Patent office found merit in Cipla’s pre-grant opposition against Gilead’s move for Tamiflu.
Cipla, globally renowned for efforts to bring down the prices of AIDS medicines by introducing low-cost variants of patented AIDS/HIV drugs, has won a patent fight against US-based Gilead Sciences on bird flu medicine in India.
The patent office found merit in Cipla’s pre-grant opposition against Gilead’s move to secure patent rights for its Tamiflu (oseltamivir phosphate) and rejected patent protection for the medicine last month.
Patent experts say the ruling emphasises the need to produce more evidence to assert the inventiveness of a product for which patent is being sought.
Swiss drug multinational Roche Scientific has the marketing rights for Tamiflu in the country. The company has sub-licensed its production and marketing rights to Hyderabad-based Hetero in India and other developing countries.
The sub-licence was granted after Roche had to cater to the global demand for oseltamivir in view of the widespread threat of birdflu during recent years. With almost all countries resorting to stockpiling, Roche announced partnerships with regional players. Hetero has built huge capacities to produce oseltamivir in emergencies.
Cipla openly opposed Gilead’s move to secure patent rights and announced its readiness to supply the medicine to 49 countries, including India, if there was an outbreak of bird flu. With the patent office favouring Cipla, the company will not face any legal hurdle now to manufacture the medicine.
A World Health Oganisation (WHO) advisory note asks all birdflu-endemic nations to stockpile the medicine to meet any emergency. While India stockpiled Roche medicines last year, it will have the option to source the cheaper version from Cipla in coming years.
According to sources close to Roche, the rejection of patent to Tamiflu will not have an impact on its marketing prospects as the government is sole procurer of the medicine in the country. Cipla officials were not available for comment. Cipla has got a marketing nod for oseltamivir from Indian drug authorities.
