Tech Transfer eNews Blog

Nobel laureate loses multi-billion dollar patent dispute with Dana-Farber Cancer Institute

By Jesse Schwartz
Published: July 29th, 2020

Nobel laureate Tasuku Honjo and his commercial partners have lost a U.S. Federal Circuit appeal in a patent dispute with the Dana-Farber Cancer Institute over revolutionary new methods for cancer immunotherapy.

The Federal Circuit upheld a Massachusetts court finding that two researchers who Dana-Farber claimed contributed to the invention must be listed as inventors, leaving Honjo and his partners Ono Pharmaceuticals and Bristol-Myers Squibb without exclusive ownership of the rights.

The six patents in question cover methods of treating cancer that involve boosting the body’s immune response to cancer cells by blocking the PD-1/PD-L1 pathway. The patents provide the basis for several major immune-oncology treatments including Opdivo, which earned Bristol-Myers Squibb $6.7 billion in 2018.

Honjo began applying for U.S. patents to protect the technologies in 2002. When granted, the patents listed only Honjo himself, two fellow Kyoto University researchers, and an Ono Pharmaceutical researcher as inventors.

However, in the course of his research, Honjo also collaborated with Gordon Freeman at Dana-Farber and Clive Wood at the Genetics Institute. The three worked on a joint journal article about the ligand that triggers PD-1 and discussed the possibility of using anti-PD-L1 antibodies to treat cancer. The same year, Honjo and Wood presented their collaborative research results at a conference.

In 2015, Dana-Farber challenged its exclusion from the patents, and the District Court for the District of Massachusetts decided that the institute had “presented clear and convincing evidence” that Freemand and Wood had “collaborated extensively” with Honjo and were, in effect, joint inventors.

Ono challenged this before the Federal Circuit, arguing that the lower court had not only erred in findings of fact, but that it also had applied an insufficiently tough inventorship test. According to Ono, the patents were novel and non-obvious over inventions patented by Freeman and Wood in 1999. In addition, the collaboration between Honjo and the two researchers was published in 2000 and “no longer qualifies as a significant contribution to conception” since it was made public, Ono says.

Nevertheless, the Federal Circuit found that “Ono asks us to adopt an unnecessarily heightened inventorship standard,” which would require each joint inventor to individually have conceived the complete invention and participated in a particular moment of conception.

Maria Zacharakis of McCarter & English says that inventorship disputes often arise from research collaborations involving multiple companies and institutions, and this case offers important guidance on questions of who gets credit.

“Some courts have called a joint inventorship analysis one of the muddiest concepts in the muddy metaphysics of patent law,” Zacharakis says, although scientists can mitigate related risks by maintaining records of the conception. “Such records may take the form of, for example, lab notebooks or copies of email communications between collaborators.”

According to Craig Titmus of Mathys & Squire, “It is very important to determine who the inventors are right from the start because, as we can see from this case, getting it wrong can have significant consequences for IP ownership. This is sometimes difficult to achieve when there is a history of free and open collaboration between institutions, as is often the case for university academics, but it’s a critical part of determining the rightful owner(s) of collaborative IP.”

Source: iam

Determining Inventorship for University IP is a distance learning program that will help you fully understand the parameters of each type of inventorship and avoid the damaging consequences of inventorship disputes. Click here for complete details.

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