<div><strong>CH Unnikrishnan</strong></div><div> </div><div>With India-US bilateral talks over economic and commercial relationship being scheduled on Monday (28 September) when Prime Minister Narendra Modi meets President Obama, the Indian pharmaceutical industry and healthcare action groups are on their toes as the US side is expected to put pressure for dilution of India’s intellectual property laws.</div><div> </div><div>Although the agenda for the top leaders’ meeting has no mention of intellectual property law in particular, there have been alerts from the industry and commercial bodies from both the sides to take up the issue during the bilateral talk. </div><div> </div><div>A team of US law makers and industry representatives had last week written to the US administration to use the upcoming US-India Strategic and Commercial Dialogue to advocate market-based reforms in India. This included a demand to take up issues such as inadequate intellectual property right protection, forced localisation, non-science-based agriculture barriers and high tariffs for American exports to the Indian market.</div><div> </div><div>Some of the key concerns, that the US industry lobby and trade groups have been raising on India’s intellectual property law, are the absence of data exclusivity for patented drugs and patent linkage for drug approvals in India. But, the Indian drug industry and healthcare groups have time and again cautioned the government about the dangers of these two provisions on the access of healthcare to Indian patients. </div><div> </div><div>Last week, US senate finance committee chairman Orrin Hatch, ranking member Ron Wyden, House Ways and Means chairman Paul Ryan and ranking member Sandy Levin had written to state secretary John Kerry and finance secretary Penny to ensure that there is ample pressure on the Indian government to modify its IP law to reflect the needed changes.</div><div> </div><div>In response to this latter, the local pharmaceutical industry lobby, Indian Pharmaceutical Alliance (IPA), had cautioned the Indian government to take a firm stand in support of its present policy in relation to its IP law, mainly data exclusivity and patent linkages. The IPA, in a letter to industry and commerce minister Nirmala Sitaraman, had prompted the government to take a strong position backing India's IP laws, even by pushing the US to take a look at its own laws concerned with intellectual property rights.</div><div> </div><div>The Indian industries had even earlier raised concerns on the mounting pressure from the US to dilute India’s patent laws.</div><div> </div><div>Indian patent law currently do not allow market exclusivity (patent protection) to drugs, which are extension of known molecules unless they demonstrate higher therapeutics efficacy compared to the earlier version as it would result in frivolous patenting. The local law hasn’t also brought in extended data exclusivity period for drugs and linkage of the patent status to drug approval as it may delay the entry of cheaper generic drugs.</div><div> </div><div>The Indian industry and healthcare groups fear that any dilution in the current law in India as far as intellectual property protection would result in treatment access issues in a country like India where more than 70 per cent of the population still do not have proper access to modern medicines and large majority of the country’s population are still covered by medical insurance. The healthcare action groups including Medicines Sans Frontiers (MSF) and Doctors Without Borders have also raised concerns about India being pressurised to dilute its intellectual property law as it many poor countries who depend on cheaper generic medicines from India may suffer if India grants frivolous patents for drugs and pharmaceuticals.</div><div> </div>
