Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Court of Appeal (Canada)
• Judge: Blais, C.J., Nadon and Trudel, JJ.A.
• Citation: (2010), 408 N.R. 166 (FCA),2010 FCA 242
• Date: 24 March 2010

Pfizer Can. Inc. v. Novopharm (2010), 408 N.R. 166 (FCA)

MLB headnote and full text

[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

Temp. Cite: [2010] N.R. TBEd. SE.029

Novopharm Limited (appellant) v. Pfizer Canada Inc., Pfizer Inc., Pfizer Ireland Pharmaceuticals, Pfizer Research and Development Company N.V./S.A. and The Minister of Health (respondents)

(A-292-09; 2010 FCA 242; 2010 CAF 242)

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

Federal Court of Appeal

Blais, C.J., Nadon and Trudel, JJ.A.

September 24, 2010.

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 dismissed the appeal.

Patents of Invention - Topic 1128.1

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

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - 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 lack of utility - Novopharm alleged the '446 patent did not demonstrate utility due to Pfizer's failure to disclose sildenafil in the patent - Novopharm submitted that utility had to be demonstrated in the patent itself and therefore, a patent had to explain what the invention was in order to have utility - The Federal Court of Appeal affirmed the rejection of the allegations - Novopharm's argument that Pfizer was required to include evidence of demonstrated utility in the patent disclosure was without merit - The requirements for demonstrated utility could be provided in evidence during invalidity proceedings as opposed to in the patent itself - So long as the disclosure made reference to a study demonstrating utility, there did not appear to be any other requirements to fulfil s. 2 of the Patent Act - See paragraphs 80 to 90.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - 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 lack of utility - The application judge rejected the allegation - The Federal Court of Appeal dismissed Novopharm's appeal - The application judge did not commit a reviewable error - Although the application judge's pronouncements seemed to denote some confusion on his part with regard to the appropriate standard of utility, this did not constitute a reviewable error - First, he noted that apart from the "scintilla of utility" standard, there had to be evidence that the invention produced that result, but that there was no requirement that the result be commercially useful - Furthermore, the application judge found that "patients who received sildenafil showed a significant improvement in erectile function" - A finding of significant improvement was an indication that the application judge found that there was more than a "scintilla of utility." - The application judge was also correct in finding that an inventor was not required to meet regulatory testing standards in order to demonstrate utility - As to the application judge's findings of fact, he explicitly turned his mind to all of Novopharm's grounds of criticism: whether erections were an appropriate clinical endpoint, the utility of statistically insignificant diary data, and the RigiScan data - The application judge's findings were open to him on the record and, consequently, he made no palpable and overriding error - See paragraphs 91 to 102.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See both Patents of Invention - Topic 1723 ].

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 argued that the '446 patent did not provide sufficient information about the invention as required by s. 27(3) of the Patent Act - The application judge rejected the assertion - First, the '446 patent included within its claims a meritorious invention, i.e., the commercially successful drug popularly known as Viagra - Second, the patent was laid open to the public in Canada on December 22, 1994, the relevant date for assessing whether a skilled reader would have sufficient information - The Novopharm allegation of insufficiency came in 2007, 13 years after it was laid open to the public, 11 years after Pfizer publically identified sildenafil as the active ingredient in the drug, and 9 years after Viagra was introduced (in the Unites States) and available for analysis - Third, the fact that this patent had not been challenged for insufficiency of disclosure until 2007 raised the question "why not" - Surely the patent would have been attacked on this basis before 2007 if there was any possibility of success - Fourth, the skilled reader knew that sildenafil was the active ingredient in the invention and would be able to make the invention when the patent expired - Fifth, the jurisprudence with respect to sufficiency of disclosure condoned the claiming of classes of compounds, and single compounds within a patent, and considered only the relevant claim with the disclosure when deciding whether the patent clearly described the patent and how it worked - Sixth, in any event, the disclosure in the '446 patent did state that "One of the especially preferred compounds" had been found to work, and in that group of compounds there were only nine compounds - Then the skilled reader would see that Claim 6 and Claim 7 each described a single compound, and the skilled reader would know that one of those two single compounds was the invention which worked - A skilled reader would then conduct tests on those two compounds and determine which of those compounds worked - In this case, Claim 7 was the compound which worked and Claim 7 did sufficiently and clearly describe sildenafil - The Federal Court of Appeal affirmed the decision - See paragraphs 64 to 79.

Cases Noticed:

Lilly Icos Ltd. v. Pfizer Ltd., [2001] F.S.R. 16; 2000 EWHC Patents 49 (H.C.), affd. [2002] EWCA Civ. 1 (C.A.), refd to. [para. 9].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 61 C.P.R.(4th) 305; 2007 FC 971, affd. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 9].

C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201; 39 C.P.R. 201, affd. [1963] S.C.R. 410, refd to. [para. 16].

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; 2006 FCA 323, refd to. [paras. 16, 17].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203; 56 C.P.R.(2d) 145, refd to. [para. 20].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, refd to. [para. 20].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), refd to. [para. 24].

Pfizer Canada Inc. v. Ranbaxy Laboratories Ltd. - see Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

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. 26].

Minerals Separation North American Corp. v. Noranda Mines Ltd., [1947] Ex. C.R. 106; 12 C.P.R. 99, refd to. [para. 37].

Teledyne Industries Inc. and Teledyne Industries Canada Ltd. v. Lido Industrial Products Ltd. (1981), 39 N.R. 561; 57 C.P.R.(2d) 29 (F.C.A.), refd to. [para. 38].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 77 C.P.R.(4th) 99; 2009 FC 676, refd to. [para. 43].

Mobil Oil Corp. et al. v. Hercules Canada Inc. (1994), 82 F.T.R. 211; 57 C.P.R.(3d) 488 (T.D.), revd. (1995), 188 N.R. 382; 63 C.P.R.(3d) 473 (F.C.A.), refd to. [para. 47].

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. 49].

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. 55].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 64].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 73].

Laboratoires Servier et al. v. Apotex Inc. et al. (2009), 392 N.R. 96; 74 C.P.R.(4th) 443; 2009 FCA 222, refd to. [para. 91].

French's Complex Ore Reduction Co. v. Electrolytic Zinc Process Co., [1930] S.C.R. 462, refd to. [para. 92].

Authors and Works Noticed:

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 180 [para. 38].

Halsbury's Law of England (3rd Ed. 1955), vol. 29, p. 59 [para. 84].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005) (Looseleaf), §§ 11 [para. 95]; 25 [para. 87]; 34 [para. 27].

Counsel:

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

Andrew M. Shaughnessy, Andrew Bernstein and Vincent de Grandpré, for the respondents.

Solicitors of Record:

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

Torys LLP, Toronto, Ontario, for the respondents.

This appeal was heard on March 24, 2010, at Montreal, Quebec, by Blais, C.J., Nadon and Trudel, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered by Nadon, J.A., at Ottawa, Ontario, on September 24, 2010.