Novo Nordisk

Patent War: Court Allows Dr. Reddy’s to Export Wegovy Generic

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Delhi High Court ruling on Novo Nordisk Wegovy semaglutide patent dispute with Dr Reddy's

The battle over the world’s most sought-after weight-loss drug escalated this week. The Delhi High Court made a pivotal decision. It cleared the path for Dr. Reddy’s Laboratories (DRL) to manufacture and export generic semaglutide. This is the key component in Novo Nordisk’s blockbuster drugs, Wegovy and Ozempic. The ruling marks a serious legal challenge to the Danish pharmaceutical giant’s exclusivity in India. Experts call it a potential watershed moment for global access to affordable anti-obesity medicines.

High-Stakes Legal Siege

Novo Nordisk initiated the legal siege. The company sued DRL for patent infringement. Novo Nordisk claimed DRL was importing the active ingredient. DRL was allegedly producing finished formulations without consent. The Danish firm asserted its right to full exclusivity. Its Indian patent for the semaglutide formulation, IN 262697, remains valid until March 2026. Novo Nordisk is aggressively protecting this intellectual property. It is preparing for the highly anticipated launch of Wegovy in the Indian market.

The market value is enormous. Semaglutide treatments generate billions globally. India’s anti-obesity drug market is experiencing a massive surge. It has grown exponentially in recent years. This lawsuit is not just a domestic quarrel. Its outcome will fundamentally disrupt future sourcing strategies worldwide.

Court Rules: India Sales Barred, Export is Free

The Delhi High Court delivered a carefully balanced interim order. Justice Manmeet Pritam Singh Arora made a crucial distinction. The court restrained DRL from selling or marketing its generic version within India. This injunction will remain in force until Novo Nordisk’s patent expires. The court upheld Novo Nordisk’s domestic exclusivity for now.

However, the ruling offered a huge victory to Dr. Reddy’s. The court allowed DRL to continue manufacturing and exporting the drug. This export is permitted to any country where Novo Nordisk does not hold a valid patent. DRL successfully presented its case for export-only manufacturing.

Crucially, the court stated DRL established a prima facie credible challenge against the validity of Novo Nordisk’s patent. This observation severely weakens the foundation of Novo Nordisk’s claim. It signals the court’s skepticism regarding the patent’s full enforceability.

DRL’s Powerful Defiance

Dr. Reddy’s based its defense on two powerful points. First, DRL challenged the patent’s legitimacy. The firm filed a separate revocation petition. It claimed Novo Nordisk was engaging in evergreening. Evergreening is a controversial tactic. It involves making minor modifications to an existing molecule. Companies use it to extend their patent monopoly beyond the intended period. DRL argued the semaglutide formulation lacked genuine novelty. It contended that the core innovation was already disclosed in an earlier patent.

Second, DRL invoked India’s Bolar exemption (Section 107A(b)). This law is vital for generic manufacturers. It permits the making, constructing, or selling of a patented invention. These actions must be solely for uses reasonably related to regulatory approval. DRL argued its exports fall under this exemption. The products are intended for markets where the patent no longer applies. This defense is a cornerstone of India’s robust generic pharmaceutical industry.

DRL’s legal counsel assured the court of compliance. They affirmed DRL holds a license to manufacture. However, they confirmed DRL lacks a license to sell domestically. This undertaking proved critical in securing the export allowance.

The Generic Wave Looms Large

The legal uncertainty creates immediate market anxiety. Novo Nordisk faces mounting pressure. Eli Lilly’s rival drug, Mounjaro (tirzepatide), has already entered the Indian market. Novo Nordisk must now defend its patent rights aggressively. It must also accelerate its commercial strategy. The company recently reduced Wegovy’s price by 37%. It partnered with Emcure Pharma for wider distribution. These moves signal a fierce battle for market share.

Other Indian drugmakers are watching closely. Cipla, Lupin, and Glenmark are reportedly preparing for the generic wave. A successful challenge by DRL could trigger a flurry of similar generic launches. Industry analysts predict massive price drops. Generic entry could slash treatment costs by nearly 80%. This would make life-changing anti-obesity treatments accessible to millions.

The Delhi High Court’s decision to allow exports is a clear boost. It validates India’s position as a global manufacturing hub for affordable medicines. It also highlights the growing international tension. Companies must balance intellectual property rights with public health needs. The final verdict on the patent’s validity will redefine this multi-billion dollar fight. The outcome remains one of the most keenly watched legal developments in the global pharmaceutical landscape today. Novo Nordisk must now mount a final, definitive defense of its prized intellectual property. DRL stands ready to disrupt the market with its generic defiance.

Novo Nordisk and D Young Defend Key Patent for Oral Semaglutide Tablet

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Novo Nordisk and its legal team at D Young & Co are defending a crucial patent for the tablet version of semaglutide, the active ingredient used in the blockbuster diabetes and weight-loss drugs Rybelsus, Ozempic, and Wegovy. The patent dispute has gained global attention as it could determine the future of oral semaglutide’s market exclusivity.

Patent Dispute at the European Patent Office

The case centers on European Patent No. 2 827 885, which covers Novo Nordisk’s innovative oral formulation of semaglutide. The company claimed a unique two-granule system designed to improve absorption of the peptide drug in tablet form. One granule type contains semaglutide, while the other holds an absorption enhancer called SNAC (sodium N-(8-(2-hydroxybenzoyl)amino) caprylate).

This separation, according to Novo Nordisk, allows the drug to dissolve effectively and remain stable through the digestive process. However, the European Patent Office (EPO) Board of Appeal revoked the patent, ruling that it lacked an inventive step. The Board concluded that Novo Nordisk’s design was too similar to earlier known formulations and did not demonstrate a clear technical advantage across all claims.

Legal and Market Implications

The loss of this patent weakens Novo Nordisk’s intellectual property position in Europe. It may allow generic drug manufacturers to move closer to producing their own oral versions of semaglutide once other protections expire.

Despite the setback, Novo Nordisk still holds a series of related patents protecting semaglutide’s composition, dosage methods, and manufacturing processes in multiple countries. These patents could extend exclusivity into the early 2030s, particularly in the United States and select Asian markets.

A spokesperson from D Young & Co emphasized that Novo Nordisk “remains committed to defending its innovation portfolio” and continues to explore all legal and strategic options to preserve market exclusivity.

Why the Oral Formulation Matters

The tablet version of semaglutide, marketed as Rybelsus, represents a major scientific milestone. It allows patients to take the once-weekly GLP-1 therapy orally, eliminating the need for injections. This has significantly expanded the drug’s market reach and patient acceptance.

If generic competition enters earlier than expected, Novo Nordisk could face price erosion across its GLP-1 product range. Analysts note that even a modest loss in exclusivity for Rybelsus could impact billions in annual revenue, given the current surge in demand for semaglutide-based therapies worldwide.

Global Impact and Next Steps

In markets such as India and China, generic drugmakers are already preparing for opportunities in the oral semaglutide space. Industry experts expect these regions to play a key role in the next phase of the GLP-1 patent landscape.

Novo Nordisk may file divisional or secondary patents to reinforce protection of its technology. The company also retains regulatory data exclusivity in several jurisdictions, offering temporary protection even without patent coverage.

Outlook

While the EPO’s ruling marks a setback, Novo Nordisk’s dominance in the GLP-1 market remains strong. Its pipeline of next-generation weight-management and diabetes drugs continues to grow. However, the patent decision highlights a growing challenge for pharmaceutical leaders — maintaining long-term protection for complex formulations as global demand and generic pressure intensify.

Delhi High Court Restrains Dr. Reddy’s, OneSource in Novo Nordisk’s Weight Loss Drug Patent Dispute

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In a significant legal development, the Delhi High Court has issued an interim injunction restraining Indian pharmaceutical major Dr. Reddy’s Laboratories and OneSource Nutra from manufacturing, selling, or distributing generic versions of a weight loss drug patented by Danish pharmaceutical company Novo Nordisk.

The dispute centers around semaglutide, the active ingredient in Novo Nordisk’s blockbuster drug Wegovy, which is used for chronic weight management and has gained global popularity due to its high efficacy in combating obesity. Semaglutide, also used in the diabetes medication Ozempic, has seen skyrocketing demand, making it a highly valuable asset for the company.

The Court’s Interim Order

On Thursday, Justice Sanjeev Narula of the Delhi High Court granted an ex parte ad interim injunction in favor of Novo Nordisk, barring Dr. Reddy’s and OneSource from infringing on the company’s patent rights related to semaglutide. The order came in response to a lawsuit filed by Novo Nordisk India Pvt. Ltd. and Novo Nordisk A/S, which alleged unauthorized use and commercialization of the patented compound by the defendants.

The court observed that a prima facie case of patent infringement had been established and that irreparable harm could be caused to Novo Nordisk if interim relief was not granted. The order restrains the defendants from importing, manufacturing, marketing, or offering for sale any product containing semaglutide until the matter is fully adjudicated.

Background of the Dispute

Novo Nordisk holds a valid Indian patent for semaglutide, which is protected until 2033. The company claimed that Dr. Reddy’s and OneSource had begun producing and marketing unauthorized generic versions of the compound in violation of its intellectual property rights.

In its petition, Novo Nordisk argued that such actions not only amounted to infringement but also posed a serious threat to its commercial interests and research investments in India and globally.

The Danish drugmaker submitted evidence including product listings and promotional material from the defendants, suggesting active commercialization efforts despite the subsistence of the patent.

Industry Impact

The injunction is likely to have far-reaching implications for the Indian pharmaceutical sector, particularly in the context of patent law enforcement and the growing market for obesity treatment drugs. With semaglutide-based therapies becoming a major growth driver for Novo Nordisk, the ruling underscores the increasing significance of patent protection in high-value therapeutic categories.

While Indian generic manufacturers have historically played a critical role in making affordable medications accessible, this case reaffirms the judiciary’s stance on respecting patent laws, particularly when infringement is clearly established.

Responses from the Parties

As of the time of publication, Dr. Reddy’s Laboratories has not issued an official statement on the court’s order. OneSource Nutra also remains silent on the issue.

Novo Nordisk, on the other hand, welcomed the decision, stating it was a “vindication of our ongoing commitment to protecting innovation and ensuring patient safety.” The company emphasized that unregulated generics could compromise treatment efficacy and patient outcomes.

Next Steps

The matter is scheduled for further hearing in July 2025, during which the defendants are expected to present their responses. Legal experts suggest that the final outcome could set a precedent for similar cases involving high-demand biologics and patented pharmaceuticals.

As India continues to balance public health interests with intellectual property rights, the resolution of this case will be closely monitored by stakeholders in the pharmaceutical and healthcare sectors both domestically and internationally.