Revocation of Patent RU 2421238 Related to Liraglutide Composition (Sun Pharmaceuticals Industries, Ltd (IN) v. Novo Nordisk A/S (DK))

Patentica’s patent attorneys, Victor Lisovenko and Ksenia Emelianova have successfully represented Sun Pharmaceuticals in opposing Novo Nordisk’s patent RU 2421238.

On September 30, 2024 the Board of a Chamber for Patent Disputes at the Russian Federal Service for Intellectual Property (RUPTO) partially revoked the patent. Specifically, as a result of the inter partes opposition proceedings Claims 1-11, relating to a formulation comprising a GLP-1 agonist—such as liraglutide (marketed as Victoza and Saxenda) or semaglutide (Ozempic and Wegovy) — were cancelled. Additionally, Claims 12-15, which covered methods for preparing the formulation, were also revoked.

Patent RU 2421238 covered pharmaceutical formulations comprising a GLP-1 agonist, an incretin mimetic that stimulates insulin production. Initially developed to treat type 2 diabetes, these formulations have also been approved for managing obesity and weight loss.

This case is notable as it reaffirms the RUPTO’s established approach to assessing the “novelty” requirement under Art. 1350 of the Russian Civil Code. A lack of novelty can be determined not only when a prior art document explicitly teaches a claimed object, but also when features disclosed in the prior art can be combined to arrive at the claimed object. In this instance, despite 15 prior art documents submitted RU 2421238 was mainly revoked for failing to meet the novelty criterion due to an earlier patent application filed by the same patentee. This repeatedly highlights the critical importance of a well-planned intellectual property strategy and filings throughout the R&D process and drug development cycle.

Patentica attorneys have extensive experience representing clients before the Chamber for Patent Disputes and the Intellectual Property Court. If you need assistance with your patent-related matters, please reach out to us at info@patentica.com.