Mylan N.V., a global pharmaceutical company, announced that the US Patent and Trademark Office (PTO) has instituted an inter partes review (IPR) proceeding on all claims against a third Copaxone 40 mg/ml patent, US patent number 8,969,302, owned by Yeda Research & Development Company Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.
The patent relates to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg/ml subcutaneous injections of glatiramer acetate per week.
On August 25, 2015, Mylan announced that the PTO instituted IPR proceedings against two related Copaxone 40 mg/ml patents, US patent numbers, 8,232,250 and 8,399,413, on all claims. The oral hearing for all three IPRs has been scheduled for May 12, 2016.
In August 2014, the US Food and Drug Administration accepted Mylan's abbreviated new drug application (ANDA) filing for a three times per week glatiramer acetate injection 40 mg/ml, the generic version of Copaxone 40 mg/ml Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.
Copaxone 40 mg/ml had US sales of approximately $2.6 billion for the 12 months ending June 30, 2015, according to IMS Health.