Purdue Pharma v. Canada (Attorney General) et al., (2010) 371 F.T.R. 215 (FC)

• Judge: Crampton, J.
• Court: Federal Court (Canada)
• Case Date: June 23, 2010
• Jurisdiction: Canada (Federal)
• Citations: (2010), 371 F.T.R. 215 (FC);2010 FC 738

Purdue Pharma v. Can. (A.G.) (2010), 371 F.T.R. 215 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. JL.019

Purdue Pharma (applicant) v. Attorney General of Canada and The Minister of Health (respondents)

(T-248-10; 2010 FC 738)

Indexed As: Purdue Pharma v. Canada (Attorney General) et al.

Federal Court

Crampton, J.

July 8, 2010.

Summary:

The Office of Patented Medicines and Liaison (OPML) determined that Purdue Pharma's patent in relation to the drug TARGIN was not eligible for listing on the patent register. Purdue Pharma applied for judicial review. It claimed that the OPML erred by misinterpreting s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations. At issue was whether the OPML erred in finding that the patent was ineligible for listing in relation to the dosage form claimed by the patent and the dosage form that was approved through the issuance of the Notice of Compliance.

The Federal Court dismissed the application. The OPML correctly interpreted s. 4(2)(c) and s. 2 of the Regulations as requiring a match between the dosage form claimed and the dosage form that was approved. It was not unreasonable for the OPML to conclude that there was in fact no match. Indeed, the OPML's conclusion in that regard was correct.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - [See first Food and Drug Control - Topic 1115 ].

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicant filed a new drug submission as part of its application for a Notice of Compliance (approved) to market and sell the drug TARGIN - TARGIN contained two medicinal ingredients, oxycodone and naloxone - The applicant applied to list the patent-at-issue in relation to TARGIN - The patent contemplated a controlled-release technology for delivering oxycodone - None of its claims mentioned naloxone - The Federal Court concluded that the Office of Patented Medicines and Liaison correctly determined that the dosage form claimed (claim 5) related to a formulation containing oxycodone as the sole medicinal ingredient, and that naloxone was not within the scope of claim 5 for the purposes of s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations - A construction of claim 5 that would recognize a potentially unlimited number of unnamed other medicinal ingredients to be within the scope of that claim would be inconsistent with the requirement of product specificity that was enshrined in s. 4 of the Regulations - "Such a construction would also '[invite] the Court to equate specificity under the Regulations with patent infringement'" - See paragraphs 37 to 49.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicant filed a new drug submission as part of its application for a Notice of Compliance (approved) to market and sell the drug TARGIN - TARGIN contained two medicinal ingredients, oxycodone and naloxone - The applicant applied to list the patent-at-issue in relation to TARGIN - The patent contemplated a controlled-release technology for delivering oxycodone - None of its claims mentioned naloxone - The Federal Court held that it was "entirely correct, and in any event was not unreasonable", for the Office of Patented Medicines and Liaison to implicitly conclude that the dosage form of TARGIN that was approved was a controlled release tablet for the delivery of specific strengths of a formulation containing both oxycodone and naloxone - A "claim for the dosage form" as defined in s. 2 of the Patented Medicines (Notice of Compliance) Regulations "clearly contemplates that a dosage form cannot merely be a delivery system, such as a controlled release tablet. It must be a delivery system for either a drug or a formulation of a drug" - That interpretation was consistent with the description that appeared in the TARGIN Product Monograph - See paragraphs 50 to 53.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The applicant filed a new drug submission as part of its application for a Notice of Compliance (approved) to market and sell the drug TARGIN - TARGIN contained two medicinal ingredients, oxycodone and naloxone - The applicant applied to list the patent-at-issue in relation to TARGIN - The patent contemplated a controlled-release technology for delivering oxycodone - None of its claims mentioned naloxone - The Office of Patented Medicines and Liason (OPML) determined that the patent was not eligible for listing on the basis that "a claim for the dosage form under paragraph 4(2)(c) [Patented Medicines (Notice of Compliance) Regulations] must take into consideration the requirement for product specificity" - On judicial review, the applicant submitted that for claims for the dosage form under s. 4(2)(c), all that was required was that the dosage form had been approved - The Federal Court disagreed - On a plain reading of the definition of "claim for the dosage form" in s. 2 of the Regulations, s. 4(2)(c) was not "devoid of any requirement relating to the medicinal ingredient" - "Keeping in mind the principle of product specificity, it follows that where a claim has been made for a delivery system for administering multiple medicinal ingredients in a drug or a formulation of a drug, the claim in question must include within its scope each of those medicinal ingredients" - See paragraphs 54 to 63.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - The Federal Court referred to the case law that endorsed the view that the determination of whether a patent was eligible for listing comprised three questions - In the context of s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations, the court restated those questions as follows: (1) what dosage form did the patent claim; (2) what was the dosage form approved by the existing Notice of Compliance (NOC); and (3) did the dosage form approved by the NOC fall within the scope of the patent at issue - The first question was a question of law that was reviewable on a standard of correctness; the second question was a question of law that was reviewable on a standard of reasonableness; and the third question was a question of mixed fact and law, the factual component of which was reviewable on a standard of reasonableness and the legal component of which was reviewable on a standard of correctness - See paragraphs 29 and 30.

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - The applicant, an innovator drug company, applied to list the patent at issue in relation to TARGIN - The Office of Patented Medicines and Liaison (OPML) determined that the patent was ineligible for listing in relation to the dosage forms (claim 5) - The applicant sought judicial review - It claimed that the OPML erred by misinterpreting s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations - The Federal Court stated that the OPML's decision would stand unless it was based on an incorrect construction of claim 5, an incorrect interpretation of s. 4(2)(c) of the Regulations, an unreasonable conclusion as to the approved dosage form of TARGIN, or an unreasonable conclusion as to whether the approved dosage form of TARGIN fell within the scope of the patent - See paragraph 31.

Words and Phrases

Claim for the dosage form - The Federal Court interpreted the phrase "claim for the dosage form" as found in s. 4(2)(c) and as defined in s. 2 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 - See paragraphs 16, 60 to 69.

Cases Noticed:

Purdue Pharma v. Pharmascience Inc. et al. (2009), 347 F.T.R. 224; 2009 FC 726, refd to. [para. 11].

Bayer Inc. v. Canada (Minister of Health) et al. (2009) 358 F.T.R. 20; 2009 FC 1171, refd to. [para. 12].

Bayer Inc. v. Canada (Minister of Health) et al. (2010), 405 N.R. 248; 2010 FCA 161, refd to. [para. 14].

Abbott Laboratories Ltd. v. Canada (Attorney General) et al., [2009] 3 F.C.R. 547; 382 N.R. 280; 2008 FCA 354, refd to. [para. 29].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 2009 FCA 35, refd to. [para. 31].

Abbott Laboratories Ltd. v. Canada (Attorney General) et al. (2008), 329 F.T.R. 190; 2008 FC 700, refd to. [para. 39].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 40].

Pfizer Canada Inc. et al. v. ratiopharm Inc. et al. (2010), 371 F.T.R. 87; 2010 FC 612, refd to. [para. 42].

Abbott Laboratories Ltd. et al. v. Canada (Attorney General) et al. (2007), 315 F.T.R. 263; 2007 FC 797, revd. in part (2008), 380 N.R. 287; 2008 FCA 244, refd to. [para. 49].

Statutes Noticed:

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 4(2)(c) [para. 15].

Authors and Works Noticed:

Sullivan, Ruth, Sullivan on the Construction of Statutes (5th Ed. 2008), p. 215 [para. 62].

Counsel:

James E. Mills and Beverley S. Moore, for the applicant;

Rick Woyiwada, for the respondents.

Solicitors of Record:

Borden Ladner Gervais, LLP, Ottawa, Ontario, for the applicant;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents.

This judicial review application was heard at Ottawa, Ontario, on June 23, 2010, by Crampton, J., of the Federal Court, who delivered the following reasons for judgment and judgment, dated July 8, 2010.