Cipla opposes Roche flu patent

Cipla, which is all set to produce and stockpile internationally patented bird flu drugs in the wake of a possible outbreak of the disease in the country, is planning to challenge the patent applications filed by the multinational companies - Roche and Gilead - for Oseltamivir, the avian flu drug currently marketed by Roche as Tamiflu, in India.

The patent applications for Oseltamivir are learnt to be in the patent mailbox in India and the publication of the same is awaited.

Yusuf K Hamied, chairman and managing director, Cipla, said that the company will file a pre-grant opposition challenging the patentability of this drug in India once it is published by the Patent Office. "Since the patent to Oseltamivir is a border-line case and still debatable, we will study the applicants' claims and prepare for the opposition," he said.

"There is no clarity over Gilead's first patent on Oseltamivir," he said, adding that while considering the fact that the date of invention of the original molecule and the applicability of the same as per the current Indian Patent Law, the government should not grant a patent to this drug in the country.

Since the drug is not yet granted a patent in the country, nobody can stop any generic manufacturers from producing it in the country. So Cipla is readying for the production of Oseltamivir as well as Zanamivir (invented by Biota and marketed by Glaxo SmithKline as Relenza) in India.

The company is currently in the process of preparing bioequivalence studies and will get necessary approvals from the regulators in due course, he added.

Cipla will make the drug available to Indian patients, as well as the patients in all the least developed countries, where there is no patent regulation yet, at the time of a health emergency, Hamied said.

"Cipla's move is a part of its commitment to India and it is the same with any other poor country which cannot afford the high drug prices fixed by multinational companies who enjoy a monopoly in the name of patent protection," he said.

In India, healthcare is in a state of perpetual crisis as the disease profile is frightening here," he said.

He added that India needs a permanent compulsory licensing system without monopoly as the companies are ready to pay royalty to innovator companies as they respect patents for intellectual property.