Purdue Pharma v. Pharmascience Inc. et al., (2009) 347 F.T.R. 224 (FC)

• Judge: Harrington, J.
• Court: Federal Court (Canada)
• Case Date: July 16, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 347 F.T.R. 224 (FC);2009 FC 726

Purdue Pharma v. Pharmascience Inc. (2009), 347 F.T.R. 224 (FC)

MLB headnote and full text

Temp. Cite: [2009] F.T.R. TBEd. AU.034

Purdue Pharma (applicant) v. Pharmascience Inc. and The Minister of Health (respondents)

(T-1837-07; 2009 FC 726)

Indexed As: Purdue Pharma v. Pharmascience Inc. et al.

Federal Court

Harrington, J.

July 16, 2009.

Summary:

The issue in this application was whether any one of Pharmascience's allegations of invalidity respecting Purdue's patent for "Controlled Release Oxycodone Compositions" was justified. If so, the Court would not prevent the Minister of Health from permitting Pharmascience to market its generic version of oxycodone hydrochloride controlled release tablets. If not, the Minister would be prohibited from granting Pharmascience a Notice of Compliance (NOC) until Purdue's patent expired in 2012.

The Federal Court prohibited the Minister from issuing a Notice of Compliance to Pharmascience until Purdue's patent expired.

Patents of Invention - Topic 1

General - The Federal Court set out "a few basics" of patents of inventions - See paragraphs 6 to 20.

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - Purdue had a patent for "Controlled Release Oxycodone Compositions" - The drug worked using a matrix system - Purdue claimed matrixes which could lead to literally hundreds upon hundreds of different formulations - Yet, according to Pharmascience, it only disclosed variants of the previously patented AcroContin system - The invention taught nothing about the use of hydroxypylmethycellulose (HPMC) in a matrix - Pharmascience wanted to use HPMC in its matrix, which appeared to fall within the group of matrixes claimed - HPMC was specifically mentioned in the disclosure - Pharmascience alleged that the drug was invalid for, inter alia, overbreadth and lack of disclosure - The Federal Court rejected the allegations - Purdue advanced the state of the art with something that was both useful and new - It was one thing to try, not knowing if the desired result was achievable - It was quite another when the path has been shown and it was known that the result was achievable - Furthermore, Purdue did not claim all routes to the desired result - The patent did not prevent Pharmascience from using other methods to control the release of oxycodone such as a reservoir or osmotic system, or from using a different in vitro profile or a different in vivo profile - See paragraphs 105 to 116.

Patents of Invention - Topic 1501

Grounds of invalidity - General - Pharmascience made a "barrage" of allegations of invalidity respecting Purdue's patent for "Controlled Release Oxycodone Compositions" - The Federal Court dealt with the issues of anticipation by prior use and commercial success, then stated "As to the other allegations of invalidity, the approach thereto urged upon me by Purdue is that allegations should be treated as separate and distinct and are watertight compartments, with limited leakage. Pharmascience is criticized for asserting a number of allegations in the same breath. For instance, one of the headings in its written memorandum is ''738 Patent - Nothing Was Invented (Obviousness, Anticipation, No Invention, Lack of Utility).' However, I prefer the 'seamless garment of the law' approach since, after all, the patent is a legal document, a regulation within the meaning of the Interpretation Act." - See paragraph 51 - The court further stated, "The well-known allegations of invalidity asserted here - overbreadth, obviousness, false promise, anticipation, ambiguity, insufficiency, lack of invention, lack of sound prediction and lack of utility - should not take on separate lives of their own. They are tied to the specific language of the Patent Act. Nevertheless, they are useful terms of reference so as to put some order into what might otherwise be an overwhelmingly amorphous exercise." - See paragraph 76.

Patents of Invention - Topic 1509

Grounds of invalidity - Commercial success - Effect of - Pharmascience made a "barrage" of allegations of invalidity respecting Purdue's patent for "Controlled Release Oxycodone Compositions" - Purdue relied on, inter alia, the commercial success of the invention - The Federal Court put no value on Purdue's evidence that controlled release oxycodone had been a commercial success - The court stated that "Purdue produced sales records and hearsay prescription records. Dr. Abram was of the view that controlled release oxycodone was a commercial success in the United States because of Purdue's marketing. Dr. Gallagher did not recall a particular marketing effort in Canada. Lawyers and judges do not need lessons in logic. The data supplied cannot possibly lead to the inference that this particular patent is valid. We are in the realm of conjecture. Furthermore, neither Dr. Abram nor Dr. Gallagher has expertise in the market place. They have stepped outside their expert qualifications. Courts must treat such evidence with great care." - See paragraph 50.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - Pharmascience alleged that Purdue's patent for "Controlled Release Oxycodone Compositions" was invalid for, inter alia, obviousness - The Federal Court disagreed - The inventive concept was controlled release oxycodone staying within the boundaries of a particular dissolution and pharmacokinetic profile from 10 to 14 hours - This combination was different from anything which formed part of the "state of the art" - The inventive concept was not the idea, but rather getting it to work - It was not self-evident that what was being tried ought to work - There was a considerable amount of work required to achieve the invention, and the trials were not routine - The work was inventive - Although Purdue certainly had motive in that it was developing a stable of controlled release opioid tablets, there did not appear to have been much motive within the pharmaceutical industry at large - If someone cared to think about it, oxycodone was a suitable candidate, but it had been around for a long time - See paragraphs 83 to 100.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - Pharmascience alleged that Purdue's patent for "Controlled Release Oxycodone Compositions" was invalid for, inter alia, obviousness - The drug worked using a matrix system - The Federal Court stated that "An invention need not be patented. If it is, however, the patent is construed as a bargain between the inventor and the public. In consideration of disclosing the invention and how to work it, the inventor is given a temporary monopoly to exploit it ..." - See paragraph 6 - The court stated that "No bargain is struck for disclosing the invention if it can be worked around by using a non-essential variant in a matrix. The question is whether what is claimed as the monopoly is something which the public already has." - The court referred to a text by Professor Vaver which provided that "A double standard operates here. Courts give patents a non-literal 'purposive' construction when they are testing for internal validity or trying to catch infringers. When testing prior documents for novelty, however, they construe them narrowly. The documents are then subjected to 'the closest scrutiny,' and a 'weighty burden' is placed on the challenger. Sauce for the patent goose should perhaps also be sauce for the prior art gander. Prior documents should be examined purposively as a skilled reader would read them. This examination should cover obvious equivalents to described or claimed elements." - The court stated that "the same approach should be taken with respect to allegations of invalidity on the grounds of obviousness in the light of the prior art. It is indeed difficult to apply the fourth step in the Windsurfing/Pozzoli approach, i.e. 'viewed without any knowledge of the alleged invention as claimed'" - See paragraphs 110 to 112.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court stated that "an invention may be based on 'sound prediction'. A prediction may turn out to be correct, but there may have been no sound basis for making it in the first place. In effect it was a lucky guess. If so the claim falls. On the other hand, a prediction may be sound, but later prove to be incorrect. In that case the claim falls, not because of lack of sound prediction, but rather because the invention was not useful." - See paragraph 101.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - Pharmascience challenged Purdue's patent for "Controlled Release Oxycodone Compositions" on the ground, inter alia, that it claimed profiles on compositions containing from about 10 to about 160 mg of oxycodone, while the range tested in vivo was only 4 mg to 30 mg - The Federal Court applied the doctrine of sound prediction as set out in Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (2002, SCC) - It had three components: firstly, a factual basis for the prediction; secondly, the inventor must have had at the date of the patent application an articulable and "sound" line of reasoning from which the desired result could be inferred from the factual basis; and thirdly, there must have been proper disclosure - The court stated that "The factual basis and sound line of reasoning from which the desired result could be inferred is grounded in the immediate release oxycodone tablets already on the market which were useful pain killers and which possessed a particular pharmacokinetic profile. Although these were 10 mg tablets, Dr. Kaiko was able to predict the characteristics of larger dosages by 'partition coefficient'." - See paragraphs 102 and 103.

Patents of Invention - Topic 5511

New substances licences - Food and medicine - General - The Federal Court stated that "To be patentable an invention must be both new and shown to be useful, either by demonstration or by sound prediction. An invention may be new even if only an improvement on what already exists, and may be useful even if only a poorer alternative to what already exists. The inventor of a new pain killer will not be denied a patent simply because it is only half as effective as aspirin and twice as expensive." - See paragraph 6.

Cases Noticed:

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299; 80 C.P.R.(3d) 368, refd to. [para. 3].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 39 C.P.R.(4th) 449; 2005 SCC 26, refd to. [para. 3].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 69 C.P.R.(4th) 251; 2008 SCC 61, appld. [para. 3].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 310 F.T.R. 185; 55 C.P.R.(4th) 271; 2007 FC 300, refd to. [para. 3].

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; 2000 SCC 66, refd to. [para. 10].

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; 2000 SCC 67, refd to. [para. 14].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 322 F.T.R. 86; 69 C.P.R.(4th) 191; 2008 FC 11, refd to. [para. 18].

Eli Lilly Canada Inc. v. Novopharm Ltd., 2009 FC 235, refd to. [para. 18].

Ratiopharm GmbH v. Napp Pharmaceutical Holdings Ltd., [2008] EWHC 3070 (Pat.); [2009] R.P.C. 11, revd. in part [2009] EWCA Civ. 252, refd to. [para. 20].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 50].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, appld. [para. 51].

Ciba Ltd. v. Commissioner of Patents, [1959] S.C.R. 378, refd to. [para. 53].

Harvard College v. Commissioner of Patents, [2002] 4 S.C.R. 45; 296 N.R. 1; 21 C.P.R.(4th) 417, refd to. [para. 76].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 79].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 99].

Lilly Icos Ltd. v. Pfizer Ltd., [2001] F.S.R. 16, affd. [2002] EWCA Civ. 1, refd to. [para. 99].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] S.C.R. 153; 296 N.R. 130; 21 C.P.R.(4th) 499; 2002 SCC 77, refd to. [para. 102].

Minerals Separation North American Corp. v. Noranda Mines Ltd., [1947] Ex. C.R. 306, refd to. [para. 106].

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. 109].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538; 2008 FC 538, refd to. [para. 111].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 112].

Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37; [2007] EWCA Civ. 588, refd to. [para. 112].

Authors and Works Noticed:

Goudge Report - see Ontario, Report of Inquiry into Pediatric Forensic Pathology in Ontario, Report: Policy and Recommendations.

Ontario, Report of Inquiry into Pediatric Forensic Pathology in Ontario, Report: Policy and Recommendations (Goudge Report) (2008), vol. 2, c. 8 [para. 50].

Vaver, David, Intellectual Property Law: Copyright, Patents, Trade-Marks (1997), p. 133 [para. 111].

Counsel:

Anthony Creber, James Mills and Chantal Saunders, for the applicant;

Carol Hitchman and Paula Bremner, for the respondent, Pharmascience Inc.;

No one appeared, for the respondent, The Minister of Health.

Solicitors of Record:

Gowlings, Ottawa, Ontario, for the applicant;

Hitchman & Sprigings, Toronto, Ontario, for the respondent, Pharma Science Inc.;

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

This application was heard at Ottawa, Ontario, on June 8-12, 2009, by Harrington, J., of the Federal Court, who delivered the following decision on July 16, 2009.