Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., (2012) 436 N.R. 299 (SCC)

• Jurisdiction: Federal Jurisdiction (Canada)
• Judge: McLachlin, C.J.C., LeBel, Deschamps, Abella, Rothstein, Cromwell and Moldaver, JJ.
• Citation: (2012), 436 N.R. 299 (SCC),2012 SCC 60
• Court: Supreme Court (Canada)
• Date: 18 April 2012

Pfizer Can. Inc. v. Novopharm (2012), 436 N.R. 299 (SCC)

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[French language version follows English language version]

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Temp. Cite: [2012] N.R. TBEd. NO.004

Teva Canada Limited (appellant) v. Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Research and Development Company N.V./S.A. and Minister of Health (respondents) and Canadian Generic Pharmaceutical Association and Canada's Research-Based Pharmaceutical Companies (intervenors)

(33951; 2012 SCC 60; 2012 CSC 60)

Indexed As: Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

Supreme Court of Canada

McLachlin, C.J.C., LeBel, Deschamps, Abella, Rothstein, Cromwell and Moldaver, JJ.

November 8, 2012.

Summary:

Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired. Novopharm alleged that the '446 patent was invalid for obviousness, lack of utility and insufficiency of disclosure.

The Federal Court, in a decision reported at 352 F.T.R. 35, allowed the application. Novopharm appealed.

The Federal Court of Appeal, in a decision reported at 408 N.R. 166, dismissed the appeal. Novopharm appealed. The main issue in the appeal was whether Pfizer failed to properly disclose its invention when it obtained the patent for Viagra.

The Supreme Court of Canada allowed the appeal. Pfizer's patent application did not satisfy the disclosure requirements provided for in s. 27(3) of the Patent Act.

Patents of Invention - Topic 5

General - Nature and purpose of grant of patent - The Supreme Court of Canada stated that "[t]he patent system is based on a 'bargain', or quid pro quo: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the [Patent] Act. The patent bargain encourages innovation and advances science and technology. ... Therefore, adequate disclosure in the specification is a precondition for the granting of a patent." - See paragraphs 31 to 35.

Patents of Invention - Topic 705

Application for grant - General - Disclosure and examination (incl. duty of candour) - [See Patents of Invention - Topic 5].

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - [See Patents of Invention - Topic 5 and all Patents of Invention - Topic 1779].

Patents of Invention - Topic 1501

Grounds of invalidity - General - Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of many compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), including sildenafil citrate, the active compound in Viagra - The Supreme Court of Canada held that Pfizer's patent application did not satisfy the disclosure requirements provided for in s. 27(3) of the Patent Act - At issue was the appropriate remedy - Although s. 27 of the Act did not specify a remedy for insufficient disclosure, the logical consequence of a failure to properly disclose the invention and how it worked would be to deem the patent in question invalid - This flowed from the quid pro quo principle underpinning the Act - If there was no quid - proper disclosure - then there can be no quo - exclusive monopoly rights - See paragraphs 81 to 87.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See first Patents of Invention - Topic 1779].

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of many compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patent was invalid for insufficiency - Novopharm also submitted that the '446 patent was invalid for insufficient disclosure of sound prediction - The Supreme Court of Canada held that this was not a case about sound prediction and Novopharm's argument on this point had to fail - Utility could be demonstrated by, for example, conducting tests, but this did not mean that there was a separate requirement for the disclosure of utility - In fact, there was no requirement whatsoever in s. 27(3) of the Patent Act to disclose the utility of the invention - In any event, Pfizer disclosed the utility of sildenafil by disclosing that tests had been conducted - Sildenafil was found to be useful before the priority date - See paragraphs 36 to 43.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of many compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patent was invalid for insufficiency - Pfizer asserted that the disclosure was sufficient because the requirements of s. 27(3) of the Patent Act were met - Pfizer further submitted that s. 58 of the Act allowed courts to consider valid claims separately from those that were not valid - The Supreme Court of Canada held that this was a misinterpretation of s. 58 - Section 58 simply stated that valid claims survived in the face of one or more invalid claims - This section was engaged once it had been determined, on the basis of the patent as a whole, whether the requirements, including the disclosure requirements, had been complied with - Section 58 did not allow a court to consider the validity of a single claim, Claim 7 in this case, independently of the rest of the specification, even if the claim in question was the only one that might be valid - This section was engaged only after the validity analysis was carried out - See paragraph 56.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Pfizer Canada Inc. and others (collectively, Pfizer) applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. for a generic version of Viagra until Pfizer's Canadian Patent 2,163,446 (the '446 patent) expired - The '446 patent claimed the use of many compounds in claims 1 to 7 for the treatment of erectile dysfunction (ED), including sildenafil citrate, the active compound in Viagra - Novopharm alleged that the '446 patent was invalid for insufficiency - Pfizer asserted that the disclosure was sufficient because the requirements of s. 27(3) of the Patent Act were met - It contended that what had to be disclosed was the invention and that, since the invention in this case was sildenafil, the disclosure had to be assessed only in relation to that claimed invention - According to Pfizer, even if a skilled person were to consider patent '446 as a whole, he or she would understand the invention to be a class of compounds useful to treat ED, where nine specific compounds (including sildenafil) were especially preferred and two specific compounds (including sildenafil) were individually claimed - The Supreme Court of Canada held that Pfizer's patent application did not satisfy the disclosure requirements provided for in s. 27(3) - The Act required that the court consider the specification as a whole to determine whether the disclosure of the invention was sufficient - Here, there was nothing to support the view that the use of sildenafil for the treatment of ED was a separate invention from the use of any of the other claimed compounds for that same purpose - No specific attributes or characteristics were ascribed to sildenafil that would set it apart from the other compounds - Even if the court took into consideration the fact that sildenafil was an "especially preferred compound", there was still nothing that distinguished it from the other eight "especially preferred compounds" - The use of sildenafil and the other compounds for the treatment of ED comprised one inventive concept - Although patent '446 included the statement that "one of the especially preferred compounds induces penile erection in impotent males", the specification did not indicate that sildenafil was the effective compound, that Claim 7 contained the compound that worked, or that the remaining compounds in the patent had been found not to be effective in treating ED - "The disclosure in the specification would not have enabled the public 'to make the same successful use of the invention as the inventor could at the time of his application', because even if a skilled reader could have narrowed the effective compound down to the ones in Claim 6 and Claim 7, further testing would have been required to determine which of those two compounds was actually effective in treating ED." - See paragraphs 44 to 80.

Cases Noticed:

C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201, affd. [1963] S.C.R. 410, refd to. [para. 7].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2009] 1 F.C.R. 253; 377 N.R. 9; 2008 FCA 108, refd to. [para. 10].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 10].

Noranda Mines v. Minerals Separation North America Corp., [1947] Ex. C.R. 306, refd to. [para. 11].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, affd., [2007] 3 F.C.R. 588; 354 N.R. 51; 55 C.P.R.(4th) 1; 2006 FCA 323, refd to. [para. 21].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 25].

Tubes, Ld. v. Perfecta Seamless Steel Tube Co. (1902), 20 R.P.C. 77, refd to. [para. 33].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, refd to. [para. 34].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 78 C.P.R.(4th) 388; 2009 FCA 97, refd to. [para. 37].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 50].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 50].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 50].

Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co., [1965] 1 Ex. C.R. 710, affd. [1966] S.C.R. 189, refd to. [para. 62].

Authors and Works Noticed:

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed.) (Looseleaf), vol. 1, p. 333 [para. 11].

Perry, Stephen J. and Currier, T. Andrew, Canadian Patent Law (2012), §§ 7.11 [para. 38]; 7.12 [para. 41]; 8.55 [para. 78]; 8.57 [para. 79]; 15.2 [para. 55]; 15.26 [para. 69].

Counsel:

David W. Aitken, Marcus Klee and Ildiko Mehes, for the appellant;

Andrew Shaughnessy, Andrew Bernstein and Yael Bienenstock, for the respondents, Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and Pfizer Research and Development Company N.V./S.A;

Jonathan Stainsby and Andrew Skodyn, for the intervener, the Canadian Generic Pharmaceutical Association;

Patrick S. Smith and Jane E. Clark, for the intervener, Canada's Research-Based Pharmaceutical Companies;

No one appeared for the respondent, the Minister of Health.

Solicitors of Record:

Osler, Hoskin & Harcourt, Ottawa, Ontario, for the appellant;

Torys, Toronto, Ontario, for the respondents, Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals and Pfizer Research and Development Company N.V./S.A.;

Heenan Blaikie, Toronto, Ontario, for the intervener, the Canadian Generic Pharmaceutical Association;

Gowling Lafleur Henderson, Ottawa, Ontario, for the intervener, Canada's Research-Based Pharmaceutical Companies.

This appeal was heard on April 18, 2012, by McLachlin, C.J.C., LeBel, Deschamps, Abella, Rothstein, Cromwell and Moldaver, JJ., of the Supreme Court of Canada. The following judgment of the Supreme Court was delivered in both official languages by LeBel, J., on November 8, 2012.