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Teva loses patent protection on lucrative MS treatment

pharmafile | August 25, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Copaxone, Mylan, Teva, multiple sclerosis 

Teva’s stock plunged 3% after a US agency ruled that two of its patents related to multiple sclerosis drug Copaxone (glatiramer acetate) were invalid.

Mylan had petitioned the US Patent Trial and Appeal Board for four of Teva’s patents relating to Copaxone to be removed. The agency is scheduled to issue a final decision on the third patent by September 1st, while one patent invalidation claim was turned down.

The drug generates around $4 billion a year in revenue for Teva, or 20% of their overall revenue. These patents specifically cover administering the drug in a 40-milligram dosage three times a week, and were due to expire in 2030.

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The under-fire Mylan believes that, because it brought the case, it will receive 180 days of marketing exclusivity upon regulatory approval. CEO Heather Bresch calls the ruling “comprehensive, well-reasoned and highly persuasive to detailing the bases for the invalidity.”

Teva, however, has indicated that it will appeal the decision. This, however, may engage the courts in a lengthy process.

CEO Erez Vigogman says: “We are prepared to defend the full suite of our intellectual property through the PTAB and the US courts regardless of the time required.”

Sean Murray

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