A federal jury in Delaware has ordered Amgen Inc. to pay Lindis Biotech GmbH $50.3 million after finding that the pharmaceutical giant's cancer drug Blincyto willfully infringes two patents related to leukemia treatment administration methods. The verdict, issued on December 17, 2024, followed a seven-day jury trial that concluded a patent dispute spanning over two years.
Patent Infringement Findings
The jury determined that Blincyto's label actively induces healthcare providers to administer the drug in a manner that infringes Lindis Biotech's U.S. Patent Nos. 10,071,158 and 8,709,421. Specifically, the jury found infringement of claims 3, 8, and 15 of patent 8,709,421 and claims 1, 12, and 20 of patent 10,071,158.
The infringement was ruled to be both direct and induced, with the jury additionally finding that the violations were willful. This finding of willful infringement could potentially expose Amgen to enhanced damages beyond the base award.
Patent Validity Upheld
In addition to the infringement findings, jurors upheld the validity of both Lindis patents, rejecting Amgen's challenges. The jury determined that the patents had not been shown to be obvious or invalid for lack of written description or enablement, strengthening Lindis Biotech's position in the dispute.
Substantial Damages Award
The reasonable royalty awarded to Lindis was calculated based on over $2.2 billion in U.S. sales of Blincyto, resulting in approximately $50 million in damages. Notably, the jury did not award any damages for Blincyto sales outside the United States, limiting the financial impact to domestic market performance.
The substantial sales figures underlying the damages calculation reflect Blincyto's commercial success. In fiscal year 2023 alone, Amgen reported Blincyto sales of $566 million in the U.S., representing a 48% increase over fiscal year 2022.
Amgen's Legal Challenge
Following the adverse verdict, Amgen has moved to challenge the jury's findings. On December 13, 2024, the company filed a Motion for Judgment as a Matter of Law seeking to overturn the findings of direct, induced, or willful infringement and eliminate the damages award.
In its motion, Amgen specifically argued that Lindis's damages calculations were impermissibly based on non-infringing off-label and pediatric uses of Blincyto. This motion remains pending before the court and could potentially reduce or eliminate the damages award if successful.
Case Background
The patent infringement case, filed as Case No. 1:22-cv-00035 in the U.S. District Court for the District of Delaware, represents a significant intellectual property dispute in the oncology space. Blincyto (blinatumomab) is a bispecific T-cell engager used in the treatment of certain types of leukemia, making it a valuable asset in Amgen's oncology portfolio.
