Canada: Amendments To The Patented Medicines (Notice Of Compliance) Regulations Now In Force

On June 12, 2008, amendments to the Patented Medicines (Notice of Compliance) Regulations (commonly referred to as the "PM(NOC) Regulations") came into force. The amendments are designed to address the impact of the recent Federal Court of Appeal decision in Ratiopharm Inc. v. Wyeth and Wyeth Canada (the Wyeth decision).¹

The PM(NOC) Regulations create the regulatory framework for pharmaceutical patents to be listed on Health Canada's Patent Register. In October 2006, the PM(NOC) Regulations were amended to significantly change the patent listing eligibility requirements for patent lists submitted after June 17, 2006 (the "2006 date"). Patents included on earlier filed patent lists (referred to as "grandfathered patents") were to remain subject to the listing requirements applicable before the 2006 date. In making the decision to grandfather those patents, the government noted the potential unfairness of subjecting listed patents to new eligibility requirements, as well as the possibility of market disruption and investment uncertainty.

Contrary to the government's intention to grandfather previously listed patents, the Wyeth decision re-interpreted the pre-2006 date listing requirements, in effect, bringing them more into line with the amended requirements. Whereas before the 2006 date, patents were listed generally against a drug, rather than against the specific drug submission for which the patent list was submitted, the Wyeth decision imposed a requirement for relevance between the invention claimed in the patent to be listed and the regulatory submission to which the patent list is related.

To address the impact of the Wyeth decision, the amendments in force as of June 12, 2008, prohibit the Minister of Health from deleting from the Patent Register patents included on patent lists submitted before the 2006 date, subject to only a few common-sense exceptions (i.e., if a patent has expired or has been declared invalid, if the drug for which a patent is listed is no longer marketed or if a court has determined that the patent is ineligible for listing under section 6(5)(a) of the PM(NOC) Regulations).

Similarly, the amendments prohibit the Minister from refusing to list a patent included on a patent list submitted before the 2006 date solely on the basis that the patent is not relevant to the regulatory submission to which the patent list relates. The prohibitions on delisting/refusing to list patents apply equally for patents submitted with new drug submissions and supplements to new drug submissions.

The amendments also make an important change in the context of litigation under the PM(NOC) Regulations. In particular, a generic drug manufacturer can no longer bring a motion asking a court to dismiss an innovative drug manufacturer's prohibition application solely on the basis that a grandfathered patent does not meet the listing requirements in effect before the 2006 date.

The amendments also contain transitional provisions that provide a limited period for an innovative drug manufacturer to request listing of a patent that was deleted from or refused listing on the Patent Register solely because it was not relevant to the regulatory submission to which the patent list related. The request must be made within 30 days of the date that the amendments come into force (i.e., by July 14, 2008²). The Minister then has 30 days to add to the Patent Register patents that are the subject of a request.³ Note that patents added to the Patent Register as a result of this process need not be addressed by a generic drug manufacturer that has already filed a submission for a notice of compliance before such addition. Nor do the amendments limiting the ability of generic drug manufacturers to bring summary dismissal motions apply to motions brought before April 26, 2008.

Innovative drug manufacturers will want to act quickly to request relisting of patents deleted from or refused listing on the Patent Register on the basis of the Wyeth decision because of the short-term remedies afforded by the transitional provisions. Expeditious requests will also minimize the risk that submissions for generic drug approvals will be filed in the interim. Requests for listing of deleted/refused patents must be filed by July 14, 2008, but again, we recommend that such requests be made as soon as possible.

Footnotes

1. 2007 FCA 264.

2. July 12, which is 30 days from date the amendments come into force, falls on a Saturday, thereby making the relevant date July 14, 2008.

3. In the case of patents delisted from the Patent Register, relisting must be done within 30 days of receipt of a request; in the case of patents refused listing, listing must be done within the later of 30 days of receipt of a request and issuance of the NOC for the regulatory submission in respect of which the request for listing was made.

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