Another Blow to Novartis and Its Patent Monopolies
Prabir Purkayastha
THE Swiss multinational Novartis and the Indian Patent Office are in the news again, as is Section 3(d) of India's Patent Act. Under the 3(d) provision, the Patent Office struck down the Novartis patent on Vymada, a heart failure drug, for lacking either novelty or an inventive step. Vymada, internationally marketed as Entresto, is a combination of two drugs: sacubitril and valsartan, and Novartis was claiming that by mixing the two, it created a "supramolecular complex", a claim rejected by the Indian Patent Office. The order was in a post-grant opposition filed by the Indian Pharmaceutical Alliance (IPA), which represents major domestic pharmaceutical companies. According to Business Standard (Thursday, September 25, 2025), 15 generic companies are set to enter the market within the next 2-3 months, and the price of Vymada generics is expected to drop by 70 per cent.
In India, Vymada has annual sales of Rs 550 crore, a significant and rapidly growing segment of India's cardiac medicine market. With an ageing population and patients suffering from heart and coronary diseases, these medicines are increasingly important in India's pharma market. The action of the Indian Patent Office followed a long battle fought by indigenous drug manufacturers against the Vymada patent, both in the courts and at the patent office.
As part of this battle, Indian generic manufacturers utilised the provisions of pre- and post-grant opposition in the Indian Patent Act to challenge the Vymada patent. While 3(d) provision in the Indian Act is well known, the less known provisions of pre- and post-grant opposition to bogus patent claims are also powerful tools to strike down such patents. In the Vymada case, various generic manufacturers and the Indian Pharmaceutical Alliance contested Novartis' claims to the patent in both the patent hearings and the courts. In the first round, the Chennai Patent Office granted Vymada a patent despite pre-grant objections. However, the Indian Pharmaceutical Alliance and some Indian generic manufacturers filed a post-grant opposition, which ultimately resulted in the Patent Office striking down the Vymada patent.
Novartis tried very hard to drag out the proceedings in patent hearings and also used court actions to challenge the proceedings. Any time gained through such delays means their monopoly over the drug continues. Finally, they presented their arguments for the grant of a patent, that by combining sacubitril and valsartan, they had created a "supramolecular complex with special properties". However, Dr Usha Rao (Deputy Controller of Patents & Designs), Indian Patent Office, held that Novartis had failed to show any inventive step in mixing/combining the two compounds, and also any specific therapeutic benefit of its claimed "supramolecular complex" over existing individual compounds. Therefore, in her order dated August 20, 2025, Dr Rao struck down the Novartis patent.
Interestingly, a battle over Entresto is also being fought in the US courts, as Novartis' patents are also coming to an end there. Novartis has also lost the case based on the claim of a "new chemical compound" resulting from the combination of the two individual molecules, a claim that the US courts have rejected on grounds similar to those used by the Indian Patent Office.
The pre- and post-grant opposition is a part of the Indian Patent Act, which allows other parties to examine any patent filed that pertains to their business and oppose any patent that makes spurious claims, thereby creating a monopoly. In other words, companies use such spurious claims to assert property rights over knowledge that is commonly known to other practitioners in the field. The 3(d) section of the Indian Patent Act defines what cannot be patented and protects us from companies like Novartis who want to fence in the knowledge commons.
With India joining the World Trade Organisation, the WTO, India had to bring the Indian Patent Act in conformity with the WTO's TRIPs Agreement by 2005. The Congress required the Left's support in the Lok Sabha, as it did not have a majority at that time to pass the required Amendments to the Patent Act. This allowed the Left, with the help of other activist bodies working on intellectual property, to modify the proposed Act in a way that utilised the flexibilities within TRIPS to protect the Indian pharmaceutical industry. These modifications are reflected in the 3(d) section and pre and post grant oppositions of the Act. These sections were specifically inserted to stop the ever-greening of patents of existing drugs by MNCs using minor tweaks and modifications, and continuing to loot monopoly profits from the Indian people. The earlier striking down of claims of the Glivec patent and now Vymada are two major, visible victories in this larger battle.
Vymada's international version is Entresto and Novartis' best-selling drug worldwide, earning a whopping $7.8 billion. Interestingly, Entresto is also facing a challenge from several generic manufacturers in Novartis' home market, the US, which accounts for half of its global sales. MSN, an Indian generic company, has recently won its case against Novartis in the US, with a federal judge rejecting Novartis' claims on very similar grounds that the Indian Patent Office used (Reuters, July 17, 2025). This means MSN Pharmaceuticals, as well as other generic companies, can market a generic version of Entresto in the US market soon, posing a serious threat to Novartis' biggest money spinner.
For those who may remember the Glivec case, this is a repeat of the same, where the Indian Patent Office denied Glivec a patent in India, followed by Novartis seeking to strike down the 3(d) section of the Indian Patents Act. The 3(d) judgment established the bar by ruling out ever-greening of patents in India on flimsy grounds and protecting the Indian people from extortion for lifesaving medicines. It also led to a number of other countries in the developing world, such as Brazil and South Africa, incorporating such flexibilities (Economic Times, October 24, 2013) in their own patent laws as well. It is not surprising that MNCs fight bitterly against any attempt to challenge their patents in India, as they know the success of such a challenge has global repercussions.
Why do global MNCs want such high prices for their medicines? When India issued a compulsory license on Bayer's Nexavar, a cancer drug, Bayer CEO Marijn Dekkers had said regarding the high price of Bayer's Nexavar, "We did not develop this medicine for Indians. We developed it for Western patients who can afford it." That is why India's amended Patent Act 2005 retains the compulsory licensing features of the earlier Patent Act, pre- and post-grant opposition, apart from the more well-known 3(d) provisions. This allows India to issue a compulsory license of such high cost patented drugs to Indian companies such that these medicines are available to the Indian people.
I will end this article by remembering those who were central to creating a movement on the relatively difficult question of what is probably an arcane and obscure area for most activists, namely, intellectual property rights. Foremost in this list are BK Keyala and Amit Sengupta, both founder members of the National Working Group on Patent Laws. They are no longer with us, and we feel their loss deeply. Another person who played a critical role is SP Shukla, former commerce secretary and India's representative at GATT.
The details of the fight against the WTO's trade and intellectual property rights regime, how, during GATT negotiations, India, Brazil and other countries fought for the exceptions and possible alternatives that developing countries could use, are spelt out in various articles in the publication Political Journeys in Health, Essays by and for Amit Sengupta (LeftWord Books, 2020). This book spells out in detail not only the battle over medicines for all but also the larger battle for health for all. Education and health are the fundamental rights of all our citizens. Providing lifesaving medicines is very much a part of that right, which the Indian State has to ensure. That is a much larger battle which we will continue to take up in these columns. Today, let us celebrate a small victory over a major global pharma company and its attempt to evergreen its patent on Vymada, and hope it brings relief to cardiac patients in India whose numbers are unfortunately growing.
