It’s that time of the year when the deadline closes for submissions to the Office of the United States Trade Representative (USTR) ahead of its ‘Special 301’ report that assesses more than 100 trading partners on their track record involving Intellectual Property Rights (IPR), its protection and implementation.

India continues to be placed on the “Priority Watch List,” (PWL), with seven countries including Argentina, Chile, China, Indonesia, Russia and Venezuela. Totally 29 countries have been placed on the PWL/Watch List.

Industry-insiders and medicine access campaigners say that India needs to continue to campaign for flexibilities provided under international trade laws. Either way, the USTR’s annual report, expected usually late April, is a closely followed exercise.

As the January deadline ended, the USTR said, 110 comments had been received (as of February 13, 2024), from industry bodies and IP practitioners, among others.


Big pharma was represented by PhRMA (Pharmaceutical Research and Manufacturers of America ), among others. Closer home, representing the domestic industry, the Indian Pharmaceutical Alliance – made its case to take India off the PWL, pointing to India’s “unwavering commitment” to IPR laws. IPA, a platform of large Indian drugmakers has been participating in this exercise for several years now.

“It has recently been noted that various countries are now understanding that the public’s access to medicines is inhibited through stringent patent laws and they are thus taking steps now to introduce certain aspects in their local patent laws which would help in increasing the public’s access,” the IPA said in its submission to the USTR.

“India, on the other hand, has always maintained an optimal balance between encouraging and protecting innovation along with the public’s access to medicines not being hampered. This attribute goes to show that India’s patent laws are adequately balanced and foremost amongst its peers. Equitable access to medicines is key and both India and US can play a greater role in this area of work,” the submission said.

Outlining measures that are in place, the IPA pointed out, “ is crucial to acknowledge the significant surge in patent filings in India. This 89 per cent increase, in 2023 from 2014-15, is not just a numerical growth but represents a flourishing culture of innovation and a deep-rooted trust in the Indian patent system. This upsurge, which reflects the highest standards set by the Indian Patents Act, is indicative of a thriving environment conducive to intellectual creativity and protection.”

Addressing concerns on pre-grant oppositions undertaken by parties before a patent is granted by the authorities, the submission said, it accounted “for a mere 1 per cent of all patents,” and deserved a more nuanced examination. In fact, it added. “This small percentage of pre-grant patents reflects more of an efficient and balanced patent system, rather than a problematic one.”

On the longstanding “3 (d)” issue, it said, Section 3(d) of the Patents Act specifically targeted secondary patents that “lack efficacy enhancement, often leading to evergreening. This practice is not merely a legal or technical issue; it has broader implications for global healthcare. By potentially delaying the entry of generic drugs into the market, patent thickets can adversely affect patient access to essential medications worldwide and contribute to rising healthcare costs. This specific provision in the Patents Act underlines India’s commitment to preventing such practices, thereby ensuring that patents serve their intended purpose of promoting genuine innovation while safeguarding public health interests,” it said.

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The view, though, was different from the other side. Pointing to “discriminatory government procurement policies” , high taxes on medicines, an “unpredictable” environment for clinical research and new drug approvals, besides standing concerns on issues like 3 (d), among others, PhRMA sought for India to remain on the PWL. The submission covered the IP track-record in other regions as well. On India, it urged the US government to continue to seek assurances that problems outlined by them would be resolved quickly and effectively.

Calling for a balance, the Association for Accessible Medicines (AAM) said, “the Special 301 review is not a trade negotiation, it still should reflect the balance between innovation and access...”. AAM calls itself the sole trade association representing America’s generic and biosimilar pharmaceutical sector.

“IPR is a multi-lateral issue and should not be addressed bi-laterally,” says KM Gopakumar with Third World Network. In the interest of public health, India should continue to exercise flexibilities available in international trade frameworks, he said, echoing the views of several advocacy representatives working on improving access to medicines.