US Patent Office invalidates two patents covering Teva's Copaxone

The US Patent Office on Wednesday ruled that two patents covering Teva's multiple sclerosis drug Copaxone (glatiramer acetate) are not valid. Shares in Teva fell as much as 6.3 percent on the news, while shares in Momenta Pharmaceuticals jumped as much as 11.3 percent. 

The patents in question, which expire in 2030, cover the thrice-weekly formulation of Copaxone, which was authorised in the US in 2014. Mylan launched challenges against the two patents last year, while an additional challenge against a third patent was initiated shortly after. 

Commenting on the ruling, Mylan CEO Heather Bresch stated "we believe the Board's decision is comprehensive, well-reasoned, and highly persuasive in detailing the bases for the invalidity of Teva's 40 mg patents, and we look forward to further demonstrating the invalidity of the patents covering Copaxone 40 mg/ml."  Meanwhile, Teva spokeswoman Denise Bradley said that the company would appeal the decision.

The three-times-a-week version of Copaxone amassed about $3.3 billion in revenue over the 12 months ended June 30. Analysts estimated that generic competition could decrease Copaxone revenue by as much as $3.2 billion by 2019. 

The FDA accepted Mylan's application in August 2014 seeking approval of a generic version of the three-times-a-week version of Copaxone. In the same month, Momenta disclosed that the agency accepted a submission by partner Novartis also requesting marketing authorisation for a generic version of the drug.

 

 

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