Indian Patent Office denies Novartis patent for Vymada, clears way for generics
Vymada, a combination of sacubitril and valsartan, is prescribed for hypertension and heart failure.
- Sep 16, 2025,
- Updated Sep 16, 2025 3:58 PM IST
The Controller General of Patents, Designs and Trademarks (CGPDTM), the Indian Patent Office, has annulled the patent granted to Novartis for its cardiac drug Vymada, also sold internationally as Entresto.
The decision, issued on 12 September 2025, cited a lack of novelty, insufficient inventive step, and inadequate disclosure of advantages in the patent application, opening the door for domestic pharmaceutical companies to produce generic versions and potentially reduce treatment costs.
Vymada, a combination of sacubitril and valsartan, is prescribed for hypertension and heart failure. It is among Novartis’ top-selling drugs, generating $7.8 billion globally in 2024. In India, the cardiovascular drug market is estimated at ₹12,000–15,000 crore ($1.5–2 billion) annually. With nearly a third of Indian adults affected by hypertension—around 300 million people—and 2–3 million diagnosed with heart failure, the entry of generics could improve access significantly. Monthly therapy costs, currently ranging from ₹10,000 to ₹ 12,000, could decrease by 30–50% depending on the level of competition.
The ruling concerns a patent granted in December 2022 for a crystalline “supramolecular complex” of sacubitril and valsartan. This followed Novartis’ original patent on the fixed-dose combination of the two drugs, which expired on 16 January 2023. Had the 2022 patent remained valid, it would have extended Novartis’ exclusivity until 2026, restricting generic production and keeping prices high.
Natco Pharma, which had filed a pre-grant opposition in September 2016 under Section 25(1) of the Indian Patent Act, argued that the crystalline complex did not provide any significant therapeutic advantage over previous formulations. The Delhi High Court stayed the patent in January 2023, noting procedural lapses and that Natco’s opposition had not been adequately considered.
In its final order, Deputy Controller of Patents and Designs D Usha Rao observed that Novartis had not submitted sufficient experimental data, comparative studies, or technical rationale to demonstrate enhanced efficacy. “The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed in D1,” Rao stated in a 262-page order. The patent conflicted with Sections 25(2)(b), 25(2)(c), 25(2)(e), and 25(2)(g) of the Patents Act.
The patent IN’518, covering Novartis’ new version of the heart drug Vymada (a combination of valsartan and sacubitril), has been rejected under Section 3(d) of the Indian Patents Act, 1970.
The Controller of Patents concluded that this new version, called a “supramolecular complex,” does not count as a patentable invention because it does not show any real improvement in how the drug works compared to the older combination. Indian law allows patents for new forms of known drugs only if they provide a clear therapeutic benefit. In this case, the evidence presented by Novartis—such as lab studies, publications, and post-filing data—did not prove any better clinical results or stronger effect on patients.
Earlier patents had already documented the combination of valsartan and sacubitril, and the new complex was seen as a minor variation rather than a meaningful innovation. The Controller also cited previous Supreme Court rulings, which make it clear that improvements in properties like solubility or stability alone are not enough to secure a patent unless they translate into better treatment outcomes.
In short, the patent was denied because the new complex does not show any significant advantage over the existing drug combination.
The case has been under scrutiny for nearly two decades. Novartis first secured a patent for the sacubitril-valsartan combination in February 2009. Following the 2023 expiration, the company introduced the crystalline supramolecular complex, a practice sometimes described as “evergreening,” intended to extend market exclusivity. Indian patent law explicitly seeks to curb such extensions that do not demonstrate meaningful innovation. The IPO ruling shows that the new patent did not meet the threshold for novelty or inventive step.
“The revocation of Novartis’s patent is a stark reminder that in India, pharmaceutical patents are scrutinized not only for novelty and inventive step but also for genuine therapeutic advancement under Section 3(d). The ruling underscores the judiciary’s intent to curb evergreening and protect access to affordable medicines. In my view, Novartis faltered in failing to establish a demonstrable improvement in efficacy beyond known formulations, which made the claims vulnerable,” said Sonam Chandwani, Managing Partner, KS Legal and Associates.
Several Indian pharmaceutical companies, including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences, had previously launched generic versions while facing potential legal challenges. With the patent now annulled, these companies can operate without uncertainty, and additional players are expected to enter the market, potentially lowering prices further.
“Going forward, companies must be meticulous in generating robust clinical and technical data to substantiate efficacy improvements and draft claims that withstand challenges on obviousness, else even blockbuster drugs risk being stripped of exclusivity in critical markets like India,” said Chandwani.
Globally, Novartis’ Entresto remains a major revenue driver, with its $7.8 billion sales in 2024 concentrated in the US, Europe, and emerging markets. The availability of Indian generics could also create opportunities to supply regions where the drug remains expensive, expanding access in emerging markets.
Novartis did not comment on the matter. The company retains the option to appeal to the Delhi High Court.
The Controller General of Patents, Designs and Trademarks (CGPDTM), the Indian Patent Office, has annulled the patent granted to Novartis for its cardiac drug Vymada, also sold internationally as Entresto.
The decision, issued on 12 September 2025, cited a lack of novelty, insufficient inventive step, and inadequate disclosure of advantages in the patent application, opening the door for domestic pharmaceutical companies to produce generic versions and potentially reduce treatment costs.
Vymada, a combination of sacubitril and valsartan, is prescribed for hypertension and heart failure. It is among Novartis’ top-selling drugs, generating $7.8 billion globally in 2024. In India, the cardiovascular drug market is estimated at ₹12,000–15,000 crore ($1.5–2 billion) annually. With nearly a third of Indian adults affected by hypertension—around 300 million people—and 2–3 million diagnosed with heart failure, the entry of generics could improve access significantly. Monthly therapy costs, currently ranging from ₹10,000 to ₹ 12,000, could decrease by 30–50% depending on the level of competition.
The ruling concerns a patent granted in December 2022 for a crystalline “supramolecular complex” of sacubitril and valsartan. This followed Novartis’ original patent on the fixed-dose combination of the two drugs, which expired on 16 January 2023. Had the 2022 patent remained valid, it would have extended Novartis’ exclusivity until 2026, restricting generic production and keeping prices high.
Natco Pharma, which had filed a pre-grant opposition in September 2016 under Section 25(1) of the Indian Patent Act, argued that the crystalline complex did not provide any significant therapeutic advantage over previous formulations. The Delhi High Court stayed the patent in January 2023, noting procedural lapses and that Natco’s opposition had not been adequately considered.
In its final order, Deputy Controller of Patents and Designs D Usha Rao observed that Novartis had not submitted sufficient experimental data, comparative studies, or technical rationale to demonstrate enhanced efficacy. “The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed in D1,” Rao stated in a 262-page order. The patent conflicted with Sections 25(2)(b), 25(2)(c), 25(2)(e), and 25(2)(g) of the Patents Act.
The patent IN’518, covering Novartis’ new version of the heart drug Vymada (a combination of valsartan and sacubitril), has been rejected under Section 3(d) of the Indian Patents Act, 1970.
The Controller of Patents concluded that this new version, called a “supramolecular complex,” does not count as a patentable invention because it does not show any real improvement in how the drug works compared to the older combination. Indian law allows patents for new forms of known drugs only if they provide a clear therapeutic benefit. In this case, the evidence presented by Novartis—such as lab studies, publications, and post-filing data—did not prove any better clinical results or stronger effect on patients.
Earlier patents had already documented the combination of valsartan and sacubitril, and the new complex was seen as a minor variation rather than a meaningful innovation. The Controller also cited previous Supreme Court rulings, which make it clear that improvements in properties like solubility or stability alone are not enough to secure a patent unless they translate into better treatment outcomes.
In short, the patent was denied because the new complex does not show any significant advantage over the existing drug combination.
The case has been under scrutiny for nearly two decades. Novartis first secured a patent for the sacubitril-valsartan combination in February 2009. Following the 2023 expiration, the company introduced the crystalline supramolecular complex, a practice sometimes described as “evergreening,” intended to extend market exclusivity. Indian patent law explicitly seeks to curb such extensions that do not demonstrate meaningful innovation. The IPO ruling shows that the new patent did not meet the threshold for novelty or inventive step.
“The revocation of Novartis’s patent is a stark reminder that in India, pharmaceutical patents are scrutinized not only for novelty and inventive step but also for genuine therapeutic advancement under Section 3(d). The ruling underscores the judiciary’s intent to curb evergreening and protect access to affordable medicines. In my view, Novartis faltered in failing to establish a demonstrable improvement in efficacy beyond known formulations, which made the claims vulnerable,” said Sonam Chandwani, Managing Partner, KS Legal and Associates.
Several Indian pharmaceutical companies, including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences, had previously launched generic versions while facing potential legal challenges. With the patent now annulled, these companies can operate without uncertainty, and additional players are expected to enter the market, potentially lowering prices further.
“Going forward, companies must be meticulous in generating robust clinical and technical data to substantiate efficacy improvements and draft claims that withstand challenges on obviousness, else even blockbuster drugs risk being stripped of exclusivity in critical markets like India,” said Chandwani.
Globally, Novartis’ Entresto remains a major revenue driver, with its $7.8 billion sales in 2024 concentrated in the US, Europe, and emerging markets. The availability of Indian generics could also create opportunities to supply regions where the drug remains expensive, expanding access in emerging markets.
Novartis did not comment on the matter. The company retains the option to appeal to the Delhi High Court.