Biopharma firms must pay $14m to block rival’s launch

The temporary injunction prevents a Pfizer unit from launching a generic| The dispute centres on a branded coronary artery test

The US Court of Appeals for the Federal Circuit has told Gilead and Astellas to post a bond of more than $14 million if it wishes to maintain a temporary injunction against Pfizer.

If Gilead and Astellas pay the bond, the temporary injunction—which blocks Pfizer’s Hospira from launching a generic version of coronary artery test Lexiscan (regadenoson)—will remain in place until oral arguments in the dispute begin in December 2022.

In September, the  US District Court for the District of Delaware granted Astellas a temporary injunction against Hospira, preventing Hospira from launching its copycat version of Lexiscan.

However, the court also rejected Astellas’ bid for a preliminary injunction, which would have prevented the launch until the case works its way through its appeal.

A few months before, in May, the court had ruled that Hospira’s generic did not infringe the Lexicon patents (which Gilead owns and licenses to Astellas, which commercialises the product in the US).

Gilead and Astellas appealed against the decision to the Federal Circuit, arguing that the Delaware court had “improperly excluded” their primary infringement evidence.

“If a defendant amends its product specification late in litigation for the purpose of defeating a patentee’s existing infringement contentions, may the patentee respond by introducing new evidence of infringement?,” said the brief.

“The answer to this question should be obvious. If a defendant may alter its product to address the patentee’s infringement theories, a plaintiff must have an opportunity to present new evidence in response. The district court’s inexplicable holding to the contrary is manifestly unfair, and it necessitates reversal.”

According to Gilead and Astellas, while the court had permitted Hospira to change the accused product late in litigation to work around the’ infringement contentions, the court also precluded Gilead and Astellas from presenting evidence in response, on the purported basis that their “evidence (but not the changes in the underlying product to which that evidence responded) was untimely”.