Annual National Commercial Estate Report of the United States Representative (USTR) on external commercial barriers, publishedIn March, it indicates the requirements of the USA of the negotiations of the Bilateral Commerce Agreement with India.
The report lists “concerns” that involve the intensive intellectual property industry (IP), specifically pharmaceutical products, aimed at public health safeguards in the Patent Law of India. In addition, IP concerns extend to the absence of data exclusivity for pharmaceutical data. And these safeguards in India are being seen as non -tariff barriers.
One of the issues raised by the UST in the Patent Law implies restrictions on obtaining patents due to section 3 (d) and the absence of an effective mechanism for the early resolution of the pharmaceutical patent confer on the procedure to the law in state state in state.
Section 3 (d) prevents multiple patents by not allowing the protection of new uses of known medications or new forms of the same medication, including derivatives or pro-drugs of existing molecules or compounds, unless an improved “therapeutic efficacy” is demonstrated. For example, Imatinib’s mesilate (used to treat cancer) was a known molecule. Novartis claimed a patent about the beta crystalline form of Imatinib mesilate. However, Novartis could not show significantly greater therapeutic efficacy of the new form, and its patent claim was rejected (Novartis vs Union of India).
Similarly, this provision does not allow patents to indicate new uses or medications. For example, semaglutida (Ozempic) is a patented medication used to treat diabetes and type 2 obesity. Discovering its use for weight loss would not be patentable.
Pharmaceutical multinational corporations (MNC) or try “perennial” a patent they have in a new molecule looking for secondary patents on trivial variations or new uses. The rejection of such patent applications allows pharmaceutical companies to produce and sell biosimilar medications at significantly reduced prices, which makes them more affordable.
Section 25 (1) or the Patent Law of India restricts the granting of non -merocated patents by allowing oppositions to requests. The disposition has played an important role in guaranteeing access to affordable medications by filtering bad claims from the beginning. For example, two survivors of tuberculosis (TB) presented an opposition prior to the concession against the secondary patent application of Johnson and Johnson for the Bedaquilin (used to treat the TB resistant to medications). Constantly, the patent office rejected the frivolous application, allowing the genericians to enter the market.
In addition to patents, USA wants exclusion in test or drug test data. The exclusivity of the data prevents the regulatory agencies from trusting the creator’s test data to approve a generic product at the door of the protected period of exclusion. This would prevent generic manufacturers from entering the market, especially in the absence of patent protection. This could be an important barrier for the generic entry of biological products. As a result, companies of origin would enjoy virtual monopolies and can sell continuous drugs at exorbitant prices.
The provisions mentioned above have played an important role in the prevention of “perestruues” or patents through applications without mere. India must firmly reject any attempt from the USA. To include problems related to IP or the exclusivity of the data, guarantee access to affordable medications must continue to be a priority of India.
(The writer is an associated professor, Law Faculty, Banras Hindu University. Opinions are personal)
Posted on April 20, 2025