Renowned as one of the biggest leaps in the field of biotechnology since the polymerase chain reaction (PCR), the CRISPR technology has drawn extensive attention from both academia as well as industry. However, the ownership of the CRISPR technology and its associated patent rights has been disputed since its announcement in 2012.

What adds to the complexity is that more parties are dwelling into this patent battle. Initially two, then three, now at least four sides are fighting in an all-out patent war. The fog lingering over the battlefield has become so thick that nobody, that the warriors themselves don’t have a clear grasp on the overall situation.

How Did the CRISPR Patent Battle Begin?

The root of the dispute originated in the autumn of 2012 when Doudna and Charpentier in UC Berkeley and Umeå University first introduced the gene-editing technique called CRISPR and filed a patent application in March 2013. However, soon enough, more attempts from additional research groups demonstrated that the CRISPR technique had enormous potential for different applications – from stem cells to mammalian embryos – and several startup companies began trying to capitalize the therapeutic potential of the method.

One of such attempts, led by the Zhang lab at the Broad Institute of MIT, filed another patent application for the CRISPR-Cas9 technique under a special expedited review program in October 2013 and was granted patent status in April 2014, followed by several additional related patents. With enough patents in hand, Zhang and Doudna co-founded Editas, one of the most prominent gene editing companies in the field. However, Doudna soon severed her connection with Editas and became the chief scientist of Intellia Therapeutics, a direct competitor of Editas.

In the meantime, Charpentier also registered her company, CRISPR Therapeutics, in Basel, and each company is claiming the throne of the CRISPR patent. Still, the game did not stop here. Luhan Yang and her registered company eGenesisbio, backed by the Church lab in Harvard, came into play mid-2014 and an all-out patent war was inevitable.

CRISPR: From Labs to Court

In April 2015, the Doudna team fired the first shot by asking the United States Patent and Trademark Office (USPTO) to initiate an interference proceeding to determine the actual inventor of the technique. Such proceeding is essentially a trench warfare: both sides have to present court-admissable evidence from their lab’s logbook to the dated letter of acceptance from journals. A panel of judges will then give the final say. Hence, well-recorded lab notes (better notarized as a standard practice in the field of the industry) become high-valued targets in this highly technical fur-flying pit fight.

Very recently, Shuailiang Lin, a junior scientist formerly employed in the Zhang group of the MIT/Broad Institute, claimed that the organization has intentionally misled the patent office. To support such claims, he presented an email between him and Doudna, in which he expressed “I am willing to give more details and records if you are interested or whoever is interested to clear the truth,” as quoted. The explosive email, whilst immediately put Doudna and her legal team in the high ground, was fiercely rebutted by the Zhang group as “a blatant breach of lab practice and scientific moral.” Nevertheless, the twist would undoubtedly add more burden to the $10.9 million that Editas had already spent on legal expenses in defending their patent rights.

What Can Be Learnt?

As observers orbiting 150 miles above the battlefield, what can we learn from this huge legal battle? With assurance, more details, as well as references to further practices within the field, will emerge after the USPTO patent panel reaches their conclusion, possibly in late 2016. Nevertheless, while similar arguments frequently happen within the area of pure scientific research (and usually concluded after an independent investigation led by the journal that initially published the results, such in the fraud case of STAP cells), it may be the first time that lab notes, publication records, and personal communications for scientific purposes have been used as evidence during a patent argument in a tribunal.

For anyone who is interested in the frontier of biotechnology, this case is important to watch, as its decision will surely set the pretext of similar ensuing cases and the measures/countermeasures one can take if ever to be involved.

Find out more here to learn how PreScouter helps companies with patents.

Further Readings:

How the US CRISPR patent probe will play out. Nature 531, 149 (10 March 2016) doi:10.1038/531149a

Bitter fight over CRISPR patent heats up. Nature 529, 265 (21 January 2016)  doi:10.1038/nature.2015.17961

In CRISPR Fight, Co-Inventor Says Broad Institute Misled Patent Office. MIT Technology Review, August 17, 2016