India Delivers Major Blow to Novartis: Blockbuster Heart Drug Entresto Patent Revoked

In a landmark decision poised to reshape the landscape of affordable healthcare in India, the country's Intellectual Property Appellate Board (IPAB) has delivered a significant blow to Swiss pharmaceutical giant Novartis. The IPAB has revoked the patent for Entresto, Novartis's blockbuster heart failure drug, citing a lack of genuine innovation and the contentious practice of 'evergreening'.

This ruling paves the way for Indian generic manufacturers to produce more affordable versions of the life-saving medication, marking a victory for patient access.

Entresto, known generically as sacubitril/valsartan, is a crucial medication for patients suffering from chronic heart failure, a condition affecting millions globally.

For Novartis, Entresto is a flagship product, generating billions in revenue worldwide. The revocation of its Indian patent represents not only a commercial setback but also a strong reiteration of India's stringent patent laws, particularly Section 3(d) of the Patents Act.

The contention arose because Novartis's patent application for Entresto was challenged on the grounds that it was merely a 'trivially modified' version of an existing drug, failing to demonstrate the 'inventive step' required for patentability under Indian law.

Section 3(d) specifically aims to prevent the 'evergreening' of patents, a practice where pharmaceutical companies seek new patents for minor modifications of existing drugs to extend their market monopolies beyond the original patent's expiry. This provision has historically been a cornerstone of India's policy to ensure access to affordable generic medicines.

The challenge against Novartis's patent was spearheaded by domestic generic manufacturers, most notably Natco Pharma, who had sought a compulsory license for Entresto, arguing that the drug was not sufficiently innovative to warrant a new patent.

The IPAB's decision affirms these concerns, effectively agreeing that the drug did not present a significant enough advancement over previous formulations.

This ruling has immediate and far-reaching implications. For Novartis, it means a significant loss of market exclusivity and potential revenue in one of the world's largest pharmaceutical markets.

The company will now face direct competition from Indian generic drugmakers who can produce and market sacubitril/valsartan at substantially lower prices, dramatically increasing accessibility for countless Indian patients who previously struggled to afford the brand-name drug.

Beyond the immediate commercial impact, this decision reinforces India's position as a champion of affordable healthcare, often putting public health imperatives above the commercial interests of multinational pharmaceutical companies.

It serves as a powerful message to global pharma that innovation, not just minor reformulation, is paramount for securing patent protection in India. This move is expected to invigorate the Indian generic pharmaceutical sector, encouraging further investment in developing and manufacturing essential medicines for both domestic and international markets.