How to slash a drug price by 97 per cent

The judgements have come in fairly quick succession, and they have directly or indirectly put patients first by prioritising the need for more affordable medicines. Not just the courts but the Patent Office has reminded drug multinationals that the laws here do not allow the evergreening—this is a term for unduly extending the patent period by tweaking the original invention—to continue raking in monopoly profits. Recent decisions by the Delhi High Court—with a nod of approval from the Supreme Court—combined with a decision by the Indian Patent Office to revoke a patent have, after a long hiatus, put the spotlight back on the special provisions in India’s Patent Act that balance patent rights with public good.

The most critical of these provisions is Section 3d, which clearly lays down what is patentable or not, and specifically bars new patents on old molecules unless these demonstrate improved efficacy. This is a unique safeguard incorporated in the amended law 20 years ago to comply with the rules of World Trade Organization (WTO) on intellectual property protection. This section has been under assault since the very inception, challenged in courts, and at the Patent Office and internationally by developed countries during trade negotiations.

An attempt was even made, unsuccessfully, to have it removed from the statute by Swiss multinational Novartis. But, strangely, since then Section 3d has not enjoyed much purchase and courts have tended to treat such challenges with caution. In recent weeks, however, Section 3d and, ironically, Novartis again have been in the spotlight after the Patent Office revoked the patent on its cardiac blockbuster drug entresto on the grounds that it lacked novelty and failed to show any inventive step. Entresto, marketed as Vymada in India, is used in the treatment of hypertension and serious heart conditions, and it is one of the top money-spinner for Novartis, bringing in revenues of $7.8 billion last year.

The patent challenge was instituted by a couple of lesser known generic companies but unusually it was backed by industry organisation, the Indian Pharmaceutical Alliance (IPA) which represents India’s top generic manufacturers. This initiative by IPA has helped to raise the stakes in the patent suit against the Swiss multinational’s claim that it had invented a "supramolecular complex" by combining two drugs, sacubitril and valsartan, a claim viewed as a clear attempt at evergreening by the generic companies. The decision by the deputy controller of patents D Usha Rao to revoke it in September has left no doubt that Novartis had resorted to the usual stratagem used by Big Pharma to extend a patent. Here is what Rao said in her order striking down the Vymada patent: "The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed in the patentee's own earlier application. No experimental data, comparative studies or technical rationale have been provided to substantiate any enhanced efficacy. Further no improved therapeutic efficacy has been shown".

It was a blunt rejection, but it begs the question why the patent office found it worthy of a patent in the first place despite a strong pre-grant opposition from generic companies. The patent was granted in 2022, while an earlier patent on another form of the same molecule expired in 2023.

Be that as it may, the good news is that a large number of generic makers are set to enter the market for a drug that is in huge demand in India—Vymada is estimated have sales close to Rs 600 crore—where cardiac cases are increasing sharply. Market reports say that several companies had earlier launched generic versions of the drug “at risk” since they were running afoul of the patent and could invite injunctions. The price of the generic version is expected to plummet sharply by a steep 70 per cent.

The more dramatic consequences of a court decision against the sophisticated patent practices of a global drug giants will be seen in the case of risdiplam, a medication invented by another Swiss major Hoffman La Roche, to treat spinal muscular atrophy (SMA), a rare but debilitating disease that requires life-long medication to control it. The case caught public attention in March this year when a Delhi High Court judge gave a verdict that went resoundingly in favour of the feisty generic company Natco of Hyderabad against a patent infringement suit filed by Roche. The company had sought an injunction against Natco for developing a generic version of its risdiplam which is a prohibitively expensive drug (see "Putting public health before patent rights", Down To Earth, 16-30 April, 2025).

Since then, the legal challenge has moved swiftly through the courts, unusually so, and over the last two weeks, Roche has failed to win a stay either in its appeal to the division bench of Delhi High Court or even in a special leave petition (SLP) filed in the Supreme Court. In this case the crux of the dispute is the ambit of the two separate patents that Roche has filed on risdiplam: the genus patent which is broader in coverage (filed earlier) and the later species patent which is more specific. Natco contends that it is an attempt at evergreening by Roche.

Of interest is the Supreme Court’s quick decision, almost immediately, not to entertain the special leave petition seeking an injunction; instead, it has urged the lower court to resolve the case expeditiously. Roche appears to have failed to make a dent with the standard argument that research on rare disease drugs necessitate high prices—in this case, an exorbitant Rs 600,000 for a bottle of risdiplam.

Of greater interest now to SMA patients is the price at which the medicine will be available to them if Natco and possibly other generics makers, go ahead with the production of risdiplam. Experts say risdiplam is a small-molecule medicine, less complex and cheaper to manufacture than other SMA treatments. Natco has promised to offer it at Rs 15,900 per bottle, according to some reports. That would mean a 97 per cent drop in the price!

The jubilation by patients will have to wait till the case is decided in the Delhi High Court. Novartis, too, may challenge the court’s verdict. But indications are that the provisions of the patent law are being taken more seriously now.