Gilead Sciences Inc. et al. v. Canada (Minister of Health) et al., (2013) 445 F.T.R. 1 (FC)

• Judge: Barnes, J.
• Court: Federal Court (Canada)
• Case Date: December 20, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 445 F.T.R. 1 (FC);2013 FC 1270

Gilead Sciences Inc. v. Can. (2013), 445 F.T.R. 1 (FC)

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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: [2013] F.T.R. TBEd. DE.031

Gilead Sciences Inc. and Gilead Sciences Canada Inc. (applicants) v. The Minister of Health and Teva Canada Limited (respondents)

(T-8-12; 2013 FC 1270; 2013 CF 1270)

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

Federal Court

Barnes, J.

December 20, 2013.

Summary:

Gilead applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Teva for a generic version of Gilead's Truvada medication, the active pharmaceutical agent of which was the antiviral compound tenofovir. Claim 32 of the 619 patent and claims 3 and 4 of the 059 patent were at issue.

The Federal Court allowed Gilead's application regarding the 619 patent and dismissed it regarding the 059 patent.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - [See second and third Patents of Invention - Topic 1589 ].

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - [See third Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Gilead applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Teva for a generic version of Gilead's Truvada medication, the active pharmaceutical agent of which was the antiviral compound tenofovir - At issue was claim 32 of the 619 patent - The inventive concept of claim 32 was the use of the carbonate promoiety disoproxil with tenofovir - Teva's product would infringe the 619 patent if claim 32 was valid - The Federal Court rejected Teva's argument that claim 32 was invalid for obviousness - An obviousness challenge would not succeed if the prior art only established that something might work - It also could not be built on a selective analysis of the prior art - Tenofovir disoproxil was the first example of a carbonate prodrug on a phosphonate nucleotide - Because there were no direct comparators, Teva's argument was built primarily around the person of skill drawing several inferences from prior art dealing with prodrugs of other parent compounds where some success had been achieved - However, the history of prodrug development included many failures and unpredictable outcomes - There were sufficient material elements of predictive uncertainty to dispel Teva's assertion of obviousness - See paragraphs 32 to 42.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Gilead applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva for a generic version of Gilead's Truvada medication, the active pharmaceutical agent of which was the antiviral compound tenofovir - At issue was claim 32 of the 619 patent - The inventive concept of claim 32 was the use of the carbonate promoiety disoproxil with tenofovir - Teva's product would infringe the 619 patent if claim 32 was valid - The Federal Court rejected Teva's argument that claim 32 was invalid for obviousness, concluding, "The lengthy and multi-step process followed by Gilead to develop tenofovir disoproxil belies Teva's assertion that the person of skill would have come to that 'self-evident' solution without difficulty. I am satisfied that the discovery of tenofovir disoproxil was inventive and, by definition, non-obvious. Gilead is therefore entitled to an order prohibiting the Minister from issuing a NOC to Teva until the expiry of the 619 Patent." - See paragraphs 43 to 68.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Gilead applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Teva for a generic version of Gilead's Truvada medication, the active pharmaceutical agent of which was tenofovir - At issue was the validity of claims 3 and 4 of the 059 patent, which claimed tenofovir disoproxil fumarate (TDF), a salt form of tenofovir - Teva asserted that the 059 patent was invalid by reason of obviousness - The parties agreed that the inventive concept of the 059 patent was the choice of the fumarate salt form of tenofovir disoproxil - The Federal Court dismissed Gilead's application - Despite its assertion that the choice of fumaric acid was counterintuitive and that its success as a useful salt former was unpredictable, Gilead presented no evidence of the inventive history behind the 059 patent - Specifically, Gilead produced no evidence to show that it had unsuccessfully screened numerous promising acidic salt formers and only resorted to fumaric acid as a last resort - In the face of an obviousness attack, the absence of evidence uniquely in Gilead's possession led the court to conclude that the development of TDF was routine and not the end product of an onerous or inventive process of discovery - The choice of a salt form for tenofovir disoproxil that met Gilead's needs and that was shown by a routine screen to be better than the free base and one other salt form of questionable value was neither surprising nor inventive - See paragraphs 69 to 84.

Patents of Invention - Topic 1590

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Evidence (incl. onus of proof) - [See third Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1605 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Gilead applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Teva for a generic version of Gilead's Truvada medication, the active pharmaceutical agent of which was the antiviral compound tenofovir - At issue was claim 32 of the 619 patent - The inventive concept of claim 32 was the use of the carbonate promoiety disoproxil with tenofovir - Teva's product would infringe the 619 patent if claim 32 was valid - The Federal Court rejected Teva's argument that claim 32 was anticipated by Bristol-Myers Squibbs Co.'s prior application for the 214 patent - Tenofovir disoproxil was not expressly identified in the 214 application - Teva's evidence rested heavily on the words "such as" in the 214 application, asserting that the person of skill would interpret the application expansively to conclude that tenofovir disoproxil was included - However, if there was doubt as to what the prior art reference included, it could not be taken to meet the definition of anticipation - The 214 application could not be read by a person of skill to include tenofovir disoproxil - Teva's selection-related invalidity assertions failed - Gilead's application was allowed - See paragraphs 23 to 31.

Cases Noticed:

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. 23].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to [para. 24].

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. 30].

Merck & Co. et al. v. Apotex Inc. et al. (2010), 381 F.T.R. 162; 2010 FC 1265, refd to. [para. 30].

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al. (2013), 429 F.T.R. 158; 2013 FC 283, refd to. [para. 34].

MedImmune Ltd. v. Novartis Pharmaceuticals UK, [2012] EWCA Civ 1234, refd to. [para. 34].

Eli Lilly & Co. v. Janssen Alzheimer Immotherapy, [2013] EWHC 1737, refd to. [para. 34].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 35].

ratiopharm inc. v. Pfizer Ltd. (2009), 350 F.T.R. 250; 2009 FC 711, affd. (2010), 405 N.R. 209; 2010 FCA 204, refd to. [para. 80].

Hoffman-La Roche Ltd. v. Apotex Inc. et al. (2013), 436 F.T.R. 198; 2013 FC 718, refd to. [para. 82].

AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al. (2013), 428 F.T.R. 269; 2013 FC 245, refd to. [para. 83].

Authors and Works Noticed:

Fleisher, David et al., Improved oral drug delivery: solubility limitations overcome by the use of prodrugs, in Advanced Drug Delivery Reviews (1996), vol. 19 pp. 115-128 [para. 59].

Krise, Jeffrey and Stella, Valentino, Prodrugs of phosphates, phosphonates, and phosphinates, in Advanced Drug Delivery Reviews (1996), vol. 19, pp. 281-310 [para. 57].

Samara et al., Pharmacokinetic Analysis of Diethylcarbonate Prodrugs of Ibuprofen and Naproxen, in Biopharmaceutics and Drugs Disposition (1995), vol. 16, pp. 201-210 [para. 48].

Counsel:

Patrick E. Kierans, Louisa Pontrelli, Brian Daley, Nisha Anand and Brian John Capogrosso, for the applicants;

Jonathan Stainsby, William P. Mayo, Lesley Caswell and Andrew McIntyre, for the respondent, Teva Canada Limited.

Solicitors of Record:

Norton Rose Fulbright Canada LLP, Toronto, Ontario, for the applicants;

Heenan Blaikie LLP, Toronto, Ontario, for the respondent, Teva Canada Limited;

William F. Pentney, Deputy Attorney General of Canada, Montreal, Quebec, for the respondent, The Minister of Health.

This application was heard at Toronto, Ontario, on September 9 to 16, 2013, by Barnes, J., of the Federal Court, who delivered the following reasons for judgment at Ottawa, Ontario, on December 20, 2013.