Type of information: Granting of a patent
Product name: CRISPR’s in-licensed gene editing technology
Compound: CRISPR/Cas9 single-guide gene editing system
Therapeutic area: Technology - Services
Action mechanism: genome editing product
Company: Crispr Therapeutics (Switzerland - UK)
- • On June 19, 2017, CRISPR Therapeutics announced that China’s State Intellectual Property Office (“SIPO”) has granted a patent broadly covering CRISPR’s in-licensed gene editing technology. The claims are directed to CRISPR/Cas9 single-guide gene editing methods for modifying target DNA in both non-cellular and cellular settings, including in cells from vertebrate animals such as human or mammalian cells – as well as composition of matter and system claims for use in any setting, including claims for use in producing medicines for treating disease.
- The European Patent Office and the United Kingdom’s Intellectual Property Office have previously issued patents from the underlying international patent application. This application is based on the same U.S. priority application that has been involved in an interference proceeding with the Broad et al., which priority application (USSN 61/652086) was filed on May 25, 2012, on behalf of CRISPR’s co-founder Dr. Emmanuelle Charpentier (currently a director at the Max-Planck Institute in Berlin) along with the Regents of the University of California (the assignee of Jennifer Doudna and colleagues) and the University of Vienna (the assignee of Krzysztof Chylinski).
- • On April 26, 2017, Intellia Therapeutics and CRISPR Therapeutics announced that the United States Patent and Trademarks Office is expected to issue a CRISPR/Cas9 genome editing patent to Vilnius University (“Vilnius”). Intellia and CRISPR are nonexclusive sublicensees for a defined field of human therapeutic, prophylactic, and palliative uses (including companion diagnostics), excluding anti-fungal and anti-microbial applications.
- The Vilnius patent claims are directed to CRISPR/Cas9 complexes assembled in vitro and used for site-specific modification of target DNA sequences. CRISPR/Cas9 complexes, referred to as CRISPR ribonucleoproteins or “RNPs,” are contemplated for use in a number of ex vivo applications in which cells, such as blood cells, may be corrected or edited outside of the body before being returned to a patient as a potential therapeutic. The patent is expected to issue on May 2, 2017 as U.S. Patent No. 9,637,739.
- This new patent, together with the companies’ respective rights to foundational CRISPR/Cas9 intellectual property co-owned by The Regents of the University of California, University of Vienna and Dr. Emmanuelle Charpentier, provide CRISPR and Intellia with complementary rights to inventions claimed by the earliest developers in the discovery and application of CRISPR/Cas9 technology.
• On March 28, 2017, Crispr Therapeutics reported that the European Patent Office (EPO) has announced its intention to grant a patent broadly covering CRISPR’s in-licensed gene editing technology. The claims are directed to the CRISPR/Cas9 single-guide gene editing system for uses in both non-cellular and cellular settings, including in cells from vertebrate animals such as human or mammalian cells – as well as composition claims for use in any setting, including claims for use in a method of therapeutic treatment of a patient.
- The European patent application (No. 13793997) was the subject of numerous third-party observations or ‘TPOs’ filed by the Broad Institute and others attempting to prevent or delay its grant. Following review of those submissions, the EPO determined that the technical evidence and associated legal arguments did not alter patentability of the inventions by the applicants, and accordingly announced its intention to advance the case to grant in Europe. The full EPO case files, TPOs, and claims intended for grant are available on-line via the EPO’s official website.
- The underlying international patent application is based on the same U.S. priority application that has been involved in an interference proceeding with the Broad et al., which priority application (USSN 61/652086) was filed on May 25, 2012, on behalf of Crispr’s co-founder Dr. Emmanuelle Charpentier (currently a director at the Max-Planck Institute in Berlin) along with the Regents of the University of California and University of Vienna.
- The United Kingdom’s Intellectual Property Office (UKIPO) has also examined the related applications, and likewise considered technical evidence and arguments submitted by third parties, before ultimately reaching similar conclusions to those of the EPO. The UKIPO granted a first UK Patent to the CRISPR/Cas9 single-guide gene editing system for uses in both non-cellular and cellular settings (No. 2518764), and a second UK Patent to ‘chimeric’ CRISPR/Cas9 systems in which the Cas9 protein is modified to provide alternative DNA-modulating activities (No. 2537000).
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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Favourable opinion USA:
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Orphan status UE:
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Pediatric exclusivity UE:
- • On April 13, 2017, CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics announced that The Regents of the University of California, the University of Vienna, and Dr. Emmanuelle Charpentier (collectively “UC”), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, have appealed to the U.S. Court of Appeals for the Federal Circuit the decision by the Patent Trial and Appeal Board to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology.
- In the appeal, UC is seeking review and reversal of the PTAB’s February 15, 2017 decision, which terminated the interference without determining which inventors actually invented the use of the CRISPR/Cas9 genome editing technology in eukaryotic cells. In its decision, the PTAB concluded that, although the claims overlap, the respective scope of UC and Broad’s claim sets as presented did not define the same patentable invention and, accordingly, terminated the interference without deciding which party first invented the use of the CRISPR/Cas9 technology in eukaryotic cells. UC is asking the Federal Circuit to review and reverse the PTAB’s decision.
- In parallel with the appeal, UC is pursuing applications in the U.S. and other jurisdictions worldwide to obtain patents claiming the CRISPR/Cas9 technology and its use in non-cellular and cellular settings, including eukaryotic cells. Corresponding patents have already been granted in the United Kingdom, and the European Patent Office is also granting a patent to UC, which will issue on May 10, 2017. UC’s earliest patent application describing the CRISPR/Cas9 genome editing technology and its use was filed on May 25, 2012, while the Broad’s earliest patent application was filed more than six months later, on December 12, 2012.
- The law firm of Munger, Tolles & Olson LLP will be handling the appeal, with Don Verrilli, former Solicitor General of the United States, as lead counsel.