Mint Explainer: Why do Indian drug makers challenge global giants' patents?

Over the past year, India has witnessed several high-stakes legal battles between domestic generic drug manufacturers and global innovators, reigniting the debate over striking a balance between innovation protection and broader drug accessibility.

Looking ahead to another year of patent challenges, Mint examines who ultimately benefits from these challenges.

What are drug patent disputes?

New drugs or methods of making them are typically protected by patents under intellectual property (IP) rights. The patent grants the innovator exclusive rights to market the drug for a set period, typically 20 years. Patented drugs are typically priced high as innovators capitalize on their monopolies, attempting to recover research and development costs and fund future innovations.

Since Indian drugmakers primarily produce generics, or copycat versions, they either wait for patents to expire or challenge the innovator’s patent once they understand the underlying innovation. These disputes often stretch years, rarely, if at all, reaching trials.

Indian courts take a strict but balanced approach to pharmaceutical patents. They closely scrutinize drug patents to prevent evergreening, while protecting genuine innovation. This approach was firmly set out in the 2013 Novartis-Glivec ruling, where Novartis AG sought a patent for its cancer drug Glivec (imatinib mesylate), claiming it was a new form of the cancer drug imatinib. The application was rejected for failing to show proven therapeutic improvement, a decision later upheld by the Supreme Court.

Why do Indian drugmakers pursue patent wars?

If a company has managed to reverse engineer a new drug before the patent expires, challenging the patent to gain market access gives it a significant edge over other generic competitors. Not only that, but launching the product at a lower cost also allows the firm to undercut the innovator and gain market share.

In many cases, Indian firms have argued against patent evergreening—innovators' way of extending the life of their patented drugs beyond the original 20-year term by making minor or incremental changes, such as new formulations, dosage forms, salts, or combinations.

Much of the debate centres on accessibility, as seen in Natco’s patent dispute with Roche Pharma over Risdiplam, a drug used to treat spinal muscular atrophy (SMA), a rare genetic disorder that causes motor neuron degeneration and progressive muscle weakness.

Natco argued that Roche was evergreening its patent, and received approval to launch the generic version from the Delhi high court, which cited public interest.

While patent battles have historically focused on life-saving cancer, cardiac, and rare-disease drugs, now they increasingly involve lifestyle medications. In 2025, three Indian companies—Natco, Dr Reddy’s, and Sun Pharma—pursued patent disputes against Novo Nordisk over its weight-loss and type 2 diabetes drug semaglutide, better known by the brand name Ozempic.

What are potential risks and rewards?

For one, the cost of litigation is high, especially in the US. Litigations can stretch on for years until the patent expires, allowing the market to open for all. Domestically, generic challengers risk inviting damages if the challenge fails.

However, should a company win, the payoff can be massive.

In the US, several Indian companies have pursued this strategy. In 2022, firms including Dr Reddy’s, Natco, and Cipla started selling blockbuster blood cancer drug Revlimid in restricted quantities after reaching settlements with innovator Celgene (acquired by Bristol Myers Squibb). The companies were allowed to sell the drug in the US in specific quantities until its patent expiry this year, which has significantly boosted their earnings.

Similarly, in the case of semaglutide, both Dr Reddy’s and Sun Pharma have the Delhi high court's nod to manufacture and export the product to countries where the Danish drugmaker does not have patent protection, giving them an early-mover advantage.

The patent expires in March, when several players will attempt to enter the lucrative weight-loss market.

How are consumers impacted?

In cases where the patent challenger wins, the end consumers benefit from lower costs and wider availability.

For instance, following its 2025 win, Natco launched Roche’s Risdiplam at a maximum retail price (MRP) of ₹15,900 per bottle, sharply beating the Swiss multinational’s price of over ₹6 lakh.

How are things evolving?

While patent disputes are not new in the country, Indian firms, with their growing balance sheets, are willing to take more risks, say experts.

Generic drugs have long been the mainstay of the Indian pharmaceutical industry, however, price erosion in the US and continued volatility have driven drugmakers to seek higher-margin avenues with more entry barriers. This comes in the form of pursuing in-house innovation as well as challenging hard-to-crack patents.

Additionally, more streamlined processes have helped. In India, several high courts, such as Delhi, Madras, Calcutta, and Karnataka, have set up dedicated IP divisions to handle patent-related cases, following the 2021 dissolution of the Intellectual Property Appellate Board (IPAB), which had struggled with understaffing, limited resources, and persistent delays.