A Delaware judge has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.
The case began in 2018, after Hospira submitted an abbreviated new drug application (ANDA) for marketing approval of a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.
Gilead and Astellas alleged that Hospira’s ANDA submission for regadenoson infringed multiple patents and sought a declaratory judgment that Hospira’s manufacture of the product would constitute direct and consequential infringement. Hospira has denied the allegations, asserting in its defense that the patents are invalid and filing counterclaims seeking judgments of non-infringement.
After a three-day trial, Judge Colm Connolly ruled against Gilead and Astellas. Connolly said Gilead and Astellas failed to prove direct infringement and did not bear any charges to establish that the infringement was violated. The parties await a final judgment.
The decision comes as Astellas wrote off more than half a billion dollars in losses last month and gutted candidates once thought to have huge potential. The company booked a two-quarter “impairment” in April, about a year after writing off $540 million following a clinical hold of its lead gene therapy AT132.
For Gilead, although the company remains at the top of the Fortune 500 list, it suffered a setback earlier this year when the FDA partially suspended studies evaluating magrolimab with azacitidine. The FDA lifted its partial grip on those studies last month, and Gilead said it was on track for an interim reading in 2023.