CRISPR Patent Dispute ‘Could Have Been Avoided’
The CRISPR patent dispute which has been raging between the University of California Berkeley and the Broad Institute of MIT and Harvard for the last two years could have been avoided, according to a new opinion article in Science. The two authors of the article argue that if both parties in the dispute had followed the written description doctrine that was instigated in 1997 under US Patent law, the dispute would not be taking place now.
UC Berkeley and the Broad Institute have been involved in a patent dispute since early 2015, which primarily concerns the use of the CRISPR-Cas system in eukaryotic cells. In 2012, Jennifer Doudna and Emmanuelle Charpentier became the first people to adapt CRISPR for use in gene editing of prokaryotic cells, for which they later filed a patent. Prior to their patent being approved, Feng Zhang and his team at the Broad Institute adapted the CRISPR system for use in eukaryotic cells and filed their own corresponding patent application. As they chose to use expedited approval, their patent was approved before UC Berkeley’s.
Then, in April 2015, UC Berkeley argued that the Broad Institute’s patent was infringing on their own, as the use of CRISPR in eukaryotic cells was an ‘obvious continuation’. The Broad Institute have disputed that claim, and the legal proceedings have continued on since then.
According to Arti Rai and Robert Cook-Deegan, it could have been resolved much sooner if both sides of the argument had more closely followed patent law. The controversial written description doctrine requires all patent applications to state in ‘full, clear, concise, and exact terms’ the nature of the work being protected by the patent, which typically means that a patent can only cover research that the team has already performed. If they haven’t completed the work, then the patent cannot exactly state what the work entails and thus, it cannot be covered.
In theory, this argument would invalidate UC Berkeley’s claim; as their researchers had not used CRISPR in eukaryotic cells, they could not cover it under their patent. However, the written description doctrine is a controversial piece of legislation and so is inconsistently used as an argument in patent disputes such as this one. Many people have argued that the doctrine makes it too difficult for researchers to file patents that cannot easily be overturned, as it introduces too many potential loopholes and stifles innovation.
From a commercial point of view, research organisations want their patents to be as broad as possible so that they can cover more ground. This concept is further supported by the Bayh-Dole Act of 1980, which enables institutions to license out federally funded research at a commercial level. The authors of this article argue against the idea, however, citing the uncertainty that comes with such broad patents as the main cause behind long, expensive, draw out legal processes like the Broad-Berkeley dispute. They also point out that centralising scientific knowledge and discovery in a few, elite institutions is harmful to scientific progress.
Should the doctrine be enforced in this case, it wouldn’t necessarily be good news for the Broad Institute either. Their own patent lays claim to all Cas9 proteins, of which many exist in nature and yet only a few of which were used in Zhang et al.’s research; by the same logic, this would invalidate the patent.
Most importantly, the authors try to draw a distinction between a scientific organisation holding a patent and winning the ‘glory’ of scientific discovery.
When speaking to Gizmodo, Arti Rai, co-author of the paper and Co-Director of the Duke Law Centre for Innovation Policy, said, “For Berkley to make the claims that it did was a great conceptual leap. We would not begrudge them scientific glory. But that’s different from claiming a patent.
“A patent is an economic instrument, not an instrument for glory.”
Broad-Berkeley CRISPR Patent Dispute Timeline:
- June 2012 – Jennifer Doudna and Emmanuelle Charpentier at UC Berkeley publish their first CRISPR paper in Science, which reports CRISPR-Cas9 being used in prokaryotic cells as a gene editing tool.
- May 2012 – UC Berkeley file a patent application that explicitly covers the use of CRISPR in non-eukaryotic cells.
- December 2012 – Ahead of paper publication, the Broad Institute files for patent to cover the work being done with CRISPR in eukaryotic cells.
- October 2013 – Feng Zhang and his team at the Broad Institute publish a paper in Nature Protocols that demonstrates the use of CRISPR in prokaryotic cells.
- April 2014 – The US Patent and Trademark Office (USPTO) award a CRISPR patent to the Broad which covers the use of the tool in eukaryotic cells.
- April 2015 – UC Berkeley alerts the USPTO to their concerns and formally requests that they review the situation. This is the start of the patent dispute.
- January 2016 – The USPTO grants UC Berkeley’s request for a review and assemble a panel to manage the dispute.
- December 2016 – The first round of oral arguments are made before the panel.
- February 2017 – The panel vote in favour of upholding the Broad Institute’s patent. The ruling doesn’t negate UC Berkeley’s patent over use of CRISPR in non-eukaryotic cells, leading to the university releasing a press release that claims they have still come out on top.
- April 2017 – UC Berkeley appeal the previous ruling.
- October 2017 – The Broad Institute files their first arguments in preparation for the oral arguments, which likely take place in the New Year.