CRISPR – Sometimes you win, sometimes you lose

On January 18, 2018, the European Patent Office (EPO) revoked European Patent No. 2,771,468 (“the ‘468 patent”),¹ one of the original CRISPR patents. The ‘468 patent was ultimately revoked by the European Patent Office because the Broad Institute could not establish a right of priority to their earliest U.S. Applications.²

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and CRISPR-associated (Cas) genes are part of a bacterial defense system that cuts up the DNA of invading bacterial viruses. The CRISPR/Cas genes can be programmed to target and modify genes in living cells and organisms.

The ability to use CRISPR technology for genome editing in prokaryotes was first demonstrated in 2012 by Jennifer Doudna (University of California, Berkeley) and Emmanuelle Charpentier (University of Vienna) (collectively “UC Berkeley”). Shortly thereafter, Feng Zhang and his group at the Broad Institute and Massachusetts Institute of Technology (collectively the “Broad Institute”) demonstrated CRISPR use in eukaryotic and mammalian cells. Both parties filed patents in the United States and abroad.

In the United States, the Broad Institute was able to obtain multiple patents to the CRISPR technology³ despite an interference being declared between the Broad Institute (as junior party) and UC Berkeley (as senior party).⁴ The USPTO found no interference-in-fact and terminated the proceedings.⁵ This decision was appealed by UC Berkley.

The Broad Institute is not experiencing the same success in Europe, however. When the corresponding European patent application filed by the Broad Institute granted as European Patent No. 2,771,468 (“the ‘468 patent”) on February 11, 2015, it was opposed by multiple parties on multiple grounds, ultimately resulting in revocation of the patent.

Under Article 87 of the European Patent Convention, a right of priority can only be claimed in a European patent application if the applicant is the same as the applicant of the priority application or if the right of priority was transferred to the applicant before the European application was filed. ⁶ If the applicant for the priority application is not the same as the applicant of the subsequent European application, the claim to priority is invalid.

The Broad Institute’s earliest U.S. priority applications included Dr. Luciano Marraffini (Rockefeller University) as a named inventor. However, Dr. Marraffini was not named as an inventor on the later-filed European patent application that claimed priority to the Broad Institute’s earlier U.S. patent applications. The Broad Institute did not submit any evidence that Dr. Marraffini had assigned his “right of priority” before the corresponding European application was filed. Consequently, under European law, the Broad Institute was not entitled to their earliest “effective filing date.”

With the loss of its earliest effective filing date, the European patent was revoked as lacking novelty based on intervening art (i.e., prior art filed after the Broad Institute’s earliest U.S. Priority applications, but before the new “effective filing date” of the European Patent Application). The Broad Institute has indicated it intends to appeal this decision⁷ and has requested a stay in Opposition proceedings relating to at least five other European patents in the same family in which “the same or nearly the same objections for lack of formal entitlement to priority…have been raised by the Opponents.”⁸