INDIA BUSINESS WORLD - DECEMBER 16^th - DECEMBER 31^st - 2007

ASTRAZENECA DENIED PATENT FOR ANTI-ULCER DRUG

In another setback for AstraZeneca, the Indian patent office has turned down the company's patent application for a new formulation of anti-ulcer drug Omeprazole, reports Khomba Singh from New Delhi. This is the UK company's third major patent rejection in India in the recent times. The Delhi patent office has rejected the application few months back as the formulation did not prove enhanced therapeutic efficacy to the existing product of the company. Ahmedabad-based Torrent Pharma's had filed a pre-grant opposition to AstraZeneca's claim for a patent of the new formulation. When contacted, an AstraZeneca spokesperson said, "The company's patent application 1354/DEL/98 (a new omeprazole formulation) has been rejected by the Indian patent office based on the section 3(d) of the Indian Patents Act." The Torrent Pharmaceutical spokesperson was not available for comment. Although, AstraZeneca can ask for a review of the ruling, the company has not made such a request so far, sources said. Patent attorneys who track status of pharma patents said the application for the new formulation was rejected as it failed to fulfil the section 3(d) criteria of the Patents Act, which says that incremental innovations can be granted to patents only if they have significantly enhanced therapeutic efficacy. Omeprazole is one of the best selling drugs of Astrazeneca and is marketed by the company under the brand name Losec and Prilosec worldwide. Leading Indian companies such as Ranbaxy Laboratories, Dr Reddy's Laboratories, Cipla and Zydus Cadila among others have been marketing the generic copies of Omeprazole in India for many years now. The UK company had filed the application seeking patent for a new combination in 1998 at the Delhi patent office.