India will keep its ‘national interest’ in mind while framing its new intellectual property rights (IPR) policy and not work under pressure of any country, Commerce and Industry Minister Nirmala Sitharaman has said.

Reacting to the US Trade Representative’s Special 301 report that placed India yet again on the ‘priority watch list’ of countries with an “unfavourable” IPR regime, the Minister said India would continue to engage with the US on the issue, but with its own specific interests in mind.

“We are engaging because we are confident of our position. We have all the relevant data in hand with which we can show upfront what is in our national interest,” Sitharaman told BusinessLine .

While the Special 301 report for 2015 appreciated India’s increased engagement with the US on IPR, it warned that ultimately, it should translate into substantive and measurable action.

“In many areas, IPR protection and enforcement challenges continue, and there are serious questions regarding the future of the innovative climate in India, across multiple sectors and disciplines,” the report said.

The report said the US continues to have concerns about Section 3(d) of India’s Patent Act, which disallows patents for incremental innovations. Earlier this year, the patent application of US-based Gilead for its Hepatitis B drug was rejected by India’s patent office on the grounds that it had no additional efficacy based on this particular section.

“Section 3(d) may have the effect of limiting the patentability of potentially beneficial innovations,” the report said.

In sync with global norms

The Minister contended that India’s patent laws were in line with international norms. “India believes in a strong patent regime. We are compliant with international standards,” she said.

However, Sitharaman added she was happy that the US had given its suggestions to the think-tank drafting the IPR policy, which includes highlighting its concerns on Section 3(d).

“Our think-tank has formulated its final version (of draft policy) taking all inputs it received in view.”

India has been fighting attempts at ever-greening of patents by global pharmaceutical companies as it could go against the interests of its thriving generic (off-patent drugs) industry and prevent its population from accessing cheap life-saving medicines.

Generic advantage

On the US allegation that India was a hotbed for counterfeit drugs, Sitharaman said she would not comment on the charge, but pointed out that the good quality of the country’s generic medicines have been time and again recognised by the US Food and Drug Administration (USFDA). “If there is one sector that has got approval repeatedly from the USFDA, it is the bulk drugs producers in India,” she said.

The Minister said the final draft of the IPR policy will be sent to the Union Cabinet for approval after inter-ministerial consultations are over. Interested parties could keep sending additional comments and suggestions till then, she added.