and
Beverley Moore
OTHER CASES OF INTEREST
PMPRB Requires Generic Company to Report
In the Matter of ratiopharm Inc.
Drugs: ratio-Omeprazole, ratio-Ketorolac, ratio-Brimonidine, ratio- Paroxetine, ratio-Cefuroxime, ratio-Lamotrigine, ratio-Acyclovir, ratio-Ramipril, ratio-Diltiazem, ratio-Simvastatin, ratio-Sertraline, ratio-Quetiapine, ratio-Fenofibrate and ratio-Tamsulosin
The main issue in this proceeding involved the definition of "patentee" as it pertains to the requirement to report to the Patented Medicines Prices Review Board (PMPRB). ratiopharm does not hold any patents. However, it is authorized to sell certain medicines in Canada by the holders of the patents. The Board held that ratiopharm must file Form I information with respect to twelve drugs at issue. Regarding two additional drugs, the Board ordered ratiopharm to produce further documentation.
The Board held that s. 79(1) of the Patent Act refers to both persons entitled to the benefit of the patent and to persons entitled to exercise rights in relation to the patent. In the case where the person entitled to the benefit of a patent grants another person the right to sell the medicine, that second person is entitled to exercise rights in relation to the patent regardless of whether the agreement between the parties disclaims the actual granting of patent rights. This exercise of rights is the ability to sell the medicine and arguably claim damages for infringement of the patent.
The Board held that the references to "medicine" in the Patent Act are clear and apply equally to patentees whether they be in the brand name pharmaceutical industry or the generic pharmaceutical industry.
OTHER INDUSTRY NEWS
The Supreme Court of Canada will issue its decisions on Thursday, July 14, 2011, regarding whether to grant leave to Apotex (34084) and the Canadian Generic Pharmaceutical Association (34085) in their Applications for Leave to Appeal the Federal Court of Appeal's decision dismissing their challenges to the Data Protection Regulations (summarized here).
Industry Canada published Electronic Commerce Protection Regulations in Part I of the Canada Gazette. Comments are due within 60 days of the publication of the notice.
Health Canada opened a Consultation on the Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q11: Development and Manufacture of Drug Substance.
Comments are due by September 30, 2011.
About BLGThe content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.