INTRODUCTION
In the landmark ruling of Novo Nordisk AS v/s Dr Reddy’s Laboratories Limited & Anr. (December 2025), the Hon’ble Delhi High Court addressed one of the most significant pharmaceutical patent dispute. The case involves Semaglutide, an active pharmaceutical ingredient used in blockbuster drugs such as Ozempic and Wegovy which is used for the treatment of Type 2 diabetes and weight management. It addresses key issues regarding patent evergreening and the scope of the Bolar Exemption. It explains how Indian law restrains evergreening practices while simultaneously protecting the production of generic medicines for the global market.
FACTS
a. Novo Nordisk AS, a global healthcare company with over 100 years of experience, alleged infringement of Patent No. 262697 (IN’697) registered in the name of Novo Nordisk and has a 20 year term from 20 March 2006 and expiring on 20 March 2026.
b. Dr Reddy’s Laboratories began manufacturing semaglutide in India under the Bolar exemption provided by Section 107A of the Indian Patents Act, maintaining that the production is intended solely for export to countries where Novo Nordisk does not hold a patent.
c. Novo Nordisk possessed two pertinent patents in India, the first, a Genus Patent that encompassed a broad class of compounds and expired in September 2024 and the other, Suit Patent, is a species patent specifically for semaglutide, which is valid until March 20, 2026.
d. It was highlighted that semaglutide was discovered in 2004, the same year the genus patent was filed and that this genus patent already encompassed the semaglutide compound.
e. A comparison of both patents showed that the chemical structure in the genus patent and the suit patent is almost identical. The only difference between the two is the substitution of Aib (2-methylalanine) instead of Ala at the 8th position in the molecule.
f. Novo Nordisk filed a suit seeking a permanent injunction, claiming that manufacturing of semaglutide by Dr Reddy Laboratories, even if meant for export, violated their exclusive rights under Section 48 of the Patents Act. At the same time, Dr Reddy filed a revocation petition under Section 64, contesting the validity of the Suit Patent on the grounds of evergreening and lack of inventive step.
ISSUES
a. Whether the Suit Patent meets the statutory requirements for novelty and non-obviousness, or if it constitutes evergreening by claiming a compound already anticipated by the prior art of the now-expired Genus Patent.
b. Whether the exclusive right of a patent holder to make a product under Section 48 applies even when the manufacturing is for export purposes only.
c. Whether exporting to non-patent jurisdictions prevents their domestic manufacturing from being classified as an infringement.
d. Whether DRL’s manufacturing activities qualify for legal protection under Section 107A as a reasonably related use.
CONTENTIONS BY NOVO NORDISK
a. Novo Nordisk claimed that semaglutide was new and inventive. They argued that its improved pharmacokinetic properties, especially the longer half-life allowing once-weekly dosing, represented a significant therapeutic improvement over earlier GLP-1 drugs.
b. It stated that Dr Reddy’s attempt to create semaglutide by modifying Example 61 of the genus patent, replacing alanine with Aib (2-methyl alanine), was an improper use. They argued that the genus patent did not specifically disclose or claim semaglutide, none of its compounds had ever become approved drugs, and it was not relevant prior art since it was published after the suit patent’s priority date.
c. It argued that Dr Reddy’s manufacture of semaglutide, even just for export, infringed their exclusive rights under Section 48 of the Patents Act.
d. It also argued that DRL’s scale of production was commercial and not merely for research or regulatory purposes, thus disqualifying them from the Section 107A exemption.
CONTENTIONS BY DR REDDY
a. Dr Reddy Laboratories argued that Semaglutide isn’t a new invention because it was already described in the broader Genus Patent. It was already disclosed in the Genus Patent. Example 61 of IN’964 covered the compound differing only by the substitution of Alanine (Ala) with Aib at the 8th position, and there was only a tiny molecular change that any skilled person would have found obvious to try.
b. They invoked Section 3(d) of the Patents Act, 1970 asserting that the subject matter constitutes a mere derivative of a known substance, which is non-patentable unless it demonstrates a significant enhancement in therapeutic efficacy.
c. DRL highlighted that Novo Nordisk does not manufacture the drug in India but only imports it at high costs, whereas DRL had invested over Rs 1,000 crore in local manufacturing infrastructure.
d. The defendants accused Novo Nordisk of evergreening, asserting that the company strategically suppressed the disclosure of Semaglutide during the genus patent filing to improperly extend its monopoly through a subsequent species patent.
ANALYSIS
The Hon’ble Court, presided over by Justice Manmeet Pritam Singh Arora, conducted a detailed analysis based on the following parameters:
a. The Court found the patent’s validity questionable, noting a credible challenge that it was merely an attempt at evergreening through a minor, obvious update to a drug already protected for 20 years.
b. The Court found that since DRL has committed that they will not sell the drug in India, which makes Novo Nordisk’s domestic profits unaffected.
c. However, an injunction on export by DRL would cause financial harm and ruin their massive investments and international supply contracts.
d. Double Patenting & Evergreening (Section 3(d): The Court suspected that Novo Nordisk discovered Semaglutide in 2004 but intentionally withheld it from their original patent to file a later one and extend their monopoly. Under the Person Skilled in the Art test, the Court ruled that the new patent’s changes were so minor that any expert in the field would have found them obvious based on the original invention.
e. The Bolar Exemption (Section 107A): The Court clarified that the Bolar Exemption is intended for research and regulatory data, not for general commercial trade. However, because the patent itself appeared legally weak and likely invalid, the Court permitted the exports to continue as an exception.
COURT’S DECISION
In December 2025, the Hon’ble Delhi High Court refused Novo Nordisk’s request for an interim injunction against Dr Reddy’s Laboratories, holding that DRL had raised a credible challenge to the validity of the Semaglutide patent. The Court observed that the patent appeared to involve evergreening and double patenting, being an obvious modification of an earlier invention. Although DRL was restrained from marketing the drug in India until the patent expires in March 2026, the Court permitted it to continue manufacturing and exporting to jurisdictions where no patent protection exists, holding that an export ban would result in irreparable financial loss and disturb the balance of convenience.
CONCLUSION
The Hon’ble Delhi High Court’s decision marks a significant victory for the generic pharmaceutical industry and a clear rejection of patent evergreening. The Court held that Novo Nordisk could not rely on a minor chemical modification, particularly when the drug appeared to be already covered by an earlier patent. By allowing Dr Reddy Laboratories to manufacture and export the drug while restraining domestic sales until 2026, the Court laid to a careful balance, safeguarding Novo’s existing Indian market while preventing the misuse of patent rights to restrain international competition.
References
a. Novo Nordisk A/S v. Dr Reddy’s Laboratories Ltd. & Anr. CS(COMM) 565/2025
b. The Patents Act, 1970, S. 3(d), S. 48, S.64, S. 107A
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