In a significant legal showdown, a U.S. Court of Appeals has upheld a pivotal ruling in favor of Roche’s Genentech, reinforcing that their groundbreaking hemophilia A therapy, Hemlibra, does not infringe on Takeda’s Baxalta’s patent protections.
This courtroom saga began when Baxalta took legal action against Genentech in 2017, alleging that Hemlibra’s manufacture, use, and sale infringed upon a specific patent known as the ‘590 patent. This patent pertained to the design and use of antibodies or antibody fragments targeting Factor IX and its activated form, Factor IXa, effectively enhancing their procoagulant activity.
In January 2022, the U.S. District Court for the District of Delaware issued a pivotal verdict in favor of Roche and Genentech. Circuit Judge Timothy Dyk’s opinion at the time raised eyebrows, as he ruled that critical aspects of Baxalta’s patents were invalid because they failed to provide clear guidance to practitioners on how to develop and utilize the claimed invention without resorting to “undue experimentation.”
Judge Dyk pointed out that the relevant claims in the ‘590 patent did not offer insights into identifying antibodies meeting the claim’s criteria or the structural features responsible for enhancing coagulant activity.
In Wednesday’s ruling, the court concurred with the initial verdict, noting that one of Baxalta’s claims was overly broad, attempting to encompass all antibodies binding to Factor IX/IXa and elevating their procoagulant activity. This overly broad definition potentially included “millions” of antibodies, while the ‘590 patent specifically named only “eleven” candidates.
The court highlighted that the undisclosed potential antibodies required extensive experimentation for identification, effectively leading to a trial-and-error process.
Hemlibra, first approved in 2017 for treating hemophilia A, is a revolutionary bispecific antibody that targets Factor IX and Factor IXa, enabling the coagulation cascade to progress. The therapy has since become one of Roche’s flagship assets, generating over $4.2 billion in revenue in 2022.