Hoffman-La Roche Ltd. v. Apotex Inc. et al., (2013) 436 F.T.R. 198 (FC)

• Judge: Kane, J.
• Court: Federal Court (Canada)
• Case Date: June 27, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 436 F.T.R. 198 (FC);2013 FC 718

Hoffman-La Roche Ltd. v. Apotex Inc. (2013), 436 F.T.R. 198 (FC)

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[French language version follows English language version]

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Temp. Cite: [2013] F.T.R. TBEd. JL.017

Hoffman-La Roche Limited (applicant) v. Apotex Inc. and The Minister of Health (respondents) and F. Hoffman-La Roche AG (respondent/patentee)

(T-1247-11; 2013 FC 718; 2013 CF 718)

Indexed As: Hoffman-La Roche Ltd. v. Apotex Inc. et al.

Federal Court

Kane, J.

July 12, 2013.

Summary:

Hoffman-La Roche Ltd. sold valganciclovir hydrochloride under the brand name Valcyte which was used to treat certain herpes viruses (the '721 patent). Apotex Inc. sought a notice of compliance respecting its generic version of the drug. Hoffman-La Roche applied for a prohibition order. Apotex challenged the validity of the patent on the grounds of anticipation, obviousness and overbreadth. Apotex also argued that, even if the patent claims were valid, its activities did not constitute infringement.

The Federal Court found that the allegations with respect to invalidity on the grounds of anticipation and obviousness were justified. The allegations of overbreadth were not justified. Although the court found that the allegations respecting anticipation and obviousness were justified, the court considered Apotex's allegations of non-infringement. The court opined that the allegation of non-infringement with respect to claim 4 was justified. The allegations of non-infringement of all other valid claims were not in dispute. The court therefore dismissed the application for the prohibition order.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - In prohibition proceedings under the Patented Medicines (Notice of Compliance) Regulations, the patent holder (Hoffman-La Roche Ltd.) argued that the generic company which was seeking a notice of compliance (Apotex Inc.), raised new issues in its argument that it had not set out in the Notice of Allegation (NOA) - The Federal Court referred to a summary of the requirements of s. 5(3)(b)(ii) of the Notice of Compliance Regulations governing the contents of the NOA which had to include a detailed statement of the legal and factual basis for the allegations - The court reviewed the NOA in this case and determined that there was no deficiency - See paragraphs 44 to 56.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - La Roche applied to prohibit issuance of a notice of compliance to Apotex Inc. for its generic product - Apotex challenged the validity of the patent and claimed that, in any event, making or constructing its own valganciclovir would not infringe the patent because it was amorphous only (i.e., not crystalline) - The Federal Court found that the allegations of invalidity on the grounds of obviousness and anticipation were justified - However, the court considered the infringement issue - The court held that the '721 patent included both amorphous and crystalline valganciclovir - There was no dispute that Apotex would infringe all valid claims other than claim 4 in the production of its amorphous product - The court opined that if the claims of the patent were valid, the allegation of non-infringement of claim 4 was justified - The court therefore dismissed the application for the prohibition order - See paragraphs 365 to 399.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - The Federal Court reviewed the issue of burden of proof in notice of compliance proceedings - See paragraphs 57 to 62.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride under the brand name Valcyte which was used to treat certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance respecting its generic version of the drug - Hoffman-La Roche applied for a prohibition order - The Federal Court noted that Apotex had raised allegations in its Notice of Allegation and led evidence as to the invalidity of the patent on the basis of anticipation, obviousness and overbreadth which was sufficient to put those issues into play - Thus the applicant, La Roche had the burden of establishing, on a balance of probabilities, that those allegations were not justified - See paragraph 63.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride under the brand name Valcyte which was used to treat certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance respecting its generic version of the drug - Hoffman-La Roche applied for a prohibition order - The Federal Court noted that Apotex had, inter alia, alleged that its generic version would not infringe the patent claims - The court stated that the law was well-settled that where a generic alleged non-infringement, the statements that it made in that regard in its Notice of Allegation were presumed to be true - Thus, the applicant, La Roche, had the burden of proof, on a balance of probabilities, to satisfy the court that the allegations of non-infringement were not justified - Merely to raise the possibility of infringement was insufficient - See paragraph 64.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The Federal Court stated that the person skilled in the art (or person of ordinary skill in the art - a "POSITA") provided the lens through which a patent was construed and many other issues were assessed - See paragraph 65.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride under the brand name Valcyte which was used to treat certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance respecting its generic version of the drug - Hoffman-La Roche applied for a prohibition order - The Federal Court held that the "person skilled in the art" in this case was someone or team of persons with expertise in medicinal chemistry, solid state chemistry, synthetic chemistry, pharmaceutical formulation, pharmacology and pharmacokinetics at the Masters or PhD level - See paragraphs 65 to 70.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride under the brand name Valcyte which was used to treat certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance respecting its generic version of the drug - Hoffman-La Roche applied for a prohibition order - The Federal Court reviewed the patent in detail and construed the claims - See paragraphs 71 to 98.

Patents of Invention - Topic 1129

The specification and claims - The description - Scope of invention - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance for its generic product - La Roche sought a prohibition order - The inventive concept was at issue - La Roche claimed that the invention was the identification that the mono-L-valine ester of ganciclovir (i.e., valganciclovir) had unexpectedly better bioavailability over the previously known esters of ganciclovir, most importantly the bis-valine ester (European Patent (EP) 329) - Apotex submitted that the invention was crystalline valganciclovir and its salts which were better (improved) than ganciclovir - The Federal Court held that the '721 patent did not assert that the invention was an improvement over the bis-ester (EP 329) and other prior art, but only over ganciclovir - Further, crystallinity was not the inventive concept, but rather a manner of making the invention - Thus the inventive concept of the '721 patent was the invention of valganciclovir, a stable prodrug with low toxicity and improved bioavailability over ganciclovir - See paragraphs 99 to 132.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - La Roche applied to prohibit issuance of a notice of compliance to Apotex Inc. for its generic product - Apotex alleged that a number of claims in the patent were broader than the invention made - Apotex argued that those claims included crystalline and non-crystalline (amorphous) compounds, and were, therefore, invalid as not being limited to the essential feature of crystallinity - The Federal Court rejected Apotex's allegations of overbreadth - The court noted that the inventive concept was not crystallinity - The claims as construed by the court included both amorphous and crystalline valganciclovir - The crystalline product was one method of preparing the compound - Crystallinity was an additional advantage and was specifically claimed in claim 4 - See paragraphs 355 to 364.

Patents of Invention - Topic 1133

The specification and claims - The description - Particular patents - [See Patents of Invention - Topic 1129 ].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals (incl. selection patents) - [See Patents of Invention - Topic 1129 ].

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - The Federal Court reviewed the jurisprudence and principles respecting selection patents - The court referred to a list of the conditions that had to be satisfied for a selection patent - See paragraphs 153 to 158.

Patents of Invention - Topic 1514

Grounds of invalidity - General - Selection patents - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance for its generic product, raising issues of invalidity - La Roche sought a prohibition order - The Federal Court stated that although it was not essential to make a finding that the '721 was or was not a selection patent as there was no attack on utility, the characterisation as a selection patent would inform the analysis, particularly with respect to anticipation and obviousness - The court determined that the '721 patent was an ordinary patent: a novel compound - The court opined that if it was wrong and if the '721 patent was a selection patent of the previously known ester, bis-valine ester (European Patent 329), that would not affect the court's ruling on anticipation and obviousness - See paragraphs 133 to 178.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court reviewed the general principles and jurisprudence with respect to the test for obviousness - See paragraphs 251 to 257.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - Apotex Inc. sought a notice of compliance for its generic product, alleging that the patent was invalid for obviousness by virtue of a prior patent (European Patent 329) and numerous additional publications - La Roche sought a prohibition order - The Federal Court concluded that the invention was obvious - The court held that the four-part test for obviousness, including the factors to be considered to determine whether it was "obvious to try" the invention all pointed in the same direction - There was a clear motivation to pursue the invention - There were a limited number of solutions to pursue - The allegation of obviousness was justified - See paragraphs 258 to 354.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The Federal Court reviewed the jurisprudence and general principles relating to anticipation - In particular, the court discussed the test for anticipation as set out in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (SCC 2008) - The court noted the pre-Sanofi law set a stringent test for anticipation and was interpreted as requiring an exact description of the invention in the prior art - However in Sanofi, the court rejected the stringent test and established a two-part test of disclosure and enablement - The court referred to a summary of the legal requirements for anticipation - See paragraphs 195 to 212.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Hoffman-La Roche Ltd. sold valganciclovir hydrochloride (Valcyte) for treating certain herpes viruses (the '721 patent) - La Roche applied to prohibit issuance of a notice of compliance to Apotex Inc. for its generic product - Apotex alleged that the patent was invalid on the basis of anticipation (i.e., anticipation by prior art, namely European Patent (EP) 329), published in 1990) - The Federal Court found that the invention of the '721 patent was disclosed in EP 329 and enabled - The "person skilled in the art" would understand the invention and make it without extensive efforts and with no additional inventive step, and in so doing, would on a balance of probabilities infringe the patent - The allegation respecting anticipation was justified - See paragraphs 179 to 242.

Patents of Invention - Topic 2945

Infringement of patent - Chemical products and substances intended for food and medicine - Particular patents - [See Food and Drug Control - Topic 1108.2 ].

Cases Noticed:

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2011), 385 F.T.R. 157; 2011 FC 239, refd to. [para. 11].

Apotex Inc. v. Lundbeck (H.) A/S, [2013] F.T.R. Uned. 402; 2013 FC 192, refd to. [para. 17].

Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al. (2009), 357 F.T.R. 75; 79 C.P.R.(4th) 243; 2009 FC 1102, refd to. [para. 58].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 58].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 58].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 414 F.T.R. 56; 2012 FC 767, affd. (2012), 440 N.R. 269; 2012 FCA 308, refd to. [para. 58].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 58].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97; 2005 FCA 270, refd to. [para. 60].

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, 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. 66].

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. 92

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 133].

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. 136].

I.G. Farbenindustrie A.G.'s Patent, Re (1930), 47 R.P.C. 289 (Ch. Div.), refd to. [para. 144].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 145].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2010), 409 N.R. 322; 2010 FCA 320, refd to. [para. 149].

GlaxoSmithKline Inc. et al. v. Pharmascience Inc. et al. (2008), 328 F.T.R. 241; 2008 FC 593, refd to. [para. 156].

Abbott Laboratories et al. v. Canada (Minister of Health) et al., [2009] 4 F.C.R. 401; 337 F.T.R. 17; 2008 FC 1359, affd. (2009), 387 N.R. 347; 73 C.P.R.(4th) 444; 2009 FCA 94, refd to. [para. 195].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 198].

F.H. v. McDougall, [2008] 3 S.C.R. 41; 380 N.R. 82; 260 B.C.A.C. 74; 439 W.A.C. 74; 2008 SCC 53, refd to. [para. 208].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2009), 343 F.T.R. 53; 73 C.P.R.(4th) 69; 2009 FC 146, refd to. [para. 209].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2009), 346 F.T.R. 42; 2009 FC 301, refd to. [para. 209].

Schering-Plough Can. v. Pharmascience (2009), 360 F.T.R. 109; 2009 FC 1128, refd to. [para. 209].

AstraZeneca Canada Inc. et al. v. Apotex Inc. et al. (2010), 376 F.T.R. 17; 2010 FC 714, refd to. [para. 209].

Merck & Co. et al. v. Canada (Minister of Health) et al. (2010), 375 F.T.R. 121; 2010 FC 1042, refd to. [para. 209].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 253].

AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al. (2013), 428 F.T.R. 269; 2013 FC 245, refd to. [para. 254].

Pozzoli SPA v. BMDO S.A. & Anor., [2007] EWCA Civ 588, refd to. [para. 268].

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. 273].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 317].

Rothmans, Benson & Hedges Inc. et al. v. Imperial Tobacco Ltd. (1993), 152 N.R. 292; 47 C.P.R.(3d) 188 (F.C.A.), refd to. [para. 318].

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. 361].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 267 F.T.R. 243; 37 C.P.R.(4th) 487; 2005 FC 9, refd to. [para. 361].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97; 2005 FCA 270, refd to. [para. 370].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 245 F.T.R. 243; 31 C.P.R.(4th) 214; 2003 FC 1428, affd. (2004), 329 N.R. 152; 38 C.P.R.(4th) 400 (F.C.A.), refd to. [para. 392].

Counsel:

Anthony Creber, Jay Zakaib and Alexander Gloor, for the applicant, Hoffman-la Roche Ltd.;

Andrew Brodkin, Richard Naiberg and Janine Roberts, for the respondent, Apotex Inc.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the applicant, Hoffman-La Roche Ltd.;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This application was heard in Ottawa, Ontario, on March 26, 27 and 28, and April 2 and 3, 2013, before Kane, J., of the Federal Court. The court delivered confidential reasons for judgment and judgment on June 27, 2013. The court delivered the following public reasons for judgment and judgment (identical to the confidential reasons for judgment and judgment) on July 12, 2013.