The European Patent Office (EPO) has revoked a foundational CRISPR-Cas9 patent granted in Europe to the Broad Institute of Cambridge Massachusetts. The patent at issue was filed in December 2013, but cites U.S. patent applications dating back to December 2012 in order to show its claims predate a patent filing by the University of California, Berkeley.
The EPO’s decision was based on the fact that Broad’s 2012 and 2013 U.S. patent filings include Luciano Marraffini of Rockefeller University as an inventor-applicant. However, Marraffini was not included on the European filing. Europe’s strict rules regarding listing inventors on patents means that the omission invalidated Broad’s claim to the 2012 “priority date”, negating its ability to claim first rights to the technology in Europe.
In the U.S., multiple patent disputes between U.C. Berkeley and Broad over CRISPR-Cas9 are ongoing. In February 2017, the U.S. Patent Trial and Appeal Board ruled that while U.C. Berkeley had laid the first claim for the use of CRISPR to cut DNA, it relied on a method developed at Broad. U.C. Berkeley has appealed this decision to the U.S. Court of Appeals for the Federal Circuit, but an appeal decision is not expected until the second half of 2018. As a result, companies seeking to commercialize products based on the technology may face having to obtain licenses from multiple entities.
The European decision arose from the first hearing at the Opposition Division of the EPO regarding Broad’s CRISPR-Cas9 claims. At least 10 challenges of other Broad patents are pending, many hinging on the same or similar issues. Broad has announced its intention to appeal the decision. If the EPO’s decision holds, which legal analysts following the case believe it will, U.C. Berkeley is expected to have the dominant patent position in Europe.
Doug Limbach is a registered patent attorney in Silicon Valley representing early stage medical device companies, the entrepreneurs who found them and the investors who fund them. He has represented more than 50 such companies, including TheraSense (acquired by Abbott Laboratories), Archus Orthopedics (acquired by Facet Solutions), Facet Solutions (acquired by Globus Medical), Novare Surgical (acquired by a major robotic-assisted surgery company), Aragon Surgical (acquired by Aesculap), Tibion (acquired by AlterG) and Xlumena (acquired by Boston Scientific). Mr. Limbach has been working in patent law since 1991.
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