Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd.
N/A - Not provided in text (2020)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
A person who makes a significant contribution to the conception of an invention as part of a collaborative enterprise is a joint inventor. A contribution is not disqualified simply because it was published before the final conception date or because the contributor was not present for the final experiments that reduced the invention to practice.
Facts:
- In the early 1990s, Dr. Tasuku Honjo discovered the PD-1 receptor and hypothesized it was an inhibitory receptor on immune T cells.
- In 1998, Dr. Honjo began collaborating with Dr. Clive Wood to identify the ligand that binds to the PD-1 receptor.
- Separately in 1998, Dr. Gordon Freeman, while studying B7 ligands, identified a sequence from a database of human ovarian tumors which he labeled '292'.
- Drs. Wood, Freeman, and Honjo began collaborating, and through shared information and reagents, confirmed that Freeman's '292' sequence (which they named PD-L1) was the ligand for Honjo's PD-1 receptor.
- At a joint meeting in October 1999, the researchers shared critical findings: Dr. Honjo shared his data showing PD-1 inhibits the immune response, Dr. Wood shared that PD-L1 antibodies inhibit the interaction, and Dr. Freeman disclosed that PD-L1 came from a human tumor.
- In early 2000, experiments directed by Dr. Freeman confirmed that PD-L1 was highly expressed in a wide variety of human tumor cells.
- In April 2000, Dr. Freeman added a sentence to a joint research paper proposing that some tumors might use PD-L1 to inhibit an antitumor immune response; the paper was published in October 2000.
- In October 2000, using reagents provided by Dr. Freeman, Dr. Honjo's lab conducted mouse experiments confirming that blocking the PD-1/PD-L1 pathway could inhibit tumor growth. After this, Dr. Honjo ceased sharing results with Drs. Freeman and Wood and filed his own patent applications.
Procedural Posture:
- Dana-Farber Cancer Institute, Inc. sued Ono Pharmaceutical Co., Ltd. and others in the U.S. District Court for the District of Massachusetts.
- The lawsuit sought to correct inventorship by adding Dr. Gordon Freeman and Dr. Clive Wood as co-inventors on six U.S. patents.
- Following a bench trial, the District Court found in favor of Dana-Farber.
- The District Court entered a judgment ordering the U.S. Patent and Trademark Office to add Drs. Freeman and Wood as co-inventors to the six patents in suit.
- Ono Pharmaceutical Co., Ltd. and the other defendants (appellants) appealed the District Court's judgment to the U.S. Court of Appeals for the Federal Circuit.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Does a researcher's contribution to the conception of an invention qualify for joint inventorship if that contribution was part of a long-term collaboration, even if the researcher was not present at the final moment of conception and some of their collaborative work was published before the final conception date?
Opinions:
Majority - Lourie, J.
Yes. A researcher's contribution qualifies for joint inventorship because invention is the product of collaboration over time, and a contribution is not negated by publication or absence from the final experiments. To be a joint inventor, one must make a significant contribution to the conception of the invention, and the court found that Drs. Freeman and Wood did so. The court rejected the argument that only the final in vivo mouse experiments constituted conception, stating that conception is complete when the idea is definite and permanent, which does not require proof that it will work. The work of Drs. Freeman and Wood—identifying the PD-L1 ligand, showing it was expressed on human tumors, and demonstrating the inhibitory nature of the PD-1/PD-L1 pathway—were essential 'building blocks' for the patented invention of using antibodies to block this pathway for cancer therapy. The court also explicitly rejected a rule that would disqualify contributions made public before conception, as this would ignore the realities of collaborative science where findings are shared over time.
Analysis:
This decision reinforces a broad and collaborative view of inventorship, especially in complex and cumulative fields like biotechnology. It establishes that foundational discoveries made during a collaboration are not nullified for inventorship purposes just because they are published or because another collaborator later conducts the final confirmatory experiments. The ruling protects contributors in long-term research projects from being excluded from patents, ensuring that the conception of an invention is viewed as a process rather than a single 'eureka' moment. This will make it more difficult for one party in a collaboration to claim sole inventorship by narrowly defining the moment of conception to only include their own final experiments.
