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30 August 2022GenericsMuireann Bolger

Novartis sued over blockbuster heart failure drug

Pharma company facing lawsuit from two universities | Dispute centres on therapeutically effective co-crystals patent.

Novartis AG is facing an infringement lawsuit from the University of Michigan and the University of South Florida in a dispute over the top-selling heart failure treatment, Entresto (sacubitril/valsartan).

The plaintiffs filed the complaint on August 29 at the US District Court for the Northern District of California alleging that the pharma company had infringed the patent, US number 10,633,344, that is jointly held by both institutions.

The ’344 patent relates to pharmaceutical compositions comprising therapeutically effective co-crystals.

The filing holds that without obtaining a licence or permission to use the inventions claimed in theʼ344 patent, Novartis has sold and marketed a co-crystal drug Entresto since 2015 to treat adult patients with chronic heart failure. Novartis has said that Entresto could hit at least $5 billion before potentially losing its patented exclusivity in 2025.

According to the complaint, Michael Zaworotko, Brian Moulton, and Nair Rodríguez-Hornedo are the named inventors of the ’344 patent.

Zaworotko and Moulton assigned their rights as inventors of the ʼ344 patent to the University of South Florida Board of Trustees, while Rodríguez-Hornedo assigned her rights as an inventor of the ʼ344 patent to the Regents of the University of Michigan.

The drug has been the subject of other IP disputes and regulatory scrutiny in recent years. In September, the US Department of Justice announced that it would probe Novartis’ marketing activities involving Ernesto.

Novartis also filed a patent suit against Crystal Pharmaceuticals last year after the Chinese company sought to create a generic version of Entresto.

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