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Dana-Farber Scores Major Legal Victory On Cancer Drug Patents Likely Worth Billions

Tasuku Honjo, left, and Gordon Freeman (courtesy Bengt Nyman/Flickr and Dana-Farber Cancer Institute)
Tasuku Honjo, left, and Gordon Freeman (courtesy Bengt Nyman/Flickr and Dana-Farber Cancer Institute)

The Dana-Farber Cancer Institute on Friday scored a major victory in Boston federal court: a ruling that one of its researchers should be listed as an inventor on six patents believed to be worth billions of dollars.

The patents are connected to immunotherapy drugs, a powerful new type of cancer treatment that unleashes a patient's own immune system against cancer.

The legal crux of the case was a dispute over a collaboration between American researchers and Japanese researchers led by Nobel Laureate Tasuku Honjo of Kyoto University. Honjo was listed as inventor on the patents, but Dana-Farber argued that the Americans — Drs. Gordon Freeman and Clive Wood — deserved to be listed on the patents as well.

One lawyer compared the case to deciding who gets credit for completing a jigsaw puzzle that includes many pieces put in by multiple players.

Given the financial stakes and the importance of the case, the verdict is likely to be appealed, says professor Jake Sherkow of New York Law School, an expert on patent disputes in the life sciences.

But at this point, "It's a total victory for Dana-Farber," he said on Friday.

"The judge's factual findings were particularly specific, and the conclusions of law were very thorough and well reasoned," he said. "So I think, given that, the likelihood of success on appeal is probably going to be scant," and the verdict is likely to stand.

One possible moral of the story, Sherkow said, is that "researchers who are engaged in long and detailed scientific collaborations with one another should be upfront about when, whether and to what extent they're applying for patents on what they view as their own contribution. Because in fact, that contribution may be a joint one."

The high-stakes legal drama pitted Honjo, 77, against another immunotherapy pioneer: Dana-Farber's Freeman, who's also a Harvard Medical School professor.

The trial focused on work done nearly 20 years ago, when some of the seminal science that led to immunotherapy was developed. The patents concerned what's called the "PD-1 pathway," which has become the basis for multiple immunotherapy drugs.

Dana-Farber, the plaintiff in the case, argued that the Americans made significant contributions and should be included on those patents. Honjo's side included the pharma giant Bristol-Myers Squibb, which now holds the licenses that control the use of those patents.

Honjo himself took the stand for hours and argued that no, he got no significant help from his American colleagues. Testimony at the trial focused heavily on the exchange of biological materials and unpublished data between the American and the Japanese researchers in 1999 and 2000.

The ruling by Judge Patti Saris reads, in part:

I find Dana-Farber has presented clear and convincing evidence that Dr. Freeman and Dr. Wood are joint inventors of the six Honjo patents. Dr. Honjo collaborated extensively with both Dr. Freeman and Dr. Wood from at least October 1999 until at least September 2000 through numerous meetings, joint authorship of scientific journal articles, written collaboration agreements, and sharing of experimental results and ideas. Indeed, Dr. Honjo himself referred to his work with Dr. Freeman and Dr. Wood as a collaboration on at least six occasions. While the relationship among these three brilliant scientists eventually soured, all three made significant contributions to the inventions.

Dana-Farber says in a press release:

The decision will enable Dana-Farber to license the technology, which is currently embodied in several of the newest immunotherapy drugs, to additional companies seeking to develop PD-1 and PD-L1 antibody therapeutics for a wide range of cancers.

Earlier:

Carey Goldberg Twitter Editor, CommonHealth
Carey Goldberg is the editor of WBUR's CommonHealth section.

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