Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017.
Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the BPCIA’s patent dance. Genentech alleges that Pfizer did not satisfy its disclosure obligations under 42 U.S.C. § 262(l)(2), despite providing Genentech a copy of Pfizer’s aBLA on September 5, 2017, and also providing additional manufacturing information on November 1, 2017. According to the complaint, Genentech provided its list of patents pursuant to 42 U.S.C. § 262(l)(3)(A) on November 3, 2017, and Pfizer has not yet provided its detailed statement concerning noninfringement and invalidity pursuant to 42 U.S.C. § 262(l)(3)(B). Genentech further alleges that, on November 17, 2017, Pfizer provided its intention to commence commercial marketing pursuant to 42 U.S.C. § 262(l)(8)(A).
We will continue to monitor this litigation. Stay tuned to Big Molecule Watch for further updates.