Source : Business Today, April 29, 2015
On April 23, while speaking at a three-day Global Exhibition of Services in New Delhi, Prime Minister Narendra Modi made a statement that intrigued many in the Indian pharmaceutical industry.
Though he spoke in Hindi, what he said was to the effect that “India must also work on intellectual property rights guidelines to match global standards.” So the obvious question is, what are these global standards?
Even experts are not sure. “India already complies with the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). So is being TRIPS-compliant not good enough?” asks Shamnad Basheer, a member of the first panel set up by the government on Intellectual Property law last year and a former professor of IP law at the West Bengal National University of Juridical Sciences.
He feels there is clearly no consistency and transparency regarding what the government is planning to do on the IPR front. This has spread a false notion that India is not globally compliant on intellectual property issues, despite being TRIPS-compliant. Plus, the fact that the government has not put out its new IPR policy, which was supposed to be out early this year, only adds to the confusion. Result: there is now a fresh guessing game in industry circles on what the government actually plans to do on the IPR front.
One leading industry representative saw in the PM’s statement “a clear signal to bureaucracy not to resist TRIPs Plus measures such as Patent Linkage, Data Exclusivity, Dilution of Section 3(d) and Declaration of No-use of compulsory license.”
These have all been pain points for the global pharma industry. Global pharma (read: some of the US drugmakers) have three major problems with India’s patent law-Section 3(d) and Section 84 of the Indian Patents Act, and absence of a period of exclusive marketing rights when a new drug gets regulatory approval.
Under Section 3(d), new forms of existing medicines can’t be patented unless they improve therapeutic efficacy. It was under this provision that India rejected a patent for Glivec, a cancer drug.
Section 84 allows issuing a compulsory licence to meet the reasonable requirements of the public at a reasonably affordable price. A compulsory licence can also be granted under Section 92 of the Act in case of a national emergency. Natco Pharma got a compulsory licence, the first ever in India, for generic Nexavar under Section 84. Multinational drug-makers say Section 84 narrows the criteria for patentability and undermines incentives for innovation.
In fact, the situation has not changed from January this year when concerns were raised on this matter just after US President Barack Obama’s visit to India.