Canada’s PM(NOC) Regulations allow innovative drug manufacturers to list patents on the public Patent Register pertaining to their drug products. This provides a public notice function to potential copycat generic manufacturers of all listed patents that must be addressed or, else the patent expired, before obtaining marketing authorization from the Canadian Minster of Health to market and sell a generic version of the drug in Canada.
When engaging these regulations, innovative drug manufacturers have faced significant opposition to listing patents pertaining to combination drug products (i.e., drug products containing two or more active medicinal ingredients). For example, it has been held that a patent claiming one medicinal ingredient of a combination drug is not eligible for listing for that drug, even though the ingredient is present in the final product.
Canada’s PM(NOC) Regulations have been recently amended to address this problem. Industry Canada deemed the amendments necessary to “restore the intent” of the PM(NOC) Regulations. Nevertheless, the application of the previous version of the PM(NOC) Regulations continues to impede innovator patent protections for combination drug products.
On March 8, 2016, the Federal Court surprisingly granted a summary motion in Gilead v Apotex, 2016 FC 231, which was brought by Apotex in the context of a PM(NOC) case over Gilead’s combination drug product TRUVADA®. Apotex sought and was granted an order dismissing Gilead’s case on the basis that Gilead’s ‘619 Patent was ineligible for listing. The Court held that the patent was ineligible for listing because it failed to specifically claim all medicinal ingredients in the combination drug product. The ruling is based on the previous un-amended version of the PM(NOC) Regulations, as Apotex’s motion was brought prior to the coming into force of the amendments.
The case effectively involved a question of statutory interpretation. That is, whether the transitional provisions of the amended PM(NOC) Regulations could be interpreted as permitting the amendments to apply retroactively. The decision, however, represents the continued application by the Federal Court of the old PM(NOC) Regulations in a manner that contravenes their intended purpose.
As Industry Canada has previously noted, the delisting of patents that fail to claim all medicinal ingredients of a combination drug would “compromise the ability of brand manufacturers to seek protection under the PM(NOC) Regulations for their innovative combination drugs, undermine the balanced interests of brand-name and generic drug producers, and harm consumers, who could be prevented from accessing combination drug products if companies opt to wait until single ingredient drug patents expire before introducing combination drugs to the Canadian market”. While the Court elected to follow prior judicial interpretations of the un-amended PM(NOC) Regulations, it remains to be seen if this reasoning will withstand review in light of the fact that the amendments were made to restore the original intent of the PM(NOC) Regulations.
Section 4 of the PM(NOC) Regulations sets out the criteria for a patent to be added to the Patent Register in respect of a drug that has received a Notice of Compliance. As a consequence of previous judicial interpretations (known as application of the “perfect match” doctrine), patents failing to explicitly claim all medicinal ingredients of a combination drug product were deemed ineligible for listing on the Patent Register. In response to these judicial interpretations, Industry Canada sought amendments to the PM(NOC) Regulations to restore the balance intended by them. Among the amendments, new subsection 4(2.1) was added to clarify the rules that apply when determining the eligibility of a patent to be added to the Patent Register. For example, paragraph 4(2.1)(a) provides that “a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients”. The amendments came into force on June 19, 2015.