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ARTICLE · 15 SEPTEMBER 2020

Federal Court Invalidates Tadalafil Dosage Patent Finding Dose Selection To Be Routine

On August 6, 2020, the Federal Court issued its decision in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2020 FC 816, invalidating Eli Lilly's patent, Canadian Patent No. 2,371,684 ...

CanadaIntellectual Property

On August 6, 2020, the Federal Court issued its decision in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2020 FC 816, invalidating Eli Lilly's patent, Canadian Patent No. 2,371,684 (the 684 Patent) directed to low doses of tadalafil, on the grounds of both anticipation and obviousness. The decision was a major victory for Osler's long-time client Mylan Pharmaceuticals ULC (Mylan) and followed a common invalidity trial across multiple proceedings involving Eli Lilly and generics Mylan, Apotex, Teva, Pharmascience and Riva. Mylan had earlier succeeded in respect of the 684 Patent in a proceeding under the Patented Medicines (Notice of Compliance) Regulations (Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 125). 

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