On Nov. 26, 2014, Industry Canada announced an important proposed change to the eligibility requirements for listing a patent against a drug in Canada under the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”). The proposed change is a direct response to recent Federal Court cases refusing to list patents against fixed dose combination drugs.
While the proposed amendments have not been issued, Industry Canada’s Notice states that the Regulations “will be amended to address the exclusion of certain pharmaceutical patents from Health Canada’s Patent Register following recent Federal Court and Federal Court of Appeal decisions relating to patents claiming single medicinal ingredients found in combination drugs.” The decisions are believed to be Viiv v Teva, 2014 FC 893 and Gilead v Canada, 2012 FCA 254, each of which held that the listing requirements under the Regulations require a patent to claim the specific combination of medicinal ingredients in a combination drug.
In Viiv, two combination drugs were at issue: KIVEXA (abacavir sulphate & lamivudine) and TRIZIVIR (abacavir sulphate, lamivudine, & zidovudine). Claim 32 of Canadian Patent No. 2,289,753 (the “753 Patent”) claimed abacavir hemisulfate and another medicinal ingredient selected from a defined group. The specification stated that lamivudine was a member of that defined group. But since there were no claims to the exact combinations of medicinal ingredients in KIVEXA and TRIZIVIR, the 753 Patent was held to be not listable against either drug.
Moreover, Claim 2 of Viiv’s 753 Patent claims abacavir hemisulfate alone. Notwithstanding Health Canada’s policy allowing the listing of patents claiming single medicinal ingredients against combination drugs the Court refused to list the 753 Patent. The Minister, in fact, appeared as a party at the hearing supporting Viiv’s argument. The Viiv decision has been appealed to the Federal Court of Appeal.
In Gilead, the drug in issue was COMPLERA (tenofovir, emtricitabine, & rilpivirine). Canadian Patent No. 2,512,475 (the “475 Patent”) included claims to tenofovir, emtricitabine, and a third antiviral agent selected from, inter alia, anon-nucleoside reverse transcriptase inhibitors (“NNRTI”). Although rilpivirine is a NNRTI, the relevant claims did not explicitly refer to rilpivirine and therefore the Federal Court of Appeal held that the 475 Patent was not listable against COMPLERA.
IndustryCanada’s Notice states, “the proposed amendments would confirm established Health Canada practices in relation to the policy intent of the NOC Regulations and clarify the listing requirements as they relate to single medicinal ingredients found in combination drugs.”
Health Canada’s relevant Guidance Document states, “a patent claiming, as a compound, a single medicinal ingredient will be eligible for listing with respect to a drug that contains the said medicinal ingredient in combination with other medicinal ingredients.” As such, it would appear that Industry Canada’s proposed amendment will bring about a welcome change for pharmaceutical innovators.