Digests

paTEnTS

Practice

Judicial review of Office of Patented Medicines and Liaison (OPML) decision finding applicant’s patent ineligible for listing on patent register—Applicant receiving notice of compliance (NOC) for Targin, controlled-release drug in tablet form containing two medicinal ingredients: (1) oxycodone, (2) naloxone—Although patent contemplating delivery of oxycodone, none of claims mentioning naloxone—Requirements for listing patents making claim to formulation containing medicinal ingredient, dosage form of drug or drug formulation containing medicinal ingredient, set out in Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations), ss. 4(2)(b),(c)—OPML, following reasoning in Bayer Inc. v. Canada (Minister of Health), 2009 FC 1171, affd 2010 FCA 161, contending that under Regulations, s. 4(2)(b), eligible patent must contain claim to formulation containing all medicinal ingredients included in formulation approved by NOC—Applicant arguing OPML misinterpreting s. 4(2)(c) in relation to drug’s dosage form—Contending ss. 4(2)(b), 4(2)(c) not having same meaning, therefore s. 4(2)(c) not requiring claim to dosage form contain both medicinal ingredients in Targin—Court not agreeing with such interpretation—Regulations, s. 2 defining “claim for the dosage form”—Plain reading of this definition making it clear Regulations, s. 4(2)(c) not devoid of any requirement relating to medicinal ingredient—Recognizing potentially unlimited number of other medicinal ingredients within claim’s scope inconsistent with requirements of product specificity enshrined in Regulations, s. 4 by 2006 amendments—Keeping product specificity in mind, claim concerning delivery system for administering multiple medicinal ingredients in drug or drug formulation must include each medicinal ingredient—OPML correctly determining that claim’s dosage form only relating to oxycodone as sole medicinal ingredient, correctly interpreting Regulations, ss. 2, 4(2)(c) as requiring match between dosage form claimed, dosage form approved through issuance of NOC—Application dismissed.

Purdue Pharma v. Canada (Attorney General) (T-248-10, 2010 FC 738, Crampton J., judgment dated July 8, 2010, 27 pp.)