Federal Appeal

Industrial and Intellectual Property

Product specificity requirement set high threshold of consistency

This was appeal of dismissal of application for judicial review. Appellant filed new drug submission (“NDS”) seeking approval of drug for treatment of HIV infection. Appellant submitted patent for listing on patent register. Issue was whether patent was eligible for listing on patent register in respect of NDS where medicinal ingredients claimed in patent did not match up with those in NDS. Respondent Minister refused to list patent on patent register as it did not meet requirements of s. 4(2)(b) of Patented Medicines (Notice of Compliance) Regulations (Can.). Appellant applied for judicial review. Judge dismissed application. Appeal dismissed. Claims at issue in patent were for new combination of medicinal ingredients so eligibility of patent for listing depended on requirements of s. 4(2)(a) of Regulations, not s. 4(2)(b). Relevant claims in patent did not meet requirements of s. 4(2)(a), as they lacked strict product specificity with respect to three medicinal ingredients listed in NDS. Both Minister and judge failed to give sufficient weight to requirement that formulations contained non-medicinal ingredients. Definition of formulation in Regulations was clear and must contain both medicinal and non-medicinal ingredients. Patent failed under s. 4(2)(a), as relevant claims consisted of chemically stable combinations of medicinal ingredients. Product specificity requirement set high threshold of consistency. Medicinal ingredients must be set out in patent claims and NOC for patent to be eligible on register. Patent claims failed requirement for product specificity under s. 4(2)(a), as they did not make specific reference to medicinal ingredient but only to broad class of compounds.

Gilead Sciences Canada Inc. v. Canada (Minister of Health) (Oct. 9, 2012, F.C.A., Trudel, Sharlow and Mainville JJ.A., File No. A-44-12) Decision at 214 A.C.W.S. (3d) 940, 101 C.P.R. (4th) 240 was reversed. 222 A.C.W.S. (3d) 500.

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