Inventorship remains the touchstone of who owns patentable technology. Yet inventorship remains, at times, one of the most perplexing and contentious aspects of patent law.
Case in point is the recent 111-page decision in Dana-Faber Cancer Institute, Inc. v. Ono Pharmaceutical Co., Ltd., et. al, Case No. 15-13443, by Judge Saris in the United States District Court in Massachusetts. On May 17, 2019, Judge Saris ordered that two American scientists, Gordon Freeman and Clive Wood, be added as inventors to six patents that had named a Japanese scientist, Tasuko Honjo, and three others. The ruling followed an exhaustive analysis of the scientific principles underlying the patents and the years of research that led to the technology described in the patents surrounding Programmed Cell Death Protein or PD-L1 and PD-L2 ligands. Despite the law of inventorship being, in her own words, “muddy,” Judge Saris concluded that Drs. Freeman and Wood should be added as inventors because they contributed to “the discovery and characterization of the PD-L1 and PD-L2 ligands, the discovery of the interaction between [the] PD-1 [receptor] and PD-L1 . . . is inhibitory and could be blocked by antibodies, and the discovery that PD-L1 is expressed in human tumors.” Slip op. at 2.
The decision highlights that the stakes in determining inventorship are frequently high. Dr. Honjo shared the 2018 Nobel Prize in Physiology and Medicine with James Allison for their independent research of the PD ligands.
Central to the court’s conclusion was the finding that Dr. Honjo and Drs. Freeman and Wood collaborated extensively for years while the technology was being conceived. Indeed, Dr. Honjo himself acknowledged the collaboration on several occasions. Although the collaboration later collapsed, the court concluded that the discovery reflected in the patents arose out of the collaboration and that Drs. Freeman and Wood made significant contributions to the technology.
The opinion highlights several salient points about inventorship. First, when multiple inventors are involved, there needs to be some form of collaboration among the inventors to create joint inventorship. Individual inventors working in silos with no contact might give rise to independent invention of the same technology, which will be governed by either the first to invent, or the first to file rules depending on when the application was or is ultimately filed. In contrast, when inventors either work side-by-side or they communicate by sharing ideas and experimental results, or they jointly publish results, joint inventorship is always a possibility.
Second, joint inventorship is frequently a close question based upon the precise nature of the work being done. The law is clear that not every joint inventor needs to contribute to the invention to the same extent or that any one of the inventors needs to conceive of the entire invention. In addition, merely reducing an invention to practice by running experiments that demonstrate the invention is insufficient to qualify one as an inventor. Thus, any determination of inventorship depends upon a close evaluation of the role and contribution of each potential inventor.
In that regard, it is critical for all scientists engaged in original research and their institutions to carefully document all of their work. Patent applications are sometimes prepared years after research is performed, and some form of corroboration is necessary under the law to confirm a person’s testimony that he or she is an inventor. Accordingly, although the advent of the first to file system of the American Invents Act has eliminated the need for written records to establish the precise date of invention, the need remains for detailed laboratory notebooks to establish the timing and contribution of work performed by potential joint inventors. As has become common practice, it is also helpful for researchers to continue to have their peers counter-sign laboratory notebooks contemporaneously with the work being done as witnesses to the work performed.
It is important for patent practitioners to work with their clients to (1) raise awareness of the importance of good record keeping, (2) instill self-awareness on the part of the researchers of the nature of the work being done, and (3) incorporate into the preparation of each application a careful review of inventorship. Awareness is critical to creating a record that is meaningful when the application is prepared. Such a record helps the researcher and the patent practitioner reach an accurate conclusion about inventorship. Carefully reviewing inventorship as part of the application process also leads to a more accurate reliable determination of inventorship.
As the Dana-Farber case highlights, inventorship is too often examined in detail for the first time after the commercial or scientific important of the technology at issue becomes apparent, which frequently happens years later after memories have faded and the researchers’ objectivity has been clouded by shifting financial, professional, and personal motivations. It is in everyone’s best interests that, throughout the process from conception to application to commercialization, (1) inventorship be foremost on the mind of everyone involved, (2) all researchers involved communicate frankly about who should be considered an inventor, and (3) inventorship be assessed as close to the time of invention as possible.