Teva patent on multiple sclerosis drug invalidated
02 Sep 2016
A US agency yesterday invalidated Teva Pharmaceutical's patent on its top-selling multiple sclerosis drug, Copaxone. The development comes as another reverse in Teva's bid to block generic versions of a drug that accounted for 20 per cent of its revenue.
The Patent Trial and Appeal Board backed Mylan NV and Amneal Pharmaceuticals LLC as it ruled that the patent covering the drug's thrice-weekly dosage should not have been issued in the first place.
The company appealed to the board to review the decision, and also petitioned an appeals court that specialised in patent law.
The board had earlier held two other patents regarding the dosage invalid. According to commentators, the company could find it harder to keep away generic-drug challengers to the medicine given that it generated $4 billion in 2015 sales, with $3.3 billion of it in the US.
Teva had five patents that are set to expire in 2030 covering 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, started facing generic competition last year.
Teva spokeswoman Doris Saltkill said in a statement that the company would appeal the ruling in the US Court of Appeals for the Federal Circuit in Washington.
She added that Teva would defend all the Copaxone patents no matter how long it took.
Mylan chief executive Heather Bresch said the company was challenging the patents to market a more affordable generic alternative of Copaxone.
After its 20mg Copaxone started facing generic competition last year, Teva switched patients 40 mg to retain dominance of the multiple sclerosis market. The company said 78 per cent of Copaxone prescriptions were now for the 40 mg version.
Meanwhile, a bench trial over Copaxone, involving several generic manufacturers, would begin in federal court in Delaware later this month.
