CRISPR-Cas9 is a remarkable gene editing technology which has the potential to revolutionise the development of medicines, particularly those for genetic diseases and cancer. Pharmaceutical companies have been quick to partner with innovators who have begun to find ways to commercialize CRISPR-Cas9, both as a research tool and as a route to the development of new gene therapy medicinal products. Given the billions of dollars in licensing fees that could be at stake for its inventors, it is not surprising that CRISPR has been the subject of fierce patent battles on both sides of the Atlantic.
In the latest episode, the Federal Circuit has confirmed an earlier decision by the US Patent and Trademark Office (USPTO) that patents granted to the Broad Institute, MIT and Harvard concerning CRISPR-Cas9 editing of eukaryotic genomes, for example in mammalian cells, do not interfere with patent claims filed by the University of California, Berkeley and the University of Vienna, which were based on studies in cell- free systems. The Federal Circuit upheld the finding by the Patent and Trademark Appeal Board of the USPTO that a person of ordinary skill in the art would not have had a reasonable expectation of success that the CRISPR-Cas9 systems, which naturally occur only in bacterial cells, could be made to function in eukaryotic cells, such as plant and animal cells. This finding relates only to the interference proceedings, which effectively decide whether the rival claims overlap. The validity of the patents may yet have to be formally determined.
Preliminary skirmishes between the Broad and UC Berkeley have already begun in the European Patent Office but the scientific merits of the competing claims have yet to be heard in Europe.
The Broad Institute already makes CRISPR tools, knowledge and methods for genome editing freely available to the academic and non-profit community. The Institute has now issued a call for all institutions to move beyond litigation and “work together to ensure wide, open access to this transformative technology”. UC Berkeley is said to be continuing to evaluate its options in all jurisdictions.