India’s bold move against Novartis’ blockbuster heart drug patent highlights the country’s uncompromising balance between innovation incentives and affordable access to medicines.

The Verdict That Stirred the Industry:

On September 12, 2025, the Indian Patent Office revoked Novartis’ patent on Vymada (internationally known as Entresto - a combination of sacubitril and valsartan). The decision came after post-grant opposition from domestic firms, who argued that the patent lacked novelty, inventive step, and failed to meet India’s unique anti-evergreening provisions.

The Deputy Controller of Patents and Designs, D. Usha Rao, concluded that Novartis had not shown a clear therapeutic advantage for the claimed “supramolecular complex” formulation over existing drugs. Without robust clinical or technical evidence, the patent could not stand.

Why It Matters:

The revocation was more than a legal blow to Novartis; it was a reaffirmation of India’s stance on pharmaceutical patents:

• Section 3(d) of the Indian Patents Act continues to be the line of defense against evergreening. Incremental modifications must show substantial enhancement of efficacy to deserve protection.
• Affordability and access remain cornerstones of Indian policy. By clearing the way for generics, the decision is expected to slash prices for a critical heart-failure treatment.
• Innovation incentives for multinational drugmakers are under renewed scrutiny. While India welcomes innovation, it demands stronger proof of novelty and efficacy before granting or upholding patents.

A Familiar Pattern:

This is not the first time India has stood firm against a global pharmaceutical giant. In 2013, the Supreme Court’s Glivec ruling denied Novartis a patent extension for its cancer drug, setting a powerful precedent against evergreening. The Vymada case extends that tradition: India’s patent office is willing to revoke rights even after grant, if challenges hold merit.

Implications for Stakeholders:

For Global Pharma

• Signals that India remains a tough jurisdiction for secondary patents.
• Requires more robust data, comparative studies, and technical evidence to prove novelty or efficacy.
• Increases the risk of post-grant challenges, adding uncertainty to long-term exclusivity.

For Indian Generics

• Creates a clear pathway for companies like Natco, Torrent, MSN, and Eris to launch affordable alternatives.
• Strengthens India’s role as the pharmacy of the world, delivering low-cost medicines without breaching TRIPS.

For Patients

• Offers a life-saving affordability boost, especially for millions of Indian patients battling heart disease.
• Reinforces India’s reputation for prioritizing public health over monopoly pricing.

The Bigger Picture:

India’s approach sits at a crossroads of law, economics, and ethics. While critics argue that strict provisions reduce incentives for pharmaceutical innovation, defenders point out that without access, innovation is meaningless for patients in low- and middle-income countries.

Globally, the Vymada revocation will likely be studied as a case in point — showing how India balances TRIPS compliance with its domestic public-health priorities.

Conclusion:

The revocation of Novartis’ Vymada patent is not an isolated event. It’s a reaffirmation of India’s unique intellectual property environment, where patents must prove their worth beyond doubt, and patients’ right to affordable medicines remains paramount.

Hence, the ‘Key Takeaways’ are as follows:

• Patent Revoked: India’s Patent Office cancelled Novartis’ Vymada (Entresto) patent on grounds of lack of novelty, inventive step, and evergreening concerns.
• Section 3(d) in Action: The ruling reinforces India’s strict bar on incremental patents unless they show substantial therapeutic advantage.
• Generics Open the Door: Indian firms like Natco, Torrent, MSN, and Eris can now launch low-cost alternatives, making treatment more affordable.
• Global Signal: The case highlights India’s unique IP stance — balancing innovation with access to essential medicines.

As the dust settles, this case will likely serve as a landmark reference in future IP disputes, shaping both corporate strategies and policy discussions. For India, it underlines a central philosophy: when patents meet patients, public health comes first.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.