Natco, partner settle patent suit over Gilead’s Tamiflu

Natco Pharma and its partner Alvogen on Monday said they have settled a patent infringement suit with Gilead Sciences Inc and others over generic version of Tamiflu oral capsules (Oseltamivir phosphate) in a New Jersey District court.

The dispute relates to Oseltamivir phosphate 30 mg, 45 mg and 75 mg.

Natco had, in 2011, challenged Gilead's patent on Tamiflu, alleging that Gilead's patent on the drug is invalid.

Natco Pharma and Alvogen had partnered on the first Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration for generic versions of Tamiflu oral capsules (oseltamivir phosphate). FDA had granted tentative approval to its generic oseltamivir phosphate capsules on 14 March 2014.

''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.

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.

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 almost identical patents on antiviral compounds and has accused Natco's planned generic Tamiflu infringement.

Meanwhile, Natco Pharma today announced that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand Harvoni. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies.

Natco will price its generic medicine, Hepcinat LP, at an MRP of Rs25,000 for a bottle of 28 tablets. Natco was the first licensed company to launch the generic version of this combination drug earlier in Nepal. Natco had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of Harvoni, in 100 other developing countries in addition to India.