Novo Nordisk

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.