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Genentech Wins Summary Judgment in Patent Dispute Over Hemophilia A Drug

Paul, Weiss won a major victory on behalf of Genentech in patent litigation brought by Baxalta, Inc. and Baxalta GmbH (now subsidiaries of Takeda Pharmaceuticals) concerning Genentech’s breakthrough hemophilia treatment HEMLIBRA® (emicizumab). The U.S. District Court for the District of Delaware granted Genentech’s motion for summary judgment, holding that Baxalta’s patent is invalid for lack of enablement.

Baxalta initially sued for infringement in 2017. Its patent concerns an antibody or antibody fragments that binds to a protein important for blood coagulation, and which increases the procoagulant activity of that protein. In our motion for summary judgment, filed in September 2021, we argued that the patent is invalid because it doesn’t teach a skilled practitioner to make or use the full scope of the invention without undue experimentation. Instead, we argued, the patent covers a very large genus of antibodies and “epitomizes the broad, unsupported genus claims that the Federal Circuit uniformly invalidates.”

The court agreed, noting that “no reasonable jury could find the full scope of the asserted claims of the ’590 patent are enabled” and explaining that “[t]o be enabling, ‘the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.’” Instead, the court compared Baxalta’s claims to “a search for a needle in a haystack,” observing that it took “almost 10 years to develop emicizumab,” including “a multi-phased, trial-and-error process that involved screening tens of thousands of antibodies and engineering the resulting antibodies for optimization before finding one that was suitable for clinical use.” The court “cannot allow Baxalta to provide a starting point for further research and then claim ‘someone else’s solution to the problem,’” it concluded.

Paul, Weiss previously won another major victory in this case when it defeated Baxalta’s motion for a preliminary injunction in August 2018. After an evidentiary hearing, the court noted that, as Paul, Weiss showed, there were serious questions about whether Baxalta could prove infringement and whether Baxalta’s patent was even valid. Among other things, Paul, Weiss showed that HEMLIBRA® “represents a potential sea change in the treatment of” a devastating disease. Regarding the need for an injunction, the court found that Baxalta’s economist’s testimony also was “simply not credible,” and that Baxalta faced no irreparable harm.

The Paul, Weiss team included, among others, litigation partners Kenneth Gallo and Catherine Nyarady, and counsel Jennifer Gordon and Josephine Young.

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