Indian firm gets anti-cancer drug rights

In what may heat up the intellectual property battle space the Controller of Patent in India has given legal rights to an Indian pharmaceutical company to manufacture and sell an expensive anti-cancer drug originally made and patented by German major Bayer.

The decision, once implemented, is likely to cheer up thousands of liver and kidney cancer patients who would not be able to access the therapy because of its prohibitory cost.
Bayer sells it at a price of Rs 2.8 lakh per month, which means an yearly expense on the anti-cancer drug Nexavar would be Rs 33.65 lakh.

On the contrary, Hyderabad-based Natco Pharma agreed to sell it at a price of Rs 8,880 for a pack of 120 tablets required for one month’s treatment. Natco will pay royalty to Bayer, which will be 6 per cent of net sales of the drug in every quarter.

After hearing lawyers from both sides, the Controller of Patents in Mumbai, gave non-exclusive right to Natco, which cannot transfer it to other drug manufacturers. Natco will also have to give the medicine free of cost to 600 needy and deserving patients every year.

Bayer’s arguments to protect its intellectual property did not cut ice with the patent controller who held that “patented invention was not available to the public at a reasonably affordable price.” The multinational was also found guilty of  failing in its duty to ensure that the medicine was available in sufficient and sustainable quantities within India.

The patent controller took the umbrage at the “compulsory licensing” provision of the patent law that gives the government legal authority to allow someone else to produce a patented product or process without the consent of the patent owner.

Though India earned global fame because of supplying generic HIV drugs to the world, those manufacturing happened at a time when there was no product patent in India. The product patent regime kick started in 2005 after which this is the first case of compulsory licensing.

“This decision marks a precedent that offers hope. It shows new drugs under patent can also be produced by generic makers at a fraction of the price, while royalties are paid to the patent holder. This compensates patent holders while at the same time ensuring that competition can bring down prices,” said Tido von Schoen-Angerer, one of the top officials of Nobel Prize winning non-governmental organisation, Médecins Sans Frontière.

The patent controller’s decision, however, could be challenged in patent appellate authority in Chennai and subsequently in the High Court.

A spokesperson from Bayer said: “We are disappointed by the decision of the Patent Controller in India to grant a compulsory licence to Nexavar. We will evaluate our options to further defend our intellectual property rights in India.”