Teva sues five companies for alleged Copaxone infringement

Israeli pharmaceutical company Teva has, in one single filing, accused five generic drug makers of infringing a patent covering its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Teva has targeted Dr Reddy’s Laboratories, Mylan, Sandoz, Synthon and Amneal in the complaint, filed at the US District Court for the District of Delaware last Friday (April 10).

The five companies had all filed Abbreviated New Drug Applications (ANDAs) seeking approval from the US Food and Drug Administration (FDA) to make and sell generic versions of the three times weekly formulation of Copaxone.

The FDA approved three times weekly Copaxone, which has a strength of 40mg/ml, in January 2014.

In its complaint, Teva accused the defendants of infringing US patent number 8,969,302, which covers three times weekly Copaxone, and is due to expire in August 2030.

The Yeda Research and Development Company owns the ‘302 patent, and licenses it exclusively to Teva.

Patent ‘302 is one of the three patents listed for the Copaxone 40mg/ml in the Orange Book, each of which are also due to expire in August 2030.

According to the complaint, the named defendants also at different times filed ANDAs in relation to the other two Copaxone 40mg/ml patents. Teva subsequently sued each of the companies at the same court. Those cases are pending.

In this case, Teva has asked the court for a judgment that the ’302 patent is valid and enforceable, and that each of the defendants have infringed the patent.

It also asked that the FDA does not approve any generic 40mg/ml glatiramer acetate product made by the defendants before the ‘302 patent expires, for a permanent injunction stopping the companies from infringing the patent, and for damages.

According to Teva, in 2014 sales of Copaxone in both dosage forms reached more than $4.2 billion.