Apotex Inc. v. Sanofi-Aventis, (2013) 447 N.R. 313 (FCA)

• Judge: Noël, Pelletier and Gauthier, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: January 28, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 447 N.R. 313 (FCA);2013 FCA 186

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313 (FCA)

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Temp. Cite: [2013] N.R. TBEd. AU.003

Sanofi-Aventis (appellant) v. Apotex Inc. (respondent)

Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership (appellants) v. Apotex Inc., Apotex Pharmachem Inc. and Signa SA de CV (respondents)

(A-7-12; 2013 FCA 186; 2013 CAF 186)

Indexed As: Apotex Inc. v. Sanofi-Aventis

Federal Court of Appeal

Noël, Pelletier and Gauthier, JJ.A.

July 24, 2013.

Summary:

Sanofi-Aventis held a Canadian selection patent (the '777 Patent), for the drug clopidogrel bisulfate sold in Canada under the brand name Plavix, and commercialized as an anticoagulant that inhibited platelet aggregation activity in the blood. Apotex Inc. tried unsuccessfully to obtain a Notice of Compliance for its generic clopidogrel bisulfate tablets under the Patented Medicines (Notice of Compliance) Regulations. Thereafter, Apotex Inc. commenced an impeachment action against Sanofi-Aventis (T-644-09), alleging that the '777 Patent was invalid for lack of utility or obviousness. Sanofi-Aventis commenced an action against Apotex Inc., alleging patent infringement (T-933-09). The actions were heard together, although the damages issues were bifurcated.

The Federal Court, in a decision reported 402 F.T.R. 1, allowed Apotex's impeachment action (T-644-09) and dismissed Sanofi-Aventis's infringement action (T-933-09). The court found that the claims of the '777 Patent were invalid for lack of utility because the patent did not disclose the requirements for sound prediction. The court opined also that the patent was invalid for obviousness. The Federal Court opined that had the '777 Patent been found to be valid, that Apotex infringed both the product and process claims of the '777 Patent. Sanofi-Aventis appealed.

The Federal Court of Appeal allowed the appeal, holding that the trial judge erred in finding that the '777 patent was invalid for lack of utility or for obviousness. The court set aside the judgment of the Federal Court, allowed Sanofi-Aventis's action for infringement of the '777 patent and declared that Apotex infringed claims 1, 3, 6, 7, 8, 9, 10, and 11 of that patent. The court dismissed Apotex's action seeking a declaration that the '777 patent was invalid. The appeal court returned the matter to the Federal Court to deal with the issue of remedies and costs.

Courts - Topic 4072

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Limitation periods - [See both Patents of Invention - Topic 3510 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See second Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - The Federal Court of Appeal stated that "In the case of selection patents ... the novelty of the selection and its advantages (including disadvantages to be avoided) are the invention and must be described in the patent ..." - See paragraph 51.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See first Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1587

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Selection patents - Sanofi-Aventis held a selection patent ('777 Patent) for the drug clopidogrel bisulfate (Plavix) - Apotex commenced an impeachment action against Sanofi-Aventis, alleging that the '777 Patent was invalid for obviousness - The trial judge opined that the invention in the '777 Patent was "obvious to try" as of the appropriate date for obviousness (November 6, 1987) - Thus the patent and its claims were invalid on the basis of obviousness - Sanofi-Aventis appealed - The Federal Court of Appeal held that the trial judge erred in finding that the invention of the '777 Patent was obvious - See paragraphs 72 to 82 and 136 to 140.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1587 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court of Appeal stated that "A patent holder whose patent is challenged on grounds of lack of utility must be able to show that, at the time of the patent was applied for, the utility of the invention could either be demonstrated or soundly predicted ... The sticking point, in this case as in others, is to determine what it is that must be demonstrated or soundly predicted. This is where the notion of the promise of the patent comes into play. The promise of the patent is the standard against which the utility of the invention described in the patent is measured" - See paragraphs 46 and 47.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court of Appeal stated that "While an inventor need not describe the utility of his invention in his patent, if he does so, he will be held to the promise which he has made ... If the inventor does not make an explicit promise of a specific result, the test for utility is a 'mere scintilla' of utility. If, on the other hand, the inventor makes an explicit promise of a specific result, then utility will be assessed by reference to the terms of the explicit promise" - See paragraphs 48 and 49.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court of Appeal stated that "When this Court said at paragraph 80 of Olanzapine, cited above, that the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result since, subject to what is said below with respect to selection patents, there is no obligation on the part of the inventor to disclose the utility of his invention in the patent. In Olanzapine, the Court was simply indicating that the first step in assessing utility was to determine the standard against which utility will be measured. This requires the Court to construe the patent to determine if a person skilled in the art would understand it to contain an explicit promise that the invention will achieve a specific result. If so, the inventor will be held to that promise. If there is no explicit promise of a specific result, then a mere scintilla of utility will do" - See paragraph 50.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine (incl. selection patents) - The Federal Court of Appeal stated that in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (2008 SCC), the court "accepted that a selection patent is like any other patent. As a result, it must satisfy the requirements of the [Patent] Act, including the requirement that the invention be new and useful. The element of novelty is satisfied by the fact that the selected compounds have not previously been made. The element of utility is usually satisfied by the presence of a special property of an unexpected character, consisting in the advantage secured or the disadvantage avoided by the selection and which is at the heart of the inventive steps ... Were it not so, no selection would meet the statutory criteria for patentability. A selection patent must also satisfy the disclosure requirements found in s. 34 of the Old Act. It does so by setting out in the specification 'in clear terms the nature of the characteristic which the patentee alleges to be possessed by the selection for which he claims a monopoly'" - See paragraphs 44 and 45.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine (incl. selection patents) - Sanofi-Aventis held a selection patent ('777 Patent) for the drug clopidogrel bisulfate (Plavix) - Apotex Inc., a generic drug manufacturer, alleged that the '777 Patent was invalid for lack of utility (i.e., the patent failed to demonstrate utility in humans) - The trial judge found that the patent was invalid for lack of utility - Sanofi-Aventis appealed - The Federal Court of Appeal allowed the appeal - The court held that the trial judge erred in law in his construction of the promise of the patent - The '777 Patent described a compound having advantages (including the absence of disadvantages) over the compounds of the main patent and those advantages were clearly disclosed in the patent specification - The trial judge found that those advantages were demonstrated at the time of the patent application - The trial judge erred in construing the patent as specifically promising a result when the invention was used in humans and then assessing the utility of the patent against that specific promise - Properly construed, the '777 Patent made no such promise - As a result, the allegation that the patent was invalid for lack of utility ought to have been dismissed - See paragraphs 34 to 71 and 124 to 135.

Patents of Invention - Topic 1725

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

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - [See Patents of Invention - Topic 2945 ].

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - Sanofi-Aventis held a selection patent ('777 Patent) for the drug clopidogrel bisulfate (Plavix) - Sanofi-Aventis sued Apotex Inc., a generic drug manufacturer, alleging patent infringement because Apotex imported, offered for sale, sold, made, possessed for commercial purposes, used and exported clopidogrel bisulfate and clopidogrel bisulfate tablets - The trial judge opined that Apotex infringed both the product and process claims of the '777 Patent - On appeal Apotex did not contest the trial judge's conclusion that it infringed the patent, but claimed that Sanofi-Aventis was precluded from recovering damages for infringement because of limitations issues, its exemption for experimental and regulatory use, and settlement agreements in litigation between the parties in the United States - The Federal Court of Appeal held that the matters raised by Apotex did not preclude the court from awarding damages for patent infringement - See paragraphs 85 to 121.

Patents of Invention - Topic 3013

Infringement of patent - Defences - Use of patented product related to development and submission of information to government authorities (regulatory use exemptions) - In a patent infringement case involving a selection patent ('777 Patent) owned by Sanofi-Aventis for the drug clopidogrel bisulfate (Plavix), a generic drug manufacturer (Apotex), claimed an exemption from liability under the experimental use exception (Patent Act, s. 55.2) - The trial judge rejected Apotex's claim for an exemption because Apotex had not shown that the clopidogrel used for regulatory purposes was destroyed once its regulatory use was completed - On appeal, the Federal Court of Appeal stated that "It is true that Apotex was entitled to the benefit of section 55.2(1) for clopidogrel so long as it was used for the purposes permitted by that provision. But clopidogrel is a valuable and highly profitable product. To the extent that Apotex was unable to account for the clopidogrel used for regulatory purposes after it was no longer required for those purposes, it was a reasonable inference that the product had been sold, a use which fell outside the protection of section 55.2(1). I can see no basis for interfering with the trial judge's conclusion on this issue" - See paragraph 103.

Patents of Invention - Topic 3510

Infringement actions - General - Limitation of actions - Sanofi-Aventis, which held a selection patent for the drug clopidogrel bisulfate (Plavix), sued Apotex Inc. for patent infringement - The trial judge found that importation from Mexico and subsequent exportation to other countries was a sufficient basis for concluding that the cause of action (infringement) was not limited to a single province, thus s. 39(2) of the Federal Court Act applied (i.e., a six year limitation period) - Sanofi-Aventis appealed - The Federal Court of Appeal held that the trial judge came to the correct conclusion on the limitation defence, but for the wrong reasons - The trial judge erred in holding that both the damages suffered as well as the act that caused the damage had to have occurred in the same province in order for s. 39(1) to apply - For s. 39(1) to apply all the elements of the cause of action had to have occurred in the same province; however, damages were not an element of the cause of action of patent infringement - Thus, to the extent that the trial judge based his conclusion on the place where the cause of action arose or the place where damages occurred, he erred - See paragraphs 102 and 105 to 109.

Patents of Invention - Topic 3510

Infringement actions - General - Limitation of actions - Sanofi-Aventis held a selection patent for the drug clopidogrel bisulfate (Plavix) - Sanofi-Aventis sued Apotex Inc., a generic drug manufacturer, for patent infringement, alleging that Apotex had infringed its patent by importing clopidogrel into Canada from Mexico and then exporting it from Canada for sale in other countries including the United States - A limitations issue arose - The Federal Court of Appeal held that the six year limitation period in s. 39(2) of the Federal Court Act applied - The court stated that "... Canada is indivisible for the purposes of importation and exportation of infringing goods. Goods are imported or exported when they enter or leave Canada, regardless of the port of entry or departure. To that extent, the infringing acts of importing and exporting clopidogrel took place other than in a province so that subsection 39(2) of the Federal Courts Act applies. As a result, none of Sanofi's claim is statute barred" - See paragraphs 110 to 113.

Patents of Invention - Topic 3514

Infringement actions - General - Effect of settlement agreements - Sanofi-Aventis held a selection patent for the drug clopidogrel bisulfate (Plavix) - Sanofi-Aventis sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex argued that Sanofi-Aventis was precluded from seeking damages for infringement because of a settlement agreement reached between Sanofi and Apotex in the context of a U.S. patent infringement action brought by Sanofi with respect to its U.S. patent (the '265 patent) for clopidogrel - The trial judge found that given the explicit references to settlement of the litigation involving the '265 patent, Apotex's position was not credible - Had it been intended to settle all possible claims involving clopidogrel the agreement would have said so, given the level of sophistication of the parties and the quality of the lawyers involved - On appeal, the Federal Court of Appeal saw no basis to disturb the trial judge's finding respecting the effect of the settlement agreement - See paragraphs 113 to 119.

Cases Noticed:

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. 19].

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. 32].

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. 33].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 33].

Commissioner of Patent v. Fabwerks Hoechst Aktiengeselschaft Vormals Meister Lucius and Bruning, [1964] S.C.R. 49, refd to. [para. 34].

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. 40].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 40].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2012), 436 N.R. 299; 2012 SCC 60, refd to. [para. 40].

Teva Canada Ltd. v. Pfizer Canada Inc. - see Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

Farbenindustrie, I.G., A.G.'s Patents, Re (1930), 47 R.P.C. 289 (Ch. D.), refd to. [para. 41].

E.I. DuPont de Nemours & Co. (Witsiepe's) Application, Re, [1982] F.S.R. 303 (H.L.), refd to. [para. 43].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 45].

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. 54].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, refd to. [para. 67].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 69].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 440 N.R. 269; 2012 FCA 308, refd to. [para. 69].

American Cyanamid Co. v. Berk Pharmaceuticals Ltd., [1976] R.P.C. 231 (Ch. D.), refd to. [para. 69].

Xerox of Canada Ltd. et al. v. IBM Canada Ltd. (1977), 33 C.P.R.(2d) 234 (F.C.T.D.), refd to. [para. 69].

Apotex Inc. v. Pfizer Canada Inc. et al. (2004), 246 F.T.R. 290; 31 C.P.R.(4th) 143; 2004 FC 190, refd to. [para. 91].

Canada v. Maritime Group (Canada) Inc. et al., [1995] 3 F.C. 124; 185 N.R. 104 (F.C.A.), refd to. [para. 105].

Kirkbi AG et al. v. Ritvik Holdings Inc. et al. (2002), 220 F.T.R. 161; 2002 FCT 585 (T.D.), refd to. [para. 106].

Precision Metalsmiths Inc. v. Cercast Inc., [1967] 1 Ex. C.R. 214, refd to. [para. 107].

Voith (J.M.) GmbH v. Beloit Corp., [1997] 3 F.C. 497; 214 N.R. 85 (F.C.A.), refd to. [para. 108].

Beloit Canada Ltd. v. Valmet-Dominion Inc. - see Voit (J.M.) GmbH v. Beloit Corp.

Markevich v. Minister of National Revenue, [2003] 1 S.C.R. 94; 300 N.R. 321; 2003 SCC 9, refd to. [para. 111].

Alsop's Patent, Re (1907), 24 R.P.C. 733, refd to. [para. 126].

Statutes Noticed:

Federal Courts Act, R.S.C. 1985, c. F-7, sect. 39(1) [para. 90].

Patent Act, R.S.C. 1985, c. P-4, sect. 34(1) [para. 36]; sect. 55.2 [para. 103].

Counsel:

Anthony G. Creber, Cristin A. Wagner and Marc Richard, for the appellants;

Harry Radomski, Benjamin Hackett, Richard Naiberg and Sandon Shogilev, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the appellants;

Goodmans LLP, Toronto, Ontario, for the respondents.

This appeal was heard at Toronto, Ontario, on January 28, 2013, before Pelletier, Noël and Gauthier, JJ.A., of the Federal Court of Appeal. The decision of the court was delivered at Ottawa, Ontario, on July 24, 2013, when the following opinions were filed:

Pelletier, J.A. (Noël, J.A., concurring) - see paragaphs 1 to 121;

Gauthier, J.A., concurring - see paragraphs 122 to 140.