New Delhi, March 12: India has for the first time exercised its legal right to arm-twist pharmaceutical companies to make available expensive, patented medicines at a lower cost, allowing the generic manufacture of a cancer drug owned by a foreign company.
The controller of patents, Mumbai, has granted Natco Pharma, a Hyderabad-based company a compulsory licence for generic manufacture of sorafenib tosylate, a drug used to treat advanced stages of liver and kidney cancer, patented by German company Bayer.
The Bayer product is sold in India at Rs 2.8 lakh per month, while Natco has declared in its application for a compulsory licence that it would sell its generic version for Rs 8,800 per month, according to documents submitted to the controller.
"The drug is exorbitantly priced and out of reach of most... people," P.H. Kurian, the Controller of Patents observed in his ruling delivered on Friday.
India's patent laws, revised in 2005, introduced product patents on medicines, but they contain a provision, Section 84, under which compulsory licences for generic manufacture can be granted in public interest either because a patented medicine is not accessible or not affordable.
Kurien has granted Natco a compulsory licence for the right to manufacture and sell sorafenib tosylate exclusively in India, and only for patients suffering from liver or kidney cancer, and under commitments that the generic product would be given free to at least 600 needy patients per year.
Natco will have to pay a royalty fixed by the patents controller to Bayer.
Sections of pharmaceutical industry executives have claimed in the past that compulsory licensing is intended to ensure sufficient drug supply during epidemics and not to reduce the prices of medicines. But this has been challenged by public health activists campaigning for access to generic drugs.
"We are disappointed by the decision of the patent controller to grant a compulsory licence," a spokesperson for Bayer in Mumbai said today. "We will evaluate our options to further defend our intellectual property rights in India."
A global cancer survey has estimated that India has about 20,000 cases of liver cancer and 8900 cases of kidney cancer each year. Sorafenib tosylate helps extend the lives of patients in advanced cancer -- by six to eight months in liver cancer, by four to five years in kidney cancer.
"We're very, very happy with this landmark ruling," said Yogendra Sapru, chairman of the Cancer Patients Aid Association, a Mumbai-based non-government organisation that helps patients unable to afford cancer treatment. "The inexpensive drug will offer a lifeline to patients with advanced liver and kidney cancer. In advanced cancer, even a few extra months of life can make a big difference to patients and their families," Sapru told The Telegraph.
Health activists say this is the first time that India's revised patent law has been used to allow generic production of a medicine unaffordable to vast sections of its population. Bayer has the right to appeal against the decision and take its arguments into court.
"This ruling could open up avenues for similar action on other expensive medicines used to treat other cancers or illnesses," said Shailly Gupta, advocacy officer with Medecins Sans Frontieres, an international agency that procures inexpensive generic drugs from India for developing countries.
Bayer had informed the patents controller that the company was willing to introduce a patient assistance programme under which the drug would be offered at a price of Rs 30,000 per month, under a 1+6 scheme in which a patient pays for one month, and would get six months' drug supply free, or a similar 2+10 scheme. The company had proposed that it would supply the drug to poor patients if oncologists certify that they cannot afford the treatment.
Sections of the pharmaceutical industry have in the past argued that the enormous investments in research and development needed to discover and develop drugs have made many new medicines relatively expensive.
Bayer and its collaborators continue to invest funds into research on sorafenib, including its possible use in other cancers such as breast cancer and lung cancer, according to documents with the patents controller.
Since 2007, Bayer's cumulative research spending has touched $8 billion. The company's worldwide sales of the drug touched $934 million during 2010, after sales of $843 million in 2009, according to the documents.