The Intellectual Property Appellate Board has rejected pharma major Bayer Corporation’s petition seeking a stay on the compulsory licence granted to Hyderabad-based Natco Pharma Ltd.

The Controller of Patents had on March 9 granted the first-ever compulsory licence to Natco Pharma to manufacture sorafenib tosylate, a generic version of Bayer’s expensive anti-cancer drug used in the treatment of liver and kidney cancer.

The Indian patent law allows grant of compulsory licence to an applicant if the patented drug is not available to the public at a reasonable price.

Bayer had obtained a patent in India in 2008 for its chemotherapy drug Nexavar, which costs Rs 2.80 lakh for a pack of 120 tablets, equivalent to a month’s dosage. Natco has been asked to sell the drug at Rs 8,800 for a pack.

According to the licence conditions, Natco has to pay six per cent royalty to Bayer from its net sale and manufacture.

Appeal dismissed

Bayer appealed against the Controller’s order before the appellate board and sought a stay on its operations. Among other reasons, it cited the fact that Cipla has started selling its generic version at a lower price, rendering the compulsory licence unnecessary as the drug was available at a reasonable price to the public. It sought a stay of the Controller’s order.

Dismissing the stay petition, the Board, comprising its Chairman, Justice Prabha Sridevan, and member D. P. S. Parmar, said in the order passed on Friday that, “if stay is granted, it will jeopardise the interest of public who are in the need of the drug. The appellant has not made out any case for granting a stay.”

The grant of licence to Natco created ripples in the pharmaceutical industry across the globe. One group felt that it would help generics makers provide affordable drugs to the needy, while felt that it would affect innovation.

In its petition, Bayer said that Cipla was selling its product ‘Soranib’ at a maximum retail price of Rs 6,840 for one month’s treatment, thereby creating an overall anti-competitive environment.

Bayer also argued that its drug was made available at Rs 30,000 to patients who cannot afford the drug at its original price, based on the recommendation of the treating oncologist.

Rejecting Bayer’s contention, the Board said: “The appellant cannot ride piggy-back on or take shelter under the sale by Cipla. It is the duty of patentee that its own supply be made available at reasonable price to the requirement of the public.”

“Selling at Rs 2.80 lakh can by no stretch of imagination satisfy the requirement of the public,” PrabhaSridevan said. Bayer’s main appeal is still pending.

Dismissing another miscellaneous petition of Bayer, the Bench declined to go into the merits of its allegation that Natco was exporting the drug to Pakistan and China, noting that the allegation was denied.

(This article was published on September 15, 2012)
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