Major breakthrough in CRISPR patent battle and why it is not over yet

CRISPR-Cas9 is the most promising, potentially lucrative gene-editing technique in development. The fight over its ownership is an enduring battle, one that has recently seen a major breakthrough.

The technique is built upon the natural viral defencee mechanism of bacteria, and counts on a fragment of viral DNA to guide a restriction enzyme that removes certain segments in the genome. The technology uses a synthetic fragment of single stranded RNA to guide the restriction enzyme, Cas9 to cut out a precise sequence in the genome. Cas9 produces a double stranded cut and the natural DNA repair system seals the break. Any sequence of DNA can be inserted during this repair process, providing huge flexibility in its potential applications.

The technology is already accelerating genetic research, scientists are starting to use it to provide livestock with resistance to certain diseases and to speed up genetic modification of crops. The prospects of curing many genetic disorders and diseases are substantial—from Hepatitis B to heart disease and cancer (with which around a thousand people are diagnosed with every day in the UK alone). Needless to say, CRISPR-Cas9 provides a very promising technique for quite a few industries.

This technology and the dispute around it stem back to 2012, when Jennifer Doudna, now at the University of California, Berkeley, and her colleagues, outlined how CRISPR-Cas9 could be used to precisely cut isolated DNA. One year later Feng Zhang, at the Broad institute of MIT and Harvard, showed how it could be adapted to edit DNA in eukaryotic cells, causing an explosion in the hype around it. Berkeley had applied for a patent but it is still in the process of being granted. At the heart of the dispute over which lab should get the rights to this possibly lucrative technology is a simple question—whether the application of CRISPR-Cas9 to eukaryotic cells is a new invention and is worthy of its own patent, or whether it is merely an extension of a previously developed technology.

The US Patent and Trademark Office (USPTO) reached a decision this month: they granted the Broad institute the patent to use CRISPR-Cas9 in eukaryotic cells. Companies wishing to use CRISPR-Cas9 are likely to be forced to seek licences from both institutions, thus making it less commercially viable.  We all know that money makes the world go around, and the holder of key patents could make millions from the applications in industry. Granting of the patent to the Broad institute will decrease the amount of money that would have gone to UC Berkeley.

You’d be forgiven for thinking that everything will be right once UC Berkley is granted their patent, however, the argument may continue for years to come. UC Berkley may appeal the ruling, but looking at the USPTO report it is unlikely that they would be successful. European patents are still up for grabs and other parties are claiming rights to certain aspects of the technology. For example, there are currently 763 patent families that claim Cas9. Over time these parties will inevitably assert their rights, further complicating and delaying the journey of this technology from university labs to companies that might be able to exploit its potential to the fullest.

The awarding of the patent for CRISPR-Cas9 in eukaryotic cells is a major breakthrough in biotechnology. However while research using gene editing is only beginning, the story of its ownership is still being written.