July 28, 2020
The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts. http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2050.OPINION.7-14-2020_1618430.pdf.
This is a story of scientists, one of which is a Nobel Laureate (Honjo) where:
This appeal presents an inventorship dispute over groundbreaking work in the field of cancer treatment. Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells.
The discovery behind the present patents was the ex-istence of an inhibitory receptor on T cells, PD-1, and that, when PD-1 binds to one of its ligands, either PD-L1 or PD-L2, the T cell is inhibited and does not attack the cell ex-pressing the ligand. Expression of the PD-1 ligands in healthy cells generally shields them from attack, but some tumor cells can also express the ligands, allowing them to circumvent an immune response. The patents in this case capitalize on the discovery of the PD-1 receptor-ligand in-teraction. Each claim recites uses of antibodies that target either the PD-1 receptor or its PD-L1 ligand, blocking the receptor-ligand interaction.
The background of this case, as described in the opinion, tells a common tale in university involved research-- labs collaborating on the science. However, when it came time to patent the invention, one party does not think the other did much to contribute to the invention. The collaborating labs were Dr. Honjo’s lab in Kyoto University’s medical school, which discovered the PD-1 receptor in the early 1990s, Dr. Wood, a researcher at Genetics Institute, who apparently suggested developing antibodies against PD-1 receptor for therapeutic applications, and Dr. Freeman, a researcher at Dana-Farber. There are numerous facts in the opinion as to the time line and details of this collaboration but what is clear is that all three professors contributed something significant to this invention. However, the patents listed only Dr. Honjo and his people while excluding Drs. Wood and Freeman--Ono Pharmaceutical Co., Ltd. is the assignee of the patents.
So as not to consider that Dr. Honjo was the only one who did not think his collaborators were inventors, it appears from the opinion that Drs. Wood and Freeman also filed applications while excluding Dr. Honjo:
Dr. Honjo’s attorneys were pursuing his inventorship claim, but Genetics Institute, the assignee of Drs. Freeman and Wood’s patents, and its attorneys de-clined to voluntarily add him to their patents. Genetics Institute stated that Dr. Honjo could pursue his inventorship claim at the PTO. Inventorship of those patents is not at issue here.
One can wonder, however, if the inventorship dispute was driven by the scientists or some well-meaning patent attorneys and/or the assignees. Notably, from the opinion: “In 2018, Dr. Honjo won the Nobel Prize in Physiology or Medicine, and it is not without interest that in his acceptance speech he credited Dr. Freeman as a major collaborator in his work.”
The District Court held that Drs. Wood and Freeman were co-inventors on Dr. Honjo’s patents. The Federal Circuit affirmed the District Court decision while reminding the parties of what co-inventorship means:
“[A] joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed.” Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997) (citing Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227 (Fed. Cir. 1994)). To be a joint inventor, one must:
(1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art. Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998); quoted in VerHoef, 888 F.3d at 1366. There is no “explicit lower limit on the quantum or quality of inventive contri-bution required for a person to qualify as a joint inventor.” Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1358 (Fed. Cir. 2004) (quoting Fina Oil, 123 F.3d at 1473). “People may be joint inventors even though they do not physically work on the invention together or at the same time, and even though each does not make the same type or amount of contribution.” Burroughs Wellcome, 40 F.3d at 1227 (citing 35 U.S.C. § 116).
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 under-stand 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)).