Patented Medicines (Notice Of Compliance) Listing Update

Listing a patent on the Patent Register maintained by the Minister of Health is the gateway through which an innovator gains access to the provisions of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Any person seeking to market a generic copy of a pharmaceutical product in Canada, in respect of which a patent is listed, must address the infringement and/or validity of that patent or await its expiry. There is an opportunity for the innovator to seek an order from the Federal Court prohibiting the Minister from issuing a Notice of Compliance (NOC) to the generic on the basis that allegations of non-infringement and/or invalidity are not justified. As this exercise is conducted prior to generic entry, it can prevent disruption of the marketplace. Conversely, in a patent infringement action, given the absence in Canada of effective injunctive relief, the generic entrant will often have access to the market over the course of the action. If the Minister refuses to list a patent on the Register at the time of submission for listing, the innovator is deprived of any opportunity to seek the preliminary determination under the PMNOC Regulations.

Recently, the Minister of Health has taken a more restrictive view of which patents are "relevant" for the purposes of the PMNOC Regulations. This change was precipitated by amendments to the PMNOC Regulations in 2006 to clarify the types of submissions which would engage an opportunity to list a patent. There was a concern that a patent might be listed for virtually any type of regulatory submission or change, leading to the listing of patents with no relevance to the product approved by the submission. To address this concern, the listing provisions were amended to require what the government termed "product specifi city." Generally, the amendments require that, where a particular medicinal ingredient, formulation, use or dosage form is approved, the patent listed in respect of the submission must contain a claim to the approved medicinal ingredient, formulation, use or dosage form.

In principle, the amendments are consistent with the purpose of the PMNOC Regulations, which is the prevention of the abuse of the "early working" exception to patent infringement. This exception permits the marketer of a generic product to use the patented invention to speed up its regulatory approval. However, recent interpretations of the "product specificity" requirement in positions taken...