Semaglutide court case involving Novo Nordisk experiences a new development
Dr. Reddy's Allowed to Export Semaglutide Despite Novo Nordisk's Patent Claims
In a significant development, Dr. Reddy's Laboratories (DRL) is allowed to export semaglutide from India, despite patent infringement claims by Novo Nordisk. This decision, based on the current legal framework and court orders, could have implications for generic drugmakers, as it may determine whether DRL can legally export semaglutide to multiple countries, including Canada, where the patent expires early 2026.
Novo Nordisk, a Danish pharmaceutical company, filed a patent infringement suit against DRL in the Delhi High Court, alleging that the unauthorized manufacture and sale of semaglutide formulations violated its patent rights under Patent No. 262697. Novo Nordisk asserts exclusive manufacturing rights and argues that export-scale production also infringes under Section 48 of the Indian Patents Act.
However, DRL defends its position based on Section 107A(b) of the Patents Act (the Bolar exemption), which allows manufacture and export for regulatory and commercial purposes in countries where the patent is not active. This defense is crucial because Novo’s patent protection for semaglutide in India will expire only in March 2026.
An interim Delhi High Court ruling dated May 29, 2025, granted an injunction preventing DRL from selling or marketing semaglutide within India, but explicitly allowed the manufacture and export of the drug to other markets. The court declined to restrain export, pending further detailed hearings on the applicability of the patent sections cited.
As a result, marketing and sale of semaglutide inside India by DRL is barred due to ongoing patent injunction, while manufacture and export of semaglutide from India remains legally permitted, per the interim court order, relying on the Bolar exemption and the fact that some export destinations do not have active Novo Nordisk patents.
The patent expiry in India in March 2026 will open the Indian market to generics including DRL. Several generic drugmakers are planning to introduce their versions of the injectable semaglutide following the patent expiration.
The ongoing case involves the weight-loss and diabetes drug Wegovy/Ozempic, which contains semaglutide as its active ingredient. Novo Nordisk recently introduced its weight-loss drug Wegovy into India. Neither Novo Nordisk nor DRL made any comments on the latest development, as the case is currently in court.
According to the Indian Patent Act (1970), the export of an infringing product amounts to infringement. However, the case is about intellectual property rights related to semaglutide. Rajeshwarie Hariharan, an IP expert, stated that the latest development in the case would bring clarity in the law. An industry-insider suggested that a ruling in favor of DRL could open the floodgates for more companies to export semaglutide.
A hearing on the issue is likely to occur later this month. The date of publication for this article is July 24, 2025.
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- The interim court order allows Dr. Reddy's Laboratories (DRL) to manufacture and export semaglutide, a weight-loss and diabetes drug, from India to various markets, despite patent infringement claims by Novo Nordisk.
- The decision could potentially impact the health-and-wellness industry, as it may determine whether generic drugmakers can legally export semaglutide to markets where the patent has expired or will expire.
- On the other hand, the marketing and sale of semaglutide within India by DRL is barred due to the ongoing patent injunction, according to the Indian Patent Act (1970).
- The upcoming hearing on this case, likely to occur this month, could influence the finance and business sectors, as a ruling in favor of DRL might create more opportunities for companies to export this drug.
