Delhi High Court Records Interim Settlement in Novo Nordisk-Dr. Reddy’s Patent Infringement Suit - 2026-03-24

Bridging the Gap: Delhi High Court Facilitates Interim Truce in High-Stakes Pharma Patent Battle

In a significant development at the Delhi High Court, a high-stakes patent row between global pharmaceutical giant Novo Nordisk and local powerhouse Dr. Reddy’s Laboratories has reached a critical interim impasse. The dispute, centred on the revolutionary weight management and diabetes drug, Semaglutide, saw both parties arrive at a temporary understanding aimed at avoiding protracted litigation while ensuring rigorous adherence to patent claims.

The Core Conflict: A Question of Concentration

The litigation, designated as CS(COMM) 294/2026, concerns Indian Patent No. IN 325669. At the heart of the matter is the specific composition of solid oral Semaglutide tablets. Novo Nordisk, the patent holder, alleges that their protected invention—which involves specific concentrations of Semaglutide in combination with the absorption enhancer SNAC (sodium N-(8-(2-hydroxybenzoyl)amino) caprylate)—was under threat by the defendant’s proposed product line.

Novo Nordisk, represented by a battery of senior counsel including Dr. Abhishekh Manu Singhvi and Mr. Amit Sibal, moved for an ex-parte ad-interim injunction to halt any activity they perceived as infringing on their intellectual property.

Technical Allegations and the Affidavit Defense

The defendant, Dr. Reddy’s Laboratories, countered the allegations with technical precision. Through affidavits submitted by their Head of Intellectual Property Management, Dr. B. Dinesh Kumar, and Global Head of R&D, Dr. Venkat Ramana Naidu, the company asserted that their formulations fall outside the scope of Novo Nordisk’s patent.

The core of their argument rested on the concentration levels of SNAC. Dr. Reddy’s maintained that their product utilizes approximately 0.398 mmol of SNAC, which the company claims is "way outside the claimed range of 0.6 to 2.1 mmol" stipulated in the plaintiff’s patent.

Seeking a Middle Ground

Presiding over the commercial suit, Hon'ble Mr. Justice Tushar Rao Gela facilitated a diplomatic resolution through an interim arrangement rather than an immediate ruling on the injunction. Under the agreed terms, Dr. Reddy’s has voluntarily committed to refraining from the commercial manufacture, sale, or export of any Semaglutide oral tablets that utilize SNAC within the contentious range of 0.6 to 2.1 mmol as claimed in Claim 1 of the plaintiff’s patent.

Additionally, to ensure transparency, the court has directed Dr. Reddy’s to provide samples of their finished products under the brand names "OBEDA" and "MASHLO" to the plaintiff’s legal team for testing, subject to strict confidentiality agreements.

Key Observations from the Court

The court’s approach focused on the balance between protecting innovation and enabling market competition. The following insights from the proceedings underscore the nature of the settlement:

• On the undertaking: "The defendant affirms and undertakes that, during the subsistence of Indian Patent No. IN325669, the Defendant shall not commercially manufacture or sell Dr. Reddy’s Oral Semaglutide Tablets... containing SNAC in an amount within the range of 0.6 to 2.1 mmol for India."
• On the Bolar Exemption: The defendant notably reserved the right to use the invention solely for activities under Section 107A of the Patents Act, 1970, commonly known as the "Bolar exemption," which permits research and development for regulatory compliance.
• On the evidence: "The copies of the said affidavits are taken on record... The defendant shall file the said affidavits within seven working days."

The Road Ahead

This interim order serves as a procedural stabilization, preventing an immediate escalation while allowing both companies to proceed with regulatory filings before the Central Drugs Standard Control Organization (CDSCO). By recording these undertakings as a court order, Justice Gela has provided a clear roadmap: any deviation from the agreed concentration ranges would now constitute a direct breach of the court’s recorded order.

The case is currently listed for further proceedings on April 24, 2026, where the court will continue to oversee the compliance of the parties and the progress of the commercial suit. For the pharmaceutical industry, this case serves as a poignant reminder of the fine margins that define modern patent law, where the difference between infringement and innovation can often be measured in millimoles.