The US Patent Trial and Appeal Board ruled on Thursday that a third patent protecting Teva's thrice-weekly version of the multiple sclerosis drug Copaxone (glatiramer acetate) is not valid. The decision follows an appeal filed last year by Mylan, alongside Amneal Pharmaceuticals which also petitioned the patent.
The US patent office invalidated two other patents protecting thrice-weekly Copaxone last week also in response to a challenge by Mylan. Meanwhile, Mylan's appeal regarding the validity of a fourth patent protecting the drug was rejected, although a challenge submitted by Amneal remains under review. Teva was awarded a fifth patent for the therapy in August.
Commenting on the news, Aude Gerspacher of Bloomberg Intelligence noted that Teva only needs one patent to survive challenge in order to fend off generic competition for thrice-weekly Copaxone. Analysts have estimated that generic competition could reduce sales of the drug by as much as $3.2 billion by 2019.
Teva received US approval for the three-times-a-week formulation of Copaxone in January 2014. Mylan's application seeking authorisation for a generic version of the drug was accepted for review by the FDA in August 2014, whith Momenta Pharmaceuticals also announcing that the agency accepted a submission by partner Novartis seeking approval of a generic version of the treatment.
For related analysis, see ViewPoints: Teva loses IP battle on Copaxone – MS drug is going, going, but not gone yet.
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