Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., (2008) 381 N.R. 125 (SCC)

• Judge: Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ.
• Court: Supreme Court (Canada)
• Case Date: April 16, 2008
• Jurisdiction: Canada (Federal)
• Citations: (2008), 381 N.R. 125 (SCC);2008 SCC 61

Sanofi-Synthelabo Can. Inc. v. Apotex Inc. (2008), 381 N.R. 125 (SCC)

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[French language version follows English language version]

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

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Temp. Cite: [2008] N.R. TBEd. NO.001

Apotex Inc. (appellant) v. Sanofi-Synthelabo Canada Inc., Sanofi-Synthelabo and Minister of Health (respondents) and Canadian Generic Pharmaceutical Association, BIOTECanada and Canada's Research-Based Pharmaceutical Companies (intervenors)

(31881; 2008 SCC 61; 2008 CSC 61)

Indexed As: Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al.

Supreme Court of Canada

Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ.

November 6, 2008.

Summary:

Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets. The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent). Apotex argued that the '777 patent was invalid on the grounds of anticipation, obviousness and double patenting.

The Federal Court, in a decision reported at 271 F.T.R. 159, allowed the application and issued the order of prohibition. Apotex appealed.

The Federal Court of Appeal, in a decision reported at 358 N.R. 135, dismissed the appeal. Apotex appealed.

The Supreme Court of Canada dismissed the appeal.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Supreme Court of Canada affirmed the four step approach to obviousness: "(1) (a) Identify the notional 'person skilled in the art'; (b) Identify the relevant common general knowledge of that person; (2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it; (3) Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art' and the inventive concept of the claim or the claim as construed;  (4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?" - See paragraph 67.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Supreme Court of Canada discussed the "obvious to try" test now adopted in the United Kingdom and the United States - In areas of endeavour where advances were often won by experimentation, an "obvious to try" test might be appropriate - In such areas, there might be numerous interrelated variables with which to experiment - If an "obvious to try" test was warranted, the following factors should be taken into consideration at the fourth step of the obviousness inquiry - This list was not exhaustive - The factors applied in accordance with the evidence in each case - "(1) Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art? (2) What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine? (3) Is there a motive provided in the prior art to find the solution the patent addresses?" - See paragraphs 68 to 71.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes -  Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets - The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - Apotex argued that the '777 patent was invalid on the ground of obviousness - The '777 patent related to the invention of the dextro-rotatory isomer of the racemate and to the invention of the bisulfate salt of the dextro-rotatory isomer - The applications judge held that the '777 patent was valid  - The Supreme Court of Canada dismissed an appeal - The applications judge correctly conducted the analysis as far as the fourth step - However, he erred in not allowing for the obvious to try test, which was warranted in this case - The applications judge found that there were five well-known techniques for separating this racemate into its isomers - He also found that there was no evidence that at the relevant time, a person skilled in the art would know which one would work with the racemate at issue in this case - The evidence was that a skilled person would eventually find the right technique - However, a possibility of finding the invention was not enough - The invention had to be self-evident from the prior art and common general knowledge in order to satisfy the obvious to try test - That was not the evidence in this case - There was a significant difference between the '875 genus patent and the '777 selection patent - The difference was not obvious - See paragraphs 72 to 93.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets - The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - The '777 patent was a selection patent - Apotex argued that the '777 patent was invalid on the ground of anticipation by a previous patent ('875 patent, a genus patent) - The Supreme Court of Canada adopted a two pronged test for anticipation - The two requirements were prior disclosure and enablement - The requirement of prior disclosure meant that the prior patent had to disclose subject matter which, if performed, would necessarily result in infringement of that patent - If the disclosure requirement was satisfied, the second requirement to prove anticipation was enablement which meant that the person skilled in the art would have been able to perform the invention - See paragraphs 24 to 30.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets - The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - The '777 patent was a selection patent - Apotex argued that the '777 patent was invalid on the ground of anticipation by a previous patent ('875 patent, a genus patent) - The Supreme Court of Canada adopted a two pronged test for anticipation - The two requirements were prior disclosure and enablement - At the stage of prior disclosure, the person skilled in the art was reading the prior patent to understand whether it disclosed the special advantages of the second invention - No trial or error was permitted - If in reading the genus patent, the special advantages of the invention of the selection patent were not disclosed, the genus patent did not anticipate the selection patent - See paragraphs 31 and 32.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets - The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - The '777 patent was a selection patent - Apotex argued that the '777 patent was invalid on the ground of anticipation by a previous patent ('875 patent, a genus patent) - The Supreme Court of Canada adopted a two pronged test for anticipation - The two requirements were prior disclosure and enablement - Drawing from the jurisprudence, the court held that the following factors should normally be considered in respect of the requirement of enablement - The list was not exhaustive - The factors applied in accordance with the evidence in each case - "1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art. 2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time. 3. The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal. If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine. 4. Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted" - See paragraphs 33 to 37.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Apotex Inc. sought a Notice of Compliance (NOC) in order to market a generic version of clopidogrel bisulfate tablets - The patent owners applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - The '777 patent was a selection patent - Apotex argued that the '777 patent was invalid on the ground of anticipation by a previous patent ('875 patent, a genus patent) - The '777 patent related to the invention of the dextro-rotatory isomer of the racemate and to the invention of the bisulfate salt of the destro- rotatory isomer - The Supreme Court of Canada adopted a two pronged test for anticipation (prior disclosure and enablement) - The court held that "[s]ince the '875 patent did not disclose the special advantages of the dextro-rotatory isomer and of its bisulfate salt, as compared to the levo-rotatory isomer or the racemate and their salts, or the other compounds made and tested or otherwise referred to in the '875 patent, the invention of the '777 patent cannot be said to have been disclosed and therefore it cannot be said to have been anticipated" - See paragraphs 38 to 41.

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention - Apotex Inc. sought a Notice of Compliance (NOC) in order to market its generic version of clopidogrel bisulfate tablets - The applicants applied for an order prohibiting the Minister of Health from issuing the NOC until the expiry of their patent ('777 patent) - The '777 patent was a selection patent - Apotex argued that the '777 patent was invalid on the ground of double-patenting - The respondent argued that the applicants had filed a prior patent ('875 patent, a genus patent) that was in essence the same invention - The applications judge held that the '777 patent was valid - The Supreme Court of Canada dismissed an appeal - Since the '875 patent and the '777 patent claimed different and distinct compounds, there could not be double patenting - See paragraphs 94 to 115.

Cases Noticed:

I.G. Farbenindustrie A-G's Patents, Re (1930), 47 R.P.C. 289 (Ch. Div.), refd to. [para. 9].

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Braning, [1964] S.C.R. 49, refd to. [para. 12].

Synthon BV v. SmithKline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 12].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 20].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 20].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (C.A.), refd to. [para. 21].

Hills v. Evans (1862), 31 L.J. Ch.(N.S.) 457, refd to. [para. 24].

Du Pont de Nemours (E.I.) & Co. (Witsiepe's) Application, Re, [1982] F.S.R. 303 (H.L.), refd to. [para. 31].

Halliburton Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA Civ. 1715, refd to. [para. 34].

Wobben v. Vestas-Celtic Wind Technology Ltd., [2007] EWHC 2636 (Pat.), refd to. [para. 36].

Application of Tomlinson (1966), 363 F.2d 928 (C.C.P.A.), refd to. [para. 56].

O'Farrell, Re (1988), 853 F.2d 894 (Fed. Cir.), refd to. [para. 56].

KSR International Co. v. Teleflex Inc. (2007), 127 S. Ct. 1727 (Ct. App.), refd to. [para. 57].

Johns-Manville Corporation's Patent, [1967] R.P.C. 479 (C.A.), refd to. [para. 59].

Generics (UK) Ltd. v. H. Lundbeck A/S, [2008] R.P.C. 19; [2008] EWCA Civ. 311, refd to. [para. 59].

Angiotech Pharmaceuticals Inc. v. Conor Medsystems Inc., [2007] R.P.C. 20; [2007] EWCA Civ. (C.A.), revd. [2008] R.P.C. 28; [2008] UKHL 49, refd to. [para. 59].

Saint-Gobain PAM SA v. Fusion Provida Ltd., [2005] EWCA Civ. 177, refd to. [para. 65].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 67].

Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37; [2007] EWCA Civ. 588, refd to. [para. 67].

Whirlpool et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 95].

Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; 28 N.R. 181, refd to. [para. 105].

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. 105].

CIBA-Geigy v. Commissioner of Patents (1982), 42 N.R. 587; 65 C.P.R.(2d) 73 (F.C.A.), refd to. [para. 105].

May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), refd to. [para. 110].

Authors and Works Noticed:

Vaver, David, Intellectual Property Law: Copyright, Patents, Trade-Marks (1997), p. 136 [paras. 51, 65].

Counsel:

Harry B. Radomski, Richard Naiberg, Andew R. Brodkin and Miles Hastie, for the appellant;

Anthony G.  Creber  and  Cristin  A. Wagner, for the respondents, Sanofi-Synthelabo Canada Inc. and Sanofi-Synthelabo;

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

Edward Hore, for the intervenor, the Canadian Generic Pharmaceutical Association;

Peter Wilcox and Jana Stettner, for the intervenor, BIOTECanada;

Patrick E. Kierans, Jason Markwell and Cynthia L. Tape, for the intervenor, Canada's Research-Based Pharmaceutical Companies.

Solicitors of Record:

Goodmans, Toronto, Ontario, for the appellant;

Gowling Lafleur Henderson, Ottawa, Ontario, for the respondents, Sanofi-Synthelabo Canada Inc. and Sanofi-Synthelabo;

Hazzard & Hore, Toronto, Ontario, for the intervenor, the Canadian Generic Pharmaceutical Association;

Torys, Toronto, Ontario, for the intervenor, BIOTECanada;

Ogilvy Renault, Toronto, Ontario, for the intervenor, Canada's Research-Based Pharmaceutical Companies.

This appeal was heard on April 16, 2008, by Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ., of the Supreme Court of Canada. The following judgment of the court was delivered in both official languages by Rothstein, J., on November 6, 2008.