The Hyderabad-based company, which has a long history of challenging innovator patents both in India and overseas, had alleged that Roche was “evergreening” its patent on Risdiplam in the country.
A division bench on Thursday upheld the March 2025 single-judge order that had denied Roche an injunction against the Indian company, citing public interest, as SMA is a rare disease and wider access to an affordable drug would benefit patients who otherwise cannot afford treatment.
Natco has described the ruling as a “landmark decision” and announced that it will launch the drug immediately at a maximum retail price (MRP) of ₹15,900 per bottle—a sharp reduction from the current price of over ₹6 lakh.
Roche can now move the Supreme Court against the order.
Mint unpacks the case, Natco’s approach, and what it reveals about the broader innovation versus access dilemma in the Indian pharmaceutical industry.
What are innovator patents?
Innovator patents refer to intellectual property (IP) rights granted to pharmaceutical companies that innovate new drugs or new methods of manufacturing them. These can cover new chemical entities, specific formulations or compounds, or the process used to make the product.
The patent grants the innovator exclusive rights to market the drug for a set period, typically 20 years.
What is patent evergreening?
Evergreening refers to instances where drug innovators try to extend 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, and seeking fresh patent protection for them.
“While Indian patent law under Section 3(d) of the Patents Act, 1970, expressly restricts such tactics, companies often litigate to defend or challenge these secondary patents. The risk for innovators lies in judicial scrutiny; if the court finds that the modification does not result in enhanced efficacy, the patent can be revoked, weakening the company’s IP (intellectual property) portfolio,” said Varun Singh, founding partner at law firm Foresight Law Offices.
Why do companies challenge patents?
While generic drugs have long been the mainstay of the Indian pharmaceutical industry, price erosion in the US and continued volatility have driven drugmakers to seek higher-margin products and verticals. Challenging patents of blockbuster drugs or life-saving drugs presents a significant avenue for growth.
In the US, Indian drugmakers often challenge innovator patents under the Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, which allows the first generic filer that successfully contests a patent to enjoy 180 days of market exclusivity.
Drugmakers often enter into settlements with innovators, sharing exclusivity for a specific period of time to market the drug in specified quantities before cheaper generics flood the market.
“People are becoming more daring because the balance sheets are bigger, so they are willing to take more risks,” said an industry executive on the condition of anonymity.
What are the risks?
In India, generic challengers pursuing aggressive litigation run the risk of inviting injunctions or damages if their challenge fails, said Singh.
In the US, the cost of litigation is high. However, companies often partner up with others to ease this. For instance, Natco partnered with US generics major Mylan (now part of Viatris) to challenge Novo Nordisk’s Semaglutide patent, for which a settlement was reached in October 2024. Terms of the settlement are confidential.
The payoffs in cases where the challenger wins can be huge. For instance, Natco and other Indian generic players, including Dr Reddy’s Laboratories, Sun Pharmaceutical Industries Ltd, Cipla Ltd, and Zydus Lifesciences Ltd, struck deals for blockbuster cancer drug Revlimid in the US in 2022.
Under the deals, the companies have been allowed to sell the drug in restricted quantities until January 2026, when the patent expires. The drug has accounted for a significant portion of earnings for these companies since then.
How did Natco manage to win a favourable ruling against Roche?
Of its global patents, Roche had not filed for the patent (#9586955), which covers and discloses Risdiplam’s broad structure in India. Instead, it only filed a second patent (#9969754), which covered a specific compound of the drug. The first patent loses exclusivity in 2033, while the second one loses exclusivity in 2035, giving it an additional two years.
However, Indian law favours a broad product claim over a specific compound. Natco used this to challenge the validity, arguing that it does not cover the drug’s broad compound.
A similar lapse led to Danish innovator Novo Nordisk losing patent exclusivity for its blockbuster weight loss drug Semaglutide in Canada. The drugmaker did not pay a maintenance fee for the patent after 2018. After a one-year grace period, the patent lapsed in 2020 and is set to expire in January 2026.
How has Natco’s record been?
Earlier this year, Natco sued Novo Nordisk over its weight-loss drug Wegovy (Semaglutide), claiming that its version does not infringe the innovator’s device or process patents, which are separate from its product patent, which expires in March 2026.
The company has previously pursued patent challenges in India with Bristol Myers Squibb over the blood thinner Apixaban (Eliquis) and the leukaemia drug Dasatinib (Sprycel), as well as with Novartis over the cancer drug Ceritinib.
In a landmark 2012 case, the Indian patent office granted the country’s first compulsory licence to Natco, allowing it to sell a generic version of Bayer’s cancer drug, Nexavar. Under the ruling, Natco was required to pay a 6% royalty to Bayer. A compulsory licence allows the production of a patented drug when it meets public health needs and remains unaffordable to the public.
Natco’s chemistry expertise has enabled it to develop tough-to-copy drugs, which few others can replicate, giving it access to high-entry-barrier, niche markets if it wins a patent challenge.
It currently has 28 Para IV filings (patent challenges in the US) in the pipeline, of which 13 have been approved, either tentatively or fully.
It also has a drug candidate (NRC-2694-A) in the trial stage to treat head and neck cancer. A Phase 2 clinical trial has been approved by the US FDA.
As of Q1FY26, 81% of its total revenue comes from export formulations, while domestic formulation sales account for 7.7% of the revenue.
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