Patent Case
HC bench refuses to stay Dr Reddy's export of semaglutide to some nations
This story was originally published at 11:32 IST on 12 December 2025
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--HC bench refuses to stay Dr Reddy's export of semaglutide to some nations
--HC notice to Dr Reddy's on Novo Nordisk plea against export of semaglutide
NEW DELHI – The division bench of the Delhi High Court Friday refused to stay the order given by its single-judge bench on Dec. 2, that allowed Dr. Reddy's Laboratories Ltd. and its contract manufacturer OneSource Speciality Pharma Ltd. to manufacture their version of diabetes and obesity drug 'semaglutide' and export the same to countries where Novo Nordisk has not been granted a patent for the drug.
On the grounds of irreparable injury and balance of convenience, it was a very weak case by Novo Nordisk for grant of stay against the single-judge order, the division bench of Justice C. Hari Shankar and Justice Om Prakash Shukla said Friday. "We will issue notice on appeal, we will not stay the (single judge's) order," said the division bench. It sought the reply of Dr. Reddy's Laboratories and OneSource Speciality on Novo Nordisk's appeal and listed the case for hearing on Jan. 15.
On Dec. 2, Justice Manmeet Pritam Singh Arora had said there was a credible challenge to the validity of Novo Nordisk's patent on the drug 'semaglutide'. However, Dr. Reddy's Laboratories and OneSource Speciality will not sell their version of 'semaglutide' drug in India till March 2026, when Novo Nordisk's patent for the drug will expire, she had said.
Currently, Novo Nordisk sells 'Wegovy' and 'Rybelsus' using its patent on the drug 'semaglutide' and had received the Central Drugs Standard Control Organisation's approval for 'Ozempic'. Danish drugmaker Novo Nordisk held a primary consumption patent for 'semaglutide', which expired in September 2024. However, Novo Nordisk still held the secondary patent in India relating to the manufacturing process and delivery mechanism of 'semaglutide' drug, which is valid till March 2026.
In December 2024, Dr. Reddy's received regulatory approval to manufacture 'semaglutide' drug and the company started the production in April. Consequently, Novo Nordisk moved the high court and filed a permanent injunction suit against Dr. Reddy's and OneSource Speciality on 'semaglutide' drug. Novo Nordisk has argued that Dr. Reddy's and OneSource Speciality imported 'semaglutide' active pharmaceutical ingredient and produced finished formulations without permission, consequently infringing its patent. Dr. Reddy's and OneSource Speciality were importing significant quantities of 'semaglutide' active pharmaceutical ingredient and exporting both the ingredient and finished injections in contravention of the Patents Act, said the Danish company.
In its reply, Dr Reddy's and OneSource Speciality said the patent of Novo Nordisk lacked novelty and amounted to an attempt at evergreening to extend exclusivity beyond the expiry of the primary patent. Dr. Reddy's and OneSource Speciality said they
hold the licence from the Central Drugs Standard Control Organisation to manufacture 'semaglutide' drug, but have no approval to sell it within India. The present production is solely for export to countries where Novo Nordisk's patent rights have expired, said Dr. Reddy's and OneSource Speciality.
In a similar case on Wednesday, Justice Arora had noted an undertaking from Sun Pharmaceutical Industries Ltd. that it will manufacture its version of diabetes and obesity drug 'semaglutide' for exporting to countries where Novo Nordisk AS has not been granted a patent for the drug. Further, the court noted that Sun Pharmaceutical will not sell its version of the semaglutide drug in India till March 2026.
At 1105 IST, the shares of Dr. Reddy's Laboratories Ltd. were down 0.4% at INR 1,268.80 on the National Stock Exchange, the shares of OneSource Speciality Pharma Ltd. were down 3.1% at INR 1,602.80. End
IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT
Reported by Surya Tripathi
Edited by Vandana Hingorani
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