35562 CIPP Leave to Intervene RECORD

SCC Court File No.: 35562 IN THE SUPREME COURT OF CANADA

(ON APPEAL FROM THE FEDERAL COURT OF APPEAL) B E T W E E N:

APOTEX INC. and APOTEX PHARMACHEM INC.

Appellants (Respondents)

and

SANOFI-AVENTIS and BRISTOL-MEYERS SQUIBB SANOFI

PHARMACEUTICALS HOLDING PARTNERSHIP

Respondents (Appellants)

MOTION RECORD OF THE PROPOSED INTERVENER CENTRE FOR INTELLECTUAL PROPERTY POLICY

(Motion for Intervention pursuant to Rules 47, 55, 56, 57 and 59

of the Rules of the Supreme Court of Canada)

Jeremy de Beer Professional Corporation 676 Roosevelt Avenue Ottawa, ON, K2A 2A7 Jeremy de Beer Tel: (613) 263-9155 Fax: (613) 562-5417 Email: [email protected] Counsel for the Proposed Intervener

Samuelson-Glushko Canadian Internet Policy & Public Interest Clinic (CIPPIC) University of Ottawa, Faculty of Law, CML 57 Louis Pasteur Street Ottawa, ON, K1N 6N5 Tamir Israel Tel: (613) 562-5800 ext. 2914 Fax: (613) 562-5417 Email: [email protected] Agent for the Proposed Intervener

TO: THE REGISTRAR

COPY TO: Counsel for the Appellants, Apotex Inc. and Apotex Pharmachem Inc. GOODMANS LLP Suite 3400, 333 Bay Street Toronto, ON, M5H 2S7 Harry B. Radomski Tel: 416-979-2211 Fax: 416-979-1234 Email: [email protected]

Agent for the Appellants, Apotex Inc. and Apotex Pharmachem Inc. NELLIGAN OBRIEN PAYNE LLP Suite 1500, 50 OConnor Street Ottawa, ON, K1P 6L2 Dougald E. Brown Tel: 613-231-8210 Fax: 613-738-3661 Email: [email protected]

AND TO: Counsel for the Respondents, Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership GOWLING LAFLEUR HENDERSON LLP Suite 2600, 160 Elgin Street Stn. D. Ottawa, ON, K1P 1C3 Anthony G. Creber C. Wagner M. Richard Tel: 613-232-1781 Fax: 613-563-9869 Email: [email protected]

Agent for the Respondents, Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership GOWLING LAFLEUR HENDERSON LLP Suite 2600, 160 Elgin Street Stn. D. Ottawa, ON, K1P 1C3 Anthony G. Creber C. Wagner M. Richard Tel: 613-232-1781 Fax: 613-563-9869 Email: [email protected]

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TABLE OF CONTENTS

Tab Description Page

1 NOTICE OF MOTION 1

2 AFFIDAVIT OF PIERRE-EMMANUEL MOYSE 6

3 MEMORANDUM OF ARGUMENT 11

PART I. STATEMENT OF FACTS 11

PART II. STATEMENT OF QUESTIONS AT ISSUE 12

PART III. ARGUMENT 12

PART IV. SUBMISSIONS ON COSTS 20

PART V. ORDER SOUGHT 20

PART VI. TABLE OF AUTHORITIES 21

PART VII. STATUTORY PROVISIONS 23

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(ON APPEAL FROM THE FEDERAL COURT OF APPEAL)

B E T W E E N:



and




NOTICE OF MOTION OF THE PROPOSED INTERVENER

CENTRE FOR INTELLECTUAL PROPERTY POLICY

(Motion for Intervention pursuant to Rules 47, 55, 56, 57 and 59 of the Rules of the Supreme Court of Canada)

TAKE NOTICE that the Centre for Intellectual Property Policy (CIPP) hereby applies to

a judge of this Court, pursuant to Rules 47, 55, 56, 57 and 59 of the Rules of the Supreme Court of

Canada, for an order granting the CIPP leave to intervene in this appeal, to file a factum not to

exceed 15 pages in length and to make oral argument at the hearing of the appeal for not more than

15 minutes, and any further or other order as this Court may deem appropriate.

AND FURTHER TAKE NOTICE that the following documentary evidence will be relied

upon in support of this motion:

1. the affidavit of Pierre-Emmanuel Moyse, Director of CIPP, sworn June 18, 2014; and

2. such further and other material as counsel may advise and this Court may permit.

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AND FURTHER TAKE NOTICE that the motion shall be made on the following grounds:

The appeal

1. By order dated January 30, 2014, the Appellants were granted leave to appeal from the

judgment of the Federal Court of Appeal (A-7-12, 2013 FCA 186), dated July 24, 2013.

2. The appeal relates to the validity of a patent over a particular compound clopidogrel

selected from a class of chemical compounds said to be useful as pharmaceutical agents

and covered by an earlier patent. Clopidogrel is the active ingredient in the pharmaceutical

product Plavix, marketed and sold by the Respondents.

3. The appeal raises both narrow and general issues. Narrowly, it deals with the application

of Canadian patent law with respect to patent construction, the asserted utility of

clopidogrel, especially its advantages over the previously patented class of compounds,

the sufficiency of disclosure of that invention, as well as the obviousness of the invention

of clopidogrel. More generally, the decision under appeal challenges two foundational

questions in Canadian patent law.

4. The first foundational question is the appropriate basis for comparing Canadian patent law

to that of other jurisdictions. Specifically, it asks whether the appropriate unit of

comparison in patent law is the legal framework that responds to a particular problem or a

narrow rule taken in isolation from all other patent rules.

5. The second of these questions is how best to ensure the continued flexibility of the patent

system. In particular, it asks whether non-obviousness analyses take into account all

primary and secondary factors or whether, in the alternative, it is appropriate to focus on

only one component of one secondary factor to the exclusion of all others.

6. As to the first of these questions, the Appellants refer, in their factum seeking leave to

appeal, to often repeated claims [of patentees] that Canadas law of utility is out-of-

step with that of other countries.1 In addition, Eli Lilly and Company, in its investor-state

1 Apotex Inc, et al v Sanofi-Aventis, et al, SCC 35562 (Memorandum of Argument of the Applicants at para 55).

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trade complaint against Canada filed under the North American Free Trade Agreement,

alleges that the law underlying the legal issues at stake in this appeal violates alleged

international standards and international trade law.2

7. In relation to the second of the foundational questions, the Federal Court Appeal held that

one sub-component of the obvious to try analysis the unanticipated benefits of the end

result trumped all other factors including motivation.3

The CIPP has an interest in the issues arising in this appeal

8. The CIPP possesses over a decade of intensive work on Canadian, American, and

European patent law, comparative patent law, international patent law and international

trade in relation to patent law. At the core of its mission, the CIPP brings the most up-to-

date knowledge about patent law and innovation to assist governments, policy-makers,

firms and courts in Canada and internationally.

9. At the centre of this appeal is the continued balance that lies at the heart of the patent system:

to provide an incentive to inventors through limited term monopolies while promoting follow-

on innovations and the ability of Canadians to use them. The CIPP is uniquely positioned to

highlight the public interest at stake in the appeal due to its non-profit nature, its commitment

to showcasing the Canadian patent system as an exemplar to other countries, and its extensive

expertise in Canadian, comparative, and international patent law, as well as innovation policy.

This different point of view will be useful to the Court, and ensuring that it is heard will

advance the mission of the CIPP. Therefore, the CIPP has an interest in this appeal.

The CIPPs submissions will be useful and different from the other parties

10. The CIPP possesses a significant and respected degree of expertise in patent law in general and

on the issues arising in this appeal in particular. The CIPP is also completely independent of the

interests of both the brand name and generic pharmaceutical industries, receiving no funding

2 Eli Lilly and Company v Government of Canada, Notice of Arbitration under the Rules of the United Nations Commission on International Trade Law and the North American Free Trade Agreement (13 September 2013), online: . 3 Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 at paras 63, 67, 69-71, [2008] 3 SCR 265.

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TO: THE REGISTRAR

COPY TO: Counsel for the Appellants, Apotex Inc. and Apotex Pharmachem Inc. GOODMANS LLP Suite 3400, 333 Bay Street Toronto, ON, M5H 2S7 Harry B. Radomski Tel: 416-979-2211 Fax: 416-979-1234 Email: [email protected]

Agent for the Appellants, Apotex Inc. and Apotex Pharmachem Inc. NELLIGAN OBRIEN PAYNE LLP Suite 1500, 50 OConnor Street Ottawa, ON, K1P 6L2 Dougald E. Brown Tel: 613-231-8210 Fax: 613-738-3661 Email: [email protected]

AND TO: Counsel for the Respondents, Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership GOWLING LAFLEUR HENDERSON LLP Suite 2600, 160 Elgin Street Stn. D. Ottawa, ON, K1P 1C3 Anthony G. Creber C. Wagner M. Richard Tel: 613-232-1781 Fax: 613-563-9869 Email: [email protected]

Agent for the Respondents, Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership GOWLING LAFLEUR HENDERSON LLP Suite 2600, 160 Elgin Street Stn. D. Ottawa, ON, K1P 1C3 Anthony G. Creber C. Wagner M. Richard Tel: 613-232-1781 Fax: 613-563-9869 Email: [email protected]

NOTICE TO THE RESPONDENT TO THE MOTION: A respondent to the motion may serve and file a response to this motion within 10 days after service of the motion. If no response is filed within that time, the motion will be submitted for consideration to a judge or the Registrar, as the case may be. If the motion is served and filed with the supporting documents of the application for leave to appeal, then the Respondent may serve and file the response to the motion together with the response to the application for leave.

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(ON APPEAL FROM THE FEDERAL COURT OF APPEAL)

B E T W E E N:



and




MEMORANDUM OF ARGUMENT OF THE PROPOSED INTERVENER

CENTRE FOR INTELLECTUAL PROPERTY POLICY

(Motion for Intervention pursuant to Rules 47, 55, 56, 57 and 59 of the Rules of the Supreme Court of Canada)

PART I. STATEMENT OF FACTS

1. The Centre for Intellectual Property Policy (CIPP) asks this Honourable Court to grant it leave to

intervene, file a factum and make argument in the herein appeal, pursuant to Supreme Court Rule 55.

2. The Federal Court of Appeal found Canadian Letters Patent No. 1,336,777 (the 777

patent) to be valid. In doing so, it reversed the decision at trial holding that (a) the inventors had

failed to sufficiently disclose their invention; and (b) that the invention was obvious.

3. The CIPP is an internationally recognized and independent think tank that conducts

research on and develops policy with respect to intellectual property and innovation in Canada

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and internationally. Its views and advice are sought by international organizations, governments,

governmental committees, universities, hospitals and private actors.1 Its mission is to ensure that

intellectual property laws and policies reach and maintain an appropriate balance by encouraging

invention through limited monopolies while ensuring that Canadians benefit from new products

and services on a long-term basis.2 In its international policy work, it uses Canadian law as an

exemplar of how a country can promote innovation while addressing domestic needs.3

4. The CIPP has both a mandate and experience in intervening in important patent law cases

and in assisting governments in patent policy. For example, through its Members, it intervened

on the issue of the patentability of human genes before the Supreme Court of the United States

and the United States Court of Appeals for the Federal Circuit.4 Its Members have also been

invited to speak to Parliamentary committees as well as foreign governmental and international

organization committees on intellectual property matters.5

PART II. QUESTION IN ISSUE

5. Should the Court grant the CIPP leave to intervene in the appeal?

PART III. ARGUMENT

6. As interpreted by this Court, Supreme Court Rule 55 provides that leave to intervene be granted

where a party has (a) an interest in the subject-matter in the appeal; and (b) the proposed intervener will

be able to make submissions that are useful and different from that of the parties to the appeal.6

7. The issues arising in the appeal affect the ability of the CIPP to pursue its mission of

ensuring a fair and balanced patent system. The CIPP will put forward arguments that address the 1 Affidavit of Prof. Pierre-Emmanuel Moyse on behalf of the Centre for Intellectual Property Policy at para 12 [Moyse, Affidavit]. 2 Moyse, Affidavit, at para 3. 3 Moyse, Affidavit, at para 4. 4 Moyse, Affidavit, at para 15. 5 Moyse, Affidavit, at para 12. 6 Rules of the Supreme Court of Canada, SOR/2002-156, s 55-57; R v Finta [1993] 1 SCR 1138; Reference re Workers Compensation Act, 1983 (Nfld), [1989] 2 SCR 335.

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underlying principles of patent law arising from the matters in appeal that are unlikely to be

raised by the Appellants or Respondents.

A) The CIPP has an interest in the subject matter of this appeal

8. The CIPP has, since its founding in 2003, worked with governments, universities and

private firms in seeking to improve the Canadian patent system.7 One of its core missions is to

translate the growing theoretical and empirical base of knowledge on how patent laws affect

innovation into concrete policy recommendations ranging from statutory reform, the

implementation of intellectual property strategies, licensing practices, the development of

guidelines on obtaining and deploying intellectual property and technology transfer policies.8

9. This appeal raises issues that are fundamental to the fairness and effectiveness of

Canadas patent system. These are as follows: 1) whether to harmonize one narrow aspect of

Canadian patent law with that of the United States or Europe on the basis of the purported

existence of an international standard; and 2) whether a non-obviousness analysis ought to

consider all primary and secondary factors or can limit itself to only one factor.

10. Because the balance inherent in Canadian patent law is in issue, the CIPP is directly

affected by this appeal. If arguments addressing this balance are not presented to the Court then

the CIPPs mission of ensuring balance will be at risk, to the CIPPs prejudice.

B) The CIPP will make useful and different submissions

11. Leave to intervene will be granted to a party who is able to present argument from a

different perspective9 and where the intervener will provide the Court with fresh information

or a fresh perspective on an important constitutional or public issue.10

7 Moyse, Affidavit, at para 14. 8 Moyse, Affidavit, at para 9. 9 Norberg v Wynrib, [1992] 2 SCR 224 at 225. 10 Ref re Workers Compensation Act, 1983 (Nfld) (Application to Intervene), [1989] 2 SCR 335 at para 12.

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12. As an independent, not-for-profit think tank at the forefront of research and policy

development in the area of intellectual property and innovation in Canada, the CIPP brings fresh

knowledge and a new perspective to the important public policy issues underlying the appeal.

13. The CIPP will raise arguments that no other party is likely to address. Both the Appellants

and Respondents will likely focus on the validity of the 777 patent. The CIPP will, on the other

hand, focus its submissions on two foundational principles of patent law that are not addressed in

the Appellants factum11 and are unlikely to be addressed in the Respondents arguments yet are

directly engaged by the matters before the Court. The first of these is that, in comparing

Canadian patent law to that of other jurisdictions, courts ought to undertake a holistic, functional

analysis of how different legal systems deal with similar problems. Courts ought not compare

narrow rules out of the context of the internal architecture and balance attained through the

system as a whole. The second principle is that courts should take a holistic approach to

determining whether an invention is obvious by focusing on the ultimate question of whether the

invention would have been, at the relevant date, obvious to one skilled in the art.

The nature of the proposed legal argument

14. The Appellant, in its Factum in support of leave to appeal, referred to the often repeated

claims [of patentees] that Canadas law of utility is out-of-step with that of other countries.12 In

addition, Eli Lilly and Company, in its investor-state trade complaint against Canada filed under the

North American Free Trade Agreement, alleges that one of the legal issues arising in this appeal the

construction of the patent to determine the applicants asserted utility and whether that asserted utility

has been soundly predicted violates alleged international standards and international trade law.13

15. The CIPP will submit that Canadas patent laws are functionally aligned with those of its

trading partners. Canadian patent law achieves the same principled balance as do foreign laws by 11 Factum of the Appellant. 12 Apotex Inc, et al v Sanofi-Aventis, et al, SCC 35562 (Memorandum of Argument of the Applicants at para 55). 13 Eli Lilly and Company v Government of Canada, Notice of Arbitration under the Rules of the United Nations Commission on International Trade Law and the North American Free Trade Agreement (13 September 2013), online: .

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encouraging invention through the award of limited term monopolies while facilitating follow-on

innovation of new products and services and their use by Canadians. Canada achieves this

balance through requirements of sufficiency of disclosure, consistent patent construction and

holding patentees to their strategic assertions of utility.

16. The CIPP will make four submissions in support of this position as follows: (i) Canadas

patent laws are functionally consistent with those of its trading partners; (ii) no formal or

informal international standard of utility or non-obviousness exists; (iii) the substantive elements

of patent law function synergistically; and (iv) Canadas patent law requires a holistic analysis of

an inventions non-obviousness.

(i) Canadas patent laws are functionally consistent with those of its trading partners

17. The CIPP will first submit that, when subjected to an appropriate, functional comparison,

the substantive requirements of Canadian patent law result in similar outcomes to those of its

trading partners, notably the United States and Europe.

18. Accepted comparative law methodology requires that when comparing law from different

legal systems such as from Canada, the United States, and under the European Patent

Convention (EPC) one compares rules with similar functions rather than rules with similar

labels.14 Rules have similar functions if they address the same underlying problem even if they

do so differently and under different names.

19. When a proper comparative methodology is employed, one finds that the patent laws of

Canada, the United States and Europe are functionally equivalent in the result but deploy the

various substantive criteria of patent law differently. For example, Canada will hold a patent

applicant to its strategic decision to assert a higher utility than required by law through the criterion

of utility and through the requirement of sufficient disclosure.15 On the other hand, United States

14 Richard Gold and Michael Shortt, The Promise of the Patent in Canada and Around the World (2014) 30:1 CIPR 35 at 58-59 [Gold and Shortt]. 15 Gold and Shortt at 40-47.

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patent law deals with this situation through the utility branch of its enablement requirement and

through its non-obviousness analysis.16 Europe holds patentees to assertions of function through a

combination of the technicality requirement and the inventive step analysis.17 Despite different

court procedures, rules of evidence, presumptions of validity and methods of patent construction,

all patent systems attempt to hold patentees to their assertions of utility.

20. Canadian patent law shows no unique pattern of either discriminating against

pharmaceutical patents or holding those patents invalid due the criterion of utility. In fact, from

2005 to the spring of 2013, only two cases involved the invalidation of a pharmaceutical patent

solely on the basis of utility.18 Another six cases under the Patent Medicines (Notice of

Compliance) Regulations relied solely on a lack of utility (including one for lack of operability)

to reject a motion to prohibit the Minister of Health from issuing a Notice of Compliance. These

latter cases were not, however, determinations of invalidity. It was still open to the patent holder

to bring an infringement action in which validity would be determined.

(ii) No formal or informal international standard of utility or non-obviousness exists

21. There is an overwhelming consensus that there exists no international norm or standard

with respect to the substantive content of the criteria for patentability.19 In fact, there exist at least

two different architectures for patent systems, one represented by the Anglo-American approach

and the other by the European approach.20 Under the former, inventions must be new, non-

obvious and useful. Under the latter, inventions must be technical in nature, be new, make an

16 Gold and Shortt at 66-70. 17 Gold and Shortt at 70-73. 18 Eli Lilly and Company v Teva Canada Limited, 2011 FCA 220; and Eli Lilly Canada Inc v Novopharm Limited, 2012 FCA 232, 2013 CanLII 26762. 19 Jerome H Reichman, Compliance of Canadas Utility Doctrine with International Minimum Standards of Patent Protection (102nd Annual Meeting of American Society of International Law, vol 108, 2014), online: ; WHO, WIPO, & WTO, Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade (Geneva: World Trade Organization, 2012) at 57 [WHO, WIPO, & WTO]. 20 Gold and Shortt at 57-58.

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inventive contribution to the art and be capable of industrial application. As the terms used

suggest, the substantive content of these rules differ both in emphasis and in content.

22. International agreements avoid discussion of the substantive requirements of patent law,

leaving those issues to the discretion of States. As the World Health Organization, the World

Intellectual Property Organization and the World Trade Organization jointly concluded in 2012:

[T]here is no agreed international understanding about the definition and interpretation of these

criteria. This creates some policy space regarding their establishment under the applicable

national law. Accordingly, patent offices and courts interpret and apply national patentability

requirements on a case-by-case basis within the applicable legal framework.21

(iii) The substantive elements of patent law function synergistically

23. While the substantive requirements of novelty, non-obviousness and utility are often

discussed separately, courts have long recognized that they are deeply intertwined.22 The World

Intellectual Property Organizations Standing Committee on the Law of Patents has also

recognized the synergy between the substantive patent criteria: Therefore, for the purposes of

full harmonization of substantive patent law, the industrial applicability/utility requirement

cannot be considered separately from other requirements.23

24. The existence of this synergy poses a particular risk for any attempt to modify one narrow

rule in patent law with the goal of ostensibly harmonizing it with that of another jurisdiction.

This type of harmonization is likely to ignore how that particular narrow rule fits into the overall

architecture of Canadian patent law, altering the fine balance achieved.

25. Thus, even though Canadian law on utility is different, on a micro level, from that of

either the utility requirement in the United States or the industrial application requirement under

21 WHO, WIPO, & WTO at 57. 22 Eli Lilly Canada Inc v Apotex Inc 2008 FC 142 at para 64, aff'd 2009 FCA 9; RatiopharmInc v Pfizer Limited, 2009 FC 711 at para 156, aff'd 2010 FCA 204; Sanofi-Aventis Canada Inc v RatiopharmInc, 2010 FC 230 at para 51. 23 WIPO, Standing Committee on the Law of Patents, The Practical Application of Industrial Applicability/Utility Requirements Under National and Regional Laws SPC5/Inf (2001) at para 24.

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the EPC (which are, themselves, different from one another), altering that micro rule without

examining its function within the entire patent system risks causing more harm than good.

26. Removing the requirement, for example, that patent applicants who strategically assert a

higher utility than required by Canadian law are held to that utility, could inadvertently

encourage applicants to game the system24 by asserting high utilities in order to satisfy the

novelty and non-obviousness requirements while not actually having a basis for that assertion.

Since the patent laws of the United States and under the EPC possess alternative mechanisms to

address this gaming that Canada does not, it is critical that Canada preserves a basis in law to

preserve the integrity of its patent system.

27. The CIPP will submit that, to the extent that Canadian patent law on utility be modified,

this modification be done with due regard to the internal architecture and history of Canadian

patent legislation and associated jurisprudence rather than as a reaction to any alleged claim that

Canadian patent law is out-of-step with that of other nations.

(iv) Canadas patent law requires a holistic analysis of an inventions non-obviousness

28. In the present case, the decision below held that the invention was not obvious solely on

the basis of considering one sub-component of the obvious to try test: whether the invention

possessed unexpected properties.25 In fact, that court held that nothing turn[ed] on the other

sub-components of the obvious to try analysis, most notably motivation.26

29. The CIPP will submit that this Court should reinforce the principle that a non-

obviousness analysis must be holistic, taking into account all relevant factors. Only through a

holistic analysis can Canadian patent law display both balance and predictability.

24 Pfizer Canada Inc v Novopharm Ltd, 2012 SCC 60 at para 80, [2012] 3 SCR 625. 25 Sanofi-Aventis v Apotex Inc, 2013 FCA 186 at para 80, [2013] FCJ No 856 [Sanofi-Aventis v Apotex Inc]. 26 Sanofi-Aventisat v Apotex Inc at para 80.

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30. In aligning Canadian law on obviousness to try with that of the United States, this Court

previously agreed with the principle in United States patent law of avoiding rules that undermine

the holistic nature of a non-obviousness analysis.27 That principle requires that all evidence

relevant to obviousness or non-obviousness be considered, and be considered collectively.28

31. A recent decision of the United States Court of Appeals for the Federal Circuit reiterated

this principle when the court rejected the claim that a new chemical entity, as a matter of law,

cannot be obvious when the claimed invention possesses unexpected properties.29 The court held,

rather, that unexpected results do not per se defeat, or prevent, the finding that a modification to a

lead compound will yield expected, beneficial properties. Rather, as secondary considerations of

non-obviousness, they come into play in determining the ultimate question of patentability.30

32. Examining all of the factors both primary and secondary in the determination of the

obviousness or non-obviousness of an invention respects the internal architecture of Canadian

patent law in which the various validity criteria act in synergy with one another to ensure that

balance is attained between the award of limited monopolies and the subsequent creation and

development of new innovations, both of which benefit Canadians. While a finding of unexpected

results (especially in the absence of a teaching that those results were possible) may, when

balanced against all other secondary factors of obviousness, lead to the overall conclusion that an

invention is not obvious, this can only be done after all factors have been considered.

33. A holistic approach increases the predictability of the obviousness determination by not

allowing any one factor, taken out of context of the entire invention, to overwhelm the analysis.

27 Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 at para 63, [2008] 3 SCR 265. 28 In re Cyclobenzaprine Hydrochloride ExtendedRelease Capsule Patent Litigation, 676 F3d 1063 at 1078 (Fed Cir 2012). 29 Bristol-Myers Squibb Company v Teva Pharmaceuticals USA, Inc, 2014 WL 2609924 at 14 (CA Fed (Del)) [Bristol-Myers Squibb Company v Teva Pharmaceuticals USA, Inc]. 30 Bristol-Myers Squibb Company v Teva Pharmaceuticals USA, Inc, at 15.

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PART VI. TABLE OF AUTHORITIES

Authority Reference in Argument

Cases Para

1 Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, [2008] 3 SCR 265 30

2 Bristol-Myers Squibb Company v Teva Pharmaceuticals USA, Inc, 2014 WL 2609924 (Fed Cir 2014) 31

3 Eli Lilly and Company v Teva Canada Limited, 2011 FCA 220, [2011] FCJ No 1028 20

4 Eli Lilly Canada Inc v Apotex Inc 2008 FC 142 23

5 Eli Lilly Canada Inc v Novopharm Limited, 2012 FCA 232, [2012] FCJ No 1160 20

6 In re Cyclobenzaprine Hydrochloride ExtendedRelease Capsule Patent Litigation, 676 F3d 1063 (Fed Cir 2012) 30

7 Norberg v Wynrib, [1992] 2 SCR 224 11

8 Pfizer Canada Inc v Novopharm Ltd, 2012 SCC 60, [2012] 3 SCR 625 26

9 R v Finta, [1993] 1 SCR 1138 6

10 Ratiopharm Inc v Pfizer Limited, 2009 FC 711 23

11 Reference re Workers Compensation Act, 1983 (Nfld), [1989] 2 SCR 335 6

12 Sanofi-Aventis Canada Inc v Ratiopharm Inc, 2010 FC 230 23

13 Sanofi-Aventis v Apotex Inc, 2013 FCA 186, [2013] FCJ No 856 28

Secondary Materials

14

Jerome H Reichman, Compliance of Canadas Utility Doctrine with International Minimum Standards of Patent Protection (102nd Annual Meeting of American Society of International Law, vol 108, 2014), online:

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15 Richard Gold and Michael Shortt, The Promise of the Patent in Canada and Around the World (2014) 30:1 CIPR 35 18, 19,

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16 WIPO, Standing Committee on the Law of Patents, The Practical Application of Industrial Applicability/Utility Requirements Under National and Regional Laws, SPC5/Inf (2001)

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17 WHO, WIPO & WTO, Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade (Geneva: World Trade Organization, 2012)

21, 22

Statutory Provisions

18 Rules of the Supreme Court of Canada, SOR/2002-156, as amended 6

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PART VII. STATUTORY PROVISIONS

Rules of the Supreme Court of Canada, SOR/2002-156

English Franais

47. (1) Unless otherwise provided in these

Rules, all motions shall be made before a

judge or the Registrar and consist of the

following documents, in the following order:

(a) a notice of motion in accordance with

Form 47;

(b) an affidavit;

(c) when considered necessary by the

applicant, a memorandum of argument in

accordance with paragraph 25(1)(e), with any

modifications that the circumstances require;

(d) the documents that the applicant intends to

rely on, in chronological order, in accordance

with subrule 25(3); and

(e) a draft of the order sought, including costs.

(2) Parts I to V of the memorandum of

argument shall not exceed 10 pages.

(3) There shall be no oral argument on the

motion unless a judge or the Registrar

47. (1) Sauf disposition contraire des

prsentes rgles, toute requte est prsente

un juge ou au registraire et comporte dans

l'ordre suivant :

a) un avis de requte conforme au formulaire

47;

b) un affidavit;

c) si le requrant le considre ncessaire, un

mmoire conforme l'alina 25(1)e), avec les

adaptations ncessaires;

d) les documents que compte invoquer le

requrant, par ordre chronologique, compte

tenu du paragraphe 25(3);

e) une bauche de l'ordonnance demande,

notamment quant aux dpens.

(2) Les parties I V du mmoire de la requte

comptent au plus dix pages.

(3) Sauf ordonnance contraire d'un juge ou du

registraire, aucune plaidoirie orale n'est

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otherwise orders. prsente l'gard de la requte.

55. Any person interested in an application for

leave to appeal, an appeal or a reference may

make a motion for intervention to a judge.

55. Toute personne ayant un intrt dans une

demande d'autorisation d'appel, un appel ou

un renvoi peut, par requte un juge,

demander l'autorisation d'intervenir.

57. (2)(b) A motion for intervention shallset

out the submissions to be advanced by the

person interested in the proceeding, their

relevance to the proceeding and the reasons

for believing that the submissions will be

useful to the Court and different from those of

the other parties.

57. (2)(b) La requte expose ce qui suitses

s, leur pertinence par rapport la procdure et

les raisons quelle a de croire quils seront

utiles la Cour et diffrents de ceux des autres

parties.

INDEXNOTICE OF MOTIONAFFIDAVITMEMORANDUM OF ARGUMENTPART I FACTSPART II ISSUESPART III ARGUMENTPART IV COSTSPART V ORDERPART VI AUTHORITIESPART VII STATUTORY PROVISIONS

35562 CIPP Leave to Intervene RECORD

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