Fortunat Nadima Nadima

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Federal Court upholds patent validity and issues declarations of infringement against two generic apixaban tablets

In one of its first patent decisions of 2021, the Federal Court tackled arguments regarding the relevant date for insufficiency allegations and the level of disclosure required for demonstrated utility. The Court resolved these and other issues in the patentees’ favour, granting declarations of infringement against two proposed apixaban generics. Background ELIQUISTM (an blood thinner) … Continue reading

Prosecution history cannot be invoked against patent licensees

The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in the context of a formulation patent. Background The Court’s decision concerns Canadian Patent No. 2,507,002 … Continue reading

FCA gives guidance for common PM(NOC) trials involving multiple actions

The Federal Court of Appeal has reversed the Federal Court’s decision to add two additional generic defendants (Taro Pharmaceuticals Inc. and Sandoz Canada Inc.) to an upcoming common trial under the Patented Medicines (Notice of Compliance) Regulations. The common trial will determine patent validity issues in Bayer Inc.’s actions against Teva Canada limited and Apotex … Continue reading

Quebec maintains drug evaluation activities for listing purposes and launches clinical trials

In this post, the Pharma in Brief team reports on two recent developments in the Quebec regulatory landscape related to the COVID-19 crisis. Adjustments to submission procedure for applications for listing of innovative drugs and blood products on formulary On April 6, 2020, Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) issued … Continue reading
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