Natco Pharma and its partner Alvogen said they have settled a patent infringement suit with Gilead Sciences Inc and others over Tamiflu oral capsules (Oseltamivir phosphate), 30 mg, 45 mg and 75 mg, in a New Jersey District court.
“Under the terms of the settlement, Natco’s partner Alvogen will be able to market the Oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA’s Orange Book for US Patent No 5,763,483, which is 23 February 2017,” Natco said in a statement. Following the announcement, Natco Pharma shares shot up by 2.88%, at R547.50, on BSE.
In 2011, Natco had challenged Gilead’s patent on Tamiflu, alleging that Gilead’s patent on the drug is invalid.
Tamiflu was developed by Gilead, which receives royalties on the drug’s sale from Roche Holding. Tamiflu is used in the prevention and treatment of influenza A and B viruses, including swine flu and has a market size of around $500 million in the US. Natco and Alvogen had filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (USFDA) for generic versions of Tamiflu oral capsules 30 mg, 45 mg and 75 mg. The USFDA granted tentative approval to Natco for the generic Oseltamivir phosphate capsules on March 14, 2014.
In March 2015, the US Supreme Court has denied a writ of certiorari for the generic version of Tamiflu oral capsules filed by Gilead Sciences Inc against Natco Pharma. This means that the Supreme Court agreed with Natco and denied petition for certiorari on generic Tamilflu patent. A writ of certiorari is an order of a higher court to a lower court to send all the documents in a case to it so the higher court can review the lower court’s decision. Gilead owns two nearly identical patents on antiviral compounds and has accused Natco’s planned generic Tamiflu infringement.
Meanwhile, Natco Pharma also said that it is the first company in India to get approval for generic Daclatasvir Dihydrochloride tablets.