On October 9, 2012, the Federal Court of Appeal issued its decision in Gilead Sciences Canada Inc. v. Canada (Minister of Health), which has further limited the eligibility for listing a patent on the Patent Register maintained by the Minister of Health pursuant to the Patented Medicines (Notice of Compliance) Regulations (the "Regulations").
This decision arose from an appeal by Gilead Sciences Canada Inc. ("Gilead") from a judgment of Justice Mosley of the Federal Court dated January 3, 2012 (Gilead Sciences Canada, Inc. v. Canada (Minister of Health), 2012 FC 2). Justice Mosley had dismissed Gilead's application for judicial review of the Minister of Health's refusal to list Canadian Patent No. 2,512,475 (the "'475 Patent") on the Patent Register in respect of Gilead's New Drug Submission for the drug COMPLERA®, which is now approved in Canada for the treatment of HIV.
COMPLERA® is a combination drug that includes three active pharmaceutical ingredients: tenofovir disoproxil fumarate, emtricitabine and rilpivirine. The patent at issue had both combination and formulation claims to the combination of tenofovir disoproxil fumarate, emtricitabine and a third antiviral agent. The claims further specified that the third antiviral agent could be a non-nucleoside reverse transcriptase inhibitor (NNRTI). It was undisputed that rilpivirine is an NNRTI.
Both the Minister of Health and Justice Mosley had considered whether the '475 Patent was eligible for listing under paragraph 4(2)(b) of the Regulations, which relates to claims to formulations. The Federal Court of Appeal held that this was an error, as section 2 of the Regulations specifically defines a "claim for the formulation" as a claim to a mixture of both medicinal and non-medicinal ingredients. Since the '475 Patent contained claims which did not refer to non-medicinal ingredients, the Court of Appeal held that the relevant provision was paragraph 4(2)(a), which relates to claims for the medicinal ingredient(s).
This finding could have been a significant victory for Gilead based on a prior Federal Court decision indicating that the "product specificity" requirement under section 4(2)(a) was not as strict as the requirement under paragraphs 4(2)(b) or 4(2)(c) (which relates to claims for a dosage form). Specifically, in Bayer Inc. v. Canada (Health) (2009 FC 1171), the Court noted that Health Canada's Guidance Document for the Regulations stated that a claim that refers to only one medicinal ingredient may be listed against an approved product containing more than one medicinal ingredient. Under this interpretation, the '475 Patent should have been eligible for listing against COMPLERA®, despite not specifically naming rilpivirine in the claims.
However, the Court of Appeal rejected the suggestion that the different paragraphs of subsection 4(2) should be subject to different interpretations in terms of product specificity. Thus, the strict product specificity requirements imposed since 2006 by the Courts and the Minister for formulation and dosage forms claims also applied for claims for a medicinal ingredient.
The Gilead decision represents an extreme example of the strict specificity requirement that has been judicially-imposed since the 2006 amendments to the Regulations, even though this is not required by the amended Regulations. This stringent specificity requirement means that a patentee who does not specifically identify in the patent claims the medicinal ingredients within a drug by name or by chemical structure will not be allowed to list a patent in respect of that drug, even though the medicinal ingredient may be generally encompassed within the scope of the claims. Consequently, a generic company who would necessarily infringe the patent will be permitted to come to market with a generic version of the innovative drug without addressing the patent under the Regulations. This scenario defeats the purpose of the Patented Medicines (Notice of Compliance) Regulations, which is to prevent generic companies from abusing the "early working exception" in section 55.2(1) of the Patent Act by marketing their product during the term of an innovator's patent.
In light of this decision, and barring a favourable Supreme Court of Canada decision or an amendment to the Regulations, innovators will have to keep product specificity in mind when drafting their patents and, if possible, consider amending the claims to reflect their product prior to the patent being issued.
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