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02 October 2006
In Canada the Patented Medicines Prices Review Board has jurisdiction to control pricing of patented medicines. A key issue is whether the board has jurisdiction to control the pricing of a medicine back to the date on which the patent application was laid open.
Although not specifically addressed in the Patent Act, the Patented Medicines Regulations 1994, the board takes the position that it does have such jurisdiction.
Often, at least one patent pertaining to a medicine has issued in Canada by the time the medicine is sold in Canada. The price of the medicine will then immediately fall under the jurisdiction of the board. In a situation where a medicine is sold in Canada before a patent is granted, the medicine falls under board jurisdiction after the patent has issued. The board takes the position that its price review jurisdiction extends retroactively to include the patent-pending period, for which the patentee receives retroactive patent infringement protection.
Therefore, the board may determine that a patented medicine was sold at an excessive price before the patent was issued and make a remedial order back to the laid open date of the underlying patent application. This is despite the recent decision of the Federal Court of Canada in Hoechst Marion Roussel Canada Inc v Canada (Attorney General) (2005 FC 1552).
In Hoechst it was held that the board does not have price control jurisdiction over a pending patent application pertaining to a medicine. However, the patent applications in Hoechst had not issued to patent by the date of the decision. It remains to be seen whether this ongoing practice of the board will come under additional judicial scrutiny in view of the Hoechst decision.
For further information on this topic please contact Daphne C Lainson at Smart & Biggar/Fetherstonhaugh by telephone (+1 613 232 2486) or by fax (+1 613 232 8440) or by email (email@example.com).
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