not in a position to know the reason why the inventor decided to insert a statement of utility in the patent, for example, whether it was to satisfy a foreign requirement, to convince the patent office that the invention was non-obvious, or to support an advantage recited in some of the claims, but not in others. Requiring knowledge of the inventor's subjective intent effectively strips the public of the ability to perform a meaningful assessment of the promised utility.

20. There is something inherently illogical in an approach to patent construction that holds that a patent for a pharmaceutical intended to treat a human condition does not promise therapeutic efficacy, but only efficacy in pre-clinical animal model testing. Surely the public is entitled to construe the 777 Patent as promising more than merely positive results in rat studies, particularly given its disclosure that pharmaceutical compositions of clopidogrel "are useful because they exhibit a platelet aggregation inhibiting activity", that "the medicine of the invention can be made available for administration in the form of tablets", that "daily doses to be administered vary ... depending upon the age of the patient and the severity of the disorder to be treated, and that "the medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders". 20 Any suggestion that the utility promised in the 777 Patent is nothing more than improving the health of rats defies common sense.

21. This is all the more so given that the 777 Patent is a selection patent over the 875 Patent which itself promised that the claimed compounds were "very useful in human ... applications".21 A selection patent must distinguish itself from the prior class through providing unexpected, substantial and peculiar advantages as compared to the prior class of compounds.22 "The inventor selects only a bit of the subject matter of the original genus patent because that bit does something better than and different from what was claimed in the genus patent. "23 This, in fact, is how this Court construed the inventive concept of the 777 Patent in Plavix: "useful in inhibiting platelet aggregations which has greater therapeutic effect and less toxicity than the other compounds of the 875 Patent."24 Upholding a selection patent that promises less than what was promised in the genus patent is inconsistent with the very notion of selection patents25 and upsets the bargain that underlies patent law.

20 777 Patent at Abstract; p. 20, lines 4-5; p. 20, lines 10-12; p. 21, lines 3-5. 21 Trial Judgment at ~168. 22 Plavix, supra, at ~10-11; Eli Lilly Canada Inc. v. Novopharm limited, 2010 FCA 197 ("Olanzapine FCA") at ~78. 23 Plavix, supra, at ~l 00. 24 Plavix, supra, at ~78. 25 Eli lilly Canada Inc. v. Novopharm limited, 2011 FC 1288 at ~110.

6 22. There are circumstances where the nature of the claimed invention requires that the patentee make specific promises, including, for example, patents claiming selection inventions or new uses for known compounds. In such cases, any promises made are relevant to all grounds of alleged invalidity. 26 The FCA approach, though, permits patentees to make promises to overcome challenges on the grounds of obviousness and anticipation, but does not require that those promises be met in the utility analysis. This is contrary to the well-established principle that a patent receives but one construction for all purposes.27

23. In its factum, Sanofi cites this Court in Consol board and Viagra for the proposition that "there is no requirement that a patentee disclose the utility of an invention in the patent. "28 This is not what Consolboard says. In Consolboard, the utility of the invention was disclosed in the patent in suit. On a fair reading, Consolboard stands only for the proposition that a patentee is not obligated to state the "way" in which the utility is achieved or to "extol the effect or advantage of his discovery. "29

Issue 2 - The law of "promise" should not be abandoned in the name of harmonization 30 24. Contrary to the argument advanced by Sanofi , the concept of the promise of a patent is not a newly created "doctrine," nor do the AZT disclosure requirements place Canadian law out­ of-step with other jurisdictions. 31

25. The term "promise" is no more than a shorthand reference to what the inventor has said in the patent the invention will do. It arises from the Patent Act32 and has been used in Canadian jurisprudence for many decades. 33 If, on a purposive construction, the court finds that the

26 O/anzapine FCA, supra, at ~32. 27 Patent claims can receive only one construction for all purposes: Whirlpool Corp. v. Cameo Inc., 2000 SCC 67, at ~43 and 49(b) The same is true for all aspects of patent construction: Plavix, supra, at ~76-8; Apotex Inc. v. Inc., 2011 FCA 236 at ~5, 23-8; Allergan Inc. v. Apotex Inc., 2012 FCA 308 at ~23-6, 55-8, 74; Hoffman-la Roche limitedv. Apotex Inc., 2011 FC 875 at ~22. 28 Sanofi Factum, supra, at ~98 29 Consolboard Inc. v. MacMillan Bloedel (Sask.) ltd., [1981] 1 S.C.R. 504 at 526. 30 Sanofi Factum, supra, at ~54-64. 31 See, e.g., Gold, R., and Shortt, M., "The Promise of the Patent In Canada and Around the World", 30 CIPR 36 and Vaver, D., "Is Canada's Patent Law Qut of Step?", Reworked Remarks for 2°d Patent Law Colloquium, November 22, 2013, at 2. 32 Patent Act, RSC 1985, c P-4, ss. 2 and 34 (now 27(3)). See Wandscheer v. Sicard ltd., [1948] S.C.R. I ("Wandscheer") at 15; Consolboard, supra, at 525-6; Teva Canada v. limited Pfizer Canada Inc., 2012 SCC 60 at ~38 ("Teva Viagra"); AZT, supra, at ~62; Monsanto Co. v. Commissioner ofPatents, [1979] 2 S.C.R. 1108 at 1116-7. 33 Wandscheer, supra, at 5, 24; New Process Screw Corporation v. P.l. Robertson Mfg. Co. ltd. (1961), 39 C.P.R. 31 at 45-6; Amfac Foods Inc. v. Irving Pulp & Paper ltd. (1986), 12 C.P.R. (3d) 193, [1986] F.C.J. No. 659 (FCA) at p. 7-9.

7 invention will not do what the patent says it will do, the patent will be found invalid for a lack of utility. To say that the promise of the patent is not met is to say no more than this.

26. It is neither necessary nor helpful to insist that concepts and principles from other jurisdictions be incorporated into Canadian law. The "harmonization" of Canadian patent law with the laws of other jurisdictions is an issue that was not raised before the lower Courts. There is no evidentiary record on which this Court could engage in a meaningful investigation of foreign patent laws or the developmental history of statutory provisions governing patent utility, let alone the interwoven provisions governing selection patents, disclosure and non-obviousness.

27. Even if "harmonization" is worth pursuing, this Court should not be asked, in an evidentiary vacuum, to select the target jurisdiction( s) for harmonization. The patent laws of the US, the UK, the European Union (which follows the European Patent Convention) and Japan, to name but a few, differ in significant respects.34 Recent efforts to arrive at a uniform global law were abandoned when the goal was seen to be unattainable. 35 International treaties do not compel or even promote harmonization, but, rather, provide that the laws of the signatory states will differ (expressly so as regards "utility" and "industrial applicability"). 36 The concept of "harmonization" raises important and related threshold questions involving matters of patent policy. Parliament alone has the responsibility and authority to make policy decisions respecting the content of Canadian statutory law. Issue 3 - Obviousness 28. In Plavix, this Court set out the test for obviousness. 37 One aspect of the test is whether

34 The UK employs the "worth a try" test for obviousness, while Canadian courts do not (Pfizer v. Apotex, 2009 FCA 8 at 28-9); the US permits reliance on post-filing proof, but Canada does not (Janssen-Ortho Inc. v. Novopharm limited, 2006 FC 1234 at ~ 113(8), aff d 2007 FCA 217, leave denied [2007] SCCA No. 442, In re Zenitz (1964), 52 CPPA 746 at ~2); selection patents are no longer part of UK law (Dr. Reddy's Laboratories v. Eli Lilly & Company Ltd., 2008 EWHC 2345 at ~95-109, affd [2009] EWCA 1362 at ~35-40); methods of medical treatment are not patentable in Canada, but are in the USA (Visx Inc. v. Nidek Co., (1997), 77 C.P.R. (3d) 532 at ~6 and Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111 at 117-9); the differences in utility and construction are discussed in Gold and Shortt, supra, generally, and at 60-2, 66, 71 and 74. 35World Intellectual Property Organization, Draft Substantive Patent Law Treaty online: http://www.wipo.int/patent­ law/en/draft splt.htm, 36 Marrakesh Agreement Establishing the World Trade Organization, Annex IC, 15 April 1994, 1869 U.N.T.S. 299; 33 l.L.M. 1197 (TR/Ps), Article 1 and 27( 1); North American Free Trade Agreement, 32 l.L.M. 289 and 605, Article 1709. Patent Cooperation Treaty, June 19, 1970, 28 U.S.T. as amended, ("PCT') Articles 5, 27(5) and (6). Articles 27(5) and (6) provide that nothing in the PCT shall be construed as limiting the Contracting States' freedom to prescribe the substantive conditions of patentability, a provision that has been recognized by the Federal Courts - see, e.g., Atomoxetine, supra, at 48-50 and Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97 at ~19. 37 Plavix, supra, ~5 l -71.

8 the solution taught by the patent under consideration was "obvious to try." In holding the 777 Patent to be non-obvious, the FCA interpreted the "obvious to try" test set out in Plavix as requiring a finding that the properties of the compound be known in advance of any experimental testing: [79] The reasons of the Trial Judge make it clear that, as was the case in Plavix, it was not possible to predict the properties of the separated enantiomers ... The lack of knowledge as to these properties is precisely what led the Supreme Court in Plavix, cited above, to hold that it was not self-evident that what was being tried ought to work ... [80] It follows that although the resolution of PCR 4099 was part of the common general knowledge, nothing turns on this as it is the unknown nature of the properties of the enantiomers which explains why the invention was not "obvious to try".38 29. The FCA has misinterpreted the reasoning in Plavix and has followed an approach that completely eviscerates the "obvious to try" test. Under the FCA approach, the finding that the properties of the compound cannot be known before the experiment has been carried is dispositive of the "obvious to try" test. This approach fails to take into account any of the other factors identified in Plavix as relevant to the central inquiry as to whether it would be more or less self-evident to obtain the invention.39

30. The evidence before this Court in Plavix was different from that before the trial judge. In Plavix there was "no evidence that at the relevant time, a person skilled in the art would know which [separation technique] would work," that "it took from November 1985 to April 1986 to find the invention," that "the investigation here was not routine, but rather prolonged and arduous," and that the motivation was only "the demand for an effective and non-toxic product to inhibit platelet aggregation [that] might be assumed to exist."40

31. In contrast, the evidence before the trial judge was that the person skilled in the art would have been directed towards the classic Pasteur method to separate the enantiomers, that the method was routine, there was a motivation to separate the enantiomers based on "pressure from regulatory agencies," and the "actual course of conduct revealed no substantial difficulty.''4 1 Thus, the evidence before the trial judge was that it was obvious-to-try to obtain the invention in

38 FCA Judgment, supra, at ~79-80. 39 Plavix, supra, at ~66. 40 Plavix, supra, at if86, 89 and 90. 41 Trial Judgment at ~709, 720, 737, 750, 782 and 783.

9 the 777 Patent, even though the properties of the separated enantiomers could not be predicted with certainty. While the unpredictability of the result was indeed a key factor in this Court' s determination in Plavix that the invention was obvious, it assumed that status precisely because the evidentiary record did not permit a finding that it was more or less self-evident to try to obtain the invention on the basis of other relevant factors.

32. Under the FCA approach, an inventi on will never be obvious-to-try where experimentation is necessary, because, by definition, the outcome of experiments cannot be known in advance. This approach is fundamentally inconsistent with the purpose and intent of the obvious-to-try doctrine, which is recognized to be appropriate in "areas of endeavour where advances are often won by experimentation."42

33. Fundamental and longstanding principles are challenged on this appeal. Re-affirming these principles will promote consistency and predictability . Adopting new and different principles will lead in the opposite direction.

PART IV - COSTS 34. The COPA does not request any order as to costs.

PART V - ORDER SOUGHT 35. The COPA repeats its request for leave to present oral argument at the hearing of the appeal for not more than I 0 minutes.

this 16111 day of September 2014.

42 Plavix, supra, at iJ68.

10 PART VI - TABLE OF AUTHORITIES

TAB AUTHORITY REFERENCE 1. Amfac Foods Inc. v. Irving Pulp & Paper Ltd. (1986), 12 FN33. C.P.R. (3d) 193, [1986] F.C.J. No. 659 (FCA) at p. 7-9.

2. Apotex Inc. v. Allergan Inc., 2012 FCA 308 at ~23-6, 55-8 FN27. and 74.

3. Apotex Inc. v. Pfizer Canada Inc., 2011FCA236 at ~5 FN27. and 23-8. 4. Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486 ("Trial FN9, FN13, FN21 Judgment") at ~168, 176-181, 573, 709, 720, 737, 750, and FN41. 782 and 783. 5. Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC FN4, FN 5, FN22, 61 ("Plavix") at ~10-11, 51-71, 76-78, 86, 89-90 and 100. FN23, FN24, FN27, FN37, FN39, FN40 and FN42.

6. Apotex Inc. V. Wei/come Foundation Ltd., 2002 sec 77 FNl, FN6, FN8, (''AZT') at ~37, 62, 70, 80 and 83. FN17 and FN32. 7. AstraZeneca Canada Inc v. Apotex Inc., 2014 FC 638 at FN14 and FN15. ~127-129. 8. Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) FN29 and FN32. Limited, [1981] 1 S.C.R. 504 at p. 525-6. 9. Dr. Reddy 's Laboratories v. Eli Lilly & Company Ltd., FN34. 2008 EWHC 2345 at ~95-109, affd [2009] EWCA 1362 at ~35-40. 10. Eli Lilly and Company v. Teva Canada Limited, 2011 FN18 and FN36. FCA 220 ("Atomoxetine '') at ~48-51.

11. Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97 at ~19. FN36. 12. Eli Lilly Canada Inc. v. Novopharm Limited, 2010 FCA FN22 and FN26. 197 ("Olanzapine FCA ''),at ~32 and 78. 13. Eli Lilly Canada Inc. v. Novopharm Limited, 2011 FC FN25. 1288 at ~110. 14. Free World Trust v. Electro Sante Inc., 2000 sec 66 at FN3. ~42. 15. Hoffmann-La Roche Limited v. Apotex Inc., 2011FC875 FN27. at ~22.

16. In re Zenitz (1964), 52 C.P.P.A. 746 at ~2. FN34.

11 TAB AUTHORITY REFERENCE 17. Janssen-Ortho Inc. v. Novopharm Limited, 2006 FC 1234 FN34. at ~113(8). 18. Monsanto Co. v. Commissioner ofPatents, [1979] 2 FN32. S.C.R. 1108 at 1116-7. 19. New Process Screw Corporation v. P.L. Robertson Mfg. FN33. Co. Ltd (1961), 39 C.P.R. 31 at45-6 20. Pfizer Canada Inc. v. Apotex Inc., 2009 FCA 8 at 28-29. FN34. 21. Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 ("FCA FNlO, FNll, Judgment") at ,54, 67, 79-80, 125, 128-129. FN12, FNl 9 and FN38. 22. Tennessee Eastman Co. v. Commissioner ofPatents, FN34. [1974] S.C.R. 111 at 117-9. 23. Teva Canada v. Limited Pfizer Canada Inc., 2012 SCC 60 FN32. ("Teva Viagra") at ,38. 24. Visx Inc. v. NidekCo., (1997), 77 C.P.R. (3d) 532, [1997] FN34. F .C.J. No. 1352 at ,6. 25. Wandscheer v. Sicard Ltd, [1948] S.C.R. 1 FN32 and FN33. ("Wandscheer") at p. 5, 15, 24

26. Whirlpool Corp. V. Cameo Inc., 2000 sec 67 at ,43 and FN27. 49(b).

Part VII - STATUTORY PROVISIONS

TAB DOCUMENT REFERENCE 27. Patent Act, RSC 1985, c P-4, ss. 2 and 34 (now 27(3)). FN34. 28. Patented Medicines (Notice ofCompliance) Regulations, FN7. SOR/93-133 29. North American Free Trade Agreement, 32 l.L.M. 289 FN36. and 605, Article 1709. 30. Patent Cooperation Treaty, June 19, 1970, 28 U.S.T. as FN36. amended, (''PCT') Articles 5, 27(5) and (6). 31. Marrakesh Agreement Establishing the World Trade FN36. Organization, Annex JC, 15 April 1994, 1869 U.N.T.S. 299; 33 l.L.M. 1197 (TRIPs), Article 1 and 27(1 ). 32. World Intellectual Property Organization, Draft FN35. Substantive Patent Law Treaty online: httQ://www.wiQo.int/Qatent-law/en/draft SQlt.htm.

12 Part VIII - OTHER SOURCES

TAB DOCUMENT REFERENCE 33. Gold, R., and Shortt, M., "The Promise of the Patent In FN31 and FN34. Canada and Around the World", 30 CIPR 36 at p. 60-2, 66, 71 and 74. 34. Vaver, D., "Is Canada's Patent Law Out of Step?", FN31. Reworked Remarks for University of Toronto 2°d Patent Law Colloquium, November 22, 2013 at p. 2.

13 Court File No. 35562

IN THE SUPREME COURT OF CANADA (ON APPEAL FROM THE FEDERAL COURT OF APPEAL)

BETWEEN:

APOTEX INC. and APOTEX PHARMACHEM INC.

Appellants (Respondents) -and-

SANOFI-AVENTIS and BRISTOL-MYERS SQUIBB SANOFI PHARMACEUTICALS HOLDING PARTNERSHIP

Respondents (Appellants) -and-

FEDERATION INTERNATIONALE DES CONSEILS EN PROPRIETE INTELLECTUELLE and CANADA'S RESEARCH­ BASED PHARMACEUTICAL COMPANIES and CENTRE FOR INTELLECTUAL PROPERTY POLICY and INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY ("AIPPI") and BIOTECANADA and CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION Interveners

FACTUM OF THE INTERVENER, CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION

AITKEN KLEE LLP AITKEN KLEE LLP Suite 300, I 00 Queen Street Suite 300, IOO Queen Street Ottawa, ON KIP 1J9 Ottawa, ON KIP 1J9

David W. Aitken/Jonathan Stainsby David W. Aitken/Jonathan Stainsby

Tel: 613-903-5099/647-3 I 7-6868 Tel: 613-903-5099/647-3 I 7-6868 Fax:6I3-695-5854 Fax:6I3-695-5854 E-mail: [email protected] E-mail: [email protected] j [email protected] j [email protected]

Solicitors for the Intervener, Agents for the Intervener, Canadian Generic Pharmaceutical Canadian Generic Pharmaceutical Association Association