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A patent dispute over CRISPR highlights the need for scientists to agree on IP ownership early.
August 31, 2016|
FLICKR, MADCOVERBOYThe path from the discovery of the CRISPR/Cas mechanism as part of bacteria’s adaptive immune system to the use of this pathway in the food industry and later as a breakthrough gene-editing tool is a good illustration of the power of collaboration among scientists across disciplines. Yet CRISPR’s development also serves as a salient warning of how failing to assign clear and up-front ownership of intellectual property (IP) can result in prolonged and costly legal friction.
A widely reported patent dispute in the U.S. between the Broad Institute and the University of California, Berkeley, over who first invented the CRISPR/Cas toolkit for gene editing is the subject of interference proceedings now before the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO). Less well known is that the earliest CRISPR patent applications filed by the Broad Institute for gene editing are the result of a collaboration among four institutions, and there is an ongoing ownership dispute between Rockefeller University and MIT/Broad over some US CRISPR patents. The fallout from this dispute may have detrimental consequences for Broad’s corresponding patents in Europe. Broad’s seven granted European CRISPR patents are already embroiled in opposition proceedings before the Opposition Division of the European Patent Office (EPO).
A statement from Broad filed with the USPTO on July 7, 2014, reveals that Broad may not be entitled to rely on the earliest filing dates of December 12, 2012, and January 2, 2013, in Europe. Within 12 months of a first patent application being filed, a subsequent patent application can be filed in another country for the same invention, by the same applicant, and can claim a right of priority to the earlier patent application. This right of priority allows the later-filed patent application to be examined as if it were filed on the same date as the earlier patent application (known as the priority date). This is useful because when the later patent application is examined, if it is entitled to priority, publications that became available between the priority date and the time the patent in question was filed cannot be used in considering whether the application is novel and inventive. However, certain conditions must be met to be able to make this claim.
In Europe, whoever files the later patent application must be the same applicant(s) named on the earlier patent application, or the earlier applicant(s) must have transferred the right to claim priority to the later applicant, who then becomes a “successor in title.” This transfer must occur prior to the filing date of the later application.
MIT/Broad’s earliest patent applications, filed at the USPTO in December 2012 and January 2013, named scientists affiliated with four different institutions: Feng Zhang of the Broad Institute and MIT, Shuailiang Lin and Naomi Habib of the Broad Institute, Patrick Hsu and Fei Ann Ran of Harvard College, and Luciano Marraffini of Rockefeller University. It was only after the research had progressed to a stage where these earliest patent applications were filed that ownership of the inventions arising out of this collaboration was evaluated—and disputed.
According to the statement the Broad submitted to the USPTO, after these priority patent applications were filed in the U.S., the patent attorney who filed the applications undertook an inventorship analysis at the institute’s request. The goal of this was to determine which of the named inventors on the US priority documents were entitled to be named as inventors on each of the 10 international Patent Cooperation Treaty (PCT) patent applications that were subsequently filed in December 2013, which claimed a right of priority of these earlier US priority patent applications. Rockefeller University disputed the outcome of these investigations, which resulted in Marraffini not being named as a co-inventor and Rockefeller University not being named as a co-applicant on certain PCT patent applications that related to CRISPR/Cas9 in eukaryotes. Nevertheless, the disputed PCT patent applications were filed by Broad. This has led to an entitlement dispute between Rockefeller University and Broad in the U.S.
The EPO will not examine ownership, but will look into whether the Broad has a valid right to claim priority. Marraffini was a named inventor and co-applicant on the earliest US patent applications, yet it appears that neither he nor Rockefeller University was an applicant on some of the subsequent PCT patent applications that led to granted European patents. Nor did Marraffini or Rockefeller sign over their priority rights to the Broad. Hence, the formal requirements for claiming priority to these earliest patent applications do not appear to have satisfied European patent law. This could severely limit the scope of the European patents, as highly relevant publications (such as Science, 339:819-23, 2013 and Science, 339:823-26, 2013) would be citeable for novelty and inventive step against these patents. To try to prevent this, MIT/Broad are arguing that the existing case law in Europe should be interpreted to allow the right of priority to be determined based on US law—which does not have the same applicant requirements as European law—because the earliest patent applications were filed in the U.S. For credibility, they have submitted statements by high-profile people in the IP field, such as Lord Leonard Hoffmann (former Lord of Appeal in Ordinary in Britain), John Doll (former commissioner of patents at the USPTO), and Paul Michel (former Chief Judge of the US Court of Appeals for the Federal Circuit).
Unless the Broad successfully convinces the Opposition Division to follow its interpretation of how priority should be determined, these CRISPR patents may provide a high-profile example of the disastrous IP consequences that can occur when collaborations result in disputes. The take-home lesson is that the earlier in the collaboration ownership and management of potential IP rights are addressed, the easier it is to come to agreement between the parties. Before entering into a collaboration consider why you are seeking to collaborate. What is each party bringing to the table? Can ownership of any potential IP be considered from the outset?
Various toolkits can aid parties in deciding ownership of IP within a collaboration, such as the Lambert toolkit, UK-Korea collaborative research IP toolkit, UK-India collaborative research IP toolkit, and European Commission Cross Border Decision Guide. However, a collaborative agreement can be any written document agreed to by all the collaborators. The technology transfer offices of your institution will also be able to help.
In addition to seeking external support, scientists should maintain a record of what contributions are made by whom and keep copies of all correspondence. Looking at lab books retrospectively can indicate who carried out the experiments, but it may be unclear who devised the experiments that were conducted. Keeping a paper trail is key. When scientific accolades and vast commercial potential are at stake, it is understandable how disputes can arise.
Catherine Coombes is a senior patent attorney with HGF Limited in the U.K.