After taking a $50 million hit in a patent lawsuit targeting its leukemia med Blincyto last year, Amgen has convinced a Delaware federal judge to negate the verdict.
In a decision issued Thursday, U.S. District Judge Gregory Williams concluded that two patents held by Lindis Biotech “are unenforceable due to inequitable conduct.” The development strikes down the $50.3 million jury verdict Lindis won in December over allegations that Amgen’s Blincyto violated Lindis-held intellectual property.
Amgen and Lindis now have two weeks to attempt to either reach an agreement or propose suggestions on how the case should proceed, the judge wrote in his decision.
Neither company responded to Fierce’s comment request by the time of publication.
Amgen was put on the hook to pay $50.3 million in damages in December when a Delaware federal jury found that the company had infringed two Lindis immunotherapy patents. The jury also determined that Amgen had infringed those patents willfully, which could have led the court to increase Lindis’ award up to $150.9 million, Reuters reported late last year.
Amgen subsequently made the case that Lindis’ patents were invalid because their named inventor allegedly provided false information in his patent application, Reuters noted in a separate report Thursday.
The patent litigation odyssey dates back to 2022, when Lindis first sued Amgen over claims that the California drugmaker’s leukemia med Blincyto violated three Lindis patents surrounding the use of steroid hormones to curb side effects when using a bispecific antibody in a cancer immunotherapy regimen.
Lindis further contended that Amgen was well aware of its patents by 2014—as evinced by efforts to strike down counterpart IP in Europe—and chose to flaunt them regardless.
Amgen quickly hit back with a motion to dismiss the case in April 2022, arguing against the way Lindis’ legal team defined Blincyto and suggesting that the plaintiff failed to demonstrate how its intellectual property was being stepped on.
The California biotech giant also took issue with the fact that one of the Lindis patents at the heart of the case, dubbed the ‘149 patent, specifically concerns the treatment of lymphoma. All of Blincyto’s FDA nods are in acute lymphoblastic leukemia (ALL).
Subsequently, in a decision by judge Williams in March 2024, Amgen’s motion to dismiss the case was both granted and denied in part, providing room for Lindis to amend its claims.
Lindis then filed an amended complaint, which Amgen again parried with its own legal filing last May.
Blincyto won its first ALL green light in December 2014 and has since racked up a number of additional nods in the indication. The drug generated $800 million in U.S. sales last year and $1.2 billion across all regions where Amgen operates, a 41% jump over the total sum the drug delivered in 2023.
Despite now being more than a decade old, Blincyto continues to deliver wins on the sales front and in the clinic for Amgen.
Late last year, Amgen reported that a Blincyto-chemotherapy cocktail helped 96% of newly diagnosed pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL) in a phase 3 trial remain alive and disease-free for three years, versus 87.9% of patients who received chemotherapy alone.
The data also pointed to a 61% reduction in the risk of disease relapse, remission or death by secondary malignant neoplasm in the Blincyto arm, with one of the study’s co-chairs calling the results “truly practice-changing.”