Federal Circuit Affirms District Court Ruling that Dana-Farber Inventors Must Be Added to Patents for Cancer Treatment

The Dana-Farber Cancer Institute last week had its district court win affirmed when the Federal Circuit upheld a decision that two of the Institute’s researchers must be added as co-inventors on several patents relating to advancements in cancer treatment. The Court ruled that the United States District Court for the District of Massachusetts did not err in its determination that Dr. Gordon Freeman and Dr. Clive Wood should be added to the patents, and said that the appellants’ arguments would require the Court to “adopt an unnecessarily heightened inventorship standard.” Ono Pharmaceutical Co. Ltd., Tasuku Honjo, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb Co. (collectively, “Ono”) appealed the district court’s ruling.

A Complicated Timeline

The claims of 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”) recite “uses of antibodies that target either the PD-1 receptor or its PD-L1 ligand, blocking the receptor-ligand interaction.” In blocking this interaction, the inventions stimulate the immune response to fight tumor cells that “would otherwise have been hidden by their expression of the PD-L1/L2 ligands.” (A ligand is a molecule that binds to another molecule).

Dr. Honjo had discovered the PD-1 receptor in the early 1990s. He met with representatives from Ono and the Genetics Institute in 1998, who connected him with Dr. Wood. Dr. Freeman was conducting independent research that year in the same field, with Dana-Farber, and the three doctors began sharing information directly, ultimately meeting in Cambridge, Massachusetts in October 1999 and disclosing their individual findings to one another, after which they began exchanging reagents. 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. When Honjo discovered this in 2000, he challenged his colleagues on the exclusion. They continued to meet and collaborate until April 2001, and in 2002, Honjo and two other colleagues filed a patent application in Japan, from which each of the three U.S. patents at issue in the present case claims priority. In 2018, 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,” noted the CAFC opinion.

Defining a Significant Contribution

Dana-Farber brought suit in the district court and laid out eight reasons that Drs. Freeman and Wood should be added as inventors. Ultimately, the court identified a number of aspects of Freeman’s and Woods’ work that served as  “contributions significant to the conception of all six patents.”

At the Federal Circuit, Ono challenged:

(1) the district court’s legal analysis of conception, and

(2) the district court’s factual findings regarding inventorship.

Ono in part argued that Freeman’s and Woods’ contributions should be deemed irrelevant because their work was published in October 2000 with Honjo prior to conception of the patented inventions. “Ono urges us to adopt a legal rule that once a contribution is made public, it ‘no longer qualifies as a significant contribution to conception,’” wrote the Court.

Instead, the CAFC agreed with Dana-Farber’s view that Ono’s view of the law was erroneous, and “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 law.” The Court continued:

Ono asks us to adopt an unnecessarily heightened inventorship standard. “[A] joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed…. Ono attacks the inventorship case for Drs. Freeman and Wood on the ground that they failed to participate in certain experiments that led to the conception of the claimed invention, but the statute and our case law make clear that joint inventors need not contribute to all aspects of a conception.

Remaining Arguments Denied

The Court also rejected Ono’s arguments that, since the Honjo patents were issued over Freeman and Wood’s 1999 provisional patent application, their “contributions were thus not significant to the dispute over inventorship of Dr. Honjo’s patents.” The Court explained:

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.

Ono’s reasoning that research made public prior to conception of a total invention should be disqualified from the inventorship analysis. “Such a rule would ignore the realities of collaboration, especially that collaboration generally spans a period of time and may involve multiple contributions, said the Court.

As to Ono’s argument that the district court erred in its factual analysis of the patents, the Federal Circuit disagreed and ultimately affirmed the district court in full.