In this case the Court accepted the Minister’s position that a patent with combination patent claims and formulation claims to a triple medicinal ingredient product was not eligible for listing.
The claims of interest referred to 2 of the 3 medicinal ingredients explicitly: tenofovir disoproxil fumarate and emtricitabine. The third medicinal ingredient as claimed in both formulation and combination compound claims was referred to as an “anti-viral agent”; an anti-viral agent selected from either an HIV protease inhibitor, an HIV nucleoside reverse transcriptase inhibitor, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) or an HIV integrase inhibitor; or, more specifically, an antiviral agent which was an NNRTI. It was acknowledged by the parties and found as a fact that rilpivirine is an NNRTI.
Counsel for Gilead argued that the Minister was incorrect in not listing the patent under s. 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") (which deals with claims to a formulation). Further, the patent was, in any event, eligible under s. 4(2)(a) (which deals with claims to a medicinal ingredient) on the basis that the product falls within the combination compound claims.
The Minister's position was that the relevant claims had to be considered under s. 4(2)(b) as formulations rather than as combinations under s. 4(2)(a), since the NDS was for the approval of a formulation of three active medicinal ingredients in a tablet.
The judge acknowledged that there were formulation and compound claims that made reference to a third antiviral agent. The Judge also accepted that different types of claims are to be construed differently and that the test for listing of claims to compounds under s. 4(2)(a) was not as restrictive as the test for listing formulation claims under s. 4(2)(b), referring to the decision in Bayer Inc. v Canada (Minister of Health), 2009 FC 1171, aff’d 2010 FCA 161. However, the Court went on to accept the Minister’s position that the patent was properly considered for listing under s. 4(2)(b). Applying the Court of Appeal decisions in Bayer and Purdue Pharma v Canada (Attorney General), 2011 FCA 132, the Court found that the failure to explicitly mention rilpivirine in the claim meant that the patent was not eligible for listing under s. 4(2)(b).
The analysis under s. 4(2)(b) alone arguably extends the doctrine of specificity beyond the Bayer and Purdue Court of Appeal decisions. In those decisions, the claims at issue did not even refer to a second medicinal ingredient at all and thus were not listable. The additional language in the claims in this case could have been the basis for a different conclusion by the Court.
A copy of this decision is attached:
