Teva Canada Ltd. v. Novartis AG, (2013) 428 F.T.R. 1 (FC)

• Judge: Snider, J.
• Court: Federal Court (Canada)
• Case Date: February 19, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 428 F.T.R. 1 (FC);2013 FC 141

Teva Can. Ltd. v. Novartis AG (2013), 428 F.T.R. 1 (FC)

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Temp. Cite: [2013] F.T.R. TBEd. MR.003

Teva Canada Limited (plaintiff/defendant by counterclaim) v. Novartis AG (defendant/plaintiff by counterclaim)

(T-2021-10)

Apotex Inc. (plaintiff/defendant by counterclaim) v. Novartis AG (defendant/plaintiff by counterclaim)

(T-833-11; 2013 FC 141; 2013 CF 141)

Indexed As: Teva Canada Ltd. v. Novartis AG

Federal Court

Snider, J.

February 19, 2013.

Summary:

Novartis AG owned a patent (the '203 Patent), which included the compounds imatinib and its salt, imatinib mesylate. Novartris Canada, a related corporate entity, sold a drug in Canada with the trademark of GLEEVEC, which was a highly effective drug for the treatment of chronic myeloid leukemia. The active ingredient in GLEEVEC was imatinib mesylate. Teva Canada Ltd. and Apotex Inc. (the plaintiffs) wished to sell generic versions of imatinib and commenced separate impeachment actions against Novartis, seeking declarations under s. 60(1) of the Patent Act that certain of the claims of the '203 Patent were invalid. The plaintiffs argued that as of April 1, 1993 (the Canadian filing date), the utility of imatinib and the other compounds of the '203 Patent had not been established. The plaintiffs also asserted that the '203 Patent failed to meet the disclosure requirements set out in s. 27(3) of the Patent Act. Novartis counterclaimed for a declaration that the '203 Patent was valid and sought an order that Apotex deliver up all bulk imatinib in its possession.

The Federal Court, for the most part, dismissed the plaintiffs' claims. Most of the patent claims were valid as utility had been demonstrated or could be soundly predicted. The '203 Patent met the disclosure requirement of s. 27(3) of the Patent Act. Apotex need not deliver up any remaining bulk imatinib in its possession. Four of the claims in the patent were declared invalid.

Editor's Note: Teva and Apotex also took steps to obtain regulatory approval for the sale of imatinib under the Patented Medicines (Notice of Compliance) Regulations. Novartis pursued prohibition proceedings under s. 6(1) of the Regulations. A decision respecting those proceedings is reported at (2013), 428 F.T.R. 80; 2013 FC 142.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court reviewed the principles applicable to construction of patent claims - See paragraphs 73 to 78.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Novartis AG owned a patent (the '203 Patent), which included the compounds imatinib and its salt, imatinib mesylate - Novatris Canada sold a drug for treating chronic myeloid leukemia, GLEEVEC, with imatinib mesylate as the active ingredient - Claim 46 of the patent claimed use of forumla 1 compounds as set out in the patent, of which Group 2 was a subset, for the preparation of a pharmaceutical composition for "use in the chemotherapy of tumours" - Tumours was not defined - A construction issue arose - The Federal Court concluded that "... it is not a reasonable construction of the '203 Patent to conclude that the word 'tumours' in Claim 46 means that any compound of Group 2 can treat both PDGF-R and ABL-driven tumours [plaintiffs' position]. Rather, the meaning to be ascribed to Claim 46 of the '203 Patent is that a Group 2 compound may be useful to treat either PDGF-R or ABL tumours" [Novartis's position] - See paragraphs 120 to 138.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Novartis AG owned a patent (the '203 Patent), which included the compounds imatinib and its salt, imatinib mesylate - Novatris Canada sold a drug for treating chronic myeloid leukemia, GLEEVEC, with imatinib mesylate as the active ingredient - The disclosure provided that the forumla 1 compounds as set out in the patent, of which Group 2 was a subset, "can be used" as tumour inhibiting ingredients - A construction issue arose as to whether the word "can" when referring to the therapeutic use of the compounds meant that the compounds were guaranteed to treat the described medical conditions (plaintiffs' position) or had the potential to be useful in treatment of tumours (Novartis's position) - The Federal Court held that that the notional skilled person would read the phrase "the compounds ... can be used" in the '203 Patent to mean that the compounds had the potential, demonstrated or predicted, to be used as "tumour-inhibiting active ingredients" (i.e., as stated in the patent) - See paragraphs 139 to 151.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - Novartis AG owned a patent entitled "Pyrimidine Derivatives and Processes for the Preparation Thereof" (the '203 Patent), which included the compounds imatinib and its salt, imatinib mesylate - Novatris Canada sold a drug for treating chronic myeloid leukemia, GLEEVEC, with imatinib mesylate as the active ingredient - Two generic drug manufacturers (the plaintiffs) sought declarations that the '203 Patent was invalid, arguing that the specification of the '203 was insufficient and did not provide adequate disclosure of the invention - The Federal Court reviewed the applicable principles - The court held that the patent met the disclosure requirements in s. 27(3) of the Patent Act - See paragraphs 336 to 387.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court reviewed the general principles relating to utility - The court noted that s. 2 of the Patent Act required that an invention be both new and useful - The court stated that utility was to be determined at the Canadian filing date based on the state of the art and information available at that time - Evidence and knowledge available after the filing date could not establish utility - However, if utility was not demonstrated at the filing date, the utility requirement could be met though sound prediction - See paragraphs 159 to 162.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court stated that "... an invention lacks utility if it is demonstrated that the invention 'will not operate at all or, more broadly, that it will not do what the specification promises that it will do'. This has given rise to the concept of the 'promise of the patent' ... The promise of the patent should be determined at the outset of the utility analysis in a purposive manner ... If the inventors do state a specific promise in the patent, the court must evaluate utility against this promise ... Just a mere scintilla of utility is insufficient in the face of a specific promise that requires more ... The promise of the patent is a question of law assessed by the court from the perspective of a skilled person, with the assistance of expert evidence ..." - See paragraphs 165 to 167.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Novartis AG owned a patent entitled "Pyrimidine Derivatives and Processes for the Preparation Thereof" (the '203 Patent), which included the compounds imatinib (a selective inhibitor) and its salt, imatinib mesylate - Novatris Canada sold a drug for treating chronic myeloid leukemia, GLEEVEC, with imatinib mesylate as the active ingredient - The patent contained numerous claims, including compound and use claims - Two generic drug manufacturers (the plaintiffs) sought declarations that the '203 Patent was invalid for lack of utility - The Federal Court held that most of the patent claims were valid as utility had been demonstrated or could be soundly predicted - Only claims 1-4 were declared invalid for want of utility - See paragraphs 159 to 335.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court stated that if utility was not demonstrated at the filing date, the utility requirement could be met through sound prediction - "A sound prediction requires that the patentee provide 'a solid teaching', and it cannot protect 'a lucky guess' or 'mere speculation' ... A patentee does not have to explain exactly why the invention works, but must provide the underlying knowledge supporting that it does work ... Sound prediction is a question of fact ... A sound prediction must meet three requirements ...: 1) There must be a factual basis for the prediction; 2) There must be an articulable and sound line of reasoning connecting the desired result and the factual basis; and 3) There must be proper disclosure of the factual basis and line of reasoning in the patent. Sound prediction is not a free-standing statutory requirement. Rather, it is a way of showing that an invention is useful when the invention has not been directly demonstrated to work. Its introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents." - See paragraphs 162 to 164.

Patents of Invention - Topic 1724

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

Patents of Invention - Topic 1725

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

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) - Novartis AG owned a patent (the '203 Patent), which included the compounds imatinib and its salt, imatinib mesylate - Novatris Canada sold a drug for treating chronic myeloid leukemia, GLEEVEC, with imatinib mesylate as the active ingredient - Apotex Inc., a generic drug manufacturer, sought a declaration of invalidity - Novartis claimed that the patent was valid and sought delivery up of any infringing material - The Federal Court held that most of the claims in the patent were valid - However, all of the imatinib acquired by Apotex, except for its remaining bulk inventory, was exempt from infringement as it was used for regulatory or experimental purposes (Patent Act, s. 55.2) - The court did not order delivery up of the remaining bulk inventory because the inventory was past its expiry date, could be used for experimental purposes, and Apotex undertook not to use it commercially - See paragraphs 336 to 401.

Words and Phrases

Can be used - The Federal Court discussed the meaning of this phrase as it appeared in a patent for a medicinal compound - See paragraphs 139 to 158.

Cases Noticed:

Sanofi-Aventis Canada Inc. et al. v. Apotex Inc. (2009), 350 F.T.R. 165; 77 C.P.R.(4th) 99; 2009 FC 676, affd. (2011), 426 N.R. 196; 97 C.P.R(4th) 415; 2011 FCA 300 refd to. [para. 42].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, affd. (2009), 392 N.R. 96; 75 C.P.R.(4th) 443; 2009 FCA 222, refd to. [para. 44].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 80 C.P.R.(4th) 1; 2009 FC 991, affd. (2010), 409 N.R. 173; 90 C.P.R.(4th) 327; 2010 FCA 240, refd to. [para. 72].

Eli Lilly Canada Inc. v. Apotex Inc. et al., [2008] 2 F.C.R. 636; 311 F.T.R. 21; 2007 FC 455, affd. (2008), 375 N.R. 381; 68 C.P.R.(4th) 167; 2008 FCA 44, refd to. [para. 72].

Windsurfing International Inc. et al. v. Entreprises Hermano Ltée et al. (1982), 69 C.P.R.(2d) 176 (F.C.T.D.), refd to. [para. 72].

Rubbermaid (Can.) Ltd. v. Tucker Plastic Products Ltd. (1972), 8 C.P.R.(2d) 6 (F.C.T.D.), refd to. [para. 72].

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. 73].

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. 516; 60 C.P.R.(4th) 277; 2007 FCA 278, refd to. [para. 73].

Consolboard Inc. v. MacMillan Bloedel (Sask.) 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. 74].

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. 75].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161 (T.D.), refd to. [para. 75].

Amfac Foods Inc. et al. v. Irving Pulp & Paper Ltd. (1986), 72 N.R. 290; 12 C.P.R.(3d) 193 (F.C.A.), refd to. [para. 76].

C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201; 39 C.P.R. 201, affd. [1963] S.C.R. 410; 41 D.L.R.(2d) 611, refd to. [para. 76].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, affd. (2009), 392 N.R. 243; 78 C.P.R.(4th) 388; 2009 FCA 97, refd to. [para. 77].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 2007 FC 596, refd to. [para. 77].

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. 77].

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. 147].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 265 D.L.R.(4th) 308; 2006 FCA 64, refd to. [para. 161].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd., [2010] 1 F.C.R. 349; 405 N.R. 1; 85 C.P.R.(4th) 413; 2010 FCA 197, refd to. [para. 161].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 95 C.P.R.(4th) 193; 2011 FCA 236, refd to. [para. 161].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 219 D.L.R.(4th) 660; 2002 SCC 77, refd to. [para. 161].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 367 N.R. 98; 60 C.P.R.(4th) 177; 2007 FCA 195, refd to. [para. 162].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 93 C.P.R.(4th) 193; 2011 FC 547, affd. (2012), 430 N.R. 326; 100 C.P.R.(4th) 203; 2012 FCA 103, refd to. [para. 166].

Novopharm Ltd. v. Eli Lilly & Co. (2011), 420 N.R. 188; 94 C.P.R.(4th) 95; 2011 FCA 220, refd to. [para. 166].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 59 C.P.R.(4th) 183; 2007 FC 26, affd. (2007), 367 N.R. 98; 60 C.P.R.(4th) 177; 2007 FCA 195, refd to. [para. 178].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2011), 399 F.T.R. 221; 100 C.P.R.(4th) 269; 2011 FC 1288, refd to. [para. 179].

Merck & Co. et al. v. Apotex Inc. et al. (2010), 381 F.T.R. 162; 91 C.P.R.(4th) 1; 2010 FC 1265, affd. (2011), 430 N.R. 66; 102 C.P.R.(4th) 9; 2011 FCA 363, refd to. [para. 271].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2012), 436 N.R. 299; 351 D.L.R.(4th) 503; 2012 SCC 60, refd to. [para. 336].

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

Tubes Ltd. v. Perfecta Seamless Steel Tube Co. (1902), 20 R.P.C. 77, refd to. [para. 342].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185; 60 D.L.R.(4th) 223; 25 C.P.R.(3d) 257, refd to. [para. 343]

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2009), 352 F.T.R. 35; 76 C.P.R.(4th) 83; 2009 FC 638, refd to. [para. 361].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 67 C.P.R.(4th) 23; 2008 FCA 108, refd to. [para. 373].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, revd. in part [2007] 3 F.C.R. 588; 354 N.R. 51; 2006 FCA 323, refd to. [para. 392].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 27(3) [para. 338]; sect. 55.2 [para. 391].

Counsel:

Andrew Brodkin, Daniel Cappe, Dino Clarizio, David Scrimger, Nando DeLuca and Michel Anderson, for the plaintiff in T-833-11, Apotex Inc.;

Jonathan Stainsby, Andrew McIntyre, Andrew Skodyn and Lesley Caswell, for the plaintiff in T-2021-10, Teva Canada Ltd.;

Anthony Creber, Isabel Raasch, John Norman, Jennifer Wilkie and Marc Richard, for the defendant in T-833-11 and T-2021-10.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the plaintiff in T-833-11, Apotex Inc.;

Heenan Blaikie LLP, Toronto, Ontario, for the plaintiff in T-2021-10, Teva Canada Ltd.;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the defendant in T-833-11 and T-2021-10.

This matter was heard in Ottawa, Ontario, on September 24, 25, 27, 28, October 1-3, 10-12, 15-17, and November 6-9 and 16, 2012, before Snider, J., of the Federal Court, who delivered the following public redacted reasons for judgment on February 19, 2013. Confidential reasons for judgment had been issued on February 8, 2013.