Tuesday, July 14, 2020

Dana Farber prevails over Ono in inventorship dispute

The outcome was affirmance of D. Mass.:

Ono Pharmaceutical Co. Ltd., Tasuku Honjo, E.R.
Squibb & Sons, L.L.C., and Bristol-Myers Squibb Co.
(collectively, “Ono”) appeal from the judgment of the United
States District Court for the District of Massachusetts after a bench trial ordering that Dr. Gordon Freeman and Dr.
Clive Wood be added to U.S. Patents 7,595,048 (“the ’048
patent”), 8,168,179 (“the ’179 patent”), 8,728,474 (“the ’474
patent”), 9,067,999 (“the ’999 patent”), 9,073,994 (“the ’994
patent”), and 9,402,899 (“the ’899 patent”) as co-inventors.
Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 379 F.
Supp. 3d 53 (D. Mass. 2019) (“Decision”).
Because we conclude that the district court did not err in its inventorship
determination, we affirm.


We have considered the parties’ remaining arguments
but find them unpersuasive. Because we conclude that the
district court did not err in holding Drs. Freeman and Wood
should be included as joint inventors of the ’048, ’179, ’474,
’999, ’994, and ’899 patents, we affirm the district court’s


Ono’s argument that work from Drs. Honjo, Freeman,
and Wood’s collaboration was too speculative until the October 2000 knockout mice studies is likewise misguided.
Conception is the touchstone of the joint inventorship inquiry, Sewall v. Walters, 21 F.3d 411, 415 (Fed. Cir. 1994),
and conception is complete when an idea is definite and
permanent enough that one of skill in the art could understand the invention, Burroughs Wellcome, 40 F.3d at 1228.
An inventor need not know, however, that an invention will
work for its intended purpose in order for conception to be
complete, as verification that an invention actually works
is part of its reduction to practice. Id. (citing Applegate v.
Scherer, 332 F.2d 571, 573 (CCPA 1964) and Oka v.
Youssefyeh, 849 F.2d 581, 584 n.1 (Fed. Cir. 1988)). While
Dr. Iwai’s work provided important in vivo data, in vivo
verification is not required for a conception to be definite
and permanent. See In re Isaacs, 347 F.2d 887, 889 (CCPA
1965) (holding that in vivo testing was not required to establish utility for claims to interferon). Moreover, the record is clear that Dr. Iwai’s work was conducted after Dr.
Freeman had shown expression of PD-L1 in human tumors
and Dr. Honjo had shown that PD-L1 expression causes tumor growth, so as a factual matter, PD-L1’s potential utility in treating human cancers was developed jointly with
Dr. Freeman before Dr. Iwai’s work.
Ono also argues that the Honjo patents were issued
over Drs. Freeman and Wood’s 1999 provisional patent application, so the latter contributions were thus not significant to the dispute over inventorship of Dr. Honjo’s
patents. As a factual matter, it is unclear that Drs. Freeman and Wood’s contributions to the inventions are co-extensive with the disclosure of their provisional application.
Regardless, 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. Eli Lilly, 376
F.3d at 1359. The novelty and nonobviousness of the
claimed inventions over the provisional application are not
probative of whether the collaborative research efforts of
Drs. Honjo, Freeman, and Wood led to the inventions
claimed here or whether each researcher’s contributions
were significant to their conception.


It is clear based on the record that Drs. Freeman and
Wood both contributed to conception of the ’474 patent. Dr.
Freeman connected the 292 sequence to PD-1 and directed
important immunohistochemistry experiments revealing
that several types of tumors express PD-L1. Dr. Wood provided Dr. Honjo with the first confirmation that the PD1/PD-L1 interaction was inhibitory, supported by experimental data. Drs. Freeman and Wood’s work on PD-L1,
Dr. Wood’s discovery that the PD-1/PD-L1 interaction inhibits the immune response, and Dr. Freeman’s discovery
of PD-L1 expression by human tumors were significant
building blocks upon which the ’474 patent is built.


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