Indian court dismisses Teva’s bid to block Copaxone generic

The Delhi High Court has  dismissed Teva’s action to stop Hyderabad-based Natco Pharma from marketing a generic version of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Teva holds the Indian patent 190,759, which covers a method for making the drug, and made $4.3 billion from sales of Copaxone last year. The remaining US patents covering the drug are due to expire in May 2014.

Teva sought a permanent injunction against Natco in 2007 to keep it from selling its own glatiramer acetate drug, also known as copolymer-1, under the mark “Glatimer” or any other mark.

It alleged that Natco’s use of the “well-known process” to manufacture copolymer-1 in India infringed Teva’s patent. It also filed to restrain Natco and its partners from exporting the product outside India.

Natco made a counterclaim, arguing that Teva’s patent is invalid due to lack of novelty.

In a February 28 decision, Justice S Muralidihar said that the court did not “consider it necessary to deal with any of [the parties’] applications”, and dismissed the case.

“We are very pleased with the decision by the New Delhi High Court to dismiss and take no action in this matter,” Natco said.

“We continue to believe that the sole Indian process patent is invalid, as reinforced by the outcomes of numerous other legal proceedings. We also are pursuing other challenges against this patent.”

Natco added that the Indian Patent Office refused to grant two additional patent applications that would have covered the copolymer-1 product.

In July last year, the US Court of Appeals for the Federal Circuit invalidated one of Teva’s Copaxone patents.

Teva did not respond immediately to a request for comment.

The Delhi High Court will hold another hearing on Teva’s action, including a petition to invalidate the ‘759 patent, on March 5.