Patent evergreening refers to the practice by pharmaceutical companies of extending the life of a patent by making minor modifications to an existing drug, such as changes in dosage, formulation, or delivery mechanisms. These modifications often do not significantly improve the therapeutic value of the medicine but are used strategically to obtain additional patents and thereby prolong market exclusivity. As a result, generic manufacturers are prevented from entering the market even after the original patent expires, which can keep drug prices high and restrict access to affordable medicines.

Section 3(d) of the Indian Patents Act, 1970 was introduced specifically to prevent such practices. The provision states that a new form of a known substance is not patentable unless it results in a significant enhancement in therapeutic efficacy. This means pharmaceutical companies must demonstrate real clinical benefits rather than merely technical or cosmetic modifications. The objective is to ensure that patents reward genuine innovation rather than incremental changes that do not significantly benefit patients.

<In practice, Indian courts apply a three-step test:

• Novelty – whether the invention is new
• Non-obviousness – whether the invention is not obvious to a skilled professional
• Enhanced therapeutic efficacy under Section 3(d) – whether the modification improves treatment outcomes

The recent rulings by the Delhi High Court allowing Indian pharmaceutical companies to manufacture or launch generic or biosimilar versions of drugs such as semaglutide, risdiplam, and nivolumab are highly significant for both the pharmaceutical industry and public health in India. These decisions reflect the judiciary’s commitment to ensuring that intellectual property protections do not override the broader objective of providing affordable healthcare.

One major implication is the expansion of access to life-saving medicines. For example, Roche’s spinal muscular atrophy drug Risdiplam (Evrysdi) was priced at about ₹6.2 lakh per bottle. Natco Pharma introduced a generic version priced at around ₹15,900 per bottle after receiving legal clearance. Such drastic reductions make treatment accessible to a far larger section of the population. Similarly, Zydus Lifesciences launched its biosimilar of the cancer immunotherapy drug Nivolumab at a fraction of the cost of the original product marketed by Bristol Myers Squibb.

These rulings also strengthen the global competitiveness of India’s generic pharmaceutical industry. Indian companies like Dr Reddy’s Laboratories, Natco Pharma, and Zydus Lifesciences are major exporters of generic medicines worldwide. By enabling them to produce and export drugs in jurisdictions where patents have expired or do not exist, the court decisions create significant economic opportunities while also reinforcing India’s reputation as a leading supplier of affordable medicines globally.

Patent expiry is one of the most important triggers for the entry of generic medicines into the pharmaceutical market. When a patent expires, the exclusive rights of the original developer—often referred to as the "originator" company—come to an end. This allows other pharmaceutical manufacturers to produce and sell the same drug, usually at significantly lower prices. In India, this process is further shaped by judicial scrutiny and the provisions of the Patents Act, which determine whether certain patents are valid or constitute attempts at evergreening.

Courts play a crucial role in assessing the validity of secondary patents related to dosage forms, formulations, or minor modifications. Judges often examine whether such claims demonstrate enhanced therapeutic efficacy as required under Section 3(d). If the courts determine that the claimed innovation does not significantly improve patient outcomes, the patent may be rejected or revoked. This creates space for generic companies to enter the market sooner.

For example, the upcoming patent expiry of semaglutide in India and Canada opens up a multi-billion-dollar opportunity for generic drugmakers. Similarly, earlier rulings involving drugs like risdiplam and nivolumab show how judicial intervention can accelerate generic entry. As patents expire and courts scrutinize follow-on patents more strictly, the pharmaceutical market becomes more competitive, which ultimately benefits patients through lower prices and wider availability of medicines.

India’s pharmaceutical patent regime attempts to strike a delicate balance between encouraging innovation and ensuring affordable access to medicines. On one hand, the patent system provides legal protection to pharmaceutical companies that invest heavily in research and development (R&D). Drug discovery often requires billions of dollars and years of clinical trials, and patent protection allows companies to recover these investments through temporary market exclusivity.

On the other hand, India has adopted certain safeguards—most notably Section 3(d) of the Patents Act—to prevent misuse of the patent system. This provision ensures that only genuine innovations that improve therapeutic efficacy receive patent protection. By restricting patents on trivial modifications, India enables earlier entry of generic medicines into the market. This has been crucial for making life-saving treatments affordable not only within India but also in many developing countries that rely on Indian generic exports.

However, the system also faces challenges:

• Multinational pharmaceutical companies argue that strict patent standards may discourage innovation and investment.
• Frequent litigation can delay market entry for both innovators and generic manufacturers.
• International trade negotiations sometimes pressure India to strengthen intellectual property protections.

The case of semaglutide, a widely used drug for diabetes and weight management marketed globally under brands such as Ozempic, Wegovy, and Rybelsus, illustrates how patent expiry and judicial decisions can significantly reshape pharmaceutical markets. The Delhi High Court recently allowed Dr Reddy’s Laboratories to continue manufacturing semaglutide in India, although it restricted sales and exports to jurisdictions where the Danish company Novo Nordisk does not hold patent protection.

This ruling coincides with the expiry of Novo Nordisk’s patent in India and Canada in March 2026. Once patents expire, the drug effectively enters the public domain, allowing generic manufacturers to produce equivalent versions. Given that semaglutide is part of the rapidly expanding global weight-loss and diabetes treatment market, the entry of generic versions could create opportunities worth billions of dollars for Indian pharmaceutical companies.

The semaglutide case also highlights the broader dynamics of pharmaceutical competition. As patents expire, companies may attempt to extend exclusivity through secondary patents on formulations or delivery systems. However, courts increasingly scrutinize such claims under Section 3(d). If generics are allowed to enter the market, prices typically decline sharply, increasing accessibility for patients. Thus, the semaglutide case demonstrates how patent law, judicial interpretation, and market competition collectively shape the availability and affordability of medicines.

Experts anticipate a significant increase in pharmaceutical patent litigation in India around 2026 due to a convergence of legal, economic, and industry factors. One major driver is the impending expiry of patents on several blockbuster drugs. As high-revenue medicines approach the end of their patent terms, originator companies often seek additional protection through secondary patents covering formulations, dosages, or manufacturing processes. Generic companies, in turn, challenge these patents to gain early market access.

Another reason is the stricter judicial interpretation of Section 3(d). Indian courts increasingly require strong clinical evidence demonstrating enhanced therapeutic efficacy for incremental pharmaceutical innovations. This higher evidentiary threshold means that many secondary patents are being challenged or revoked, leading to a rise in legal disputes between multinational pharmaceutical companies and domestic generic manufacturers.

Additionally, litigation tactics themselves contribute to the increase in disputes. Originator companies often seek interim injunctions in infringement cases, which can temporarily block generic competition even if the underlying patent is weak. Even a six-to-twelve-month delay can have significant commercial implications. As a result, both innovators and generic manufacturers actively pursue legal strategies to protect their market positions, making litigation an increasingly central feature of India’s pharmaceutical patent landscape.