Purdue Pharma v. Canada (Attorney General) et al., (2011) 417 N.R. 223 (FCA)

• Judge: Blais, C.J., Layden-Stevenson and Stratas, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: March 29, 2011
• Jurisdiction: Canada (Federal)
• Citations: (2011), 417 N.R. 223 (FCA);2011 FCA 132

Purdue Pharma v. Can. (A.G.) (2011), 417 N.R. 223 (FCA)

MLB headnote and full text

Temp. Cite: [2011] N.R. TBEd. AP.042

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

(A-288-10; 2011 FCA 132)

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

Federal Court of Appeal

Blais, C.J., Layden-Stevenson and Stratas, JJ.A.

April 14, 2011.

Summary:

Purdue Pharma filed a new drug submission in relation to the drug TARGIN and received a notice of compliance. TARGIN contained oxycodone hydrochloride and naloxone hydrochloride. Purdue's Canadian Patent No. 2,098,738 was listed on the register with respect to its OXYCONTIN drug, which contained oxycodone as the only medicinal ingredient. The Minister of Health determined that Purdue's patent in relation to TARGIN was ineligible for listing on the patent register. Purdue applied for judicial review. It claimed that the Minister erred by misinterpreting s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations.

The Federal Court, in a decision reported at 371 F.T.R. 215, dismissed the application. The Minister 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. Purdue appealed.

The Federal Court of Appeal dismissed the appeal. Although the judge erred in importing the legislative requirements of s. 4(2)(c) into his construction of the patent, he did not err in dismissing Purdue's application for judicial review. The product specificity requirement of s. 4(2)(c) required a matching between: (1) the claim for the dosage form; and (2) the dosage form that had been approved through the issuance of a notice of compliance. Purdue's TARGIN drug did not meet the matching requirement.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court of Appeal considered and applied the analytical framework developed for the determination of the eligibility of a patent for listing on the basis of a new drug submission - The framework consisted of three questions and could be adapted or reformulated in accordance with the particular nature of the claim - In the case of a dosage form claim, the questions were: (1) what dosage form did the patent claim; (2) what was the dosage form approved by the existing notice of compliance; and (3) was the dosage form claimed by the patent that which was approved by the existing notice of compliance - The product specificity requirement of s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations underlay the analysis of question three - That was primarily what this case was about - See paragraphs 11 to 14.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Minister of Health determined that Purdue Pharma's Canadian Patent No. 2,098,738 was ineligible for listing on the patent register maintained under the Patented Medicines (Notice of Compliance) Regulations - Purdue's application for judicial review was dismissed - On appeal, Purdue asserted that the judge, having accepted its expert as a person skilled in the art, erred in favouring the Minister's interpretation since Purdue's evidence "is the only evidence before the Court relating to construction" - The Federal Court of Appeal held that there was no error warranting its intervention - First, "[i]n the context of patent listing, expert evidence regarding the construction of a patent claim is permissive, but not obligatory" - Second, the judge clearly considered the evidence of Purdue's expert - Third, the judge was entitled to adopt a construction that differed from that put forth by the parties, or either of them - Fourth, although the judge did not explicitly reject Purdue's expert's opinion, he did so implicitly - Fifth, the evidence of Purdue's expert was not without difficulty - See paragraphs 15 and 16.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Minister of Health determined that Purdue Pharma's Canadian Patent No. 2,098,738 was ineligible for listing on the patent register maintained under the Patented Medicines (Notice of Compliance) Regulations - Purdue's application for judicial review was dismissed - The Federal Court of Appeal agreed with Purdue that the judge impermissibly imported the legislative requirements of s. 4(2)(c) of the Regulations into his construction of the patent - The provisions of the Regulations factored heavily into the judge's conclusion - That approach did not accord with Whirlpool Corp. et al. v. Camco Inc. et al. (2000) (S.C.C.) - The judge erred when he defined and applied the product specificity concept of the Regulations at the claims construction stage of the analytical framework - See paragraphs 17 and 18.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - The Federal Court of Appeal stated that the product specificity requirement of s. 4(2)(c) of the Patented Medicines (Notice of Compliance) Regulations required a matching between: (1) the claim for the dosage form; and (2) the dosage form that had been approved through the issuance of a notice of compliance - In the case at bar, the product specificity requirement was not met - Absent precise and specific matching, the patent was not eligible for listing on the patent register under the Regulations - The requirement for that level of specificity was consistent with the text, the object and the purpose of the Regulations - It was also consistent with the interpretation of the other classes of claims in s. 4 of the Regulations as determined by the court's jurisprudence - See paragraphs 41 to 44.

Words and Phrases

Claim for the dosage form - The Federal Court of Appeal 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 33 to 44.

Cases Noticed:

Wyeth Canada et al. v. ratiopharm Inc. et al., [2008] 1 F.C.R. 447; 370 N.R. 89; 2007 FCA 264, refd to. [para. 2].

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. 2].

Searle (G.D.) & Co. et al. v. Canada (Minister of Health) (2009), 386 N.R. 262; 71 C.P.R.(4th) 389; 2009 FCA 35, refd to. [para. 2].

Bayer Inc. v. Canada (Minister of Health) et al. (2009), 358 F.T.R. 20; 2009 FC 1171, affd. (2010), 405 N.R. 248; 86 C.P.R.(4th) 81; 2010 FCA 161, refd to. [para. 9].

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. 15].

Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc., [2005] 3 F.C.R. 261; 2005 FCA 11, refd to. [para. 16].

Abbott Laboratories Ltd. et al. v. Canada (Attorney General) et al. (2008), 380 N.R. 287; 68 C.P.R.(4th) 445; 2008 FCA 244, leave to appeal refused [2008] 3 S.C.R. v; 392 N.R. 398, refd to. [para. 30].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 36].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 2, sect. 4(2)(c) [paras. 7, 33].

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

Counsel:

James E. Mills and Beverley Moore, for the appellant;

F.B. Woyiwada, for the respondents.

Solicitors of Record:

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

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

This appeal was heard at Ottawa, Ontario, on March 29, 2011, before Blais, C.J., Layden-Stevenson and Stratas, JJ.A., of the Federal Court of Appeal. In written reasons by Layden-Stevenson, J.A., the Court of Appeal delivered the following judgment on April 14, 2011.