Determining who owns the intellectual property surrounding the gene-editing CRISPR/Cas9 technology has been a combative affair, and the Broad Institute just came out on the wrong side of the latest skirmish.
The European Patent Office (EPO) has just revoked one of the patents assigned to the Broad—EP 2771468 B1 (PDF)—on the grounds that it lacked novelty. The Cambridge, Massachusetts-based institute, which was set up by Harvard University and the Massachusetts Institute of Technology (MIT) in 2004, said immediately that it intends to appeal the decision.
The patent in question is entitled “Engineering of systems, methods and optimized guide compositions for sequence manipulation” and is considered to be one of the core patents in a series that were filed by Broad molecular biologist Feng Zhang, Ph.D. It is identical in wording to U.S. patent number 20140242664 A1.
At the heart of the ruling is a dispute between Broad and the Rockefeller Institute regarding ownership of patent filings on CRISPR/Cas9 in eukaryotic cells, in which Rockefeller maintained that its scientist Luciano Marraffini, Ph.D., should have been credited on some filings along with Zhang. The EPO deems that omission sufficient to invalidate EP 2771468 B1.
Crucially, failing to include Marraffini means that the Broad cannot claim the earlier dates of its U.S. patents as being prior to others filed in Europe and, worryingly for the Broad, that situation affects several of its EU patents.
As it stands, the EPO’s decision is at odds with the situation in the U.S., where the Broad settled its differences with Rockefeller. The latter said it would abide by the findings of an arbitration process which concluded that the patents in question should remain unchanged.
In a statement, the Broad said that it “is confident that the EPO will, on appeal, harmonize the EPO procedures to be consistent with international treaties and compatible with the fundamental principles of the Paris Convention—and that it will recognize the same priority dates for the inventions as those the USPTO has repeatedly affirmed for the Broad's U.S. applications.”
The ruling could be bad news for Editas Medicine, which holds licenses to the Broad patent estate, and conversely a boost to CRISPR Therapeutics and Intellia Therapeutics, biotechs based on the work of Jennifer Doudna and collaborators at UC Berkeley, the Broad’s archrival in the CRISPR IP battle. So far, the Broad is considered to be in the driving seat in the U.S. after winning a patent dispute last year.
The intensity of the battle for rights to CRISPR reflects the potential attached to the technology both as a research tool and ultimately as a human therapeutic. Doctors at the University of Pennsylvania are on the brink of starting a clinical trial of CRISPR as a way to supercharge human immune cells so they are more effective at fighting tumors. MIT Technology Review notes this could be the first medical use of the technology outside China.