Eligibility for Supplementary Protection: The Federal Court of Appeal Considers the Issue for the First Time
In Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71, the Federal Court of Appeal opined on the Certificate of Supplementary Protection Regulations, S.O.R./2017-165 ("CSP Regulations") for the very first time.
At issue before the Court was GSK’s 905 Patent (CA 2,600,905), expiring in 2026. The 905 Patent claims an immunogenic composition that includes an antigen, an adjuvant, and certain excipients, along with uses of the composition. Pursuant to the Patent Medicines (Notice of Compliance) Regulations ("PMNOC Regulations"), the 905 Patent was previously found eligible for listing on Canada’s Patent Register (similar to the US's Orange Book) in respect of drug submissions relating to SHINGRIX, a vaccine against shingles.
GSK applied for a certificate of supplementary protection ("CSP"), which would, if issued, extend the 905 Patent's expiry date by a maximum of two years. GSK’s CSP application was denied by the Minister of Health on the grounds that the 905 Patent did not pertain "to a medicinal ingredient, or combination of medicinal ingredients" – one of the threshold eligibility requirements established in section 106 of the Patent Act.
The Minister found that the 905 Patent was ineligible for a CSP because it did not include one of the eligible types of claims listed in subs. 3(2) of the CSP Regulations. The Minister also found that the adjuvant recited in the 905 Patent's claims was not a medicinal ingredient for the purposes of a CSP.
GSK sought judicial review before the Federal Court, urging the Court to adopt a broader definition of "medicinal ingredient". GSK argued that the adjuvant should be considered a medicinal ingredient under the Patent Act and CSP Regulations because it has some biological activity. GSK also argued that the 905 Patent pertained to a combination of medicinal ingredients in accordance with section 106 of the Patent Act . The Federal Court agreed with GSK and set aside the Minister’s decision. The Minister appealed to the Federal Court of Appeal.
The Federal Court of Appeal reviewed the Minister’s decision and found it reasonable. In detailed reasons, the Court’s analysis and decision offer guidance on three key topics:
- What types of patents are eligible for supplementary protection under the CSP regime?
- What is a "medicinal ingredient" for the purposes of a CSP?
- How does the CSP regime fit with Canada’s other drug-regulatory frameworks?
Eligibility Under the CSP Regime
The Court provided a detailed overview of the CSP regime and its various underlying policies. As the Court noted, the CSP regime was implemented pursuant to Canada’s commitments under CETA (the Canada-European Union Comprehensive Economic and Trade Agreement). The regime establishes sui generis rights: an additional period of protection for a drug containing a new medicinal ingredient, or a new combination of medicinal ingredients, that is protected by an eligible patent.
In 2017, the Patent Act was amended to create a framework for the issuance and administration of certificates of supplementary protection; this new CSP framework is found in sections 104-134 of the Act. The CSP Regulations specify and define timelines, eligibility, and other requirements practically needed to implement the regime.
Among other things, a patent's eligibility for a CSP depends on the subject matter of its claims. As outlined in subs. 3(2) of the CSP Regulations, a patent must contain at least one claim for a medicinal ingredient or combination of medicinal ingredients (even if defined by a specific process) or a use thereof, in order to be assessed for CSP eligibility. Notably, among the eligible patent claim types identified in subs. 3(2) of the CSP Regulations, there is no mention of a claim directed to a formulation. For CSP eligibility, a patent must also pertain to a new medicinal ingredient or new combination of medicinal ingredients, meaning one for which there has been no previous notice of compliance.
In support of its CSP application, GSK argued that the adjuvant in SHINGRIX provides biological activity, and that the composition claims of the 905 Patent define a combination of two medicinal ingredients: antigen + adjuvant. It was not disputed in the case that the antigen, which induces an immune response in a human to prevent shingles, could not act properly in the absence of the adjuvant. The Minister disagreed with GSK on two counts: (1) The Minister reiterated Health Canada’s position that an adjuvant is not a medicinal ingredient, even if it has biological activity, because it merely improves, but does not itself induce, the specific cellular and immune response induced by the antigen. (2) The Minister noted that the 905 Patent claimed a composition containing both medicinal and non-medicinal ingredients, and, therefore, defined an ineligible formulation.
The Court upheld the Minister’s decision on the basis that it was reasonable to conclude in the circumstances that the adjuvant was not a medicinal ingredient:
The Minister adopted a reasonable interpretation of the words "medicinal ingredient" and made a scientific determination that in this case, the adjuvant was not in fact a medicinal ingredient because it had no independent therapeutic effect on the body; thus the Minister’s decision was based on a legal and scientific position backed up by the consistency between the medicinal ingredient listed in the NOC issued under the Food and Drug Regulations, the medicinal ingredient referred to in the application for a CSP and the Patent Act (para. 70) [emphasis added].
As the Court noted, the Minister's finding was consistent with GSK’s own actions. For example, GSK's new drug submission for SHINGRIX and its subsequent CSP application identified the antigen as the sole medicinal ingredient in the vaccine. In none of its regulatory submissions did GSK present the vaccine as a combination of two medicinal ingredients: the antigen and the adjuvant. Furthermore, in the information submitted to establish that SHINGRIX was an innovative drug and eligible for data protection under the Food and Drug Regulations, GSK identified a sole medicinal ingredient – the antigen; it did not identify SHINGRIX as a combination drug (i.e., one with at least two medicinal ingredients).
After considering the definitions of "claim for the formulation" and "claim for the medicinal ingredient" in the PMNOC Regulations, the Court upheld the Minister's conclusion that the 905 Patent claimed a formulation, not a medicinal ingredient or combination of medicinal ingredients "as such" or per se. As the Court noted, the composition claims of the 905 Patent recite non-medicinal ingredients besides the adjuvant. Therefore, the subject matter of the invention, as defined by the claims, was not confined to the medicinal ingredient alone, as para. 3(2)(a) of the CSP Regulations requires ("a claim for the medicinal ingredient"). It is interesting that the Court addressed this issue after first considering whether the adjuvant qualified as a "medicinal ingredient". Given the recitation of other non-medicinal ingredients in the claims of the 905 Patent, the question of claim type (formulation vs. medicinal ingredient(s) per se) seems sufficient to dispose of the overarching question of CSP eligibility in this case.
Relationship to Other Regulatory Frameworks
Aside from shedding light on the meaning of "medicinal ingredient", the Court’s reasons also highlight some of the differences in eligibility requirements for the key regulatory regimes at the IP/drug-regulatory interface in Canada: data protection for innovative drugs, listing on the Patent Register under the PMNOC Regulations, and certificates of supplementary protection. In particular, this case highlights the more limited categories of patent claims supporting CSP eligibility.
Although claims to formulations can, in some circumstances, provide a basis for Patent Register eligibility, they do not support a CSP. Accordingly, while a patent may be eligible for inclusion on the Patent Register under the PMNOC Regulations, and a drug protected by the patent may qualify as an innovative drug, neither guarantees that the patent will also be eligible for a certificate of supplementary protection.
For more information, please contact the McCarthy Tétrault Intellectual Property Litigation or Intellectual Property groups in Toronto.