India’s move to strip German drug maker 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 licence 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 licence for a cancer drug. Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licences for HIV/AIDS and heart disease treatments.
“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.”
The new wording is seen as a lower threshold for compulsory licences, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licences allow them to authorise the local manufacture or importation of much cheaper, generic versions. Global drug makers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection.