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). This update examines recent developments which impact the accessibility of the 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 that create 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 specificity.” 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 stated purpose of the PMNOC Regulations — 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 by the Minister, which have now been largely accepted by the Federal Court, have resulted in a more restrictive application of the listing provisions.
The Minister has taken the view that it is not enough that a patent claim encompass or cover the medicinal ingredient, formulation, use or dosage form of the commercial product. The claim must also expressly “match” the approved form. The result is that even where a claim would be clearly infringed by a generic copy, the claim would not be listable unless its language precisely matches that of the submission. While such a stringent requirement is not apparent from the language of the PMNOC Regulations, and does not support the purpose of preventing abuse of early working through infringement, the Court recently gave support to this strict interpretation.
In the context of a patent where the claims listed one approved medicinal ingredient in the formulation/dosage form and the commercial product contained two medicinal ingredients, the Court held that the Minister did not err in not listing the patent, given that “precise and specific matching” is required. (Purdue Pharma v. Canada 2011 FCA 132; 2010 FC 738; see also Bayer Inc. v. Canada 2009 FC 1171). In a later decision, the Federal Court upheld the Minister’s refusal to list claims comprising three approved medicinal ingredients, where two of the three ingredients were explicitly set out in the claims, and the third was clearly encompassed within a class of compounds listed in the claims. (Gilead Sciences Canada Inc. v. Canada 2012 FC 2). Absent the explicit mention of the third medicinal ingredient, the Court held the patent could not be listed. This decision was upheld by the Court of Appeal (2012 FCA 254; leave to appeal to the Supreme Court of Canada denied) which indicated that strict product specificity was required whether the claims related to the medicinal ingredient, formulation, dosage form or use. A similar rationale was applied in respect of formulation and dosage form claims in Novartis Pharmaceuticals Canada Inc. v. Canada 2012 FC 836.
Given these developments, the best approach is to identify the attributes of the potential commercial product and the contents of the regulatory submission at an early stage and draft patent claims which, to the extent possible, precisely match the commercial product. This can be difficult in view of the research and development process and the effect of disclosure on patentability. Nonetheless, absent a clarification in the legislation or the jurisprudence, it is the most effective way to ensure entry through the gateway to the PMNOC Regulations.