Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., (2010) 367 F.T.R. 179 (FC)

• Judge: Heneghan, J.
• Court: Federal Court (Canada)
• Case Date: January 22, 2010
• Jurisdiction: Canada (Federal)
• Citations: (2010), 367 F.T.R. 179 (FC);2010 FC 447

Pfizer Can. Inc. v. Can. (2010), 367 F.T.R. 179 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. AP.025

Pfizer Canada Inc. and Pharmacia Atkiebolag (applicants) v. The Minister of Health and Apotex Inc. (respondents)

(T-124-08; 2010 FC 447)

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

Federal Court

Heneghan, J.

April 26, 2010.

Summary:

The applicants applied, under the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension. Apotex alleged that its product would not infringe the '132 patent and that the '132 patent was invalid on several grounds.

The Federal Court allowed the application.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court stated that "[c]laims construction must be approached in an informed and purposive manner, with close regard to the purpose and intent of the authors. Information is to be gained from the patent as a whole in order to determine the context in which the claims are to be considered. The role of experts is to provide assistance, if necessary, relative to the technical meaning of the words and concepts used in the claims [...] In construing the claim, the Court should be neither harsh nor benevolent but approach the claim with a mind willing to understand." - See paragraph 65.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid because the claims at issue were broader than the invention claimed - Apotex said that the claims did not include the use for the treatment of humans - It said that claims 19, 31, 37 and 38 were overbroad because there was no disclosure dealing with the prevalence of irritation or hyperemia - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - It was within the discretion of the inventors of the '132 patent to refrain from making a claim in relation to hyperemia - The claims in issue were not overbroad because the inventors decided not to claim a particular benefit - See paragraphs 187 to 191.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of obviousness - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - The inventive concept of the claims in issue was the use of Latanoprost to reduce eye and intraocular pressure (IOP) in the treatment of glaucoma or ocular hypertension without causing substantial ocular irritation - The '132 patent, in comparison with the prior art, "correctly and fully" described the invention - The person of skill in the art, even a highly skilled one, would not have been led to Latanoprost by the prior art - See paragraphs135 to 166.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of anticipation by previously published articles of prior art - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - Having regard to the conflicting evidence given by the expert witnesses for the applicants and Apotex, and having reviewed the documents in question, the court was satisfied that none of the documents relied upon by Apotex disclosed the chemical composition of Latanoprost as defined in the '132 patent for the treatment of glaucoma or ocular hypertension - There was not a single prior publication that disclosed all the information that was necessary, for practical purposes, to perform the claimed invention without the exercise of any inventive skill - See paragraphs 99 to 108.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of anticipation by the previously published '560 patent - Apotex asserted that the effect of including the '560 patent on the Form IV Patent List was enough to establish invalidity of the '132 patent on the grounds of anticipation - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - Apotex cited no jurisprudence in support of its position - Inclusion of the '560 patent on the Form IV was not per se anticipation - See paragraphs 109 to 113.

Patents of Invention - Topic 1604

Grounds of invalidity - Anticipation - Selection patents - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of anticipation - Apotex asserted that the only defence available to the applicants to the allegation of anticipation, was to claim that the '132 patent was a selection patent arising from the genus patent, that was the '560 patent - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - There was no evidence in the record that the applicants claimed ownership of the '560 patent - They did not assert that the '132 patent was a selection patent and the court declined Apotex's invitation that the court make such a finding - It was beyond the court's jurisdiction to advance an allegation that had not been made by the parties, that was that the '132 Patent was a selection patent of the '560 patent - See paragraphs 114 to 134.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See both Patents of Invention - Topic 1603 and Patents of Invention - Topic 1604 ].

Patents of Invention - Topic 1651

Grounds of invalidity - Anticipation by prior patent - General - [See second Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid for double patenting and referred to the '560 patent issued on July 29, 1986 - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - The '560 was owned by the Trustees of Columbia University in New York City - The '560 patent was not owned by the applicants - Further, the claims in the '560 patent were different from those in the '132 Patent - In these circumstances, Apotex had not established that the '132 Patent was invalid on the grounds of double patenting - See paragraphs 93 and 94.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of lack of utility - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - The patent showed utility - The '132 patent demonstrated utility, disclosed what the invention was and how it worked, as claimed - Furthermore, the disclosure requirements were met as of the issue date - Disclosure could be assessed against documents published between September 12, 1989 and July 29, 1997 - Expert witnesses referred to studies that were done comparing Latanoprost to timolol and discussing the effectiveness of Latanoprost - See paragraphs 167 to 175.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that the '132 patent was invalid on the basis of lack of sound prediction - The Federal Court held that Apotex's assertions of invalidity were not justified and allowed the applicants' application - The date and the example of the '132 patent provided a sound line of reasoning and disclosure - Page 16 of the patent disclosed how to make Latanoprost - Page 23 showed a diagram of the Latanoprost molecule - Pages 21 to 22 and 29 disclosed test results in healthy humans - Pages 25 to 29 disclosed test results where Latanoprost was tested on animals - The applicants' experts said that the animals used and experiments performed were within the common models in the 1980s to test ophthalmological drugs - The court was satisfied that the evidence tendered by the applicants' experts supported the claim for sound prediction utility - See paragraphs 176 to 186.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 and Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 3006

Infringement of patent - Defences - Patent indistinguishable from prior art (Gillette defence) - The applicants applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. until the expiry of Canadian Patent 1,339,132 (the '132 patent) with respect to Latanoprost, used in the treatment of glaucoma or ocular hypertension - Apotex alleged that its product would not infringe the '132 patent because the '132 patent claimed an old use for an old compound (Gillette defence) - The Federal Court rejected the allegation and allowed the application - The application of the Gillette defence depended upon the determination of many allegations of invalidity raised by Apotex - The applicants had demonstrated on a balance of probabilities that the allegations of invalidity respecting the '132 patent were not justified - It followed that the Gillette defence was not available - See paragraphs 84 to 91 and 192 to 194.

Cases Noticed:

Simard (Emmanuel) & Fils (1983) Inc. v. Raydan Manufacturing Ltd. (2005), 276 F.T.R. 164; 41 C.P.R.(4th) 385 (F.C.), refd to. [para. 18].

Eli Lilly & Co. et al. v. Nu-Pharm Inc. et al. (1996), 199 N.R. 185; 69 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 59].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 59].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al., [2001] 4 F.C. 518; 208 F.T.R. 105 (T.D.), affd. (2002), 291 N.R. 168 (F.C.A.), refd to. [para. 59].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al. (1994), 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 31].

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

Whirlpool Corp. et al. v. Camco Inc. et al. (2000), 263 N.R. 88; 9 C.P.R.(4th) 129 (S.C.C.), refd to. [para. 64].

Free World Trust v. Electro Santé Inc. et al. (2000), 263 N.R. 150; 9 C.P.R.(4th) 168 (S.C.C.), refd to. [para. 64].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2008), 381 N.R. 125; 298 D.L.R.(4th) 385 (S.C.C.), appld. [para. 68].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2009), 360 F.T.R. 200 (F.C.), refd to. [para. 71].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 57 C.P.R.(4th) 6 (F.C.), affd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116 (F.C.A.), leave to appeal refused, [2007] 3 S.C.R. xii; 383 N.R. 397, refd to. [para. 83].

Gillette Safety Razor Co. v. Anglo-American Trading Co. (1913), 30 R.P.C. 465 (H.L.), refd to. [para. 84].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 75 C.P.R.(4th) 165 (F.C.), refd to. [para. 85].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685 (H.L.), refd to. [para. 95].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 67 C.P.R.(4th) 23 (F.C.A.), refd to. [para. 97].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2009), 353 F.T.R. 35; 78 C.P.R.(4th) 1 (F.C.), consd. [para. 110].

Wyeth Canada et al. v. ratiopharm inc. et al. (2007), 310 F.T.R. 265; 58 C.P.R.(4th) 154 (F.C.), affd. in part (2007), 370 N.R. 89; 60 C.P.R.(4th) 375 (F.C.A.), refd to. [para. 112].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 310 F.T.R. 185; 55 C.P.R.(4th) 271 (F.C.), refd to. [para. 112].

Solvay Pharma Inc. et al. v. Apotex Inc. et al. (2008), 323 F.T.R. 1; 64 C.P.R.(4th) 246 (F.C.), refd to. [para. 112].

Dr. Reddy's Laboratories (UK) Ltd. v. Eli Lilly and Co., [2010] R.P.C. 9 (C.A.), refd to. [para. 121].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 131].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 176].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161 (F.C.), affd. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401 (F.C.A.), refd to. [para. 178].

Lovell Manufacturing Co. and Maxwell Ltd. v. Beatty Brothers Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.), refd to. [para. 188].

Counsel:

Brian Daley, Judith Robinson and Kavita Ramamoorthy, for the applicants;

Andrew Brodkin, Dino Clarizio and Belle Van, for the respondent, Apotex Inc.

Solicitors of Record:

Ogilvy Renault, LLP, Montreal, Quebec, for the applicants;

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

John H. Sims, Q.C., Deputy Attorney General of Canada, Montreal, Quebec, for the respondent, The Minister of Health.

This application was heard on September 14 to 17, 2009, and January 22, 2010, at Montreal, Quebec, and Toronto, Ontario, by Heneghan, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on April 26, 2010.