The Supreme Court of Canada has dismissed Gilead's application for leave to appeal the decision of the Federal Court of Appeal (Gilead Sciences Canada Inc. v. Canada (Minister of Health) 2012 FCA 254), involving the eligibility of a patent for listing on the Patent Register in relation to a combination drug product.
On October 9, 2012, the Federal Court of Appeal dismissed Gilead's appeal of the lower court decision and upheld the Minister of Health's finding that Canadian Patent No. 2,512,475 (the "'475 Patent") was ineligible for listing on the Patent Register against COMPLERA, on the ground that the claims did not meet the specific formulation requirements set out in paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance) Regulations. The Court of Appeal decision highlights the requirement for consistency between patent claims and the drug's Notice of Compliance ("NOC"), and has potentially important consequences for innovative drug manufacturers.
In 2010, Gilead filed a New Drug Submission ("NDS") for COMPLERA. The drug product, which is used for the treatment of HIV, contains three medicinal ingredients: tenofovir, emtricitabine, and rilpivirine. The '475 Patent, among others, was submitted for listing on the Patent Register against COMPLERA. However, the patent was found by the Minister to be ineligible for listing because it did not contain a claim specifically naming all of the medicinal ingredients included in the NDS. Instead, the '475 Patent contained claims directed to tenofovir, emtricitabine, and a third antiviral agent selected from a class of agents known as non-nucleoside reverse transcriptase inhibitors. Rilpivirine is a member of this class. Gilead sought judicial review of the Minister's decision.
On review, Mosley J. of the Federal Court held that the Minister had correctly determined that the patent was ineligible for listing on the register. Mosley J. applied paragraph 4(2)(b) of the Regulations and concluded that the strict product specificity requirement, with regards to formulations, was not met in this case. The Court held that the claimed formulation and the approved formulation did not match precisely, and on this basis, dismissed Gilead's application for judicial review. Gilead appealed.
At the Court of Appeal, the majority determined that the '475 Patent was not directed to a formulation on the ground that the definition of formulation in the Regulations clearly indicates that both medicinal and non-medicinal ingredients must be contained therein. Instead, the '475 Patent was found to fall under paragraph 4(2)(a) because it was directed to a new combination of chemically stable medicinal ingredients. The Court affirmed the need for product specificity between the patent claims and the NOC for the approved drug as a key requirement for a patent to be considered eligible for listing on the register. The Court of Appeal ultimately dismissed Gilead's application for judicial review, finding that the relevant claims in the '475 Patent lacked strict product specificity with respect to the medicinal ingredients listed in the NDS.
The Supreme Court's dismissal of Gilead's application will have important consequences for manufacturers of innovative combination drug products. It appears that in order for a patent to be eligible for listing on the register against a combination product, the patent claims must contain specific references to all medicinal ingredients in the combination. This suggests that patents with claims directed to a single medicinal ingredient may not be eligible for listing against a product with multiple medicinal ingredients on the basis that the patent claims do not specifically correspond to the combination drug product. This also appears to go against Health Canada's Guidance on the Regulations (PDF), which provides that a patent claiming a single medicinal ingredient is eligible for listing with respect to a drug that contains the medicinal ingredient in combination with other medicinal ingredients.
 Paragraph 4(2)(a) of the Regulations states that a patent is eligible to be added to the register if the patent contains "[…] a claim for the medicinal ingredient […]". [Emphasis added]
 Paragraph 4(2)(b) of the Regulations states that a patent is eligible to be added to the register if the patent contains "[…] a claim for the formulation that contains the medicinal ingredient […]". [Emphasis added]