Pfizer Canada Inc. et al. v. ratiopharm Inc. et al., 2010 FC 612

• Judge: Kelen, J.
• Court: Federal Court (Canada)
• Case Date: June 08, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 612;(2010), 371 F.T.R. 87 (FC)

Pfizer Can. Inc. v. ratiopharm Inc. (2010), 371 F.T.R. 87 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. JN.017

Pfizer Canada Inc. and Pfizer Inc. (applicants) v. ratiopharm Inc. and The Minister of Health (respondents)

(T-955-08; 2010 FC 612)

Indexed As: Pfizer Canada Inc. et al. v. ratiopharm Inc. et al.

Federal Court

Kelen, J.

June 8, 2010.

Summary:

The applicants applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to the respondent for a generic version of REVATIO until the applicants' Canadian Patent 2,324,324 (the '324 Patent) expired. The respondent alleged that the applicants' patent for REVATIO was invalid for lack of soundly predicted utility, obviousness, and anticipation.

The Federal Court dismissed the application.

Patents of Invention - Topic 704

Application for grant - General - Claim to patent prior to application date - The applicants applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to the respondent for a generic version of REVATIO until the applicants' Canadian Patent 2,324,324 (the '324 Patent) expired - The applicants obtained the '324 Patent on December 20, 2005, from an application filed in Canada on October 26, 2000 which claimed priority from Great Britain Patent Application No. 9925970.7 filed on November 2, 1999 - The applicants submitted that the '324 Patent was entitled to an earlier priority claim date because of its prior application for a United Kingdom patent, GB 9925970.7 (GB 970), filed on November 2, 1999 - The applicants submitted that GB 970 disclosed the same subject matter as claim 10 in the '324 Patent - The Federal Court granted the request - The court could not apply Canadian patent law to decide if a patent application filed in Great Britain disclosed a patentable invention under British patent law - Section 28.1(1)(a)(ii) of the Canadian Patent Act recognized a patent application filed in another country for which Canada had a treaty or convention - GB 970 disclosed "the same subject matter" as claimed in the '324 Patent - The court concluded under s. 28.1(1)(a)(ii) that GB 970 entitled the applicants to a priority claim date of November 2, 1999 - See paragraphs 79 to 90.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court stated that "[p]atent construction is to be done on the basis that the addressee is a person skilled in the art and the knowledge that person is expected to possess is to be considered. The hypothetical person who is skilled in the art possess the ordinary skills and knowledge of the particular art to which the invention relates, a mind willing to understand a specification, and is assumed to be someone who is going to try to achieve success and not one who is looking for difficulties or seeking failure." - See paragraph 64.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - The applicants applied for an order under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to the respondent for a generic version of REVATIO until the applicants' Canadian Patent 2,324,324 (the '324 Patent) expired - The '324 Patent claimed the use of sildenafil or preferably sildenafil citrate for treating or preventing pulmonary hypertension - The respondent alleged that the applicants' patent for REVATIO was invalid for, inter alia, obviousness in light of the prior art - The Federal Court reviewed the prior art, including prior patents and articles published in various medical journals, and concluded that before the priority date of November 2, 1999, a person skilled in the art with the common general knowledge shown in the prior art would consider that it was "obvious to try" sildenafil for the treatment of pulmonary hypertension and that the skilled person would have a "fair expectation of success" - Accordingly, the court found that the applicants had not proven on the balance of probabilities that the respondent's allegation of patent invalidity for obviousness was unjustified - See paragraphs 114 to 176.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1584 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See Patents of Invention - Topic 1584 ].

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 under the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to the respondent for a generic version of REVATIO until the applicants' Canadian Patent 2,324,324 (the '324 Patent) expired - The '324 Patent claimed the use of sildenafil or preferably sildenafil citrate for treating or preventing pulmonary hypertension - The respondent alleged that the applicants' patent for REVATIO was invalid for, inter alia, lack of soundly predicted utility - The Federal Court found that all the expert witnesses agreed that the 1024 clinical study as disclosed in the '324 Patent did not soundly predict that sildenafil would treat pulmonary hypertension - Moreover, the failure the 1024 study to assess the effect of sildenafil on chronic obstructive diseases and congestive heart failure patients deprived the patent from disclosing a factual basis to soundly predict the efficacy of sildenafil upon such patients - The '324 Patent claimed to soundly predict the use of sildenafil in treating all types of chronic pulmonary hypertension by relying on a limited set of data from a few patients in one group - The applicants were studying the effect of sildenafil on patients suffering from important secondary forms of pulmonary hypertension at the same time, but it did not wait for those results before it filed the '324 Patent on October 26, 2000 - Accordingly, the applicants had not proven on the balance of probabilities that the respondent's allegation of lack of soundly predicted utility was unjustified - The '324 Patent was therefore invalid for lack of sound prediction - See paragraphs 91 to 113.

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 ].

Cases Noticed:

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. 15].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 62].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 62].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 2007 FC 971, refd to. [para. 62].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, refd to. [para. 62].

Whirlpool Corp. et al. v. Camco Inc. et al. (2000), 263 N.R. 88; 9 C.P.R.(4th) 129; 2000 SCC 67, refd to. [para. 63].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553, refd to. [para. 63].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 64].

Abbott Laboratories Ltd. et al. v. Canada (Minister of Health) et al. (2006), 304 F.T.R. 104; 2006 FC 1411, affd. (2007), 367 N.R. 120; 2007 FCA 251, refd to. [para. 75].

Merck & Co. et al. v. Apotex Inc., [2007] 3 F.C.R. 588; 354 N.R. 51; 2006 FCA 323, refd to. [para. 82].

Laboratoires Servier et al. v. Apotex Inc. et al. (2009), 392 N.R. 96; 75 C.P.R.(4th) 443; 2009 FCA 222, affing. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, refd to. [para. 85].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 477; 296 F.T.R. 254; 2007 FC 81, revd. in part [2008] 1 F.C.R. 529; 361 N.R. 290; 2007 FCA 173, refd to. [para. 86].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 2007 FC 688, refd to. [para. 87].

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. 94].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 392 N.R. 243; 2009 FCA 97, refd to. [para. 95].

Biovail Corp. et al. v. Canada (Minister of Health) et al. (2010), 361 F.T.R. 158; 2010 FC 46, refd to. [para. 117].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 118].

Authors and Works Noticed:

Atz, Andrew M., and Wessel, David L., Sildenafil Ameliorates Effects of Inhaled Nitric Oxide Withdrawal (1999), 91(1) Anesthesiology 307, pp. 307 [para. 140]; 308 [paras. 142, 147]; 309 [paras. 143, 144].

Cheitlin, Melvin D., Hutter, Jr., Adolph M., Brindis, Ralph, Ganz, Peter, Kaul, Sanjay, Russell, Jr., Richard O., Zusman, Randall M., Use of Sildenafil (Viagra) in Patients with Cardiovascular Disease (1999), 99 Circulation 168, pp. 171, 172 [paras. 127, 158].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005), pp. 139, § 11 [para. 94]; 311 to 312, § 26 [para. 66].

Jackson, Graham, Benajmin, Nigel, Jackson, Neville, and Allen, Michael J., Effects of Sildenafil Citrate on Human Hemodynamics (1999), 83(5) American Journal of Cardiology 13, pp. 13C [para. 130]; 20C [para. 131].

Lepore, John J., Pereira, Naveen, Maroo, Anjli, Ginns, Geo, Bigatello, Joca M., Dec, G. William, Rubin, Robert, Zapol, Warren M., Bloch, Kenneth D., and Semigran, Marc Jay, Sildenafil is Pulmonary Vasodilator Which Augments and Prolongs Vasodiation by Inhaled Nitric Oxide in Patients with Pulmonary Hypertension (1999), 100(18) Circulation 168, generally [para. 119 et seq.].

Weimann, J., Ullrich, B., Hromi, J., Fujino, Y., Bloch, K.D., and Zapol, W.M., Sildenafil (Viagra) is a Selective Pulmonary Vasodilator in Acute Pulmonary Hypertension in Awake Sheep (1999), 159(3) American Journal of Respiratory Care and Critical Care Medicine (1999 Supp.), p. A 163 [para. 119].

Counsel:

Andrew Bernstein and Yael Bienenstock, for the applicants;

David W. Aitken and Marcus Klee, for the respondent (ratiopharm Inc.).

Solicitors of Record:

Torys, LLP, Toronto, Ontario, for the applicants;

Osler, Hoskin & Harcourt, LLP, Ottawa, Ontario, for the respondent (ratiopharm Inc.);

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent (Minister of Health).

This application was heard from April 19 to 22, 2010, at Toronto, Ontario, by Kelen, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on June 8, 2010.