Generic drugmakers in India reacted in alarm earlier this year on a report that the government had assured the U.S-India Business Council it would take a harder line on compulsory license drug patent challenges.
India's commerce ministry denied the reports, but concern has remained--particularly after Gilead Sciences ($GILD) received Indian Patent Office approval for its blockbuster hep C treatment Sovaldi (sofosbuvir) this month.
However, a review of the National Intellectual Property Rights Policy--passed through the country's cabinet last week--signaled it would continue to see TRIPS, or the Trade-Related Aspects of Intellectual Property Rights, as the bedrock for data exclusivity and patent rules.
“We believe that our existing laws, they are all WTO compliant, and as and when global trends move forward, a continuous evolution of these laws will always be required,” Finance Minister Arun Jaitley told reporters in New Delhi last week.
That affirmation was welcomed by academics and civil society groups such as Médecins Sans Frontières (MSF) concerned that access to low-cost generics in the developing world would be curbed by a stricter take on IP, Live Mint newspaper said--but noted that a hoped-for stronger show of support for aggressive licensing was missing.
“This policy has something for everyone, be it industry, or public, or the US negotiators,” Biswajit Dhar, professor of economics at Jawaharlal Nehru University, told the newspaper.
But Dhar said for generic drugmakers, the language could have championed a national industry at a time that other trade efforts, most notably the Trans-Pacific Partnership (TPP), go well beyond TRIPs on data exclusivity.
Still, one MSF campaigner told the newspaper it is clear the government is not drastically changing policy.
“If you combine the finance minister’s speech and the text of the policy, then it is clear that the government is not going to do anything more than TRIPs and that is really good,” Leena Menghaney, head of the South Asia Access Campaign for MSF told Live Mint, adding the reaffirmation of Section 3(d) of Indian Patent Act of 1970 is key to that.
One concern with Jaitley's statement came from D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, who told the newspaper that the word "evolution" seemed to suggest that if any aspect of IP was changed it would lead to stricter enforcement.
- here's the story from Live Mint