Controversy Over CRISPR Patents

December 5, 2014 | Earlier this week, Editas Medicine of Cambridge, MA, announced a series of IP licensing deals giving the company exclusive rights (with certain caveats) to several pieces of intellectual property governing the use of the CRISPR-Cas9 gene editing system, as reported in Bio-IT World. Editas, like its counterparts CRISPR Therapeutics and Intellia Therapeutics, plans to adapt the CRISPR-Cas9 system for safe use in humans, to target disease-causing mutations or viral infections.

Now, at MIT Technology Review, Antonio Regalado looks in much greater depth at the background of the relevant IP. If all the patents and licensing deals currently claimed stand up to scrutiny, Editas would seem to have first choice of gene and disease targets for potential CRISPR-based therapies. However, as Regalado reports, there are questions about the priority and eligibility of the one key CRISPR patent that has already been issued: the Broad Institute's patent on the use of CRISPR gene editing in eukaryotic cells, including human cells.

Regalado's piece should be read in full. At Bio-IT World, we would only add that the relevant patent, US 8697359 B1, is very broad in its scope. Rather than claiming a specific method of introducing guide RNA and Cas9 protein — the two functional elements of the CRISPR system — into a eukaryotic cell, the patent claims any vector for transporting the guide RNA and Cas9 coding elements into a cell, including the routinely-used plasmids and viral vectors. This could be seen to support speculation, as reported by Regalado, that the material covered in the patent may be "obvious" — something that a "person having ordinary skill in the art" might have tried, to use the terms of patent law — and could therefore be vulnerable to legal challenge.

However the patent claims and likely court challenges shake out, CRISPR technology is of enormous promise in treating very difficult diseases, including cancers and a whole host of rare hereditary disorders. It is to be hoped that the academic and commercial players in this space continue to have the freedom and incentive to aggressively pursue CRISPR-based platforms for next-generation gene therapies.