The recent United States Trade Representative Special 301 Report, which labels India as a challenging major economy for intellectual property protection, has sparked criticism from Indian legal experts who argue it overlooks significant advancements in India's IP ecosystem. India's ongoing efforts in IP awareness, process simplification, legal strengthening and reduced timelines have been overlooked, unfairly tagging the country, IP lawyers said.
Continued designation of India on a US priority watch list for alleged shortcomings in intellectual property protection and enforcement has drawn sharp criticism.The United States Trade Representative Special, or USTR, 301 Report released last week (see here) — outlining the government's perspective on international intellectual property enforcement in trade — labeled India as "one of the world’s most challenging major economies with respect to protection and enforcement of IP.”
Saya Choudhary Kapur, Senior Partner at Singh & Singh, argued that the Special 301 report overlooks significant progress in strengthening the country's IP ecosystem. It has "unfairly tagged India to remain on the priority watch list" given its ongoing and consistent efforts to enhance its intellectual property ecosystem by spreading awareness, simplifying protection processes, aligning with global standards, strengthening legal frameworks, and reducing intellectual property right-related timelines, she said.
India was among the eight countries placed on the priority watch list for 2025; the others being Argentina, Chile, China, Indonesia, Mexico, Russia and Venezuela (see here).
Echoing Kapur's sentiment, Aman Sinha, a Delhi-based IP lawyer, called the US criticism a "habit."
"It is a habit of the US to criticize India for IP protection," Sinha told MLex.
Indian courts have upheld the rights of US companies especially when it comes to luxury brands, Sinha said, citing the Whirlpool case against a local Indian entity. The case "primarily revolved around the principle of prior user rights and transborder reputation in India, consistent with Trade-Related Aspects of Intellectual Property Rights, or TRIPS, obligations," he said.
The Special 301 report specifically highlights perceived "restrictions on patent-eligible subject matter in Section 3(d) of the Indian Patent Act and its impacts. The provision aims to prevent the granting of "evergreening" patents, whereby additional patents for drugs lacking therapeutic benefit, effectively extend patent monopolies.
India's 1970 Patent Act has provisions to restrict the "evergreening" of patents, especially in the pharmaceutical industry. This prevents innovator drug companies from extending their market exclusivity beyond the standard 20-year patent term by securing new patents for minor modifications or reformulations that lack significant therapeutic advancement, thereby ensuring that monopolies do not extend indefinitely.
There has been ongoing pressure from the US, the UK, and the European Union to amend India's Patents Act and permit the "evergreening" of patents. The Special 301 report comes amid ongoing talks between the US and India to sign the India-US Bilateral Trade Agreement, which reportedly includes weakening patent protection.
Commerce and industry Minister Piyush Goyal recently criticized global pharmaceutical companies often "requesting" India to grant them the ability to have "incremental changes to their patents and allow them to have a fresh patent for a long period of time," a concept often referred to as evergreening of patents.
Expressing strong concern over the prioritization of corporate gain above global health, the minister, addressing a world health summit* in New Delhi last month, said: "It is so sad that just for the supernatural profits of a select few companies and possibly their shareholders, the world has to suffer and be deprived of quality and equitable healthcare."
Addressing the US criticism of Section 3(d) of the Patents Act, Sinha cited the Novartis case in which India's stance was against "recycled innovation," where follow-on innovations do not significantly improve therapeutic efficacy.
Indian courts have time and again clarified that Section 3(d) "does not embargo grant of patents but merely aims to prevent evergreening," Kapur asserted. In the last decade following the Novartis judgment, "we have seen hundreds of patent applications successfully overcoming objections raised under section 3(d)," she said.
"Both the US Supreme Court and the Indian Supreme Court scrutinized the extent of disclosure versus the breadth of the claim, and denied protection where the patentee failed to justify how the claim met the enablement requirement," Sinha said.
The single-judge bench of the Delhi High Court refused to grant an injunction to Roche concerning the drug "RISDIPLAM" in the Roche v Nato Pharma judgment, also underscores India's commitment to ensuring access to affordable medicines for critical diseases (see here).
The Special 301 report further states that “pharmaceutical stakeholders also express concerns as to whether India has an effective mechanism for the early resolution of potential pharmaceutical patent disputes."
"Patent jurisprudence has been consistently developing and the courts have played a major role in streamlining various issues specifically ones related to non-patentable subject matter," Kapur said. The Special 301 report has overlooked the fact that the time for grant of patent has also reduced drastically, she added.
Different judicial views cannot be labelled as “vagueness in interpretation” of the Indian Patents Act, Kapur said.
India has consistently maintained that the Special 301 Report is a unilateral tool under its 1974 Trade Act, designed to pressure countries into adopting IPR protections exceeding TRIPS requirements. India has also asserted that its IPR regime is already fully aligned with global trade norms.
Regarding trademark law, Kapur underscored the proactive measures taken by Indian courts nationwide against counterfeit and pirated goods across various sectors, including pharmaceuticals, fast-moving consumer goods, and fashion.
"Courts have been imposing substantial costs in cases related to counterfeiting and are actively pushing for swift resolution of such matters," Kapur said.
In February this year, US e-commerce giant Amazon Technologies was penalized $39 million for trademark infringement (see here).
Sinha also asserted India's superior trademark protection, citing the Bukhara case as an example of US shortcomings. Bukhara is a renowned Indian restaurant chain, located in the ITC Maurya hotel in New Delhi, and expanded the chain globally.
While Indian courts have recognized "Bukhara" as a well-known mark, granting it enhanced protection, similar trademark protection was denied in the US by two court rulings due to the US not enacting provisions for the protection of well-known marks under Article 6bis of the Paris Convention and Article 16 of the TRIPS Agreement, Sinha said.
In the ITC Ltd. v. Punchgini Inc case, despite ITC arguing for protection under the "famous marks doctrine," the Federal Court in New York swiftly determined that no federal law violation occurred, reasoning that trademark ownership is jurisdiction-specific and requires proactive registration in each country where rights are sought.
"This discrepancy creates a situation where trademark infringers in India can sometimes cite the US rulings as a defense, Sinha said, adding that "the US does not give them any protection from misuse."
* The World Health Summit Regional Meeting Asia 2025, New Delhi, April 25-27, 2025.
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