Dana-Farber Cancer Institute, Inc. v. Ono Pharm. Co., et al. (Bristol-Myers Squibb)
Docket No. 2019-2050
NEWMAN, LOURIE, STOLL
July 14, 2020
Brief Summary: DC order to add Dana Farber and GI/Pfizer inventors to the Ono/BMS relating to the use of anti-PD1 antibodies affirmed.
Summary: Ono/BMS appealed DC order requiring Dr. Gordon Freeman and Dr. Clive Wood to be added as co-inventors to U.S. Pat. Nos. 7,595,048; 8,168,179; 8,728,474; 9,067,999; 9,073,994; and 9,402,899, each relating to methods for treating cancer using anti-PD1 antibodies. Dana Farber successfully alleged to the DC that its employee Dr. Freeman and Genetics Institute/Pfizer employee Dr. Wood should be named inventors on the patents that only name Ono’s Drs. Honjo, Minato, and Iwai. Drs. Freeman and Wood collaborated with Dr. Honjo before the JP priority application to which the disputed patents claim priority was filed. The FC panel reviewed the DC inventorship decision de novo and the underlying findings of fact for clear error (Vapor Point, FC 2016; 35 U.S.C. § 116(a) (joint inventorship)). Ono argued Drs. Freeman and Wood “were too far removed from the claimed subject matter of the patents”, their “contributions were public and were hence in the prior before the alleged conception”, and the Ono inventors’ work “performed independently of Drs. Freeman or Wood, were what led directly to the conception of the claimed inventions, and the previous work was at most speculative because it was not in vivo.” Dana-Farber argued that “Ono offers an erroneous view of the law” since that “would require each joint inventor to individually have conceived the complete invention and have participated in a particular moment of conception, which is inconsistent with the law.” The FC panel agreed with Dana-Farber that Ono proposed an “unnecessarily heightened inventorship standard” (Fina, FC 1997 (“[A] joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed.”); Pannu, FC 1998 (e.g., “contribute in some significant manner”, “do more than merely explain to the real inventors well-known concepts and/or the current state of the art”); Eli Lilly, FC 2004 (“may be joint inventors even though they do not physically work on the invention together or at the same time”); Burroughs Wellcome, FC 1994 (“An inventor need not know…that an invention will work for its intended purpose in order for conception to be complete…”)). Ono also unsuccessfully argued that the contributions of Drs. Freeman and Wood were not significant because “the Honjo patents were issued over” that provisional application, the FC panel explaining that whether their “contributions to the inventions are co-extensive with…their provisional application” is factually unclear and “joint inventorship does not depend on whether a claimed invention is novel or nonobvious over a particular researcher’s contribution” (“Collaboration and concerted effort are what result in joint inventorship.” (citing Eli Lilly)). The FC panel also rejected Ono’s argument “that research made public before the date of conception of a total invention cannot qualify as a significant contribution to conception of the total invention.” The FC panel also agreed that “knowing the structure and function of PD-L1 was essential to all the claimed inventions”, which was contributed by Drs. Freeman and Wood. The DC decision was therefore affirmed.