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Paul, Weiss won a significant victory for Genentech, Inc. in litigation brought by Baxalta Inc. concerning Genentech’s HEMLIBRA®, a potentially life-changing treatment for hemophilia A. Baxalta asserted that HEMLIBRA® infringes one of its patents and moved for a preliminary injunction to prevent Genentech from marketing and selling HEMLIBRA® in the United States to certain hemophilia A patients. The U.S. District Court for the District of Delaware denied Baxalta’s motion.
In its opinion, the court held that Baxalta had not proven a substantial likelihood of success on the merits, and that “Baxalta has [also] failed to establish that it is at risk of significant irreparable harm or that the public interest weighs in favor of enjoining the sale of Hemlibra.” On the contrary, the judge noted that Genentech made an “especially strong showing on the public interest” and concluded that a preliminary injunction is not appropriate.
The U.S. Food and Drug Administration has twice granted HEMLIBRA® “Breakthrough Therapy” status, indicating that it may represent “a substantial improvement over existing therapies” for a serious or life-threatening condition. In November 2017, FDA approved HEMLIBRA® for hemophilia A patients with inhibitors that prevent traditional Factor VIII therapy. In June 2018, FDA granted priority review to HEMLIBRA® for hemophilia A patients without inhibitors, and is expected to make a decision on approval by October 4, 2018.August 7, 2018