Diabetes Drug Drama: Dr. Reddy’s Bows to Novo Nordisk Patent Claims in Delhi High Court

In a swift courtroom showdown over blockbuster diabetes drug formulations, the Delhi High Court has recorded a key undertaking from Dr. Reddy’s Laboratories, agreeing not to launch its oral semaglutide tablets in a way that infringes Novo Nordisk's Indian Patent No. IN 325669. Justice Tushar Rao Gedela presided over the March 24, 2026 hearing in suit CS(COMM) 294/2026, where plaintiffs Novo Nordisk A/S and another moved for urgent interim relief under Order XXXIX Rules 1 & 2 CPC.

The case spotlights oral semaglutide—a GLP-1 agonist tablet for type 2 diabetes management—featuring semaglutide combined with SNAC (sodium N-(8-(2-hydroxybenzoyl)amino)caprylate) to boost absorption.

From Patent Protection to Pre-Launch Patent Clash

Novo Nordisk, pioneers of semaglutide therapies like Ozempic and Rybelsus, holds IN 325669 claiming solid oral compositions of semaglutide (0.01-100 mg) with SNAC (0.6-2.1 mmol). Spotting Dr. Reddy’s advancing its "OBEDA" and "MASHLO" branded versions (3 mg, 7 mg, 14 mg strengths), Novo filed suit alleging imminent infringement.

Dr. Reddy’s had secured a Clinical Trial No Objection Certificate (CT NOC: BIO/CT/24/000142) and registered trials (CTRI/2025/06/088110), plus a manufacturing/marketing application (BIO/CT21/FF/2025/52117) with CDSCO. This triggered Novo’s urgent suit, with multiple interlocutory applications for exemptions, documents, and injunctions.

Plaintiffs Push for Lockdown, Defendant Counters with Chemistry

Senior advocates Dr. Abhishek Manu Singhvi and Amit Sibal for Novo argued for ex-parte ad-interim injunction, stressing the patent's scope and Dr. Reddy’s launch threat.

Dr. Reddy’s, represented by Dayan Krishnan and J. Sai Deepak, fired back with affidavits from Dr. B. Dinesh Kumar (Head, IP Management) and Dr. Venkat Ramana Naidu (Global R&D Head - Orals). They asserted their tablets use ~0.398 mmol (~120 mg) SNAC— way outside the patented 0.6-2.1 mmol range—thus no infringement. They invoked Section 107A Patents Act (Bolar exemption) for trial/manufacturing rights.

"Dr. Reddy’s Oral Semaglutide Tablets do not infringe Indian Patent No. IN 325669, in as much as they contain approximately 0.398 mmol ( ≈120 mg) of SNAC, which falls way outside the claimed range of 0.6 to 2.1 mmol."
— Affidavit of Dr. B. Dinesh Kumar

Court Brokers an Interim Peace Deal

Justice Gedela heard arguments, took the affidavits on record (to be formally filed in 7 days), and noted a plaintiffs' note agreed by defendants. Both sides settled on an interim arrangement without prejudice:

  • No commercial manufacture/sale/export/offer of semaglutide oral tablets with SNAC 0.6-2.1 mmol and semaglutide 0.01-100 mg (per Claim 1).
  • Strict adherence to non-infringement on SNAC range.
  • Dr. Reddy’s to provide 10 strips each (3/7/14 mg) of OBEDA/MASHLO at cost pre-launch for testing.
  • Plaintiffs to keep test reports confidential, solely for the suit.

The court exempted pre-institution mediation (citing Supreme Court in Yamini Manohar vs. T.K.D. Keerthi (2024) 5 SCC 815 for urgent relief cases), allowed additional documents/exemptions, issued notice on interrogatories, and set timelines: reply in 2 weeks, list on April 24, 2026.

"The defendant has agreed not to commercially manufacture, sale, supply/export, offer for sale Semaglutide (Oral Tablet)... wherein the amount of said salt(s)... is in the range of 0.6 - 2.1 mmol..."
— Court Order, Para 31(i)

What This Means for Pharma Giants and Patients

This accord halts potential market disruption while Dr. Reddy’s proceeds under Bolar shield. Novo gets sample assurance and confidentiality, preserving IP. Suit proceeds: WS in 30 days, JR on May 26, 2026.

For India’s diabetes market—where semaglutide demand soars—this signals robust patent enforcement, potentially delaying generics but ensuring innovation incentives.

Key Observations from the Bench: - On exemption urgency: "As the present matter contemplates urgent interim relief..." (Para 5). - Undertaking clarity: "Apart from the above, the defendant shall also not breach the range 0.6 to 2.1 mmol claimed under claim 1..." (Para 31(ii)). - Sample protocol: "The plaintiffs undertake that the Technical Data/Report... shall be kept confidential..." (Para 31(iv)).

The plaint is registered, summons accepted—gearing up for deeper infringement scrutiny.