Delhi High Court Directs Sun Pharma to Seek Prior Court Approval Before Launching Generic Semaglutide Tablets

Kaustav Chowdhury

Aug 23

8 min read

In a significant development for India's pharmaceutical patent landscape, the Delhi High Court has directed Sun Pharmaceutical Industries Limited to seek prior court approval before commercially launching generic semaglutide tablets. The order, passed by Justice Anup Jairam Bhambhani, comes in the wake of a patent infringement petition filed by Danish pharmaceutical major Novo Nordisk, which holds a formulation patent covering oral semaglutide tablets marketed under the brand name Rybelsus. The ruling underscores the growing complexity of pharmaceutical patent disputes in India, particularly the distinction between compound patents and formulation patents, and their respective implications for generic drug manufacturers seeking to enter the market.

Background: The Semaglutide Patent Landscape

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist originally developed by Novo Nordisk for the treatment of type 2 diabetes and, more recently, for weight management. The drug has gained enormous global attention for its efficacy in both therapeutic areas, making it one of the most commercially valuable pharmaceutical molecules in the world today.

Novo Nordisk markets semaglutide in multiple forms: as injectable formulations under the brand names Ozempic (for diabetes) and Wegovy (for weight management), and as an oral tablet under the brand name Rybelsus. Each of these product forms is covered by distinct intellectual property protections. The compound patent, which covered the semaglutide molecule itself and protected the injectable formulations, expired in March 2026. This expiry triggered a wave of generic injectable semaglutide products entering the Indian market, as manufacturers rushed to capitalize on the immense demand for the drug.

However, Novo Nordisk retains a separate and distinct patent that specifically covers the oral tablet formulation of semaglutide. This formulation patent relates to the innovative use of Salcaprozate sodium (SNAC), a permeation enhancer that facilitates the absorption of large peptide molecules like semaglutide through the stomach lining. The SNAC technology is what makes oral delivery of semaglutide possible, and Novo Nordisk contends that this formulation patent remains valid and enforceable, protecting Rybelsus from generic competition even after the compound patent expiry.

The Compound Patent vs. Formulation Patent Distinction

The present dispute highlights a critical distinction in pharmaceutical patent law: the difference between a compound patent and a formulation patent. Understanding this distinction is essential for generic manufacturers, legal practitioners, and industry stakeholders alike.

A compound patent protects the active pharmaceutical ingredient (API) itself, covering the chemical structure of the molecule regardless of how it is formulated or delivered. Once a compound patent expires, generic manufacturers are generally free to manufacture and sell the API in conventional dosage forms.

A formulation patent, on the other hand, covers a specific method of delivering or combining the API with other excipients, carriers, or enhancers. Even after the compound patent expires, a formulation patent can prevent generic manufacturers from producing the drug in that particular dosage form or delivery mechanism.

In the case of semaglutide, while the compound patent expiry in March 2026 opened the door for generic injectable versions, the oral tablet formulation incorporating SNAC technology remains protected by a separate patent. This is precisely the patent that Novo Nordisk relies upon in its infringement action against Sun Pharma.

Novo Nordisk's Patent Infringement Claims

Novo Nordisk filed a patent infringement petition before the Delhi High Court, arguing that Sun Pharma's proposed generic semaglutide tablets would infringe its oral formulation patent. The core of Novo Nordisk's argument rests on several key assertions:

Sun Pharma received approval from a subject expert committee to manufacture semaglutide tablets in 3 mg, 7 mg, and 14 mg strengths, which are the same dosage strengths as Novo Nordisk's Rybelsus.
The oral tablet formulation necessarily involves the use of SNAC or a similar absorption enhancer, which falls within the scope of Novo Nordisk's formulation patent.
Sun Pharma could be in a position to launch its generic product as soon as it receives marketing approval from the Drug Controller General of India (DCGI), making it imperative to obtain interim protection before such a launch occurs.
Once a generic product enters the market, withdrawing it becomes extremely difficult, causing irreparable harm to the patentee's exclusive rights under Section 48 of the Indian Patents Act, 1970.

Section 48 of the Indian Patents Act, 1970 confers upon a patentee the exclusive right to prevent third parties from making, using, offering for sale, selling, or importing the patented product without authorization. Novo Nordisk's petition invokes these rights to argue that Sun Pharma's proposed launch of generic oral semaglutide tablets would constitute direct infringement of its formulation patent.

The Court's Interim Order

Justice Anup Jairam Bhambhani, after hearing the parties, passed an interim order with significant implications for Sun Pharma's market entry plans. The Court directed that:

If Sun Pharma receives a licence for the commercial manufacture of semaglutide tablets, it must inform the Court of such development.
Sun Pharma must seek prior approval from the Court before taking any further steps towards the commercial launch of the generic semaglutide tablets.
Sun Pharma is required to file its response to Novo Nordisk's patent infringement petition.

This interim direction, while stopping short of a full injunction prohibiting manufacture, effectively places a judicial checkpoint on Sun Pharma's path to market. The Court recognized the practical reality that once a generic pharmaceutical product is launched and distributed through India's vast pharmacy network, recalling it or undoing the market impact would be extraordinarily difficult. This reasoning aligns with the well-established principle in patent litigation that the balance of convenience favours preserving the status quo when irreparable harm is likely.

Under Section 108 of the Indian Patents Act, the Court has broad powers to grant relief in suits for patent infringement, including injunctions (whether interim or permanent), damages, and accounts of profits. The interim direction in this case reflects the Court's exercise of discretion under these provisions to protect the patentee's rights while the substantive patent infringement claim is adjudicated.

Sun Pharma's Jurisdictional Challenge

In a notable procedural development, Sun Pharma challenged the territorial jurisdiction of the Delhi High Court. The company argued that it is headquartered in Maharashtra and has no substantial connection with the National Capital Territory of Delhi that would warrant the Delhi High Court exercising jurisdiction over the dispute.

Section 104 of the Indian Patents Act governs the jurisdiction of courts in patent infringement suits. It provides that a suit for infringement shall be instituted in a court not below the level of a District Court having jurisdiction to try the suit. The question of territorial jurisdiction in patent cases has been a recurrent issue in Indian patent litigation, with courts frequently examining where the cause of action arises and where the defendant carries on business.

In response to Sun Pharma's jurisdictional objection, Novo Nordisk pointed out that Sun Pharma Laboratories (a group entity) has a registered address in Delhi and conducts business activities within the National Capital Territory. This argument, if accepted, would establish a sufficient territorial nexus for the Delhi High Court to exercise jurisdiction. The Court has not yet ruled definitively on this jurisdictional question, and it is likely to be addressed in subsequent hearings as Sun Pharma files its detailed response.

Earlier Proceedings: The December 2025 Undertaking

The present proceedings are not the first encounter between Novo Nordisk and Sun Pharma over semaglutide. In December 2025, the Delhi High Court recorded an undertaking from Sun Pharma regarding the compound patent (which was then still in force). Under this undertaking:

Sun Pharma agreed not to sell semaglutide in India until March 20, 2026, the date of the compound patent's expiry.
The Court permitted Sun Pharma to manufacture semaglutide for the purpose of export during this period.

This earlier arrangement reflected a pragmatic resolution of the compound patent dispute, allowing Sun Pharma to maintain its manufacturing operations while respecting Novo Nordisk's patent rights during the remaining patent term. The current proceedings, however, involve the separate formulation patent, which extends beyond the compound patent's expiry date and protects the specific oral delivery mechanism rather than the semaglutide molecule itself.

Impact on India's Generic Pharmaceutical Industry

The Delhi High Court's direction carries significant implications for India's generic pharmaceutical industry, which has long been a global leader in producing affordable versions of patented drugs. The semaglutide saga illustrates how innovator companies are increasingly using layered patent strategies to extend their market exclusivity beyond the life of a single compound patent.

Following the compound patent expiry in March 2026, several Indian generic manufacturers moved swiftly to launch injectable semaglutide products. Companies such as Dr. Reddy's Laboratories and others entered the market with generic versions of the injectable formulation. However, the oral tablet segment, which represents a potentially larger commercial opportunity due to patient preference for oral medications over injections, remains contested due to the formulation patent.

For generic manufacturers, this case serves as a cautionary example of the risks associated with launching products that may infringe formulation patents, even when the underlying compound patent has expired. The distinction between these two types of patents is not always immediately apparent, and companies that fail to conduct thorough patent landscape analyses before proceeding with product development may find themselves exposed to infringement claims and injunctive relief.

The Broader Patent Strategy: Compound vs. Formulation

Novo Nordisk's approach to semaglutide patent protection illustrates a sophisticated intellectual property strategy that is increasingly common among global pharmaceutical innovators. By obtaining separate patents for the compound itself and for specific formulations or delivery mechanisms, an innovator can maintain market exclusivity on particular product forms even after the base compound enters the public domain.

This strategy has several advantages for the patent holder:

It extends the period of market exclusivity for high-value product forms beyond the compound patent term.
It creates multiple layers of intellectual property protection, requiring generic manufacturers to navigate a more complex patent landscape.
It allows selective enforcement, where the patent holder can permit generic competition in one dosage form (such as injectables) while maintaining exclusivity over another (such as oral tablets).
It incentivizes continued innovation in drug delivery, as companies invest in developing novel formulations that improve patient compliance and therapeutic outcomes.

However, this layered patent approach has also attracted criticism from advocates of affordable healthcare, who argue that it can delay the availability of lower-cost generic alternatives. In the Indian context, where affordability and access to medicines are pressing public health concerns, these patent strategies are likely to face continued scrutiny from both the courts and policymakers.

It is also worth noting that Section 3(d) of the Indian Patents Act imposes a higher threshold for patentability of pharmaceutical inventions. This provision, which was introduced to prevent "evergreening" of patents through trivial modifications, requires that new forms of known substances must demonstrate enhanced therapeutic efficacy. The validity of formulation patents in India may therefore be challenged on the grounds that the formulation does not meet the Section 3(d) threshold, although this argument has not been specifically raised in the present proceedings.

Key Takeaways for Pharma Companies

The Delhi High Court's direction in the Novo Nordisk vs. Sun Pharma dispute offers several important lessons for pharmaceutical companies operating in India:

Comprehensive patent landscape analysis is essential: Generic manufacturers must conduct thorough freedom-to-operate analyses that go beyond the compound patent to identify all relevant formulation, process, and use patents that may restrict market entry for specific dosage forms.
Compound patent expiry does not guarantee unrestricted market access: The expiry of a compound patent opens the market for the API in conventional dosage forms, but formulation patents can continue to block specific delivery mechanisms and product forms.
Courts are willing to impose pre-launch judicial checkpoints: The interim direction requiring Sun Pharma to seek court approval before launch demonstrates that Indian courts may impose conditions that effectively require generic manufacturers to obtain judicial clearance before entering the market, even without a full injunction.
Jurisdictional challenges can be a strategic tool: Sun Pharma's challenge to the Delhi High Court's jurisdiction under Section 104 of the Patents Act underscores the importance of forum selection in patent litigation. Defendants may seek to challenge jurisdiction as a procedural strategy to gain tactical advantage.
Early engagement with patent holders can mitigate litigation risk: Generic manufacturers should consider engaging with innovator companies early in the product development process to explore licensing arrangements or to challenge patent validity proactively, rather than facing enforcement actions at the point of market entry.

Conclusion

The Delhi High Court's direction to Sun Pharma to seek prior court approval before launching generic semaglutide tablets represents a significant development in India's evolving pharmaceutical patent jurisprudence. The case brings into sharp focus the interplay between compound patents and formulation patents, and the strategies that both innovator and generic companies employ to protect and challenge market exclusivity.

As the proceedings continue, the substantive questions of patent infringement, patent validity under Section 3(d), and territorial jurisdiction under Section 104 will need to be resolved. The outcome will have implications not only for the parties involved but also for the broader generic pharmaceutical industry in India.

For pharmaceutical companies and legal practitioners, this case reminds us that the expiry of a single patent does not necessarily clear the path for generic competition. A nuanced understanding of the full patent portfolio covering a drug product is essential for navigating the Indian pharmaceutical market.