The United States Trade Representative’s (USTR) annual National Trade Estimate report on foreign trade barriers, releasedin March, indicates the US’s requirements from the bilateral trade agreement negotiations with India.
The report lists “concerns” involving intellectual property (IP) intensive industry, specifically pharmaceuticals, targeting public health safeguards in the Indian Patents Act. Further, the concerns on IP extend to the absence of data exclusivity for pharmaceutical data. And these safeguards in India are being viewed as non-tariff barriers.
One of the issues raised by the USTR in the Patents Act involves restrictions on obtaining patents due to Section 3(d), and the absence of an effective mechanism for the early resolution of pharmaceutical patent disputes — a reference to the oft-stated concern over the pre-grant opposition procedure under the Patents Act.
Section 3(d) prevents multiple patents by disallowing protection on new uses of known drugs or new forms of the same drug, including derivatives or pro-drugs of existing molecules or compounds, unless enhanced “therapeutic efficacy” is demonstrated. For example, imatinib mesylate (used to treat cancer) was a known molecule. Novartis claimed a patent over the beta crystalline form of imatinib mesylate. However, Novartis failed to show significantly higher therapeutic efficacy of the new form, and its patent claim was rejected (Novartis vs Union of India).
Similarly, this provision disallows patents for indicating new uses of known medicines. For instance, semaglutide (Ozempic) is a patented drug used to treat type 2 diabetes and obesity. Discovering its use for weight loss would not be patentable.
Pharmaceutical multinational corporations (MNCs) often try to “evergreen” a patent they have on a new molecule by seeking secondary patents on trivial variations or new uses. The rejection of such patent applications enables pharmaceutical firms to produce and sell biosimilar drugs at significantly reduced prices, thereby making them more affordable.
Section 25(1) of India’s Patents Act restricts the grant of unmerited patents by allowing oppositions to the applications. The provision has played a significant role in ensuring access to affordable medicines by filtering out bad claims early on. For example, two tuberculosis (TB) survivors filed pre-grant opposition against Johnson & Johnson’s secondary patent application for bedaquiline (used to treat drug-resistant TB). Consequently, the patent office rejected the frivolous application, enabling generics to enter the market.
Apart from patents, the US wants exclusivity on test trial data of drugs. Data exclusivity prevents regulatory agencies from relying on the test data of the originator to approve a generic product during the protected period of the exclusivity. This would prevent generic manufacturers from entering the market, especially in the absence of patent protection. This could be a major barrier for the generic entry of biologics. As a result, originator companies would enjoy virtual monopolies and can continue selling drugs at exorbitant prices.
The above mentioned provisions have played a significant role in preventing “evergreening” of patents through unmerited applications. India must firmly reject any attempts by the US to include issues related to IP or data exclusivity — ensuring access to affordable medicines should remain a priority of India.
(The writer is an Associate Professor, Faculty of Law, Banaras Hindu University. Views are personal)
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Published on April 20, 2025