Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., (2007) 328 F.T.R. 41 (FC)

• Judge: Snider, J.
• Court: Federal Court (Canada)
• Case Date: June 25, 2007
• Jurisdiction: Canada (Federal)
• Citations: (2007), 328 F.T.R. 41 (FC);2007 FC 898

Pfizer Can. Inc. v. Can. (2007), 328 F.T.R. 41 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. OC.013

Pfizer Canada Inc. and Warner-Lambert Company, LLC (applicants) v. The Minister of Health and Ranbaxy Laboratories Limited (respondents)

(T-507-05; 2007 FC 898)

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

Federal Court

Snider, J.

October 5, 2007.

Summary:

Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (collectively referred to as Pfizer). Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium. Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent. Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India. Ranbaxy sought approval to sell its product in Canada. Pfizer applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Ranbaxy. Pfizer did not contest Ranbaxy's assertion that Ran-Atorvastatin contained the amorphous form of atorvastatin calcium, and none of the patented crystalline forms. Rather, Pfizer contended that Ranbaxy used one of the patented crystalline forms as an intermediate in the process to make the amorphous material contained in Ran-Atorvastatin, and that Ranbaxy infringed the process described in the 455 Patent. Ranbaxy asserted that it did not infringe either the 018 Patent or the 455 Patent and that the 455 Patent was invalid for insufficiency.

The Federal Court held that Pfizer met its burden of showing, on a balance of probabilities, that Ranbaxy's allegation that it would not infringe the 018 Patent was not justified. Accordingly, an order of prohibition would issue prohibiting the Minister from issuing a Notice of Compliance to Ranbaxy until the expiry of the 018 Patent. With respect to the 455 Patent, the court held that Ranbaxy led sufficient evidence to rebut the presumption of validity and Pfizer failed to meet its burden of showing that the allegation of invalidity was not justified. Accordingly, the application for an order of prohibition failed with respect to the 455 Patent.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Ranbaxy - Pfizer contended that Ranbaxy used one of the patented crystalline forms as an intermediate in the process to make the amorphous material contained in Ran-Atorvastatin - Pfizer argued that Ranbaxy did not raise the location of the manufacture and use of the intermediates as an alleged basis of non-infringement in its January 31, 2005, Notice of Allegation (NOA) and its NOA was therefore insufficient to support that allegation - The Federal Court rejected the argument - The court stated that "the words of the NOA are sufficient to allow Pfizer to know that the basis of the allegation was likely that Ranbaxy was not using a compound that could be identified as either crystalline Form I atorvastatin as defined in the 018 Patent or as a hydrate, as required by the 018 Patent. We must also look at the subsequent disclosures made after the Confidentiality Order was in place. On May 11, 2005, the manufacturing sites were disclosed to Pfizer. At that point, it should have been apparent to Pfizer that Ranbaxy was relying - at least in part - on the fact that all of the manufacturing steps were taking place in India" - See paragraphs 30 to 36.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Ranbaxy - With respect to the adequacy of Ranbaxy's Notice of Allegation (NOA), Pfizer argued that two questions related to the construction of the claims of the 455 Patent were not evident to Pfizer until after the affidavit evidence of Ranbaxy's expert was filed - The Federal Court found that the issue of "claims construction" was not raised and contained in the Ranbaxy NOA - Further, the fact that Pfizer sought leave to file reply evidence was strong evidence that it did not have an understanding of the case it had to meet - The court rejected Ranbaxy's argument that, since the reply evidence was permitted and full submissions had been made on the issue, there was no prejudice and the NOA could not be said to be inadequate - Pfizer had been handicapped in the application by Ranbaxy's failure to disclose as part of the NOA - See paragraphs 110 to 122.

Patents of Invention - Topic 1004

The specification and claims - General - Substances intended for food and medicine - [See Patents of Invention - Topic 1032 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer applied for an order prohibiting the issuance of a Notice of Compliance to Ranbaxy - Ranbaxy submitted that there was no reference in the 455 Patent to any techniques to make amorphous atorvastatin other than evaporative techniques - Thus, Ranbaxy argued, on a purposive construction of the 455 Patent, a skilled addressee would conclude that the phrase "removing the solvent to afford amorphous atorvastatin" referred to a process in which the solid amorphous atorvastatin was formed prior to the removal of the solvent, by evaporative techniques only - Ranbaxy's technique for creating its product involved precipitation - The Federal Court stated that "The failure of the inventors to refer to any other method of removal of the solvent is strong evidence that the inventors intended evaporative techniques to be an essential element of the invention and did not turn their minds to other methods of solvent removal. Thus, I would lean towards concluding that the proper construction of the 455 Patent is that the phrase 'removing the solvent to afford amorphous atorvastatin' refers to a process in which the solid amorphous atorvastatin is formed prior to the removal of the solvent, by evaporative techniques only" - However, the court stated that it did not need to make a conclusive finding on this issue and it would not do so - See paragraphs 100 to 109.

Patents of Invention - Topic 1128.1

The specification and claims - The description - Sufficiency of description of invention - [See Patents of Invention - Topic 1779 ].

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium called Form I, Form II and Form IV - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - The Federal Court held that the 455 Patent was invalid for insufficiency - The court found that the 455 Patent required the use of a seed to make the crystalline Form I atorvastatin and as the 455 Patent did not explicitly teach how to make a seed, it did not teach how to make crystalline Form I atorvastatin calcium - Further, a methodology for making the necessary seed was not part of the common general knowledge as of the date of publication of the 455 Patent - Pfizer could not rely on the existence of the 018 Patent, or an identical U.S. patent to cure this defect - As of the date of publication on February 6, 1997, the 455 Patent contained no reference to the U.S. patent - References to the U.S. patent were only added after the 455 Patent issued - In addition, the U.S. patent did not issue until 1999 - The 018 Patent, which was published on the same date as the 455 Patent, was also not part of the common general knowledge as of February 6, 1997, as it would not likely have been discovered in a reasonable and diligent search by a skilled addressee - See paragraphs 123 to 163.

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - [See Patents of Invention - Topic 2941 ].

Patents of Invention - Topic 2889

Infringement of patent - Acts constituting an infringement - Importation of product made using process patented in Canada - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer contended that Ranbaxy used one of the patented crystalline forms as an intermediate in the process to make the amorphous material contained in Ran-Atorvastatin - Ranbaxy argued that production in India and use there of a patented substance could not be infringement of the 018 Patent - Ranbaxy submitted that the "Saccharin" doctrine should be limited to process claims and not extended to apply to products that were used off-shore as intermediates - The Federal Court stated that "the focus of any analysis must be on whether the inventor has been deprived, even in part or even indirectly, of the full enjoyment of the invention. Under this approach, I see no reason why I should necessarily limit the application of the doctrine to process claims" - The court concluded that the "Saccharin" doctrine was not limited to process claims - However, a court had to proceed cautiously when either off-shore products or processes were concerned - The court set out some factors that had to be considered when faced with a situation where the question had to be addressed - See paragraphs 74 to 91.

Patents of Invention - Topic 2889

Infringement of patent - Acts constituting an infringement - Importation of product made using process patented in Canada - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer contended that Ranbaxy used one of the patented crystalline forms as an intermediate in the process to make the amorphous material contained in Ran-Atorvastatin - Ranbaxy argued that production in India and use there of a patented substance could not be infringement of the 018 Patent - The Federal Court found that Ranbaxy had infringed the 018 Patent by the use of the Ranbaxy intermediates, even though the use made of the intermediates occured outside Canada - The infringing product was not used as a preliminary step - Rather the Ranbaxy intermediates were used in the final three stages of the manufacturing process - The function of the intermediates was not incidental - Without the intermediates, it appeared that Ranbaxy would not have been able to produce its amorphous form of atorvastatin - Although it appeared that none of the intermediates constituted any element of the end product, that was not sufficient to conclude that Ranbaxy did not infringe - See paragraphs 74 to 96.

Patents of Invention - Topic 2941

Infringement of patent - Chemical products and substances intended for food and medicine - General - Atorvastatin calcium was the active ingredient in Lipitor, an anti-cholesterol drug marketed in Canada by the applicants (Pfizer) - Canadian Patent No. 2,220,018 (the 018 Patent) claimed and protected particular and novel crystalline forms of atorvastatin calcium called Form I, Form II and Form IV - Canadian Patent No. 2,220,455 (the 455 Patent) claimed a novel process for making atorvastatin calcium in amorphous form from one of the crystalline forms of the 018 patent - Ranbaxy Laboratories Ltd. manufactured Ran-Atorvastatin, which contained the amorphous form of atorvastatin calcium, in India - Ranbaxy sought approval to sell its product in Canada - Pfizer contended that Ranbaxy used one of the patented crystalline forms as an intermediate in the process to make the amorphous material contained in Ran-Atorvastatin - The Federal Court found that Ranbaxy infringed the 018 Patent - The court was satisfied that: (a) the matching of the XRPD peaks of the patented Form I crystalline atorvastatin calcium with the three intermediate forms of the atorvastatin calcium used by Ranbaxy in its manufacture of Ran-Atorvastatin, together with other testing carried out by Pfizer's experts, was sufficient to demonstrate that the three intermediate forms were covered by Claims 1 to 5 of the 018 Patent; (b) by not providing evidence of the 13C NMR data for its intermediates, Ranbaxy had failed to allege any facts to support its allegation of non-infringement of Claims 6 to 9 of the 018 Patent; (c) Ranbaxy used the hydrate as an intermediate in the making of Ran-Atorvastatin; (d) the use of the patented crystalline Form I atorvastatin calcium in India, as an intermediate, constituted infringement of the 018 Patent - See paragraphs 37 to 98.

Cases Noticed:

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168, refd to. [para. 15].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 15].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, leave to appeal refused (2007), 364 N.R. 396 (S.C.C.), refd to. [para. 31].

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. 31].

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. 32].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, refd to. [para. 37].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 90; 2007 FCA 73, refd to. [para. 37].

Saccharin Corp. v. Anglo-Continental Chemical Works Ltd. (1900), 17 R.P.C. 307 (Ch. Div.), consd. [para. 75].

Wellcome Foundation Ltd. et al. v. Apotex Inc. (1991), 47 F.T.R. 81; 39 C.P.R.(3d) 289 (T.D.), revd. in part (1995), 187 N.R. 284; 60 C.P.R.(3d) 135 (F.C.A.), consd. [para. 77].

American Cyanamid Co. v. Frosst (Charles E.) & Co. (1965), 47 C.P.R. 215 (Ex. Ct.), refd to. [para. 77].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201, consd. [para. 78].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., [2004] F.T.R. Uned. B08; 36 C.P.R.(4th) 117; 2004 FC 1633, revd. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97; 2005 FCA 270, consd. [para. 81].

Domco Industries Ltd. v. Mannington Mills Inc. and Congoleum Corp. (1990), 107 N.R. 198; 29 C.P.R.(3d) 481 (F.C.A.), refd to. [para. 83].

Dole Refrigerating Products Ltd. v. Canadian Ice Machine Co. et al. (1957), 28 C.P.R. 32 (Ex. Ct.), refd to. [para. 83].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, refd to. [para. 85].

Wilderman v. Berk (F.W.) & Co. (1924), 42 R.P.C. 79 (Ch. Div.), refd to. [para. 88].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 312 F.T.R. 274; 2007 FC 506, refd to. [para. 118].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 127].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185, refd to. [para. 128].

Airseal Controls Inc. v. M & I Heat Transfer Products Ltd. (1993), 72 F.T.R. 196; 53 C.P.R.(3d) 259 (T.D.), affd. (1997), 220 N.R. 58; 77 C.P.R.(3d) 126 (F.C.A.), refd to. [para. 129].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1283, refd to. [para. 129].

Lubrizol Corp. v. Esso Petroleum Co., [1998] R.P.C. 727 (C.A.), refd to. [para. 129].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (C.A.), refd to. [para. 129].

Illinois Tool Works Inc. et al. v. Cobra Anchors Co. (2002), 221 F.T.R. 161; 20 C.P.R.(4th) 402 (T.D.), affd. (2003), 312 N.R. 184; 29 C.P.R.(4th) 417 (F.C.A.), refd to. [para. 129].

Counsel:

Andrew M. Shaughnessy, Peter R. Wilcox and Vincent de Granpre, for the applicants;

Ronald E. Dimock, David M. Reive and Angela M. Furlanetto, for the respondent (Ranbaxy Laboratories Limited).

Solicitors of Record:

Torys LLP, Toronto, Ontario, for the applicants;

Dimock Stratton LLP, Toronto, Ontario, for the respondent (Ranbaxy Laboratories Limited);

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent (The Minister of Health).

This application was heard on June 25, 2007, at Toronto, Ontario, before Snider, J., of the Federal Court, who delivered the following decision on October 5, 2007.