by Dennis Crouch
In an interesting inventorship dispute, the Federal Circuit has affirmed a lower court ruling that two scientists should be added to the list of inventors on a set of patents obtained by Ono Pharmaceuticals. The change in inventorship means a change in ownership rights as well, and these are valuable patents.
Dana-Farber Cancer Institute, Inc. v. Ono Pharma Co. (Fed. Cir. 2020).
Ono holds a number of tied to cancer therapies that disrupt PD-1 receptor/ligand activity on certain cancer cells. That disruption then allows a stronger immune response by the patient’s body. US7595048; US8168179; US8728474; US9067999; US9073994; and US9402899.
In the 1990’s Dr. Tasuku Honjo discovered the PD-1 receptor, isolated its DNA sequence, and studied various aspects of its relationship to “programmed cell death.” He was awarded the Nobel Prize for this research. Honjo then started a quest to find a ligand binding to PD-1.
At some point, Honjo began collaborating with Drs. Freeman and Wood who were working in the US. The trio shared substantial data and plans back-and-forth and began a collaborative research project.
Then what happened — Freeman and Wood filed a patent application on a response-modulation therapy but did not include Honjo on the application (even after he asked to be included). Honjo then filed his own patent application in Japan — the parent application for all of the patents at issue here. Although years later, Dana-Farber eventually sued for correction of inventorship under 35 U.S.C. § 256(b) — a move that would give it partial ownership over the patents.
Invention is generally thought to have two key points of demarcation: (1) conception of the invention; (2) reduction of the invention to practice. That said, the primary focus is usually on the first point – conception. Joint inventorship creates some confusion on this point – but the basic requirement is that each joint inventor must significantly contribute to the conception or reduction to practice. On this point, the Judge Lourie quotes one of his own opinions from 1998:
All that is required of a joint inventor is that he or she (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.
Quoting Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998). Regarding conception, the court also notes that “conception” may be somewhat speculative:
[C]onception 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, 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.
Slip Op. citing Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994).
Some of the information provided by Freeman and Wood had already been made public by the time of the “complete invention.” The Federal Circuit, however refused to “hold categorically 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.”
[A] collaborative enterprise is not negated by a joint inventor disclosing ideas less than the total invention to others, especially when, as here, the collaborators had worked together for around one year prior to the disclosure, and the disclosure occurred just a few weeks prior to conception.
Id. In the end, the court concluded that Ono’s arguments were essentially a request to “adopt an unnecessarily heightened inventorship standard.” The court declined.