Willkie Obtains Significant Victory for Hospira in Pharmaceutical Patent Litigation

April 6, 2020

The case, which was tried in federal court in Delaware, concerned a Hospira formulation of epinephrine, a drug used to treat critically-ill patients.

On March 31, 2020, Willkie achieved a significant victory for Hospira, Inc., a division of Pfizer Inc., in a pharmaceutical patent litigation tried before Chief Judge Stark of the U.S. District Court for the District of Delaware. The litigation concerned a Hospira formulation of epinephrine, a drug typically used to treat critically-ill patients. The case was tried in June 2019. The Court ruled in favor of Hospira on non-infringement and invalidity of Belcher Pharmaceuticals U.S. Patent No. 9,283,197 (“the ’197 patent”). The Court also found the patent unenforceable because Belcher’s Chief Scientific Officer had engaged in inequitable conduct during the prosecution of the patent—a rare finding in patent cases.

The concentration of epinephrine in the Hospira product is ten times lower than the concentration claimed in the patent, and the infringement case centered around whether the two are equivalent. Rejecting Belcher’s arguments to the contrary, the Court agreed with Hospira that the claims are drawn solely to a concentration of epinephrine in the formulation during manufacture, and that the concentration of epinephrine in Hospira’s product is not equivalent to the claimed concentration. The Court further ruled that Hospira proved that the asserted claims are invalid as obvious over two prior art epinephrine products.

Willkie and Hospira also achieved victory on two rarer grounds. First, the Court agreed with Hospira that the sole named inventor of the ’197 patent was not properly named as inventor of the claimed subject matter. Based on the inventor’s admissions during trial, the Court concluded that at most, he provided only a general instruction for research and a hope or wish that his suggestion would be successful. The Court also ruled that there was no contemporaneous evidence corroborating that the named inventor ever delivered the alleged instruction.

The Court also ruled that the Belcher patent is unenforceable due to inequitable conduct. Based on Willkie’s cross-examination, the Court found that Belcher’s Chief Scientific Officer helped “create a fiction” that the patent represented a new invention, and then withheld from the Patent Office “any information that undermined that fiction.” Based on the full record that Hospira presented at trial, the Court concluded that the CSO intentionally withheld key literature published by prior scientists, and that the ’197 patent would not have issued had the Patent Office known about the literature. The Court also found that he made material misrepresentations to the Patent Office in promoting his fiction.

The Willkie team includes partners Thomas Meloro and Matthew Freimuth, and associates Devon Edwards and Eric Saunders.