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Cancer drug to be produced cheaply in India, as ruling breaks Bayer's monopoly

Mahesh Kumar A / AP

An Indian Pharmacologist examines the reaction of cytotoxic drugs on a mouse inside a containment facility of the Research and Development Centre of Natco Pharma Ltd. in Hyderabad, India, on March 13. India effectively ended Bayer's monopoly on a patented cancer drug Monday, licensing a much cheaper generic under a unique law aimed at keeping costs affordable. In a decision likely to upset Western pharmaceuticals, the patent office approved Natco Pharma Ltd.'s application to produce the kidney and liver cancer treatment sorefinib.

Mahesh Kumar A / AP

An Indian Pharmacologist removes mice from cages to study the reaction of cytotoxic drugs, inside a containment facility of the Research and Development Centre of Natco Pharma Ltd. in Hyderabad, India, on March 13.

Reuters -- India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say.

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

Krishnendu Halder / Reuters

A pharmacologist checks the toxic reaction on a swiss albino inside the bio safety cabinet at Natco Research Center in the southern Indian city of Hyderabad, on March 13. India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say. On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.

"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

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Mahesh Kumar A / AP

An Indian scientist works inside a laboratory of the Research and Development Centre of Natco Pharma Ltd. in Hyderabad, India, on March 13.