[A big thanks to Praharsh and Swaraj for their inputs on this post.]
[Disclaimer: Long post ahead]
A recent order (pdf) by the Delhi High Court (DHC) has drawn significant attention regarding the manufacture and availability of the diabetes management and weight-loss assistance drug semaglutide (sold as Wegovy and Ozempic). On 29 May 2025, the Single Bench (SB) comprising Justice Amit Bansal restrained Indian companies Dr. Reddy’s Laboratories (DRL) and OneSource Specialty Pharma Ltd (OSSPL) from selling semaglutide domestically in a patent infringement suit filed by Novo Nordisk, a Danish drug manufacturer (pdf). However, the SB has allowed the companies to continue manufacturing and exporting the drug. Moreover, the SB will continue to hear the Danish company’s injunction application.
India bears one of the highest burdens of type 2 diabetes globally, earning it the informal title of the “diabetes capital of the world.” The World Health Organisation (WHO) estimates that around 77 million Indian adults live with type 2 diabetes, while another 25 million are considered prediabetic, facing a heightened risk of developing the disease soon. As interest in effective treatment options grows, Glucagon-like peptide-1 (GLP-1) drugs have emerged as a major pharmaceutical category. Financial analysts like Goldman Sachs project that the global market for these drugs could soar to $95 billion by 2030. In this context, ensuring timely access to advanced therapies like GLP-1 receptor agonists becomes especially critical for India.
This post will analyse certain aspects of interest that this order brings to light, specifically the argument of evergreening semaglutide and the refusal to allow an injunction on manufacture for export.
A Look at the Thick and Thin: The Background of the Case
The suit, CS(COMM) 565/2025, has been filed in the lead-up to the anticipated Indian launch of Novo Nordisk’s blockbuster weight-loss drug, Wegovy. The SB’s order restraining Dr. Reddy’s Laboratories (DRL) and OneSource Specialty Pharma Ltd (OSSPL) from selling semaglutide in the domestic market follows a patent infringement claim initiated by Novo Nordisk. The Danish pharmaceutical company has alleged that DRL and its affiliate infringed its patent by manufacturing and marketing semaglutide formulations without a patent license from Novo. Semaglutide is the active pharmaceutical ingredient in several of Novo Nordisk’s key GLP-1 products, including Ozempic, Wegovy, and Rybelsus, all of which are widely prescribed for type 2 diabetes and obesity.
To also provide a brief global context: Novo Nordisk initiated infringement proceedings in 2024 against DRL and other major US-based pharmaceutical companies for alleged violations of its U.S. patent rights in Semaglutide. These actions also included efforts to curb the sale of counterfeit versions of Ozempic. Between 4 and 8 October 2024, Novo Nordisk, DRL, and several other pharma companies submitted joint motions before the US Patent Trial and Appeal Board (PTAB), notifying the Board of a settlement concerning the validity of U.S. Patent No. 10,335,462 (the ‘462 patent), which covers specific “dosage regimes” of Ozempic used for treating type 2 diabetes.
Thin Edge of the Wedge: The Analysis of the Case and the Bigger Implications It’ll Have
Three major aspects merit close attention in the aforementioned Order.
First, much of the current discourse centres on the fact that DRL will not launch its version of the drug in India owing to an undertaking. What’s particularly interesting here, as highlighted by Dr. Amitavo Mitra’s LinkedIn post here, is that this undertaking is not to refrain from launching until patent expiry, but only until DRL obtains the regulatory licence to sell the product. This is, as he points out, a significant difference as it doesn’t quite require maintaining the status quo on not launching the drug until an interim judicial determination. Instead, it suggests that once DRL secures regulatory approval, the matter is likely to be contested again. One can reasonably expect Novo Nordisk to revive its objections at the point after licensing approvals are in the hands of DRL and it starts providing to the domestic market as well.
This brings us to the second issue: the evergreening argument raised by DRL. There are two key patents of Novo Nordisk for Semaglutide that are relevant in the present context. Novo Nordisk filed its first national phase application (IN1313/DELNP/2006) (pdf) with PCT International Filling date as 17/09/2004), (Patent Number: 275964). A second national phase application (IN5107/DELNP/2007) (pdf) with PCT International Filing date as 20/03/2006), (Patent Number: 262697), was filed subsequently. Since the term of patent for international applications commences from the date of international filing (Section 53), the first patent, which was granted in 2016 (pdf), expired on 17 September 2024 (see image 1).
The second patent was granted in 2014 and is set to expire on 20 March 2026 (see image 2).
Thirdly, there’s also a patent application (IN202047010224) (pdf) pending by Novo Nordisk, filed in 2020 with priority date of 24/08/2017, for a specific formulation of semaglutide (the active ingredient in its commercial blockbuster drug, Ozempic) described as “Semaglutide liquid formulations (no more than 0.01% (w/w) phenol.”
Adding to the complexity is a recent revocation petition filed by DRL in May 2025 (as reported by the media here). While the number of the patent against which this revocation petition has been filed is unclear, we have been told by one of our long-time readers that it’s against the patent ‘697. Overall, the close timing of these filings and the overlap in subject matter raise familiar questions about evergreening, especially in a pharmaceutical context where extending exclusivity is often as commercially significant as the innovation itself (discussed on the blog before here).
While official filings or detailed arguments are not publicly available, media reports indicate that DRL has challenged Novo Nordisk’s ‘697 patent on the grounds of lacking novelty, inventive step, being insufficiently disclosed, and the patent being obtained through misrepresentation. DRL contends that Semaglutide had already been disclosed in Novo’s earlier Indian patent, and that the only difference in the current patent was the substitution of Alanine with Aib at the eighth position. This modification was claimed to be a popular and standard modification aimed at enhancing molecular stability and resistance to enzymatic degradation.
DRL has further accused Novo Nordisk of employing evergreening tactics. Under Section 3(d) of the Indian Patent Act 1970 this refers to the strategy wherein patent holders make minor modifications to existing products or formulations in order to prolong market exclusivity without enhancing the innovation’s “efficacy.” Whether these claims will hold up before the authorities remains to be seen.
Extending Monopoly? Analysing whether Novo Nordisk is employing Evergreening and Patent Layering Tactics
The global generic landscape for Semaglutide is already shifting. Just a day before the Delhi High Court’s order, it was reported that Russian pharmaceutical company Geropharm had been granted a compulsory licence to produce a generic version of Novo’s Ozempic. The generic, named Semavic, reportedly sold over one million packs in Russia in its first full year on the market.
Novo Nordisk’s patents for Semaglutide-based products are expiring in different jurisdictions at different times. For a detailed breakdown, one may refer to the section titled “Patent status for products with marketing authorisation” on page 25 of Novo Nordisk’s Annual Report 2024.
Moreover, Indian pharmaceutical giants such as DRL, Sun Pharma, Biocon, and Cipla are already developing their own versions of GLP-1 receptor agonists, including generic variants of Semaglutide. The competitive landscape is also heating up internationally. United States-based innovator Eli Lilly has already introduced Mounjaro (tirzepatide) in India, a once-weekly injectable for type 2 diabetes and weight management. Lilly, however, has opted to launch Mounjaro in vial form, unlike Novo’s pen-based delivery system. Mounjaro in India at ₹3,500 for a 2.5 mg vial and ₹4,375 for a 5 mg vial, which is significantly more affordable compared to the Ozempic injection that costs at least ₹20,000 per shot and can exceed ₹80,000 per month due to its weekly dosage, as per The Mint. Moreover, in the first direct comparison study, Eli Lilly’s anti-obesity drug Zepbound outperformed Novo Nordisk’s Wegovy. In light of this, if Novo Nordisk succeeds in defending its patent, it would considerably strengthen its position in the Indian market. However, whether the patent challenge based on lack of novelty and allegations of evergreening will stand legal scrutiny is something that remains to be seen.
Another extremely interesting and latest update shows that in 2020, Novo Nordisk quietly lost its Canadian patent for semaglutide due to a missed maintenance fee of just ~1,200 CAD. With no other semaglutide patents listed in Canada’s Patent Register, generic and biosimilar players now have a clear path, like Sandoz’s CEO has already signaling plans to launch a GLP-1 generic in Canada as soon as exclusivity ends in January 2026. Was this a case of bad due diligence or a calculated decision to deprioritise a maturing market while pivoting to next-gen GLP-1 assets in the pipeline? That’s up for debate.
The Ambiguity on ‘Export-Only’ Manufacturing for DRL
The “export-only” argument for manufacturing merits closer scrutiny. To begin with, it is necessary to distinguish whether such export is being undertaken for regulatory purposes or for commercial exploitation (following the train of thought expressed by Dr. Amitavo Mitra here), and whether this distinction alters the applicability of Section 107A(a) of the Indian Patents Act, 1970 (India’s version of the Bolar exception, discussed earlier on this blog here). As Section 107A(a) provides that certain acts shall not be considered patent infringement, specifically allowing for the making, constructing, using, selling, or importing of a patented invention solely for uses reasonably related to the development and submission of information required under any law, whether in India or in another country, that governs the manufacture, construction, use, sale, or import of any product.
The jurisprudence on this provision, especially within the pharmaceutical and healthcare sectors, is fairly evolved and, in my view, well-settled in the Delhi High Court (DHC). Landmark cases such as Bayer v. Union of India (2019) have interpreted Section 107A(a), affirming that exports made for regulatory purposes fall within its scope. However, what remains to be tested in this instance is whether such export, when meant for non-regulatory or commercial reasons, enjoys the same exemption.
In the present matter, DRL has clearly stated that it holds a valid licence to manufacture Semaglutide and claims it intends to export solely to jurisdictions where no valid patent exists. Yet, it continues to face litigation. This is because the courts appear to treat such conduct as an infringement “by implication,” on the reasoning that the goods are being exported for sale, which falls within the patentee’s exclusive rights under Section 48 (an interpretation the Delhi High Court adopted in Lundbeck v Hetero). This approach has drawn criticism, especially for stretching the interpretation of patent rights beyond India’s borders, raising concerns about the territorial nature of patents, as discussed here.
The stakes are particularly high given the enormous commercial potential of the GLP-1 and obesity drug markets. These drugs have triggered a wave of consumer interest, especially with the entry of generic manufacturers. With Eli Lilly moving ahead of Novo Nordisk in launching its competing products, the outcome of this patent dispute becomes especially critical for Novo’s positioning in the Indian market. On the other hand, the market impact is already being felt. Shares of DRL and OSSPL declined by up to 3% following the DHC’s order banning the sale of Semaglutide in India. While several legal questions remain open for the court’s determination, it is evident that this case is far from an open-and-shut matter under Section 48 of the Patents Act, 1970.