martes, 13 de agosto de 2019

Amgen wins a lawsuit ... yet again

The Readout
Damian Garde

Amgen wins a lawsuit ... yet again


Amgen, the law firm with a drug-making side gig, scored another big legal victory. Late Friday, a federal judge in New Jersey ruled in Amgen’s favor in a lawsuit brought to defend the validity of two patents covering the blockbuster psoriasis drug Enbrel. The defendant in the case was Sandoz, the generics arm of Novartis, which was trying to launch a biosimilar version of Enbrel.

The ruling means Sandoz can’t start selling its Enbrel biosimilar in the U.S. until 2029, instead of 2021, which would have been the case had the judge decided against Amgen. Enbrel was first approved in 1998 and its original patent expired in 2012, but a thicket of subsequently filed (and granted) patents has protected the antibody drug from domestic biosimilar competition. Sandoz’s Enbrel biosimilar was approved here three years ago, but still sits on a shelf.

Enbrel accounts for about one-fifth of Amgen’s total revenue, so the ruling means the drug will continue to deliver meaningful cash flow for an additional eight years. Enbrel sales are still falling each year, but thanks to Amgen’s lawyers — and a New Jersey judge — those sales will decline slower than they could have.

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