Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., 2008 FCA 108

• Judge: Linden, Nadon and Ryer, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: May 22, 2007
• Jurisdiction: Canada (Federal)
• Citations: 2008 FCA 108;(2008), 377 N.R. 9 (FCA)

Pfizer Can. Inc. v. Can. (2008), 377 N.R. 9 (FCA)

MLB headnote and full text

Temp. Cite: [2008] N.R. TBEd. JN.023

Pfizer Canada Inc. and Warner-Lambert Company, LLC (appellants) v. The Minister of Health and Ranbaxy Laboratories Limited (respondents)

(A-79-07; 2008 FCA 108)

Indexed As: Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al.

Federal Court of Appeal

Linden, Nadon and Ryer, JJ.A.

March 20, 2008.

Summary:

Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent). In its Notice of Allegation, Ranbaxy had alleged that the 546 patent was invalid for obviousness, double patenting, insufficiency and anticipation.

The Federal Court, in a decision reported at [2007] F.T.R. Uned. 689, dismissed Pfizer's prohibition application. The court concluded that the disclosure of the 546 patent was insufficient as it failed to comply with the requirements of s. 27(3) of the Patent Act. Pfizer appealed.

The Federal Court of Appeal allowed the appeal, holding that the applications judge was incorrect in dismissing Pfizer's application on the basis of insufficiency. The court set aside the judgment of the Federal Court and rendered a judgment prohibiting the Minister from issuing an NOC to Ranbaxy for atorvastatin calcium until after the expiry of the 546 patent.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - In its Notice of Allegation (NOA), Ranbaxy had alleged that the 546 patent was invalid for obviousness, double patenting, insufficiency and anticipation - The Federal Court of Appeal held that Ranbaxy's NOA did not constitute a sufficient basis upon which to challenge the data underlying the 546 patent - The court stated that "On its face, the 546 patent is a selection patent, the validity of which depends on it having unexpected advantages over the class from which it is selected. By failing to attack the data underlying the selection under the headings of anticipation, obviousness and double patenting, Ranbaxy has not challenged the validity of the selection. Consequently ... there is no need to examine Ranbaxy's allegations under those headings" - See paragraphs 68 to 69.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents - Pfizer's application was dismissed - The applications judge found that the data did not substantiate the promise of a ten-fold increase in activity and, as a result, he concluded that the disclosure of the 546 patent was insufficient as it failed to comply with the requirements of s. 27(3) of the Patent Act - Pfizer appealed - The Federal Court of Appeal allowed the appeal - The court held, inter alia, that the applications judge was incorrect in construing the 546 patent as promising a ten-fold increase in activity for atorvastatin as opposed to its racemate - Rather, the promise was that the compounds covered had an "unexpected and surprising inhibition of biosynthesis of cholesterol", i.e. greater than twofold - Although the 546 patent referred to data from a CSI assay which showed a ten-fold increase in activity, the data was merely illustrative of the magnitude of that promise in vitro - A person skilled in the art would know that CSI data did not reflect the activity of the compound in vivo - See paragraphs 53 to 55.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents - Pfizer's application was dismissed - The applications judge found that the data did not substantiate the promise of a ten-fold increase in activity and, as a result, he concluded that the disclosure of the 546 patent was insufficient as it failed to comply with the requirements of s. 27(3) of the Patent Act - Pfizer appealed - The Federal Court of Appeal allowed the appeal - The applications judge was wrong in interpreting the disclosure requirement of s. 27(3) as requiring that a patentee back up his invention by data - By doing so, he confused the requirements that an invention be new, useful and non-obvious with the requirement under s. 27(3) that the specification disclose the "use" to which the inventor conceived the invention could be put - Whether a patentee had obtained enough data to substantiate its invention was an irrelevant consideration with respect to the application of s. 27(3) - An analysis thereunder was concerned with the sufficiency of the disclosure, not the sufficiency of the data underlying the invention - See paragraph 56.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents - Pfizer's application was dismissed - The applications judge found that the data did not substantiate the promise of a ten-fold increase in activity and, as a result, he concluded that the disclosure of the 546 patent was insufficient as it failed to comply with the requirements of s. 27(3) of the Patent Act - Pfizer appealed - The Federal Court of Appeal allowed the appeal - The court held, inter alia, that the fact that the 546 patent did not provide a justification as to why the calcium salt of atorvastatin was the preferred embodiment of the invention did not render the disclosure insufficient - There was no requirement that a patentee explain in the disclosure why and how his invention was useful - When read as a whole, a skilled reader would understand the patent as claiming that the calcium salt of atorvastatin was the compound covered by the 546 patent that demonstrated the most surprising and unexpected inhibition of cholesterol biosynthesis because it had the most preferred physical properties - Pfizer was not required to include in the 546 patent data which supported its statement that the calcium salt of atorvastatin was the preferred embodiment of the invention, nor was it required to explain why the calcium salt was the preferred embodiment - See paragraph 62.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents - Pfizer's application was dismissed - The applications judge found that the data did not substantiate the promise of a ten-fold increase in activity and, as a result, he concluded that the disclosure of the 546 patent was insufficient as it failed to comply with the requirements of s. 27(3) of the Patent Act - Pfizer appealed - The Federal Court of Appeal allowed the appeal - The court stated that "The applications judge erred in construing the promise of the patent and mischaracterized the disclosure requirement under s. 27(3) of the Act by asking whether there was sufficient data to substantiate the promise of the patent. Such an examination exceeds the scope of the provision. An attack on a selection patent on the basis that there is no data to support the claimed advantage is certainly relevant for the purposes of validity (most likely to the question of utility), but it is not relevant with respect to disclosure under s. 27(3) of the Act. The patent must disclose the invention and how it is made. The 546 patent does this. It also discloses the advantages that underlie the selection. This, in my view, is the extent of the requirement under s. 27(3) of the Act" - See paragraphs 63 to 64.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See all Patents of Invention - Topic 1128 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents (the 768 and 893 patents) - Pfizer's application was dismissed - Pfizer appealed - Ranbaxy argued that the 546 patent was not a selection patent since it claimed compounds covered by another patent - The Federal Court of Appeal stated that Ranbaxy's argument disregarded the fact that selecting a narrow class of compounds covered by a genus patent was the very nature of the selection patent - The court stated that "the 546 patent is a selection patent. It covers the lactone, acid and pharmaceutically acceptable salts of atorvastatin, one of the many compounds covered by the 768 and 893 patents. The basis for the patent is that the compounds claimed therein display a special advantage, namely the surprising and unexpected inhibition of cholesterol biosynthesis, i.e. greater than twofold" - See paragraphs 44 to 46.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1604 ].

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents (the 893 and 768 patents) - Pfizer's application was dismissed - Pfizer appealed - Ranbaxy argued that the 546 patent was anticipated by the 768 patent which disclosed atorvastatin calcium - The Federal Court of Appeal held that the allegation of anticipation was not justified - The court stated that "A claim to a specific chemical compound cannot be anticipated by a prior art reference which only teaches a broad class of genus of compounds into which the compound falls because the prior art reference does not give directions which inevitably result in the specific compound ... Ranbaxy did not allege that the prior art teaches that the calcium salt of atorvastatin would have greater inhibition activity than expected, i.e. more than two-fold" - See paragraphs 79 to 83.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Pfizer Canada Inc. and Warner-Lambert Co. LLC (collectively Pfizer) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy Laboratories Ltd. with respect to atorvastatin calcium until after the expiration of Canadian Patent No. 2,021,546 (the 546 patent) - The 546 patent claimed a selection of compounds covered by two other Pfizer patents - Pfizer's application was dismissed - Pfizer appealed - Ranbaxy argued that the 546 patent was invalid for double patenting - Ranbaxy submitted that the process claims of another Pfizer patent (the 441 patent) and the product claims of the 546 patent were, in reality, two aspects of the same invention - Hence, there was no ingenuity in taking the products disclosed in the 441 patent and separately patenting them in the 546 patent and the 546 patent was not patently distinct from the 441 patent - The Federal Court of Appeal held that the double patenting allegations were not justified - The 441 patent covered processes, whereas the 546 patent covered compounds - A previous patent for a product produced by a claimed process did not invalidate a later patent for the product alone for reasons of double patenting - Further, where a patent had been found to be a proper selection patent, and therefore not obvious, there was no double patenting - See paragraphs 70 to 78.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - [See all Patents of Invention - Topic 1128 ].

Cases Noticed:

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 303 F.T.R. 284; 2006 FC 1471, refd to. [para. 13].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1, refd to. [para. 31].

Whirlpool et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 31].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 34].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 34].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, refd to. [para. 38].

Beecham Group Ltd. v. Bristol Laboratories International S.A., [1978] R.P.C. 521 (H.L.), refd to. [para. 39].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 39 C.P.R.(4th) 202; 2005 FC 390, refd to. [para. 39].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2006), 358 N.R. 135; 2006 FCA 421, refd to. [para. 42].

American Cyanamid Co. v. Ethicon Ltd., [1975] R.P.C. 215 (Ch. D.), refd to. [para. 53].

R. v. American Optical Co. et al. (1950), 11 Fox Pat. C. 62, refd to. [para. 57].

Pharmascience v. Sanofi-Aventis Canada Inc. - see Aventis Pharma Inc. et al. v. Pharmascience Inc. et al.

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 352 N.R. 99; 2006 FCA 229, refd to. [para. 75].

Aventis Pharma Inc. v. Mayne Pharma (Canada) Inc. et al., [2005] F.T.R. Uned. A62 (F.C.), refd to. [para. 76].

GlaxoSmithKline Inc. et al. v. Apotex Inc. et al. (2003), 234 F.T.R. 251 (T.D.), refd to. [para. 77].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 81].

Free World Trust v. Electro Santé Inc. et al. (2000), 263 N.R. 150; 9 C.P.R.(4th) 168 (S.C.C.), refd to. [para. 81].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (1997), 134 F.T.R. 201; 77 C.P.R.(3d) 547 (T.D.), refd to. [para. 83].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 27(3) [para. 25].

Authors and Works Noticed:

Canadian Intellectual Property Office, Manual of Patent Office Practice, s. 11.12 [para. 41].

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 163 [para. 34].

Henderson, Gordon F., Patent Law of Canada (1994), pp. 211, 212 [para. 40].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed.) (2005 Looseleaf), vol. 1, pp. 172, § 15 [paras. 76, 77]; 333 [para. 36].

Counsel:

Andrew Shaughnessy, Peter Wilcox and Grant Worden, for the appellants;

Ronald Dimock, Angela Furlanetto and David Reive, for the respondent, Ranbaxy Laboratories Ltd.

Solicitors of Record:

Torys LLP, Toronto, Ontario, for the appellants;

Dimock Stratton LLP, Toronto, Ontario, for the respondents, Ranbaxy Laboratories Ltd.

This appeal was heard on May 22, 2007, at Ottawa, Ontario, before Linden, Nadon and Ryer, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered by Nadon, J.A., on March 20, 2008.