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14 May 2007
Sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations came into force on October 5 2006 (for further details please see "Amendments to Linkage and Data Protection Regulations").
In general, these regulations protect innovators from patent infringement by prohibiting Health Canada from issuing a notice of compliance to a generic manufacturer (allowing it to market a generic version of a drug in Canada) until it has addressed patents relating to the drug listed on the Patent Register. This usually leads to a court proceeding involving issues of patent validity and infringement.
In order for an innovator to have a patent listed on the Patent Register, a patent list including the patent must be submitted to Health Canada. The regulatory submission to which it relates is filed at the same time or within 30 days of issue of the patent. No extensions of time are available for filing a patent list. In addition, a patent is eligible for listing only if its Canadian filing date precedes the filing date of the related regulatory submission. The Canadian filing date is the actual date of filing the application in Canada, and not the Paris Convention priority filing date. In the case of a patent issuing from an application originally filed under the Patent Cooperation Treaty (PCT), the Canadian filing date is the PCT filing date. These timing requirements are unchanged by the recent amendments.
The timing requirements apply to all regulatory submissions that may support a patent listing, including new drug submissions and supplemental new drug submissions for a change in formulation, dosage form or use. Therefore, it is critical that innovators coordinate patent filings and regulatory submission filings so that an opportunity for patent listing is not missed.
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 (firstname.lastname@example.org).
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