Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Gilead Sciences and patent-partner Roche Holding units have sued Natco Pharma for the infringement of US Patent No. 5,763,483 covering Tamiflu (oseltamivir phosphate) capsules 75 mg.
Subscribe to our email newsletter
Tamiflu is FDA Approved for the treatment of uncomplicated acute illness due to influenza infection in patients one year or older who have been symptomatic for no more than two days and for the prophylaxis of influenza in patients one year or older.
According to the complaint filed by Maryellen Noreika, a lawyer for the plaintiffs, the action arises because of Natco’s efforts to gain approval from the US Food and Drug Administration to market generic copies, while claiming the Gilead patent is not valid.
Gilead, which developed Tamiflu, receives royalties on the drug’s sale from Roche Holding.
Reportedly, Gilead had appealed a federal court in Delaware to block generic versions of Tamiflu until its patent expires in 2017.
However, in February this year, Natco Pharma filed an abbreviated new drug application with US regulators for a generic version of Tamiflu.
Subsequently the India-based generic drug maker sent a notice to Gilead and alleged that its patent on the drug was invalid.