Proposed PMNOC Regulations amendments published for comment following dismissal of Viiv appeal re: listing claim for medicinal ingredient against fixed-dose combination

by Nancy Pei

As we previously reported, Viiv's application against Teva for a prohibition Order regarding a combination product containing abacavir and lamivudine, Viiv's KIVEXA, was dismissed by a prothonotary 2014 FC 328, which decision was upheld on appeal 2014 FC 893. The patent explicitly claimed only abacavir, and contained no claim for the combination of abacavir and lamivudine. Citing the Federal Court of Appeal's decision in Gilead Sciences Canada v Minister of Health, 2012 FCA 254 ("Gilead"), the Prothonotary held that "the medicinal ingredient or formulation approved in the NOC [notice of compliance] must 'match up' and be claimed in the patent sought to be listed." As the patent claimed only one of the active ingredients, she held it was not eligible for listing. Viiv's further appeal to the Federal Court of Appeal was dismissed on April 15, 2015: ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93, finding the Federal Court correctly concluded that Gilead applies to the facts of the case.

In short order, on May 2, 2015, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (Bilingual PDF) were published to clarify the intent of the Governor in Council. The deadline for comments is June 1, 2015.

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