Actavis loses Atelvia patents

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Actavis loses Atelvia patents

Generics/News | Posted 27/03/2015 0 Post your comment

Teva Pharmaceutical Industries (Teva) has won a legal battle against Actavis after a federal judge invalidated two patents protecting the post-menopausal osteoporosis drug Atelvia (risedronate sodium delayed-release tablets, 35 mg). Actavis acquired Atelvia in 2013 when it bought Irish drugmaker Warner Chilcott [1], which continues to produce the drug as an Actavis subsidiary.

A New Jersey district court judge ruled that claims on two of Atelvia’s patents (‘459 and ‘460) were invalid because they would have been obvious for other drugmakers to try.

‘We are disappointed in today’s ruling and strongly disagree with the court’s decision,’ said Mr Brent Saunders, CEO and President of Actavis in a statement from the company. ‘We are reviewing the decision and will evaluate all available options to defend our intellectual property rights on Atelvia, including an appeal.’

In June 2014, Actavis/Warner Chilcott settled challenges from Ranbaxy Laboratories, Amneal Pharmaceuticals and Impax Laboratories in deals that allowed for generics entry in 2025, several years before the last of Atelvia’s patent protection runs out in 2028. Teva’s successful bid might now move up generics entry from those firms if their infringement settlements included provisions permitting marketing if another firm began marketing the drug first.

The shoe was on the other foot earlier in March 2015 when Actavis was sued by Uceris for infringing patents protecting their drug for ulcerative colitis, Uceris (budesonide) [2]. New drug application holder Santarus and patent owner Cosmo wish to prevent Actavis from marketing a generic version of their drug until all six of its patents expire.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Actavis makes definitive agreement with Warner Chilcott [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: www.gabionline.net/Pharma-News/Actavis-makes-definitive-agreement-with-Warner-Chilcott
2. GaBI Online - Generics and Biosimilars Initiative. Drug companies seek to block generic version of ulcerative colitis therapy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from: www.gabionline.net/Generics/News/Drug-companies-seek-to-block-generic-version-of-ulcerative-colitis-therapy

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Source: Reuters, Actavis, Law360