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HomeWhat Semaglutide’s Patent Expiry Should Really Mean for India – SpicyIP

What Semaglutide’s Patent Expiry Should Really Mean for India – SpicyIP

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[This post is co-authored with Khushi Krishania. Khushi is a third-year B.Sc. LL.B. (Hons.) {Cybersecurity} student at the National Law Institute University, Bhopal, with a particular interest in the intersection of copyright and data protection law.]

Christmas came early for Indian generic manufacturers as the Indian patent on Semaglutide, a potent GLP-1 receptor agonist, expired on March 20. The drug is commercially sold by Novo Nordisk as Ozempic and Wegovy and is used to manage type-2 diabetes and obesity. After the expiry of Semaglutide’s patent term, Novo Nordisk is now set to face tough competition from generic manufacturers, notably Dr. Reddy’s Labs, Natco Pharma, Zydus, Torrent Pharma, and Sun Pharma. With generic competitors adopting a different strategy towards marketing and administering the drugs, these drugs are available at a price as low as INR 1300 to INR 1700/ month (depending on the dosage). This is a substantive price drop for the drug, which had seen a price cut only last year from INR 16,260 to INR 10,850 (see here). Those familiar with the Semaglutide journey would know that March 2026 was particularly an action-packed month, witnessing court orders concerning patents and drug regulation. In this post, we’ll take a look at some of the important events preceding the Semaglutide patent cliff and also reflect on the systematic approach that pharma companies, doctors, and the general public should have towards these drugs moving forward, especially considering the way these are being projected as a wonder drug to cure the obesity problem in the country.

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Division Bench Order in Novo Nordisk v. Dr. Reddy’s Labs

Even before the whirlwind of media outlets reporting on the drug in 2026, Semaglutide had grabbed the attention of Indian pharma folks in mid 2025. This was largely due to the intense court battle between Novo Nordisk and Dr. Reddy’s Labs, where the Danish pharma giant had alleged that the Indian generic manufacturer had infringed its patent by exporting its generic version to countries where Semaglutide is not patented. On the flipside, Dr. Reddy’s Labs challenged the validity of the suit patent and argued that its activities would fall under the Section 107A exception. In a 99-page order, the Delhi High Court refused to grant an interim injunction to Novo Nordisk, finding a credible challenge against the validity of the suit patent. But controversially, it still barred Dr. Reddy’s Labs from selling its drugs in India, holding that they failed to “clear the way” by challenging the patent before manufacturing. This was attributed to show their procedural mala fide (Tejaswini and Yogesh have written on this litigation here, here, and here).  

On March 09, a division bench of the Delhi High Court (DB) brought some closure to this saga and refused to intervene with the above order by the Single Judge bench. The DB agreed that a credible challenge had been established by Dr. Reddy’s Labs, but disagreed on which section it fell under. Its central holding: the Single Judge erred in classifying the challenge under Section 64(1)(a) (a patent can be revoked if the invention was claimed in an earlier patent in India). Instead, the DB found Section 64(1)(f) to be a more relevant provision, which allows revocation of a patent on the grounds of obviousness or lack of any inventive step. The DB explained that Section 64(1)(a) requires a strict claim-to-claim identity between the suit patent and the prior patent. It involves no disclosure analysis, no enablement inquiry, and no role for the person skilled in the art (POSITA). It clarified that the Single Judge’s reasoning, which asked whether the genus patent’s teachings enabled a POSITA to reach Semaglutide, was precisely the kind of analysis that belongs under Section 64(1)(f) (obviousness), not Section 64(1)(a). In doing so, the Court seemed to have narrowed the scope of the ground available under Section 64(1)(a), asking for a claim-to-claim literal comparison.

A Cautious Approach Towards Interim Reliefs   

The DB decision also highlights a cautious approach to interfering with interim relief orders passed by single-judge benches. The Court relied on Supreme Court judgements in Wander v Antox and Pernod Ricard v. Karanveer Singh Chhabra to disclaim that an appellate court should not interfere with the findings of commercial courts unless they err on principle. By expressly relying on these decisions, the DB sets a right path for the benches in the future, reminding them to adopt a cautious approach in dealing with interim relief appeals. 

Another notable aspect of the decision was the stinger in the first 5 pages, where the Court wondered whether it makes sense for it to pass a judgement when the suit patent is set to expire in a matter of a couple of months from the date of the hearing. Is it actually a matter that can be regarded as “urgent”? In fact, by the time the judgement was published, only 11 days were remaining in the life of the suit patent. This reminds us of the 2024 Novartis-Natco saga, when the DB judgement was passed after the suit patent had expired, and eventually the Supreme Court had to clarify that, considering this was a matter of interim injunctions, the DB intervention was not needed. While it’s true that technically these orders do not bear any precedential value, considering that many high-stakes patent disputes in India are settled after interim stages, such orders (unfortunately) do often end up setting up the Indian patent jurisprudence and discourse. 

Another notable observation of the Court here was on the standard of the POSITA in prima facie assessment of obviousness. While dealing with obviousness, the Court clarified that the factors in F. Hoffmann-La Roche Ltd. v. Cipla Ltd to assess the obviousness would be more suitable after trial. The Roche-Cipla factors basically assess if a skilled expert, armed with existing knowledge, would have obviously arrived at the invention without the benefit of hindsight. The DB in the present case held that if these tests are applied at an interim stage, it might result in a mini-trial, something which the Supreme Court in Brihan Karan Sugar Syndicate Private Limited v. Yashwantrao Mohite Krushna Sahakari Sakhar Karkhana expressly prohibits. Instead, the Court opined that it should don the mantle of POSITA and should prima facie satisfy itself on whether a credible challenge to the validity of the suit patent has been made or not. This observation might change things drastically at interim stages, as it lowers the threshold that the defendants would have to fulfill while challenging the validity of the suit patent as a defence in infringement proceedings. 

Beyond the Patent: The Bigger Semaglutide Conversation

The patent expiry surely calls for celebration owing to the availability of more affordable options, but these developments are unlikely to quiet the conversation around the drug. In many ways, the next chapter may be louder than the last. Let’s pause here for a minute and think about all the recent “obesity awareness” ads some of us might have come across- in newspapers, Insta feeds, billboards, airports, featuring familiar faces like Boman Irani, Supriya Pathak, and Ratna Pathak Shah. These ads, which have popped up recently, are surely going to attract the attention of a large number of Indians, considering that 24% of Indian women and 23% of Indian men are overweight (as per the National Family Health Survey (NFHS)-5 (2019-21), see pages 382-383). What is worth noting here is that these ads often feature logos of pharma companies (here and here). With these affordable medicines now available in the market, India’s increasingly weight-conscious population with growing disposable incomes now has access to a cheap and seemingly quick fix for weight loss. This development also comes at a time when the fitness, gym, and nutrition market is already booming, and the arrival of this so-called ‘magic pill’ into this landscape (while exciting for pharma folks) demands serious caution. 

From a marketing perspective, one may understand the reason behind such an aggressive advertisement campaign. People are generally hesitant in switching from one brand of drugs to another, and a loyal patient base means long-running, continuous gains for the brand of drugs that the patients resort to first. However, at the same time, the success of all the companies trying to get a piece of the pie is largely dependent on how the patients are educated and engaged with. Drugs like Semaglutide are long-term drugs that are not just anti-obesity but can also transform diabetes-care and metabolic-care in the country, and therefore, it needs to be explained and projected as such, instead of projecting them as wonder drugs for weight loss. 

This also makes the role of doctors more important than ever in this Semaglutide boom. The starting few lines of this (paywalled) piece by Siddharth Kumar Singh for The Hindu describe a doctor’s experience in dealing with patients who walk up and ask for such weight loss drugs upfront. In such situations, it is necessary that the doctors explain all the effects and ill effects of the drugs to their patients. Similarly, doctors also need to educate themselves on global indications around prescribing Semaglutide and understand that they need to evaluate patients more holistically, taking into account the other ailments that are connected with obesity, such as cardiovascular diseases, osteoarthritis, kidney ailments, etc., before prescribing such drugs to them.

As per an empirical study by Armin Farahvash (et. al.) in Ontario, there has been an increasing trend in Semaglutide prescriptions for weight loss from 2018 to 2023, with most prescriptions coming from family physicians compared to specialists. Considering the prevalence of self-medication among Indians, it seems very likely that India too might witness such an attitude towards Semaglutide and go for a Jugaad fix/ dose of these so-called miracle drugs. Therefore, it is important that doctors exercise caution and educate patients about all the aspects of the drug, especially its side effects

(Side note: Interested readers can also tune into this fantastic podcast episode by the Morning Brief on Semaglutide with an in-depth discussion on some of the points raised above.)

The lack of discussion around the need for caution towards the dosage of Semaglutide reminds us of the 2025 PIL Jitendra Chouksey v. Union of India, where the petitioner raised ethical and legal issues involved in the approval of “certain drug combinations” which are sold in the market for weight loss treatment. While the order doesn’t specify the details, as per this paywalled article on Bar and Bench, the petition alleged that drugs such as Ozempic (Semaglutide), Mounjaro (Tirzepatide), and Victoza (Liraglutide) were being promoted as “quick-fix” weight-loss solutions and that there was inadequate India-specific clinical data for weight-loss indications. The Delhi High Court had then directed the Drugs Controller General of India (DCGoI) to take into account the concerns raised in the writ petition. Owing to inaction over the Court’s directions, the petitioner filed a contempt petition against the DCGoI (see here for the order by the Court issuing notice). However, just a few days before this contempt petition was heard, the government had issued an advisory (pdf) against any form of advertisements, direct or indirect, related to GLP-1 receptors, stating that the same may amount to misleading promotion and may attract provisions of the Drugs Rules, 1945. Although the move is hailed as a “crackdown” in the media (see here and here), whether the advisory will actually result in any legal actions against those who are still carrying out such campaigns (for instance, see this Instagram post by Eli Lilly India, which was published after the advisory) is something that we are yet to see. Lastly, while we have a lot of companies rushing towards coming up with their own version of the drug, it is worth noting that Semaglutide is not a small molecule drug but is a peptide that requires intense cold chain storage and a sophisticated distribution chain. So while there is a lot of enthusiasm and excitement right now, chances are that in the future we may end up having only some big players who are able to sustain the pressure from the market while being able to meet the challenges of sophisticated storage and distribution.





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