Enoxaparin – USA

Enoxaparin – USA

On Jul. 21, 2017, federal jury handed Amphastar Pharmaceuticals Inc a big win after it was accused of infringing on a patent held by Momenta Pharmaceuticals Inc through its production of a generic version of the blood-thinner Lovenox (Enoxaparin). The verdict by the jury in Boston came in a lawsuit by Cambridge, Massachusetts-based biotechnology company Momenta and Novartis’ unit Sandoz that sought nearly $940 million in damages. The jury found that while Amphastar had infringed Momenta’s patent, it was invalid and unenforceable.

The patent in suit was US, 7.575,886 which claims a method for analyzing enoxaparin. Momenta and Sandoz filed the lawsuit in 2011 after the USFDA approved Amphastar’s generic version of Sanofi’s blockbuster Lovenox, an anticoagulant used to treat and prevent blood clots. Momenta claimed Amphastar infringed its patent covering a method used to confirm the structural signature of Lovenox, known generically as enoxaparin. Momenta, whose generic version Lovenox was the first to receive FDA approval in 2010, claimed Amphastar’s infringement and subsequent sales of its own generic caused it to suffer a significant loss of profits.

Before the trial, the case reached the U.S. Federal Circuit Court of Appeals twice, leading to reversals of an injunction against Amphastar in 2012 and a later ruling granting judgment in Amphastar’s favor in 2015.
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