The US universities of Michigan and South Florida claim that the pharma giant is infringing a co-crystal patent the two educational institutions hold and have filed a lawsuit in the US district court for the Northern District of California, seeking damages.

At the center of the dispute is US Patent no. 10,633,344, awarded to the universities in April 2020, covering a technology that the plaintiffs say can produce multicomponent solid drugs with “improved drug solubility, dissolution rate, stability and bio-availability.”

Entresto is a combination of sacubitril and valsartan. The universities allege that the two co-crystals comprise “supramolecular synthons” that touch on their patented supramolecular technology.

Given the stakes, the institutions want a jury trial, which, if successful, presumably could result in Novartis paying significant damages, in view of Entresto’s annual global sales of $3.55 billion.

Novartis itself has filed patent infringement lawsuits against several US generics manufacturers, including Teva, Viatris, Aurobindo and Lupin. Due to multiple patent extensions it has won for various components and combinations of Entresto, the Swiss pharma giant has piled up patents protecting various aspects of its formulation into 2036 in some cases.

In late 2021, Novartis also filed a citizen petition asking the US Food and Drug Administration not to greenlight any Entresto copies until at least February 2024. At the time, it noted, at least 18 drugmakers had submitted applications seeking approval of a generic version.

Author: Dede Williams, Frelance Journalist