Still on the Scales: The Ongoing Patent Battle for Semaglutide
Back in May 2025, the order (pdf) by the Delhi High Court (DHC), the Single Bench (SB) comprising Justice Amit Bansal, granted Novo Nordisk an interim injunction, preventing Indian companies Dr. Reddy’s Laboratories (DRL) and OneSource Specialty Pharma from selling or marketing semaglutide (the key ingredient in Ozempic/Wegovy) within India. However, they were allowed to manufacture and export to countries where Novo Nordisk’s patent does not apply. The order arose from a patent infringement suit filed by Novo Nordisk, a Danish drug manufacturer (pdf).
Importantly, the SB permitted the companies to continue manufacturing and exporting the drug. The original composition patent for semaglutide expired in September 2024. However, a formulation patent (Indian Patent No. 262697, expiring in March 2026) remains enforceable and forms the crux of Novo Nordisk’s infringement claim.
Dr. Reddy’s has countered with a revocation petition under Section 64 of India’s Patents Act, arguing that the formulation patent lacks novelty and inventive step, framing it as a classic case of evergreening. The argument also hinges on Section 107A(b) in the Indian Patent Act 1970, India’s “Bolar exemption,” which may allow generic manufacturing for export during the patent term without constituting infringement. I covered these aspects in depth here.
The SB will continue to hear the Danish company’s injunction application. The next court date is set for August 19, 2025, where deeper legal arguments, such as the validity of the formulation patent and the legality of exports, will be examined.
Semaglutide has never really gone out of the news since this controversy began, honestly. This post is your update on all that has been happening in connection with this drug over the past few months.
Over the Counter and Out of Control: The Rising Semaglutide Safety Concerns
On 2 July 2025, in Jitendra Chouksey v. Union of India, W.P.(C) 8773/2025 (pdf), the DHC’s Division Bench (DB) comprising Chief Justice Devendra Kumar Upadhyay and Justice Tushar Rao Gedela, expressed serious concern over the misuse of these drugs while disposing of a public interest litigation (PIL) that raised alarm over the off-label and unregulated use of powerful anti-diabetic drugs like Ozempic (semaglutide), Mounjaro (tirzepatide) and Victoza (liraglutide) for weight loss.
Originally developed to manage Type 2 diabetes by regulating blood sugar levels, GLP-1 receptor agonists have gained global popularity for their secondary effect of promoting weight loss. The PIL highlighted their growing repurposing for aesthetic weight loss without India-specific clinical trials, safety evaluations, or regulatory safeguards, citing 82 deaths in the UK, pending lawsuits in the US, and serious health risks including pancreatitis, thyroid cancer, cardiovascular complications, and potential neurological damage. It also flagged unregulated promotion through influencers, clinics, and digital wellness platforms targeting youngsters, arguing this violated the right to health under Article 21 and the precautionary principle. The petitioner sought urgent measures such as suspension of approvals for non-diabetic use, a ban on off-label promotion, and a pharmacovigilance mechanism. While not ruling on these prayers, the Court directed the Central Drugs Standard Control Organisation (CDSCO) to respond to the representation within three months.
These concerns are not unfounded, especially in light of counterfeit (in the context of these products infringing the trademarks of Novo Nordisk) versions being sold in India even before the drug was approved. In late 2023, Novo Nordisk partnered with IndiaMART to remove counterfeit and illegal listings of Wegovy and Ozempic, for which it remained the sole patent holder of the active ingredient semaglutide. (Side note: IndiaMART and counterfeits in another context have been covered on the blog here.) Although neither drug was approved in India, they remain available via personal import. A Reuters review found dozens of listings between September and November featuring Wegovy, Ozempic, and claimed semaglutide copies from a Bangladesh-based firm. While a legally imported box of Wegovy with three injection pens costs about €1,200 ($1,309), similar boxes with four pens purporting to be Wegovy were listed on IndiaMART for as little as ₹18,000 ($216.50).
The scale of counterfeit circulation led a leading United States government agency to place IndiaMART on its 2022 “Notorious Markets” list. However, these are to be read in the larger geopolitical context of the U.S. government reporting any market as concerning, often not being particularly informative, as such reports tend to conflate separate issues to push for stronger IP protections regardless of the specific regulatory or public health context. More recently, an Indian national was arrested in the US for shipping counterfeit oncology drugs, including Keytruda in mid-2024, while in early 2025, Indian chemical companies Raxuter Chemicals and Athos Chemicals were indicted for smuggling fentanyl precursors into the US and Mexico.
Moreover, on 12 July 2025, authorities arrested eight individuals, including four employees of Dr. Reddy’s Laboratories, in connection with the theft of approximately 460 grams of semaglutide worth over ₹2 crore as well as possession of counterfeit stock of 460 grams, mainly to meet over-the-counter market demand for aesthetic use. , underlining that counterfeiting continues to be a central concern in the most recent developments around these drugs.
In both of the above case studies, “counterfeits” refers to trademark-infringing versions involving unauthorised use of branding and packaging being sold in India. This is distinct from, though it can overlap with, regulatory concerns over product quality, where a drug may be packaged exactly like Ozempic yet contain substandard or spurious ingredients. Conversely, a drug might have legitimate authorisation to use Ozempic’s packaging but still fail quality standards. The next part deals with such an issue.
Global Side Effects: An Alleged International Counterfeit Drug Scam
On 11 August 2025, in the State of Delhi v. Vicky Ramancha (pdf), a single bench comprising Additional Sessions Judge (ASJ) Saurabh Partap Singh Laler of Patiala House Courts, New Delhi, refused to grant anticipatory bail to businessman Vicky Ramancha, the prime accused in an alleged US$18.8 million international scam involving counterfeit doses of the anti-diabetic drug Ozempic. A United States-based firm, Assure Global LLC, accused Ramancha and his associated entities in Dubai and the United States of agreeing to supply 125,000 doses of Ozempic but instead delivering spurious drugs that were seized by the United States Food and Drug Administration (FDA) as counterfeit. Ramancha allegedly represented that he had political connections in India and produced agreements and invoices purportedly from China and Hong Kong’s Ouchi Pharma, notarised at Patiala House.
The bail was rejected in view of, firstly, the scale of the alleged fraud and the serious health risks posed by exporting spurious pharmaceuticals to the United States, which made it inappropriate to grant anticipatory bail. The landmark case of Gurbaksh Singh Sibbia v. State of Punjab (1980) established that anticipatory bail is a discretionary remedy, to be granted on a case-by-case basis after considering the gravity of the accusation, the accused’s conduct, the risk of flight, and public interest, and not as a shield for the guilty, with courts free to impose suitable conditions. A relevant parallel is Mukesh Saini v. State of Himachal Pradesh (2023), where anticipatory bail was denied in a case involving the manufacture and distribution of spurious drugs. The court there noted that the offence jeopardised innocent lives, the accused was not cooperating with the investigation, and that in such “heinous” crimes, anticipatory bail could not be treated as a right.
Secondly, the SB observed that India’s pharmaceutical industry is a strategic national asset that must be protected from criminal exploitation. It commented taht counterfeit drugs pose a direct threat to public health and safety and necessitate swift legal action to preserve India’s position as the “Pharmacy of the World.” This is particularly relevant given how poor-quality generics have previously damaged India’s reputation. The record is replete with major fines and criminal settlements, such as Ranbaxy Laboratories’ 2013 guilty plea and US$500 million settlement for felony violations involving adulterated drugs and falsified clinical data aimed at the US market. US FDA has been sending warning letters for manufacturing and quality control lapses to Indian firms like Cadila Pharmaceuticals (2014, 2016, 2019), Glenmark Pharmaceuticals (2019-2025), Zydus Lifesciences (2024), Kilitch Healthcare (2024) and Natco Pharma (2024), among others. Several other firms, including Aurobindo Pharma, Emcure, Strides Pharma, Lantech, Indoco, B. Jain, Glint Cosmetics, and Rxhomeo, have also faced repeated violations.
Some incidents have had severe international consequences, such as the toxic cough syrup scandal of 2022-2023, where Indian-made syrups with deadly contaminants caused child deaths in Uzbekistan and Cameroon, prompting WHO alerts and investigations into manufacturers like Marion Biotech, Riemann Pvt Ltd, and Wellona Pharma. Moreover, academic reviews like Can We Trust the Quality of Generic Drugs? and Bottle of Lies have further exposed how such practices jeopardise patient safety and erode regulatory credibility. Clearly, strengthening compliance and enforcement is therefore critical, not only to protect global patients but also to preserve India’s hard-earned reputation as a trusted leader in affordable, quality pharmaceuticals, especially with important drugs going off-patent and entering India’s list for generic manufacture and global export.
Accordingly, the anticipatory bail application was dismissed on the grounds that the jurisdictional complexity presented mixed questions of fact and law requiring comprehensive investigation, which could not be conclusively addressed at the preliminary stage. This appears to be a legally sound approach, balancing investigative needs with due process. With the patent dispute on semaglutide still unresolved but exports permitted, quality concerns are bound to resurface sooner or later. The ongoing legal and regulatory battles over semaglutide remain particularly interesting to track, as policy will have to evolve to accommodate generic availability in India while ensuring that exported drugs meet international quality standards.