All 12 Zhang/Broad Institute CRISPR patents declare US funding and rights in inventions

February 15, 2017, the USPTO ruled that 12 genome-editing CRISPR-Cas9 patents and one patent application assigned to the Broad Institute of Harvard and MIT did not interfere with a patent application from scientists at the University of California. A copy of the ruling is available here.

Following the ruling by the USPTO that the Broad Institute and the University of California both issued statements, as did several firms with an interest in the dispute.

Federal government rights in CRISPR patents

All 12 of the Broad Institute patents declare US funding and rights in the patents, as does the patent application from the University of California that was involved in the challenge to the Broad Institute patents. Under the Bayh-Dole Act, the federal government has worldwide royalty free rights in federally funded patented inventions [35 USC 202(c)(4)], and the public has the ability to petition to government for “march-in” rights” [35 USC 203] to use the patents when the inventions are not made “available to the public on reasonable terms.” [35 USC 201(f)]. This gives the federal government the ability to ensure that the CRISPR patents are not monopolized or expensive to use. George W. Bush used the same legal leverage to force WARF to license its stem cell patents on reasonable terms. KEI will be among those asking DHHS to use its leverage to ensure non-discriminatory access to the CRISPR technologies on reasonable terms, and also to explore possible reach-in licensing provisions related to this.

Table 1: Zhang/Broad Institute CRISPR Patents
Patent No. Inventors Government rights declaration Title Filing Date
8697359 Feng Zhang This invention was made with government support under NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas systems and methods for altering expression of gene products 10/15/2013
8771945 Feng Zhang This invention was made with government support under NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas systems and methods for altering expression of gene products 2/18/2014
8795965 Feng Zhang This invention was made with government support under the NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas component systems, methods and compositions for sequence manipulation 2/18/2014
8865406 Feng Zhang; Fei RAN This invention was made with government support under the NIH Pioneer Award (1DP1MH100706) awarded by the National Institutes of Health. The government has certain rights in the invention. Engineering and optimization of improved systems, methods and enzyme compositions for sequence manipulation 3/24/2014
8871445 Le Cong; Feng Zhang This invention was made with government support under the NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas component systems, methods and compositions for sequence manipulation 4/23/2014
8889356 Feng Zhang This invention was made with government support under the NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas nickase systems, methods and compositions for sequence manipulation in eukaryotes 2/18/2014
8895308 Feng Zhang; Fei RAN This invention was made with government support under the NIH Pioneer Award (1DP1MH100706) awarded by the National Institutes of Health. The government has certain rights in the invention. Engineering and optimization of improved systems, methods and enzyme compositions for sequence manipulation 6/2/2014
8906616 Feng Zhang; Le Cong; Patrick Hsu; Fei RAN This invention was made with government support awarded by the National Institutes of Health, NIH Pioneer Award DP1MH100706. The government has certain rights in the invention. Engineering of systems, methods and optimized guide compositions for sequence manipulation 5/29/2014
8932814 Le Cong; Feng Zhang This invention was made with government support under the NIH Pioneer Award DP1MH 100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas nickase systems, methods and compositions for sequence manipulation in eukaryotes 4/22/2014
8945839 Feng Zhang This invention was made with government support under NIH Pioneer Award DP1MH100706, awarded by the National Institutes of Health. The government has certain rights in the invention. CRISPR-Cas systems and methods for altering expression of gene products 4/18/2014
8993233 Feng Zhang; Le Cong; Randall Jeffrey Platt; Neville Espi Sanjana; Fei RAN This invention was made with government support under the NIH Pioneer Award (1DP1MH100706) awarded by the National Institutes of Health. The government has certain rights in the invention. Engineering and optimization of systems, methods and compositions for sequence manipulation with functional domains 12/12/2013
8999641 Feng Zhang; Le Cong; Randall Jeffrey Platt; Neville Espi Sanjana This invention was made with government support under the NIH Pioneer Award (1DP1MH100706) awarded by the National Institutes of Health. The government has certain rights in the invention. Engineering and optimization of systems, methods and compositions for sequence manipulation with functional domains 3/26/2014

Additional details here:

Note also that patent application 13/842,859, from the University of California, inventors Jennifer A. DOUDNA, Martin Jinek, Emmanuelle Charpentier, Krzysztof Chylinski, James Harrison Doudna Cate, Wendell Lim and Lei Qi (parties contesting the Broad Institute patents), also declares government rights in the invention:

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
This invention was made with government support under Grant No. GM081879 awarded by the National Institutes of Health. The government has certain rights in the invention.

https://www.google.com/patents/US20140068797


This is from the Editas Medicine SEC Form 8-K filed on 01/23/2017

CPF1 LICENSE AGREEMENT

This Cpf1 License Agreement (this “Agreement”) is entered into as of this 16th day of December, 2016 (the “Effective Date”), by and between the Broad Institute, Inc., a non-profit Massachusetts corporation, with a principal office at 415 Main Street, Cambridge, MA 02142 (“Broad”), and Editas Medicine, Inc., a Delaware corporation, with a principal office at 11 Hurley Street, Cambridge, Massachusetts 02141 (“Company”). Company and Broad are referred to herein as a “Party” and together, the “Parties.”

2.2 Reservation of Rights. Notwithstanding anything herein to the contrary:

2.2.1 Government and Non-Profit Rights. Notwithstanding anything to the contrary herein, any and all licenses and other rights granted under this Agreement are limited by and subject to (a) any rights or obligations of the Institutions and United States government under 35 U.S.C. §§ 200-212 and 37 CFR Part 401 et seq.; any right granted in this Agreement greater than that permitted under 35 U.S.C. §§ 200-212 and 37 CFR Part 401 et seq. shall be subject to modification as may be required to conform to the provisions of those statutes and regulations, and (b) Institutions’ reservation of the right, for Institutions and other academic, government and non-profit entities, to make, use and practice the Patent Rights for research, teaching, or educational purposes.

2.2.2 Research Reservation. Notwithstanding anything to the contrary herein, in addition to the reservation of rights under Section 2.2.1, the exclusive license granted to Company in the Field under Section 2.1.1 of this Agreement is subject to Institutions’ reservation of the right, for each of them and any Third Party (including non-profit and for-profit entities), to research, develop, make, have made, use, offer for sale, sell, have sold, import or otherwise exploit the Patent Rights and Licensed Products as research products or research tools, or for research purposes, in the Field. Without otherwise limiting or expanding the foregoing, for the purposes of this Section 2.2.2, “research purposes” shall not be interpreted to include the administration of Licensed Products into humans.

Since inventing the CRISPR gene editing technologies, the three leading scientists, Jennifer Doudna, Emmanuelle Charpentier, and Feng Zhang, have all started new companies to commercialize the inventions.

Jennifer Doudna

  • Co-Founder, member of Scientific Advisory Board – Caribou Biosciences, http://cariboubio.com
  • Co-Founder – Intellia Therapeutics, http://intelliatx.com

Emmanuelle Charpentier:

  • Founder and Scientific Advisory Board Member – CRISPR Therapeutics, http://crisprtx.com
  • ERS Genomics: Founder and Scientific Advisor – ERS Genomics, http://ersgenomics.com

Feng Zhang:

  • Founding Scientific Advisor – Editas Medicine, http://editasmedicine.com

Jennifer A. Doudna’s new company Caribou Biosciences, Inc. was issued two CRISPR patents in 2016. Neither one disclosed federal funding.

  • 9,410,198 Compositions and methods of nucleic acid-targeting nucleic acids
  • 9,260,752 Compositions and methods of nucleic acid-targeting nucleic acids
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