Delaware court rules against Gilead and Astellas in years-long patent case
A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.
The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market 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 upon several patents, and sought a declaratory judgment that Hospira’s manufacturing of the product would constitute a direct and induced infringement. Hospira denied the allegations, asserting in its defense that the patents are invalid and filing counterclaims seeking judgments of noninfringement.
After a three-day bench trial, Judge Colm Connolly ruled against Gilead and Astellas. Connolly stated that Gilead and Astellas failed to prove any direct infringement, and did not meet any burden to establish that infringement was breached. The parties are awaiting a final judgement.
The decision comes as Astellas wrote off more than half a billion dollars in losses last month and gutted candidates that were once thought to have massive potential. The company booked an “impairment loss” over two fiscal quarters back in April, about a year after writing off $540 million following a clinical hold on its lead gene therapy AT132.
For Gilead, while the company remains high on the Fortune 500 list, it suffered a setback earlier this year when the FDA slapped partial holds on studies evaluating magrolimab with azacitidine. The FDA lifted its partial hold on those studies last month, and Gilead said it’s on track for an interim readout in 2023.