The US Patent office has recently (May 28) issued a patent to the French biologist Emmanuelle Charpentier and US colleague Jennifer Doudna covering the methods of modulating DNA transcription with the much-vaunted but controversial CRISPR-Cas9 system.
The patent (No. 10,301,651) which included University of California (UC), as well as the University of Vienna where Charpentier was based at the time, covers techniques that enable sequence-specific repression or activation of gene expression in all types of cells, including both prokaryotic (bacteria) and eukaryotic (plant and animal) cells.
Complex legal disputes over who invented of CRISPR-Cas9 technique erupted in 2015 between The Broad Institute and Berkeley. In 2011 and 2012, Doudna and Charpentier, now based at Umeå, University in Sweden were researching CRISPR-Cas9. Simultaneously but separately, Feng Zhang at the Broad Institute was working on the same problem.
Although Doudna published her findings and applied for a patent before Zhang, her experiments focused on CRISPR-Cas9 in test tubes. Zhang’s research focused on its use in human and mouse cells.
The court room shenanigans have been live ever since.
They have even spilled over into the international courts with The European Patent Office granting Doudna and Charpentier two CRISPR-Cas9 patents in March 2017 and more recently in January 2018.
The EPO gave the Doudna-Charpentier team gene editing rights over eukaryotic cells in the European Union. And it revoked the Broad Institute’s first patent for CRISPR-Cas9 in January 2018.
In a statement last week UC’s legal representative said the issue centred on the numerous CRISPR-Cas9 techniques covered by UC’s patents.
“UC is committed to ensuring the technology is used to benefit society,” said Eldora L Ellison, the lead patent strategist on CRISPR-Cas9 matters for UC and a director at legal firm Sterne, Kessler, Goldstein & Fox which specialises in protecting intellectual property rights.
“We anticipate that UC’s robust portfolio of intellectual property surrounding its CRISPR-Cas9 inventions will continue to expand.”
The core dispute between the two centres of learning is unlikely to be settled anytime soon. Broad has had some impressive victories along the way. After widely reported proceedings, the Patent and Trademark Office ultimately sided with the Broad in 2018, determining that the technologies were sufficiently distinct.
Reacting with cool reserve to the latest patent approval Broad Institute spokesman David Cameron said in a statement that this new patent decision: “Does not affect the CRISPR patent estate held by Broad, MIT, and Harvard in any way.”
It’s believed to be the fifth patent in UC’s burgeoning CRISPR-Cas9 patent portfolio. Five additional applications have received notices of allowance and are expected to be issued as patents in the coming months.
The methods claimed in this latest patent were included among the CRISPR-Cas9 technology disclosed first by the Doudna-Charpentier team in its May 25, 2012, priority patent application.
The international scientific community seems to widely acknowledge the pioneering nature of the Doudna-Charpentier invention of the CRISPR-Cas9 gene editing technology and its applications. The list of awards, including the Breakthrough Prize in Life Science, Japan Prize, Gruber Prize in Genetics, BBVA Frontiers of Knowledge Award and Kavli Prize in Nanoscience continues to grow.
This patent and four previously issued U.S. patents cover CRISPR-Cas9 compositions and methods useful to target and edit genes and to modulate expression of genes, in any setting, including within plant, animal and human cells.
Patent offices in the UK, China, Japan, Australia, New Zealand, Mexico and other countries have also recognised the value of the work done by Doudna-Charpentier.
Berkeley insists its policy around CRISPR-Cas9 is to open-licensing policies, allowing non-profit institutions, including academic institutions, to use the technology for non-commercial, educational and research purposes.
Only last month University of Pennsylvania announced the first US human trial of cancer patients using CRISPR following on from the first official trial underway for about a year in Germany.
The outcry over the use in China of CRISPR to edit the human genome which led to the birth of genetically altered twins lingers in the background with hard ethical issues over its use yet to be resolved.
It has also encouraged widespread commercialisation of the CRISPR-Cas9 technology through its exclusive license with Caribou Biosciences, of Berkeley, Caribou has sublicensed the technology to many companies internationally, including Intellia Therapeutics. for certain human therapeutic applications.
Additionally, Charpentier has licensed the technology to CRISPR Therapeutics AG and to ERS Genomics Limited.