Proposed Amendments to NOC Regulations Change Patent Listing Requirements Established by Federal Court of Appeal

Recently, the Canadian Government proposed additional amendments to the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations"). The amendments remove the requirement that a patent submitted for listing on Canada's patent register before June 17, 2006, must be "relevant" to the submission for a notice of compliance ("NOC") to which the patent list relates. A drug company seeking regulatory approval to sell and market a generic drug in Canada must address the patents listed on the patent register for the innovator's version of that drug. When the Regulations were amended on October 5, 2006, additional requirements were added mandating that patents submitted for listing on Canada's patent register must be relevant to the strength, dosage form and route of administration of the approved drug. In order to ensure that patentees were not disadvantaged with the new and different requirements, a "grandfathering" provision was introduced to ensure that patents submitted for listing prior to June 17, 2006 (the date on which the 2006 amendments were published) remain subject to the listing requirements as they stood prior to the amendments ("grandfathered patents"). Shortly after the 2006 amendments, the Federal Court of Appeal ("FCA") released a decision in Ratiopharm Inc. v. Wyeth and Wyeth Canada, 2007 FCA 264 ("Wyeth"). The FCA held that for a patent submitted for listing prior to June 17, 2006, there must be "relevance" between the invention claimed in the patent and the change to the drug affected by the underlying drug submission for which the patent is listed. In proposing the 2008 amendments, the Government acknowledged that the FCA's interpretation in Wyeth brought the old patent listing requirements closer into line with how the 2006 amended requirements were intended to operate. However, the concern was that this decision might have resulted in many patents submitted in compliance with the listing requirements prior to June 17, 2006, "being deleted from, or not added, to the register" with a resulting sudden and unexpected loss of market exclusivity for a number of innovative drugs. As a result, the Government has now proposed amendments to reverse the effects of the Wyeth decision on the eligibility of grandfathered patents. The proposed changes include the following:

• Prohibiting the Minister from deleting a grandfathered patent from the patent register, subject to certain exceptions.
• Prohibiting the Minister from refusing to add a grandfathered patent to the patent register solely on the grounds that it is not relevant to the submission to which the patent relates.
• Preventing generic drug manufacturers from seeking to have an application for a prohibition order dismissed on the basis that a grandfathered patent is not eligible for inclusion on the patent register.
• Transitional provisions to undo any actions by the Minister in relation to grandfathered patents as a result of the Wyeth decision.

For a copy of the proposed amendments to the NOC Regulations, visit: http://canadagazette.gc.ca/partII/2006/20061018/html/sor242-e.html Summary by: Nicholas Wong