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Teva Loses Decision on Validity of Third Copaxone Patent

  • Mylan, Amneal win patent office ruling on Teva’s MS drug
  • Two other patents were already deemed invalid by U.S. agency

Teva Pharmaceutical Industries Ltd. had a third patent on its top-selling multiple sclerosis drug, Copaxone, invalidated Thursday by a U.S. agency, a further blow to its bid to block generic versions of a drug that accounts for 20 percent of its revenue.

The Patent Trial and Appeal Board sided with Mylan NV and Amneal Pharmaceuticals LLC in ruling that the patent covering the drug’s thrice-weekly dosage never should have been issued. Teva’s next step is to ask the board to reconsider that decision, and to petition an appeals court that specializes in patent law.

The ruling is a further strike against Teva -- the board previously said two other patents regarding the dosage were also invalid. It could make it harder for the company to fend off generic-drug challengers to a medicine that generated $4 billion in 2015 sales, with $3.3 billion of it in the U.S.

Teva has a total of five patents expiring in 2030 that cover ways to administer the drug in a 40-milligram dosage three times a week. The original version of Copaxone, consisting of 20 milligrams taken every day, began facing generic competition last year.

Fourth Patent

A fourth patent was unsuccessfully challenged by Mylan, though a petition filed by Amneal is pending. The fifth patent was issued Aug. 2. All...