This question has come into focus again following recent oral proceedings before the EPO Technical Board of Appeal concerning three patents filed by the Broad Institute. The hearing in consolidated cases T 2360/19, T 2516/19 and T 2689/19 addressed priority entitlement.
These proceedings came after the Enlarged Board of Appeal decision in case G 1/22, which found that there is a strong rebuttable presumption that an applicant for a European patent application is entitled to claim priority. In other words, the burden to prove that an applicant is not entitled to claim priority now lies with the challenger.
Different decisions on priority
As we reported in our previous article, in 2020 the Broad Institute lost a key CRISPR patent in Europe due to improper assignment from one of the named inventors (T 0844/18). The latest cases involve very similar facts.
Priority for these patents was challenged because the PCT application did not name as applicant either the priority co-applicant and inventor Dr Marrafini or his successor-in-title, Rockefeller University. At the time of filing, Broad and Rockefeller were in dispute over inventorship, though this dispute was later settled following arbitration.
Following oppositions filed by various entities, the patents were either revoked or narrowed down. Broad appealed these findings.
Although the written decision in the three consolidated cases is not available at the time of writing, the minutes of the oral proceedings have been published. As expected, the minutes do not provide details of the decision. What can be seen is that the Technical Board of Appeal refused the request for referral to the Enlarged Board of Appeal (EBoA), set aside the decision under appeal and remitted the case back to the Opposition Division for further prosecution.
Implications of the decision
G1/22 has made it more difficult for a third party to challenge a patent on the ground of lack of entitlement to priority.
By refusing to refer the case to the EBoA, the Technical Board of Appeal in these three consolidated cases appears to have followed G1/22. G1/22 does not clarify what level of evidence is required to validly rebut the presumption of priority entitlement. In the present case, it is well-known that there was a dispute between the Broad Institute, Rockefeller University and Dr Marrafini over inventorship. Although inventorship and entitlement to priority are two separate issues, they are linked. Despite this dispute, the Technical Board of Appeal appears to have concluded that the presumption of entitlement to priority has not been validly rebutted. The reasoning for this should become clearer when the written decision is published later this year.
From a commercial point of view, the decision contrasts with the earlier decision in T 844/18 and means that the Broad Institute has successfully maintained these three patents at the EPO. The decision may also have implications for other CRISPR-Cas9 patent applications/patents where priority is in issue.
As we noted in our previous post on this topic, CRISPR has enormous potential in treating diseases such as cancer, heart disease, sickle cell disease and HIV. It is also of interest to researchers in agriculture and those addressing climate change.
The ownership of fundamental IP rights relating to CRISPR and the licensing of them is therefore of widespread interest in various industries. Many applications involving CRISPR are expected to emerge over the next few years.
Keltie attorneys will be monitoring developments, and we will provide an update when it is available. However, if you have any questions in the meantime, please contact us.
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