Apotex Inc. v. Sanofi-Aventis, (2011) 402 F.T.R. 1 (FC)

JudgeBoivin, J.
CourtFederal Court (Canada)
Case DateDecember 06, 2011
JurisdictionCanada (Federal)
Citations(2011), 402 F.T.R. 1 (FC);2011 FC 1486

Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2012] F.T.R. TBEd. JA.006

Apotex Inc. (plaintiff) v. Sanofi-Aventis (defendant)

(T-644-09)

Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holdings Partnership (plaintiffs) v. Apotex Inc. Apotex Pharmachem Inc. and Signa Sa de CV (defendants)

(T-933-09; 2011 FC 1486)

Indexed As: Apotex Inc. v. Sanofi-Aventis

Federal Court

Boivin, J.

December 6, 2011.

Summary:

Sanofi-Aventis held a selection 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. Plavix was the subject of Canadian Patent No. 1,336,777 (the '777 Patent) issued on August 22, 1995. Apotex Inc. tried unsuccessfully to obtain a Notice of Compliance for its generic clopidogrel bisulfate tablets under the Patented Medicines (Notice of Compliance) Regulations. Apotex Inc. thereafter 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 allowed Apotex's impeachment action (T-644-09) and dismissed Sanofi's infringement action (T-933-09). The court found that each of 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.

Courts - Topic 4072

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

Estoppel - Topic 377

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - When applicable - [See Patents of Invention - Topic 2946 ].

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - [See Patents of Invention - Topic 2946 ].

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - 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 - Sanofi-Aventis sued Apotex Inc., alleging patent infringement - The Federal Court noted that in a patent case such as this, the court had to first construe the claims of the patent in accordance with the established principles of claims construction - The court reviewed the applicable principles and assessed who was the hypothetical person of ordinary skill in the art (POSITA) for purposes of this case - See paragraphs 58 to 80.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - [See Patents of Invention - Topic 1026 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular 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 - Sanofi-Aventis sued Apotex Inc., alleging patent infringement - The Federal Court construed the claims of the '777 Patent - See paragraphs 81 to 183 - The court summarized its conclusions - See paragraph 182.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - 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 overbreadth (i.e., claim 6 of the patent encompassed processes that were not invented) - The Federal Court held that Apotex's allegations of overbreadth were unfounded - See paragraphs 295 to 302.

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See Patents of Invention - Topic 1130 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court referred to the four-step approach to be used when assessing obviousness as set out in Sanofi-Synthelabo Canada Inc. v. Apotex (SCC 2008) - See paragraph 589.

Patents of Invention - Topic 1584

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

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 Federal Court held that the '777 Patent was invalid for lack or utility, but 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 also invalid on the basis of obviousness - See paragraphs 587 to 787.

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 1603

Grounds of invalidity - Anticipation - By previously published article or patent - 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 on the basis of anticipation by prior printed publications (abstracts) and a prior patent - The Federal Court held that neither the abstracts nor the prior patent disclosed the invention of the '777 Patent - A POSITA (a person of ordinary skill in the art) would not be able to come up with the invention of the '777 Patent through reliance on any of those documents - Accordingly the invention of the '777 Patent was not disclosed and was therefore not anticipated - See paragraphs 306 to 330.

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Sanofi-Aventis held a selection patent ('777 Patent) for the drug clopidogrel bisulfate (Plavix) - Apotex Inc., a generic drug manufacturer, commenced an impeachment action against Sanofi-Aventis, alleging that the '777 Patent was invalid for double patenting - The Federal Court rejected the double patenting argument - See paragraphs 331 to 335.

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, commenced an impeachment action against Sanofi-Aventis, alleging that the '777 Patent was invalid for lack of utility (i.e., the patent failed to demonstrate utility in humans) - The Federal Court was unconvinced that the utility in humans had been demonstrated by Sanofi-Aventis as of the filing date (Feb. 8, 1988) - Therefore, the court went on to consider whether, as of the filing date, Sanofi-Aventis had a sound prediction for the invention in the patent - The court concluded that there was a factual basis for the prediction that the invention would have a use in the treatment of humans and a sound line of reasoning that would link the factual basis to the prediction - However, the court was persuaded, on a balance of probabilities that the disclosure in the '777 Patent was insufficient and, therefore, the claims in the '777 Patent were invalid for lack of sound prediction - See paragraphs 336 to 586.

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, commenced an impeachment action against Sanofi-Aventis, alleging that the '777 Patent was invalid for lack of utility (i.e., the patent failed to demonstrate utility in humans) - The Federal Court held that the disclosure in the '777 Patent was insufficient; therefore, the patent was invalid for lack of sound prediction - The court found that upon reading the '777 Patent, it did not instruct the POSITA (person of ordinary skill in the art) that there was a factual basis and a line of reasoning for the prediction that the animal studies conducted on rat models could be extrapolated to the prediction that the compound, clopidogrel had a use in humans - There was no basis for the POSITA to make "the leap" to predict use in humans - The underlying factual basis and line of reasoning that grounded the inventor's alleged prediction were not disclosed - See paragraphs 358 to 586.

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 - Sanofi argued that the conditions of a selection patent, such as the '777 Patent, applied differently to utility compared with novelty, obviousness and double patenting (i.e., that utility could be distinguished from the other invalidity allegations in the context of a selection patent) - Further, Sanofi argued that the "advantages" of a selection patent did not apply to the utility analysis - The Federal Court stated that the advantages of a selection patent were relevant to the entire inquiry of patent validity, obviousness, novelty, utility and sufficiency - Further, for the '777 selection patent, the promise of the patent was the utility for which the patent had to be measured - The promise of the patent, information upon which to base the promise and information to soundly predict the promise were discrete inquiries, each requiring a separate analysis - See paragraphs 363 to 366.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court referred to the three components of a sound prediction - In order to have a sound prediction, there had to be: (1) a factual basis; (2) a sound line of reasoning; and (3) proper disclosure - See paragraph 362 - The court elaborated on the disclosure requirement - See paragraphs 564 to 567.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See all Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See all 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) - Apotex Inc., a generic drug manufacturer, commenced an impeachment action against Sanofi-Aventis, alleging that the '777 Patent was invalid - Sanofi-Aventis sued Apotex, 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 Federal Court held that the '777 Patent was invalid, but nevertheless addressed the infringement issue - The court held that Apotex infringed both the product and process claims of the '777 Patent - The court rejected Apotex's claim for an exemption from liability under the experimental use exception (Patent Act, s. 55.2) - See paragraphs 184 to 238.

Patents of Invention - Topic 2946

Infringement of patent - Chemical products and substances intended for food and medicine - Effect of Notice of Compliance (NOC) proceedings in infringement action - Sanofi-Aventis held a selection patent ('777 Patent) for the drug clopidogrel bisulfate (Plavix) - Apotex Inc. sought a Notice of Compliance for its generic clopidogrel bisulfate tablets, alleging non-infringement and invalidity on the grounds of obviousness, anticipation and double patenting - The applications judge rejected all three grounds, a decision ultimately affirmed by the Supreme Court of Canada (SCC) - Subsequently, Sanofi-Aventis sued Apotex for patent infringement, relying extensively on the SCC decision in the NOC proceedings - Apotex impeached the patent's validity - The Federal Court stated that the NOC proceedings, whilst instructive, were not fact-determinative - The evidence adduced and the issues raised in the infringement/impeachment proceedings, particularly a sound prediction issue, differed from the NOC proceedings - It followed that the NOC proceedings did not constitute res judicata - "NOC proceedings are not the gospel" - See paragraphs 18 to 28.

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) - [See Patents of Invention - Topic 2945 ].

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 - Apotex asserted that the two year limitation in s. 4 of the Ontario Limitations Act applied by virtue of s. 39(1) of the Federal Courts Act (FCA) - Section 39(1) directed that, in the absence of an express provision, where a cause of action arose in a province, the laws of prescription and limitation of that province applied - Sanofi-Aventis claimed that Apotex's global enterprise, which resulted in the infringement, could not be said to be confined to a single province - Thus, because the cause of action arose "otherwise than in a province" within the meaning of s. 39(2) of the FCA, a six year limitation period applied - The Federal Court opined that the six year limitation applied by virtue of s. 39(2) - See paragraphs 240 to 258.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action (incl. standing) - Section 55(1) of the Patent Act provided that "A person who infringes a patent is liable to the patentee and to all persons claiming under him for all damages sustained by the patentee or by any such person, by reason of the infringement" - The Federal Court discussed who qualified as a person claiming under a patentee within the meaning of s. 55(1) - See paragraphs 33 to 39.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action (incl. standing) - 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 - Sanofi-Aventis and Bristol-Myers Squibb Sanofi Pharmaceuticals Holdings Partnership sued Apotex Inc., alleging patent infringement - Apotex claimed that the Partnership lacked standing - The Federal Court, considering the broad meaning of "persons claiming under" a patentee in s. 55(1) of the Patent Act, and based on the Partnership Agreements and the testimony given in that regard, found that the Partnership had a "credible and legally sufficient basis" for claiming under a patentee in the circumstances - The court stated that in fact, the evidence clearly showed that the Partnership was granted an exclusive licence for clopidogrel products through the various Agreements as of 1997 - It followed that the Partnership had standing to bring the action at issue for any infringement that it alleged to have occurred prior to December 6, 2007, when the licence agreement was amended - See paragraphs 29 to 38.

Words and Phrases

Medicine of the invention - The Federal Court discussed the meaning of this phrase as it appeared in Canadian Patent No. 1,336,777, a selection patent for the drug clopidogrel bisulfate, sold in Canada under the brand name Plavix - See paragraphs 108 to 118.

Words and Phrases

Otherwise than in a province - The Federal Court discussed the meaning of this phrase as it appeared in s. 39(2) of the Federal Courts Act, R.S.C. 1985, c. F-7 - See paragraphs 249 and 250.

Words and Phrases

Person claiming under [a patentee] - The Federal Court discussed who qualified as a "person claiming under" a patentee pursuant to s. 55(1) of the Patent Act, R.S.C. 1985, c. P-4 - See paragraphs 33 to 39.

Cases Noticed:

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 16].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) - see Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al.

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al. (2005), 334 N.R. 55; 2005 SCC 26, refd to. [para. 20].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2006), 358 N.R. 135; 59 C.P.R.(4th) 46; 2006 FCA 421, refd to. [para. 23].

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. 25].

ratiopharm inc. v. Pfizer Ltd. (2010), 405 N.R. 209; 87 C.P.R.(4th) 185; 2010 FCA 204, refd to. [para. 27].

ratiopharm Inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 76 C.P.R.(4th) 241; 2009 FC 711, refd to. [para. 28].

Eli Lilly Canada Inc. v. Novopharm Ltd. (2009), 73 C.P.R.(4th) 253; 2009 FC 235, refd to. [para. 28].

American Cyanamid Co. v. Novopharm Ltd., [1972] F.C. 739; 7 C.P.R.(2d) 61 (F.C.A.), refd to. [para. 34].

Domco Industries Ltd. v. Armstrong Cork Canada Ltd. et al. and Congoleum-Nairn Inc. et al., [1982] 1 S.C.R. 907; 42 N.R. 254; 66 C.P.R.(2d) 46, refd to. [para. 35].

Heap v. Hartley (1889), 42 Ch. D. 461, refd to. [para. 35].

Signalisation de Montréal Inc. v. Services de Béton Universels ltée et al., [1993] 1 F.C. 341; 147 N.R. 241; 46 C.P.R.(3d) 199 (F.C.A.), refd to. [para. 36].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, refd to. [para. 37].

JAY-LOR International Inc. et al. v. Penta Farm Systems Ltd. et al. (2007), 313 F.T.R. 1; 59 C.P.R.(4th) 228; 2007 FC 358, refd to. [para. 38].

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. 58].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 58].

Amazon.com Inc. v. Canada (Attorney General) (2011), 423 N.R. 337; 2011 FCA 328, refd to. [para. 58].

Dimplex North America Ltd. v. CFM Corp. (2006), 292 F.T.R. 38; 54 C.P.R.(4th) 435; 2006 FC 586, affd. (2007), 370 N.R. 316; 60 C.P.R.(4th) 277; 2007 FCA 278, refd to. [para. 59].

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. 60].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161 (T.D.), refd to. [para. 60].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 67 C.P.R.(4th) 94; 2008 FC 538, refd to. [para. 61].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 62].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 85 C.P.R.(4th) 321; 2010 FC 510, refd to. [para. 64].

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 2009 FC 676, refd to. [para. 128].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 85 C.P.R.(4th) 413; 2010 FCA 197, refd to. [para. 141].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 93 C.P.R.(4th) 81; 2011 FC 547, refd to. [para. 142].

Apotex Inc. v. Bristol-Myers Squibb Co. et al., [2007] N.R. Uned. 171; 2007 FCA 379, refd to. [para. 160].

I.G. Farbenindustrie A.G.'s Patents, Re (1930), 47 R.P.C. 289 (Eng. Ch. Div.), refd to. [para. 169].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 31 C.P.R.(4th) 161; 2004 SCC 34, refd to. [para. 186].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 80 C.P.R.(4th) 1; 2009 FC 991, refd to. [para. 187].

Weatherford Canada Ltd. et al. v. Corlac Inc. et al. (2010), 370 F.T.R. 54; 84 C.P.R.(4th) 237; 2010 FC 602, refd to. [para. 187].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al. (1992), 150 N.R. 207; 45 C.P.R.(3d) 449 (F.C.A.), refd to. [para. 187].

Allied Signal Inc. v. Du Pont Canada Inc. and Complax Corp. (1995), 184 N.R. 113; 61 C.P.R.(3d) 417 (F.C.A.), refd to. [para. 192].

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. 217].

Micro Chemicals Ltd. v. Smith, Kline & French Inter-American Corp., [1972] S.C.R. 506, refd to. [para. 233].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 2006 FC 524, revd. (2006), 354 N.R. 51; 55 C.P.R.(4th) 1; 2006 FCA 323, refd to. [para. 233].

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. 250].

Markevich v. Minister of National Revenue (2003), 300 N.R. 321; 223 D.L.R.(4th) 17 (S.C.C.), refd to. [para. 250].

Kirkbi AG et al. v. Ritvik Holdings Inc. et al. (2002), 220 F.T.R. 161; 20 C.P.R.(4th) 224 (T.D.), refd to. [para. 250].

Canada v. Maritime Group (Canada) Inc. et al., [1995] 3 F.C. 124; 185 N.R. 104 (F.C.A.), refd to. [para. 250].

Gingras v. Canada (1994), 165 N.R. 101; 113 D.L.R.(4th) 295 (F.C.A.), refd to. [para. 250].

Eli Lilly & Co. et al. v. Novopharm Ltd. et al., [1998] 2 S.C.R. 129; 227 N.R. 201, refd to. [para. 279].

Minister of National Revenue v. General Motors of Canada Ltd. (2008), 379 N.R. 60; 292 D.L.R.(4th) 331; 2008 FCA 142, refd to. [para. 283].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1; 2001 SCC 44, refd to. [para. 288].

Toronto (City) v. Canadian Union of Public Employees, Local 79 et al., [2003] 3 S.C.R. 77; 311 N.R. 201; 179 O.A.C. 291; 2003 SCC 63, refd to. [para. 288].

Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248; 2 N.R. 397, refd to. [para. 259].

CPU Options Inc. v. Milton [2006] O.T.C. 60; 79 O.R.(3d) 365 (S.C.), refd to. [para. 289].

Apotex Inc. v. Hoffmann-LaRoche Ltd. (1989), 99 N.R. 198; 24 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 295].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, refd to. [para. 306].

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. 362].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2011), 399 F.T.R. 221; 2011 FC 1288, refd to. [para. 489].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2010), 409 N.R. 322; 88 C.P.R.(4th) 325; 2010 FCA 320, refd to. [para. 561].

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. 564].

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. 565].

Novopharm Ltd. v. Eli Lilly & Co. (2011), 420 N.R. 188; 2011 FCA 220, refd to. [para. 567].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 2008 FC 142, affd. (2009), 392 N.R. 243; 2009 FCA 97, refd to. [para. 582].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, refd to. [para. 582].

Xerox of Canada Ltd. et al v. IBM Canada Ltd. (1977), 33 C.P.R.(2d) 24 (F.C.T.D.), refd to. [para. 591].

Rice v. Christiani & Nielson, [1930] S.C.R. 443, refd to. [para. 598].

Canadian General Electric Co. v. Fada Radio Ltd., [1930] A.C. 97; [1930] 1 D.L.R. 449; 47 R.P.C. 69, refd to. [para. 598].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 57 C.P.R.(4th) 6; 2006 FC 1234, refd to. [para. 603].

Mahurkar v. Vas-Cath of Canada Ltd. and Gambro Canada Ltd. (1988), 16 F.T.R. 48; 18 C.P.R.(3d) 417 (T.D.), affd. (1990), 105 N.R. 138; 32 C.P.R.(3d) 409 (F.C.A.), refd to. [para. 617].

Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al. (2010), 376 F.T.R. 104; 2010 FC 746, refd to. [para. 637].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 659].

Statutes Noticed:

Federal Courts Act, R.S.C. 1985, c. F-7, sect. 39(1), sect. 39(2) [para. 246].

Patent Act, R.S.C. 1985, c. P-4, sect. 27(1)(b) [para. 309]; sect. 55(1) [para. 33]; sect. 55.01 [para. 245]; sect. 55.2(1) [para. 232].

Authors and Works Noticed:

Fridman, G.H.L., The Law of Contract in Canada (2006), p. 454 [para. 279].

Counsel:

Harry Radomski, Richard Naiberg, Andrew Brodkin, Nando De Luca, Benjamin Hackett, David Scrimger, Sandon Shogilev, and Belle Van, for the plaintiff, Apotex Inc.;

Anthony G. Creber, Cristin A. Wagner, Marc Richard, Rick Dearden, Isabel Rassch, and Livia Aumand, for the defendants, Sanofi-Aventis.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the plaintiff;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the defendants.

This case was heard in Toronto and Ottawa, Ontario, on April 18-21, 26-29, May 3-5, 9-11, 16-19, 24, 25, 30, 31 and June 1, 13-15, 2011, before Boivin, J., who delivered the following decision on December 6, 2011.

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24 practice notes
  • Teva Canada Ltd. v. Novartis AG, (2013) 428 F.T.R. 1 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • February 19, 2013
    ...Schering-Plough Can. v. Pharmascience (2009), 360 F.T.R. 109 ; 2009 FC 1128 , refd to. [para. 132]. Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1; 101 C.P.R.(4th) 1 ; 2011 FC 1486 , refd to. [para. Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183 ; 265 D.L.R.(4th) 3......
  • Aux Sable Liquid Products LP c. JL Energy Transportation Inc.,
    • Canada
    • Federal Court (Canada)
    • May 6, 2019
    ...459 ; E. Mishan & Sons, Inc. v. Supertek Canada Inc., 2015 FCA 163, 134 C.P.R. (4th) 207 ; Apotex Inc. v. Sano-Aventis, 2011 FC 1486, 101 C.P.R. (4th) 1; Pfizer Canada Inc. v. Apotex Inc., 2007 FC 971 , 61 C.P.R. (4th) 305; Takeda Canada Inc. v. Canada (Health), 2015 FC 570 ,......
  • Hoffman-La Roche Ltd. v. Apotex Inc. et al., (2013) 436 F.T.R. 198 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • June 27, 2013
    ...177 ; 2007 FCA 195 , leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 61]. Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1; 101 C.P.R.(4th) 1 ; 2011 FC 1486 , refd to. [para. Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024 ; 263 N.R. 150 ;......
  • Alcon Canada Inc. et al. v. Apotex Inc. et al., (2014) 459 F.T.R. 255 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • August 8, 2014
    ...may be pertinent to other issues that arise in respect of a patent under consideration by the Court. [66] In Apotex Inc v Sanofi-Aventis , 2011 FC 1486, [2011] FCJ 1813 , Justice Boivin (as he then was) noted: [64] In assessing the hypothetical POSITA, the Court must define the person or g......
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14 cases
  • Teva Canada Ltd. v. Novartis AG, (2013) 428 F.T.R. 1 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • February 19, 2013
    ...Schering-Plough Can. v. Pharmascience (2009), 360 F.T.R. 109 ; 2009 FC 1128 , refd to. [para. 132]. Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1; 101 C.P.R.(4th) 1 ; 2011 FC 1486 , refd to. [para. Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183 ; 265 D.L.R.(4th) 3......
  • Aux Sable Liquid Products LP c. JL Energy Transportation Inc.,
    • Canada
    • Federal Court (Canada)
    • May 6, 2019
    ...459 ; E. Mishan & Sons, Inc. v. Supertek Canada Inc., 2015 FCA 163, 134 C.P.R. (4th) 207 ; Apotex Inc. v. Sano-Aventis, 2011 FC 1486, 101 C.P.R. (4th) 1; Pfizer Canada Inc. v. Apotex Inc., 2007 FC 971 , 61 C.P.R. (4th) 305; Takeda Canada Inc. v. Canada (Health), 2015 FC 570 ,......
  • Hoffman-La Roche Ltd. v. Apotex Inc. et al., (2013) 436 F.T.R. 198 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • June 27, 2013
    ...177 ; 2007 FCA 195 , leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 61]. Apotex Inc. v. Sanofi-Aventis (2011), 402 F.T.R. 1; 101 C.P.R.(4th) 1 ; 2011 FC 1486 , refd to. [para. Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024 ; 263 N.R. 150 ;......
  • Alcon Canada Inc. et al. v. Apotex Inc. et al., (2014) 459 F.T.R. 255 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • August 8, 2014
    ...may be pertinent to other issues that arise in respect of a patent under consideration by the Court. [66] In Apotex Inc v Sanofi-Aventis , 2011 FC 1486, [2011] FCJ 1813 , Justice Boivin (as he then was) noted: [64] In assessing the hypothetical POSITA, the Court must define the person or g......
  • Request a trial to view additional results
10 firm's commentaries
  • The Best Of The Decade – Canadian Patent Law In The 2010s
    • Canada
    • Mondaq Canada
    • February 18, 2020
    ...approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. Sanofi-Aventis v Apotex Inc, 2013 FCA 186, rev'g 2011 FC 1486, var'd 2013 FCA 209. The Federal Court of Appeal overturned the Federal Court's decision invalidating the patent that claims clopidogrel bisul......
  • The Best of the Decade – Canadian Patent Law in the 2010s
    • Canada
    • JD Supra Canada
    • February 14, 2020
    ...approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. Sanofi-Aventis v Apotex Inc, 2013 FCA 186, rev’g 2011 FC 1486, var’d 2013 FCA 209. The Federal Court of Appeal overturned the Federal Court’s decision invalidating the patent that claims clopidogrel bisul......
  • The 'Reasonably Diligent Search' In Canadian Obviousness Analysis
    • Canada
    • Mondaq Canada
    • October 16, 2015
    ...that it would have been found by the Skilled Person. The Court of Appeal acknowledged the test set out in Apotex Inc v Sanofi-Aventis, 2011 FC 1486, where it was stated that "...the prior art must have been publicly available as of the [relevant] date... – and it must further have been loca......
  • Canada’s Utility Requirement For Patentability – Looking For Good News For The Innovative Pharmaceutical Industry
    • Canada
    • Mondaq Canada
    • November 14, 2013
    ...Inc, 2011 FCA 236. 10 Sanofi-Aventis v Apotex Inc, 2013 FCA 186. 11 http://www.bereskinparr.com/Doc/id141. 12 Apotex Inc v Sanofi-Aventis, 2011 FC 1486. 13 Reported in greater detail in: 14 Plavix II confirmed that selection patents must set out an explicit promise because both "the novelty......
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