Mint Explainer: Does India need special courts for complex drug patent wars?

While Dr Reddy’s can't sell the drug domestically until Novo's patent expires in March 2026, it can export it to countries where the Danish drugmaker does not have patent protection.

Given the order has significant implications for India’s domestic pharma landscape, dotted with patent litigations between the country’s generic players and innovators, Mint explains how Indian courts rule on complex patent disputes.

What is the Novo-Reddy's case?

In May 2025, Novo Nordisk filed a patent-infringement suit against Dr Reddy’s and contract manufacturer OneSource Specialty Pharma, alleging that the two were locally producing large quantities of semaglutide despite the drug being protected by patent until March 2026, and sought an injunction to stop them.

Dr Reddy’s argued that the innovator’s patent lacks novelty and inventive step, being similar to a previously filed patent, and hence can be challenged.

Another Indian generics player, Natco Pharma Ltd, sued Novo in August over semaglutide, claiming that its version does not infringe the innovator’s device or process patents.

How did the court rule and why?

The single-judge bench of Justice Manmeet Pritam Singh Arora rejected Novo’s plea to restrain Dr Reddy’s from manufacturing and exporting the drug to countries where the healthcare giant doesn't have patent protection.

The court found that Dr Reddy’s had raised a credible challenge to Novo’s suit patent (IN’697), pointing out that the compound had already been disclosed in an earlier genus patent (IN’964), which expired in 2024, indicating “evergreening" or “double patenting"—processes through which innovator companies often attempt to extend their monopoly on a drug.

However, the court clarified that Dr Reddy’s could not sell the drug domestically until the patent expiry, noting that it commenced manufacturing without challenging the suit patent.

Why are drug patent cases complex?

Drug patent disputes often centre around the specific chemistry of a compound or its processes. For instance, in this case, the dispute centred around the two patents filed by the innovator, both of which cover the semaglutide compound.

While the chemical structure is the same in both, the only variation is that one amino acid (Alanine or ALA) is swapped for another (α-aminoisobutyric acid or AIB) in the chain that makes the compound. This swap makes the molecule more stable and long-lasting. However, Dr Reddy’s contended that this substitution has been well-known in literature since the 1990s.

A similar granular detail won Natco its landmark case against Roche Pharma over Risdiplam, a drug used to treat spinal muscular atrophy (SMA) in October. Natco challenged the validity of the patent filed by Roche, which only covered a specific compound rather than broad structural protection.

A thorough understanding of biology, chemistry, and trade is needed in addition to law in patent cases. Subject experts are hired by the litigating parties, and the courts, too, if needed, a legal expert told Mint.

Who judges such cases?

In 2021, the Indian government dissolved the Intellectual Property Appellate Board (IPAB), which had been plagued by issues such as understaffing, a lack of resources, and delays. All pending cases were transferred to high courts.

In 2022, the Delhi high court established an IP division and notified the DHC-IPD Rules, 2022, which streamlined the process for resolving IP disputes in the country. Several other high courts, like Madras, Calcutta, and Karnataka, have followed suit, setting up their own IP divisions for all patent-related cases.

Timelines for patent disputes can still stretch years—often a setback for companies working with time-sensitive patent deadlines, which expire before a case makes it to trial in most cases.

Yet, experts said things have vastly improved over the last two decades, in terms of IP protection as well as processes. “A lot of litigation happens in Delhi high court [as] they have a separate bench only for doing IP, and things are getting better," said a senior industry executive on the condition of anonymity.