Hyderabad-based pharmaceutical and bulk chemicals manufacturer, Natco Pharma Limited, today said the US Patent and Trademark Office (PTO) issued a final office action rejecting Teva Pharmaceutical Industries Limited’s application seeking a reissue of US patent number 5,800,808 (or the 808 patent), which was found to be invalid by the court of appeal for the Federal Circuit in July 2013.
Natco and Teva had been in a patent fight over top-selling multiple sclerosis drug Copaxone. Teva’s Copaxone is indicated for the treatment of multiple sclerosis and had registered a revenue of $4.2 billion in the US during 2013.
Teva’s Copaxone patents expiring in September 2015 were held invalid by a US court in July 2013, making generic entry possible in May this year, when the remaining patents expire.
“The final rejection issued today finds the first claim of the reissue application, which is identical to the only claim in the '808 patent', to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting.