While the CRISPR-cas9 patent fight between the Broad Institute (“Team Zhang”) and the UC Berkeley (“Team Doudna”) in the US saw its first hearing at the USPTO´s Patent Trial and Appeal Board on December 5, the UC Berkeley has only a few days later received good news from the European Patent Office. An Office Action from December 8, 2016 indicated allowability of broad claims for its European patent application (publication number EP 2 800 811). Claim 1 reads as follows:
1. A method of modifying a target DNA, the method comprising contacting the target DNA with a complex comprising:
(a) a Cas9 polypeptide and
(b) a single-molecule DNA-targeting RNA comprising:
(i) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a sequence in the target DNA, and
(ii) a protein-binding segment that interacts with said Cas9 polypeptide, wherein
the protein-binding segment comprises two complementary stretches of nucleotides that
hybridize to form a double stranded RNA (dsRNA) duplex,
wherein said two complementary stretches of nucleotides are covalently linked
by intervening nucleotides,
wherein said contacting is in vitro or in a cell ex vivo; and
wherein said modifying is cleavage of the target DNA.
A restriction to either eukaryotic or procaryotic cells seems not to be present. The contacting of the target DNA to be modyfied by the method, however, according to the claim has to take place in vitro or in a cell ex vivo.
A notice of allowance from the EPO (communication under Rule 71(3) EPC) can be expected soon.
Disclaimer: Neither I myself nor the patent firm Betten & Resch, of which I am a partner, is involved in any patent cases relating to CRISPR-cas9 technology.
(picture by sporst)
The revolutionary CRISPR-Cas9 gene editing method is presently the hottest issue in molecular biology. The scientists Jennifer Doudna of UC Berkely, Emmanuelle Charpentier of the Max-Planck Institute for Infection Biology in Berlin and Feng Zhang of the Broad Institute (jointly operated by the MIT and Harvard University) are regarded as pioneers in this field and areeach involved in start-up companies commercializing the new technology.
In parallel a dispute about who owns the IP related to this scientific breakthrough has evolved. Interference proceedings are pending before the USPTO to decide ownership of the technology.
Meanwhile Mr. Zhang and the Broad Institute obtained four granted patents in Europe by means of an ultra-fast prosecution procedure between February 11 and September 2, 2015. The 9-months opposition period against the first grated patent EP 2 771 468 expired on November 11 and nine oppositions have been filed (according to the EPO patent register on November 13, 2015). The opponents are:
- CRISPR Therapeutics AG
- Novozymes A/S
- Boxall Intellectual Property Management Ltd.
- Sarittarius Intellectual Property
- Mr. George Schlich
- Dr. Martin Grund
- Mr. Harvey Adams
- Dr. Ulrich Storz
The first opponent in the list is the company co-founded by Emanuelle Charpentier for commercializing the gene editing technology, opponent 2 is a Danish biotech company, opponents 3 to 5 are IP law firms and opponents 6 to 9 are patent attorneys from the UK or Germany. It is not unlikely that opponents 3 to 9 are so-called “strawman opponents”, i.e. acting for a different party wishing not to be named in the proceedings. Such strawman oppositions are explicitly allowed under EPO case law and are quite common if the “real opponent” e.g. wishes not to endanger ongoing cooperation with the patentee.
Despite much interest of the biotech community in the case, a first instance decision of the opposition division cannot be expected earlier than in about two years, in particular in view of the huge amount of evidence filed by the opponents.
The revolutionary CRISPR-Cas9 gene editing method is presently the hottest issue in molecular biology. The scientists Jennifer Doudna of UC Berkely and Emmanuelle Charpentier of the Max-Planck Institute for Infection Biology in Berlin even are among the top contenders for the Nobel prize for Chemistry to be announced on Wednesdy, October 7. But there is also a dispute about who owns the IP related to this scientific breakthrough. A third scientist, namely Feng Zhang of the Broad Institute (jointly operated by the MIT and Harvard University) has built up a strong patent position and achieved the first patent grant for CRISPR technology in the US already in April 2014. The original patent application by Doudna and Charpentier (and from which the above illustration of the DNA editing is taken) is still pending (on October 5, 2015) before the USPTO and the EPO. In April 2015 the University of California has meawhile initiated interference proceedings before the USPTO to decide ownership of the technology.
A review of the EPO register now reveals that the agggressive patent stategy of the Broad Institute and Mr. Zhang was even more successful in Europe. By means of an ultra-fast prosecution procedure the grant of 4 patents was achieved between February 11 and September 2, 2015. Further applications are still pending. The patents were issued by the EPO even with knowledge of the original publications of Doudna and Charpentier, which predate the priority dates of the Zhang patents and have been submitted to the EPO files by anonymous third-party observations.
It is therefore not unlikely that a further main battleground of the IP dispute on who owns the CRISPR-Cas9 technology will soon be the EPO, where opposition proceedings against the 4 granted patents are likely and the legal rules for determining ownership on an invention differ from that in the US.
Let´s see how the Nobel committe will decide on Wednesday this week. It will then be interesting to observe if a Nobel prize for CRISPR-Cas9 in 2015 or one of the following years will influence the outcome of the legal dispute.