Impact Of India’s New Patent Rules, 2025 on Pharmaceutical Generic Licensing

Introduction

India plays an important role in the global pharmaceutical industry as a major drug manufacturing hub that supplies generic medicines worldwide. Indian patent law is robust in protecting pharmaceutical innovations while preventing patent evergreening. It maintains a balance between intellectual property rights (IPR) and providing low-cost medicines remain accessible to the public. The recent amendments to the Indian Patent Rules will have impact both positive and negative on the pharmaceutical industry.

Multinational companies frequently file new patents with slight modifications in the existing drug to extend their market exclusivity. To prevent this monopolistic practice, Indian patent law applies Section 3(d), which contains stricter provisions than those found in other nations.

Branded pharmaceutical companies across the globe invest huge capital in research and development for drug discovery. Patents are granted to drugs after passing the complex patent law process, and intellectual property rights (IPR) provide companies with sole right for their patented drugs. Small and domestic pharmaceutical companies license these patented drugs to manufacture generic medicines, which are similar in composition and are as effective as original patented drugs for the treatment. Generic drugs are significantly cheaper than patented drugs because manufacturers do not bear the costs of research, the patenting process, or clinical trials. Domestic companies pay royalties to branded companies for licensing, enabling them to provide generic medicines to the public on a large scale at affordable prices.

The recent amendments to the Indian patent Rules have simplified the patent process. These amendments will impact both global and domestic pharmaceutical markets for generic medicines.

Appurtenant Provisions Post-amendment

1. Pre-grant Opposition, Section 25(1) – Pre-grant oppositions are essential that can prevent the grant of invalid patents. Any person can oppose a patent application before grant on various grounds. Generic companies can challenge patents on new drugs if the drug is new forms or modifications of existing drugs, thereby preventing the grant of weak patents. However, the new Rules introduce a fee for filing pre-grant oppositions. The objective is to discourage frivolous oppositions and avoid delays in the patent process.
2. Expedited Examination – The timeline for filing a Request for Examination has been shortened from 48 months to 31 months. This accelerated process will speed up patent grants, offering generic manufacturers earlier visibility into the patent landscape for new drugs. The faster timeline creates opportunities to domestic companies to plan effectively to manufacture generic medicines before entering in market.
3. Working of Invention (Form 27) – The statement of working of invention in India must now be furnished once every three financial years. This requirement is crucial grounds for compulsory licensing and ensuring that patented inventions are being worked in India to serve the public interest.
4. TRIPS-Plus Provisions – Many developing countries, including India, were force to accept TRIPS-Plus provisions. Under these provisions, patent terms would extend beyond 20 years, the use of compulsory licensing would be limited, and generic competition would be restricted.

TRIPS also includes data exclusivity provisions. To obtain market authorization, pharmaceutical companies submit clinical trial data to drug regulatory authorities. This information regarding the safety and efficacy of clinical trials is kept confidential for several years. Generic manufacturers cannot produce these drugs without demonstrating their own clinical trial data, that will create problems to early entry in the market.

These provisions may result in high-cost for essential medicines in India, impacting the country’s role as a major supplier of affordable generic drugs to developing countries.

Analysis

These amendments highlight India’s dual focus on supporting innovation without impacting public health.

Balancing Innovation for New Drug and Affordable Generic Medicines – The 2025 Patent Rules objective is to maintain harmony by promoting innovation in new drug development and providing generic medicines to the public.

The Rules promote advancement in drug industry by giving strengthened intellectual property protection. Stronger IP protection in India will attract pharma industries to spend money in research and development (R&D) for new drug for the treatment of many diseases like cancer, tuberculosis and HIV.  The stronger IP protection will establish India as a global innovator in pharmaceutical industry and the investment in innovation will develop new drugs in the future.

However, the new patent Rules will significantly impact India’s capacity to produce generic medicines for developing nations. The delay in generic market entry due to enhanced drug-linkage mechanisms, may result in increased medicine costs and reducing public access to essential drugs. Countries that depend on India’s generic medicines may face challenges due to the higher costs of new pharmaceutical drugs.

Compulsory Licensing of patented drug that are vital for the health of public will play an important role for generic manufacturing companies. It will be challenging for the Indian Patent Office to balance stronger Intellectual Protection for patented drugs while allowing generic manufacturers to produce economical medicines for public access.

Relevant Case Laws

1. Novartis AG v. Union of India (2013) – The Supreme Court of India case rejected Swiss pharmaceutical giant Novartis’ attempt to patent a modified version of the cancer drug Gleevec. The case centred on Section 3(d) of India’s Patents Act, which prevents “evergreening” – the practice of making slight variation to present drugs to extend patent protection without providing enhanced therapeutic efficacy. This decision proven a crucial precedent protecting India’s generic drug industry and providing affordable essential medicines to public.
2. Roche vs. Natco (Delhi High Court, March 2025) – Swiss pharmaceutical giant F. Hoffmann-La Roche AG filed an interim injunction application against Indian drugmaker Natco Pharma Limited, alleging that Natco was manufacturing Risdiplam without authorization. Risdiplam is an oral medicine for Spinal Muscular Atrophy (SMA) in patients two months of age or older. This case highlights the balance between protecting patent rights and providing essential medicines to public access. The Delhi High Court has considered rights for the patented drug as well as public health concerns.
3. Gilead Sciences Lenacapavir Patent Challenge (Ongoing) – Gilead Sciences applied for a patent on Lenacapavir, a new HIV drug, in India. The Indian Patent Office is currently reviewing objections to Gilead Sciences’ patent applications for this long-acting HIV medication. The Sankalp Rehabilitation Trust, a civil society organization, contends that Gilead’s applications for the choline and sodium salt forms of lenacapavir lack novelty and originality and may constitute “evergreening,” which is prohibited under Section 3(d) of India’s Patent Act. This ongoing case shows the continued importance of the Novartis precedent and India’s vigilance against patent evergreening procedures in the pharmaceutical industry.

Practical Implications

1. Free Trade Agreement Impact – India signed a Free Trade Agreement (FTA) with the European Free Trade Association (EFTA), that includes Norway, Iceland, Liechtenstein, and Switzerland. The European countries are pressuring India to accept TRIPS-Plus measures in the agreement. TRIPS-Plus provisions will create barriers to the production of generic medicines, potentially increasing medicine prices both in India and abroad.
2. Pre-grant Opposition – The Indian Patent Office rejected the secondary patent application for an anti-tuberculosis (TB) drug by Johnson & Johnson in 2023. The pre-grant opposition was filed by two individuals – Phumeza Tisile from South Africa and Nandita Venkatesan from India. These applicants successfully proved that the secondary patent application on Bedaquiline was frivolous in nature. The court decision allowed generic manufacturing companies to continue production from July 2023, ensuring continued access to affordable TB treatment. Similarly, many companies have faced pressure to withdraw patent applications before grant. The pre-grant opposition filed by the patient group Delhi Network of Positive People (DNP+) and Ganesh Acharya (an Indian activist and TB survivor) forced a French pharmaceutical company to withdraw its application for 3HP, a TB preventative treatment.
3. Globally Accessing Medicines – India providing generic medicines to the developing nations and least developed nations like Africa and many more will suffer due to high cost of patented medicines for HIV/AIDS and other diseases.

Conclusion

The India patent Rules (2025) have refined the complex and lengthy patent process. The reduction in time for request for examination from 48 months to 31 months will speed up the process of patent grant. The new fees for pre-grant opposition will reduce the patent opposition by any person and avoid unnecessary delays in the process of patent grant. As patent status will appear in a shorter time, companies manufacturing generic medicines need to plan accordingly. The research, legal preparation and obtaining permission from authorities should be planned as per the Central Drugs Standard Control Organization (CDSCO) requirements and market demand.

India providing stronger IP protection will enhance the pharmaceutical companies to invest huge capital in innovation of new drugs and setting up research and development facilities in India. But these companies need to maintain the criteria of Section 3(d) or they have to show the data of enhanced therapeutic efficacy for new drugs. The Indian patent office will not grant patent for new forms or slight modifications of known drugs. Increased therapeutic efficacy is an essential criterion to overcome the standard of 3(d).

With the new amendment in patent Rules (2025), India is trying to encourage new drug development but also making sure that affordable medicines are available to the public who need them. The success of this balance will depend – whether India can provide low-cost generic medicines to the world while encouraging new drug research and attracting foreign investment.

Author: Rajni Desai, in case of any queries please contact/write back to us via email to [email protected] or at IIPRD. 

References

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7. The Patents Act, 1970 (Act No. 39 of 1970), § 3(d).
8. The Patents Act, 1970 (Act No. 39 of 1970), § 25(1).
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10. Hoffmann-La Roche AG v. Natco Pharma Ltd., Order dated March 2025.
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14. Indian Patent Office, Pre-Grant Opposition Order in Sanofi 3HP Patent Application, 2023, https://ipindia.gov.in/opposition-order-sanofi-2023.pdf.
15. World Trade Organization (WTO), Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – Article 27: Patentable Subject Matter (Exclusions for Therapeutic Methods), April 15, 1994, https://www.wto.org/english/docs_e/legal_e/27-trips.pdf.