Several American pharma industry players have raised concerns over India’s patent act particularly Section 3(d), which restricts patents for already known drugs unless the new claims are superior in terms of efficacy.
Hectic parleys are on to get the National National Intellectual Property Rights (IPR) Policy rolled out before Prime Minister Narendra Modi sets foot in the US by the end of this month even as a “much better and improved version” is expected compared to the draft policy.
The policy, which is now awaiting the approval of the Cabinet, is going to be launched after much delay.
The government had made an announcement in September last year that it will be released by February 2015.
However, now that the PM is going to visit US again and will also have a bilateral meeting with President Barack Obama, the government was keen that India should “have something in hand” to show it to them before both leaders met. Intellectual property rights (IPR) has been one such area in the India-US bilateral ties that both have been at loggerheads.
The American firms, especially the pharmaceutical companies, had been extremely critical about India having a lax IPR and patents laws, discriminating them against the domestic firms.
On the other hand, India has maintained that it is in compliance with the global IPR rules under the TRIPS Agreement of the World Trade Organization (WTO).
Obama and Modi are scheduled to have their third bilateral meeting on September 28 in New York.
However, before that both sides are going to hold their first ever Strategic and Commercial Dialogue (S&CD) on September 21-22, which is going to take up this issue substantially along with other bilateral issues.
Some of the significant concerns that the US has on India’s IPR and patents regime is the use of compulsory licensing, patent linkages and standards of patentability.
Several American pharma industry players have raised concerns over India’s patent act particularly Section 3(d), which restricts patents for already known drugs unless the new claims are superior in terms of efficacy.
“We have serious concerns on the two demands made by US. However, what they have demanded cannot be resolved in the policy as that requires amendment of the Drugs and Cosmetics Act has to be amended.
The new policy cannot overrule compulsory licensing in order to satisfy the US but the government might make some announcement that it will happen only in rare cases of public emergency.
On standards of patentability, which is the controversial Section 3(D), the government might make some announcement.
Our apprehension is that the government might try to please US and do something on these lines,” said DG Shah, secretary general, Indian Pharmaceutical Alliance (IPA). Shah, however, added that the government should not deviate from its policy of upholding the country’s acquiescence to TRIPS Agreement. The draft IPR policy was released in December 2014.
It drew much ire within the country and internationally for not being elaborate on compulsory licensing and Section 3(D). According to Patrick Kilbride, executive director (international IP), Global Intellectual Property Centre at the US Chamber of Commerce, America hopes that the National IPR Policy will contain commitments to the legal rights of patent, copyright, and trademark holders.
“Under the current administration, political attitudes toward IP seem to have improved."
"For instance, the previous bias toward the use of compulsory licenses as a commercial tool appears to have diminished. Likewise, recent moves confirming the scope of patentability for computer related inventions suggest that the linkage between intellectual property and innovative output is becoming more widely recognised and will provide the necessary incentive for increased R&D investment in the IT sector,” he said.
