FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Court Upholds Invalidation of Eli Lilly’s Axiron Patents

Nov. 30, 2017

The Federal Circuit upheld a decision invalidating Eli Lilly’s patent on the testosterone drug product Axiron.

Last year’s lower court opinion sided with the generic defendants — including Perrigo, Watson, Lupin and Actavis, who Lilly had sued for patent infringement. However, the lower court also found that Amneal infringed two other Lilly patents. The Federal Circuit upheld both findings.

On appeal, Lilly argued the lower court improperly reached an early decision of obviousness and treated its secondary considerations “as an afterthought.” However, according to the Federal Circuit, the drugmaker failed to prove the non-obviousness of the patents.

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