India Pharma Outlook Team | Tuesday, 16 September 2025
Swiss drugmaker Novartis suffered a major blow as the Indian Patent Office (IPO) stripped off the patent for its heart failure drug Vymada (Entresto internationally) citing it as a lack of novelty and inventive step. The ruling, which is based on September 12 data, is going to be the gateway for affordable generics, as the competition in the therapy segment, having last year 7.8 billion dollars of global sales, will get more intense.
This verdict is the final of a legal feud with generic manufacturers who had appealed against the restrictions imposed by the courts following Novartis’ lawsuits. Among the companies to be released from the bondage of the patent are those that will be able to bring out their versions and thus anonymity prices can be lowered substantially.
Indian Pharmaceutical Alliance, together with IPCA and Micro Labs, had filed an objection to the grant of the patent, referring to the issue of Section 3(d) of the Patents Act and arguing that the invention was not an improvement over the prior art. This section had been in the spotlight in 2013 when the Indian Supreme Court ruled against Novartis’ claim for patent protection on Glivec cancer therapy.
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Deputy Controller of Patents and Designs D. Usha Rao accused Novartis of not providing sufficient information for the claimed supramolecular complex to show less-traded compounds or drug combinations with increased therapeutic effects to be backed up by scientific publications. "No Experimental data, no comparative studies, no technical reasons given," was the comment given by the order.
