On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of U.S. Patent No. 9,402,899 (“the ’899 patent”).  BMS alleges that the ’899 patent covers “Nobel Prize winning methods of treating cancer” by using “an antibody to inhibit the interaction between PD-1 and PD-L1 to treat cancer in patients.”  BMS further alleges that its OPDIVO (nivolumab) is the first antibody targeting the PD-1/PD-L1 pathway that has been approved anywhere in the world for cancer treatment.  BMS seeks a judgment of infringement of the ’899 patent, damages, and an award of attorneys’ fee and costs due to alleged willful infringement.

This is the second case that BMS has filed against AstraZeneca alleging infringement of the ‘899 patent.  In July 2017, BMS filed a complaint against AstraZeneca, also alleging that use of AstraZeneca’s IMFINZI (durvalumab) infringes claims of the ‘899 patent.  See C.A. No. 1:17-01028 (D. Del.).  That case was dismissed without prejudice in June 2019, based on a stipulation of the parties in view of an inventorship dispute raised in a related case.  Specifically, in a related case in the District of Massachusetts (15-cv-13443), the court ordered that Dr. Gordon Freeman (Dana Farber Cancer Institute) and Dr. Clive Wood (Genetics Institute) are additional co-inventors of the ’899 patent.  In July 2020, the Federal Circuit affirmed the inventorship determination.

Stay tuned to Big Molecule Watch for further developments with this case.

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