In our October 2006 issue of IP Perspectives, we reported on sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations which came into force on October 5, 2006. 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: at the same time the regulatory submission to which it relates is filed; or, within 30 days of patent issuance. There are no extensions of time available for filing a patent list. Also, a patent is only eligible for listing 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.
These timing requirements apply to all regulatory submissions that may support a patent listing, which include new drug submissions and supplemental new drug submissions for a change in formulation, dosage form or use.
For innovators, it is therefore critical that patent filings and regulatory submission filings be coordinated so that an opportunity for patent listing is not missed.
For more detailed information regarding the amendments to the Regulations, please see the October 2006 Special Edition of our pharmaceutical newsletter, Rx IP Update.