Mylan N.V., a global pharmaceutical company, announced that the US Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two Copaxone 40 mg/ml patents, US Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.
The patents relate to methods for the treatment of multiple sclerosis through the administration of at least three 40 mg subcutaneous injections of glatiramer acetate over a period of seven days with at least one day between each injection. Mylan also has filed another petition for inter partes review of a related patent (US Patent No. 8,969,302), which the PTO is expected to act upon shortly.
Mylan CEO Heather Bresch commented, "We believe that the patents at question are invalid and are pleased that, in instituting an inter partes review on all claims, the PTO has determined that there is a reasonable likelihood of prevailing on the invalidity assertion. We believe our generic version of Copaxone 40mg/ml represents an exciting first-to-file opportunity for Mylan."
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.