By Ken W. Pung, Associate Attorney, Standley Law Group LLP

Dana-Farber Cancer Inst., Inc., v. Ono Pharm. Co.

2020 U.S. App. LEXIS 21704; 2020 U.S.P.Q.2D (BNA) 10775
Opinion by: Circuit Judge Alan Lourie

Patents at Issue

U.S. Patent Nos.: 7,595,048, 8,168,179, 8,728,474, 9,067,999, 9,073,994, and 9,402,899.

Background

The facts of this case concern an inventorship dispute over methods of treating cancer by administering antibodies targeting PD-1 (receptor) and PD-L1 (ligand) interactions on T cells (a type of lymphocyte that develops in the thymus gland). The three scientists involved in this inventorship dispute are: Nobel Prize laureate Dr. Honjo (of Ono Pharm., herein “Ono”), Dr. Wood (of the Genetics Institute, now owned by Pfizer), and Dr. Freeman (of Dana-Farber).

Dr. Honjo discovered and started researching the PD-1 receptor in mouse models in the early 1990’s. In 1998, Drs. Honjo, Freeman, and Wood began collaborating by sharing information and reagents with one another in an attempt to find a ligand that binds to PD-1. In 1999, Drs. Freeman and Wood filed a provisional patent application disclosing modulation of the immune response via activating or blocking the PD-1/PD-L1 pathway, but did not list Dr. Honjo as an inventor. Dr. Honjo challenged his exclusion as an inventor, and stopped sharing information with Drs. Freeman and Wood in 2001. In 2002, Dr. Honjo filed his own patent applications that did not include Drs. Freeman and Wood as inventors. These patent applications culminated in the patents at issue (above). In response, Dana-Farber filed this suit on behalf of Dr. Freeman in the United States District Court for the District of Massachusetts, alleging that Drs. Freeman and Wood should be added as inventors on Dr. Honjo’s patents.

The District Court determined that Drs. Freeman and Wood significantly contributed to the conception of the patents at issue and ordered that Drs. Freeman and Wood be added as inventors to all six of them. The Federal Circuit, in an opinion by Judge Lourie, affirmed.

Ono's Legal Arguments

(1) The contributions of Drs. Freeman and Wood were too far removed from the claimed subject matter of the patents at issue.

Here, Ono pointed to the fact that: (1) Dr. Honjo and his research group performed experiments independently from Drs. Freeman and Wood, and that these experiments were what led to the conception of the claimed inventions; and (2) that the work of Drs. Freeman and Wood was merely speculative at best because the work was not done in vivo.

As to (1), the Federal Circuit determined that joint inventors need not contribute to all aspects of a conception. Id at 15. The fact that Drs. Freeman and Wood were not present for or participants in all the experiments that led to the conception of the claimed inventions does not negate their overall contributions throughout their collaboration with Dr. Honjo. Id.

As to (2), the Federal Circuit determined that “conception is complete when an idea is definite and permanent enough that one of skill in the art could understand the invention … An inventor need not know 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. Thus, in vivo verification is not required for a conception to be definite and permanent.

Lesson to be learned: Conception of a joint invention does not require each joint inventor to contribute to all aspects of the joint invention, nor does it require knowledge that the invention will actually work.

(2) The fact that the patents at issue were allowed over Drs. Freeman’s and Wood’s 1999 provisional application is evidence that the patents claim treatments were novel and nonobvious over Drs. Freeman’s and Wood’s alleged contributions.

Here, the Federal Circuit held that “joint inventorship does not depend on whether a claimed invention is novel or nonobvious over a particular research’s contribution.” Id at 16. 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.” Id.

Lesson to be learned: Patentability does not equate to inventorship. Collaboration and concerted effort are what result in joint inventorship, not novelty and nonobviousness.

(3) The Federal Circuit should adopt a legal rule that once a contribution is public, it no longer qualifies as a significant contribution to conception.

Here, Ono was urging the Federal Circuit to categorically hold that research made public before the date of conception of a total invention cannot qualify as a significant contribution of the conception of another total invention. In effect, “Ono's rule would require each joint inventor to individually have conceived the complete invention and have participated in a particular moment of conception.” Id at 14. For this reason, the Federal Circuit declined to adopt Ono’s proposed legal rule because it amounts to an “unnecessarily heightened inventorship standard” that “ignores the realities of collaboration.” Id at 17.

In support of this holding, the Federal Circuit acknowledged that collaboration generally spans a period of time and may involve multiple contributions (especially for complex inventions). The Federal Circuit reasoned that “there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public.” Id at 18.

Lesson to be learned: There is no heightened standard for inventorship. The standard remains, as it has been, pursuant to 35 U.S.C. § 116(a) and the case law. See e.g., Fina Oil & Chem. Co. v. Ewen,123 F.3d 1466, 1473 (Fed. Cir. 1997); Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir.1998); Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1358 (Fed. Cir. 2004); and Burroughs Wellcome, 40F.3d at 1227.

If you have questions regarding inventorship of an invention, seek the advice of your patent attorney.