US patent office invalidates 2 patents of Teva's blockbuster drug Copaxone

The Hyderabad-based Natco Pharma Ltd has announced that the US Patent and Trademark Office (PTO) has ruled in favour of its marketing partner, Mylan, in a case pertaining to patent protection case of Teva’s Copaxone 40 mg dosage injection, a multiple sclerosis drug. The US agency has invalidated two of the patents, protecting Copaxone (glatiramer acetate), of the three that are being challenged by Mylan at the PTO’s Patent Trial and Appeal Board (PTAB). A decision by the PTAB on Mylan's third petition seeking review of US patent is expected on or before September 1, 2016.

“Natco’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for a three times per week glatiramer acetate injection (40 mg/mL) and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval,” said Natco in a press statement. 

Copaxone (40 mg/mL) had US sales of approximately $ 3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.

While the original version of Copaxone, consisting of 20 milligrams (mg) taken every day, is facing generic competition since last year, Teva had obtained patent, which expires in 2030, for its three times a week version (ie Copaxone 40 mg). This has been challenged by Mylan.