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Hearings begin in CRISPR US patent dispute

12 December 2016

By Antony Blackburn-Starza

Appeared in BioNews 881

Oral arguments from lawyers acting for the Broad Institute of MIT and Harvard and the University of California (UC), Berkeley, in the high-profile CRISPR/Cas9 patent dispute have been heard in Virginia.

As part of the patent interference procedure initiated by UC Berkeley last year, the parties were given 20 minutes each to present their arguments on the issue of who first invented the genome-editing technique (see BioNews 802 and 835). The judges have already considered hundreds of documents filed by both sides.

Patent rights over the use of CRISPR/Cas9 were awarded to Professor Feng Zhang at the Broad Institute in April 2014. This decision was contested, however, by UC Berkeley, which argued that Professor Jennifer Doudna, working alongside Professor Emmanuelle Charpentier, published a paper in 2012 describing the technique and as such were the first to invent the technology. It also claimed that earlier patents filed by Professor Doudna and colleagues covered the use of the technique in question.

UC Berkeley is asking the US Patent and Trademark Office (USPTO) to invalidate or redact Professor Zhang's core patents in relation to CRISPR/Cas9, a decision that would have significant financial implications for both sides.

Acting for UC Berkeley, Todd Walters of the law firm Buchanan Ingersoll & Rooney, explained to the judges that Professor Doudna's paper and subsequent provisional patent application identified the key components of CRISPR/Cas9 and its use for altering the DNA of bacteria (or prokaryotes).

Walters asserted that, once the technique was shown to work in bacteria, it would then be obvious to a reasonable person skilled in that field that it could be used in more complex (eukaryotic) cells. As such, Professor Doudna and Professor Charpentier's work covers aspects of Professor Feng's patent, which is concerned specifically with the use of CRISPR/Cas9 in eukaryotic cells.

Representing the Broad Institute, Steve Trybus of Jenner and Block argued that Professor Doudna had struggled to get the technique to work in eukaryotic cells, and pointed out that she did not manage to do so until months after the initial work in prokaryotes. 'That is the antithesis of something that would have been obvious', he said.

On the other hand, Walters had said getting the technique to work in eukaryotic cells was so obvious that six different teams had managed to do so within six months of Professor Doudna's publication.

Commenting on the proceedings, a special adviser for technology transfer at the National Institutes of Health, Dr Mark Rohrbaugh – as reported in The Scientist – explained that the issue for the judges was about 'obviousness': 'Was this the system that just happened to successfully easily move from a prokaryotic to eukaryotic system? Were they just lucky in that? Or was it predictable and obvious based on the prior art that it could move from one system to the other?'

The Scientist adds there were other issues in contention, including differences in the molecules used and the approach taken by the researchers. It may be that, following the outcome of the interference proceedings, some patent claims held by the Broad Institute would remain intact while others could be awarded to UC Berkeley.

Robert Cook-Deegan of Arizona State University, who was also at the hearing, is quoted in Nature News as saying: 'My impression is both will end up with something.'

The Wall Street Journal explains that patent interferences typically involve two stages. The first involves arguments that attempt to invalidate a patent – as UC Berkeley has sought to do. The second involves determining the date of priority – the USPTO will still need to decide if the relevant date of filing is the provisional or final applications submitted by the parties.

Although there is no timeline for when the USPTO must give its verdict, some experts have indicated a decision on the first stage of proceedings will be made before February 2017.

SOURCES & REFERENCES
The Scientist | 06 December 2016
 
Nature News | 06 December 2016
 
Science | 06 December 2016
 
Wall Street Journal | 05 December 2016
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

31 July 2017 - by Dr Rachel Brown 
The University of California has moved to appeal a decision of the US Patent Trial and Appeal Board over the use of CRISPR in eukaryotic cells...
17 July 2017 - by Kulraj Singh Bhangra 
The Broad Institute of Massachusetts Institute of Technology and Harvard will take part in an initiative to simplify licensing CRISPR genome editing technology to other organisations and institutions...
03 July 2017 - by Rachel Siden 
China's State Intellectual Property Office has granted the University of California a patent on CRISPR-Cas9 gene editing technology in the country.
03 April 2017 - by Jennifer Willows 
The European Patent Office has declared that it intends to grant a broad patent for the use of CRISPR technologies to the University of California, the University of Vienna and Dr Emmanuelle Charpentier of the Max-Planck Institute in Berlin...
20 February 2017 - by Ryan Ross 
The US Patent and Trademark Office has upheld the right of the Broad Institute of MIT and Harvard to the genome-editing tool CRISPR/Cas9...

22 August 2016 - by Chee Hoe Low 
A former MIT visiting student who worked in the Zhang lab for nine months in 2011 has claimed that patents over the CRISPR genome-editing technology were 'mis-patented'...
18 January 2016 - by Antony Blackburn-Starza 
The CRISPR 'patent wars' have now officially kicked off in the USA, with formal proceedings to determine who controls key patents over the revolutionary genome-editing technology...
23 November 2015 - by Dr James Legg 
On 26 October this year the CRISPR/Cas patent wars truly began with the filing of European oppositions against what appears to be the first patent granted in Europe for this revolutionary gene-editing technology....
18 May 2015 - by Ari Haque 
Patents for the gene-editing technology, CRISPR/Cas9, are the subject of a dispute between scientists at University of California, Berkeley and the Broad Institute of MIT and Harvard....

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