Industry Canada has sponsored proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”) that broadens the eligibility to list patents on the Patent Register. These amendments are a direct response to the “perfect match” doctrine recently endorsed by Canadian courts. They reaffirm Health Canada’s long-standing practice regarding patent listing. In so doing, Industry Canada is seeking to restore the balance between innovators and their generic competitors as intended by the PM(NOC) Regulations.
Notice of the proposed amendments were published in a Regulatory Impact Analysis Statement (the “RIAS”) published May 2, 2015 in the Canada Gazette Part I (Vol. 2, No. 18). As noted in the RIAS, Health Canada has for many years interpreted the PM(NOC) Regulations as permitting patents to be listed that contain a claim for a medicinal ingredient on the Patent Register in respect of any approved drug that includes that medicinal ingredient, including combination drugs comprised of two or more medicinal ingredients. This practice was recently struck down in two decisions of the Federal Court and Federal Court of Appeal. The courts construed the PM(NOC) Regulations to require a “perfect match” between the claims and the corresponding submission as a requirement for listing. For combination claims, this required each medical ingredient in the submission to be explicitly claimed.
Industry Canada has indicated that this is a purely judge–made rule. The RIAS confirms that the interpretation in both the Gilead and ViiV decisions was “inconsistent with the policy intent of the PM(NOC) Regulations”, to allow the listing of patents that claim at least one of the medicinal ingredients contained in an approved combination drug, and noted that the “policy intent of the PM(NOC) Regulations is reflective of the realities of the drug development process”, referring to the fact that innovators often seek to create novel combination drugs without intending to forgo the benefit of protection under the PM(NOC) Regulations.
The RIAS notes that listing patents on the Patent Register “is perhaps the most important step to allow brand manufacturers to protect their patented drugs”. As the RIAS further explains, refusing to list patents claiming only one/some of the medicinal ingredients in 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”.
Amongst other revisions, the proposed amendments include:
- Medicinal Ingredients: Patents containing a claim for “the medicinal ingredient” are eligible for listing in respect of a submission that contains that medicinal ingredient in combination with other medicinal ingredients (new ss. 4(2.1)(a));
- Formulation: Patents containing formulation claims can be listed even where the formulation does not claim all of the non-medicinal ingredients specified in the submission (new ss. 4(2.1)(b)); and
- Use: Patents containing claims for the use of a medicinal ingredient are eligible to be added to the register if the submission includes the use claimed in the patent, regardless of whether the submission in respect of which the patent is sought to be listed includes additional medicinal ingredients, additional uses, or the use requires the use of the medicinal ingredient in combination with another drug (new ss. 4(2.1)(c)).
Transitional Provisions and Coming Into Force
The amendments will attempt to address past problems. The amendments provide that previous listing denials to list, or patent removals from the Patent Register, may be reconsidered within 30 days following the coming into force of the section.
The RIAS provides that interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of the notice, with the coming into force scheduled for the day on which the amendments are registered (yet to be determined),