Universities of Michigan and South Florida Sue Novartis Over Entresto Patents; Lawsuit Updates

Novartis_Harold Cunningham/Getty Images

The University of Michigan and the University of South Florida have filed a lawsuit against Novartis, alleging the company’s cardiac drug, Entresto, infringes a cocrystal patent held by both universities.

The FDA approved an expanded indication for Entresto (sacubitril/valsartan) in February 2021 to reduce the risk of cardiovascular death and hospitalization for adults with chronic heart failure. Benefits are most clearly seen in patients with left ventricular ejection fraction below normal. The patent in question was granted in April 2020, emcompassing a technology used to make multicomponent solid drugs.

Entresto works on the beneficial neurohormonal systems while inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system.

The drug brought in $1.13 billion in the second quarter, even while facing generic competition from Teva, Viatris, Aurobindo and Lupin.

The patent covers “a method for identifying complementary chemical functionalities to form a desired supramolecular synthon. The subject invention also pertains to binary phase compositions comprising one or more pharmaceutical entities and methods for producing such compositions.”

Broadly, the patent describes a way to engineer crystals to design new drugs.

The lawsuit alleges that the U.S. patent and trademark office issued the patent to Michael Zaworotko, Ph.D., Brian Moulton, Ph.D., who both assigned patents rights to the University of South Florida Board of Trustees, and Nair Rodriguez-Hornedo, Ph.D., who assigned the rights to the Regents of the University of Michigan.

The patent describes more than a dozen chemical structures and they argue that Entresto infringes at least one of them. The lawsuit specifically cites Entresto tablets at three dosages: 24.3 mg sacubitril, 25.7 mg valsartan; 48.6 mg sacubitril, 51.4 mg valsartan; and 97.2 mg sacubitril, 102.8 mg valsartan.

Other Lawsuit Updates

  • In May, Greece’s Health Minister Thanos Plevris sued Novartis over what Greece alleges are illegal practices. For its part, Novartis claimed to have paid Greek public officials and health care providers to increase prescriptions for its drugs and maintain higher prices.
  • In August, Moderna filed lawsuits against Pfizer and BioNTech, alleging the companies of infringing its patents related to its COVID-19 vaccine mRNA technology. The suits argue that two key features of Moderna’s technologies are vital to the success of mRNA vaccines. Moderna claims that neither Pfizer nor BioNTech had their experience with mRNA vaccines for infectious diseases and “knowingly followed Moderna’s lead in developing their own vaccine.”
    • Pfizer and BioNTech “ultimately decided to proceed with the vaccine that has the same mRNA chemical modification to its vaccine as Spikevax (Moderna’s vaccine),” according to Moderna.

The waning of the COVID-19 pandemic has marked several vaccine-related lawsuits.

  • In July, Germany-based CureVac filed a lawsuit in a German court against BioNTech over intellectual property related to the Pfizer-BioNTech COVID-19 vaccine.
  • Alnylam has filed suits against Pfizer, BioNTech and Moderna over the mRNA delivery system used in their COVID-19 vaccines.
  • In February, Arbutus Biopharma and GeneVant filed lawsuits against Moderna over patent infringement related to the LNP delivery technology.

Back to news