Novartis v. Alembic: Impact on Pharmaceutical Patent Law and Entresto’s Future

The recent legal case Novartis Pharms. Corp. v. Alembic Pharms. Ltd. has caught the attention of legal professionals worldwide with its implications on patent law concerning pharmaceuticals, specifically the drug Entresto® (Sacubitril/Valsartan).

The case was officially listed as Civ. No. 22-1395-RGA, by the court with Delaware jurisdiction, in the United States. The judgement, which falls under patent law, was passed on September 29, 2023, by Judge Andrews.

Of particular interest within this case is the patent under litigation, more formally known as U.S. Patent No. 11,096,918, widely referred to as the ’918 patent. This patent covers the composition of the drug Entresto®, a medication used for treating heart failure, which comprises two active ingredients: sacubitril and valsartan.

The specifics of the case, including the details of the ’918 patent, its validity, and the implications this case has on pharmaceutical patent law are known only in broad strokes. Details such as these are crucial for legal professionals working within the pharmaceutical industry and dealing with patent law, as they set precedents for future cases.

For further understanding of the nature of this case, refer to this brief explanation provided by the team at Robins Kaplan LLP.