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Who owns CRISPR? - An update on the Interference.

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Here is a brief discussion of this important technology and the legal dispute before the USPTO about rights to the technology

Published in: Health & Medicine
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Who owns CRISPR? - An update on the Interference.

  1. 1. Who Owns CRISPR? Stephen J. Lieb Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, New York 10151 slieb@flhlaw.com (212) 588-0800
  2. 2. What is CRISPR and What is Going On? • CRIPSR-Cas9 is a gene editing technique originally identified a part of a bacteria's immune system. • The natural mechanism has been adapted to target and cut DNA – It is highly accurate, inexpensive, and allows editing of multiple sites on the genome simultaneously. – “Breakthrough of 2015” by Science magazine • There is a dispute (an Interference) between MIT’s Broad Institute and Univ. of California about who owns the basic patents for the use of CRIPSR. https://acts.uspto.gov/ifiling/PublicView.jsp?identifier=106048&identifier2=null&t abSel=4&action=filecontent&replyTo=PublicView.jsp
  3. 3. What is CRIPSR?
  4. 4. Doudna Ted Talk CRISPR-Cas9 system
  5. 5. What is CRIPSR?
  6. 6. Who are the Player in the Dispute? • Senior Party – Jennifer Doudna of the University of California, Berkeley, and – Emmanuelle Charpentier, currently at the Helmholtz Center for Infection Research in Germany • Junior Party – Feng Zhang of the Broad Institute and MIT
  7. 7. Who are the Player in the Dispute? • Broad has 13 issued patents – Broad filed after U.C. but paid to have examination “fast tracked” • U.C. has 8 Pending applications related to the one being disputed
  8. 8. What is an Interference? • A trial to see who invented first • Motions must be pre-authorized – Do the parties claim the same subject matter (no interference-in-fact)? – And which of the parties’ claims actually interfere (which claims “correspond” to the “count”)? – Are each of the parties entitled to claim that subject matter? • Do the parties’ applications really disclose the whole invention (written description support)?
  9. 9. What is the “count?” A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule … comprising: contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered CRISPR-Cas system comprising: a) a DNA-targeting RNA comprising i) a targeter-RNA …, and ii) an activator-RNA or tracr sequence … and b) a Cas9 protein, wherein the DNA-targeting RNA forms a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said target DNA molecule is cleaved or edited ….
  10. 10. What is U.C.’s Proposed Count? • A method of cleaving or editing a target DNA molecule …, the method comprising: • contacting a target DNA molecule … with an engineered …(CRISPR- 17 Cas) system comprising: • a) a single-molecule DNA-targeting RNA or guide RNA comprising – i) a targeter-RNA that hybridizes with the target sequence, and – ii) an activator-RNA, or a trans-activating CRISPR RNA (tracrRNA), that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment, and • b) a Cas9 protein, • wherein i) and ii) are covalently linked to one another, and • wherein a) forms a complex with b), thereby targeting the Cas9 protein to the target 26 DNA molecule, whereby said target DNA molecule is cleaved or edited ….
  11. 11. What issues Will Be Raised in the Interference? • Allowed Motions – Broad • There is no “interference-in-fact” (Broad Motion 2) • Broad is entitled to the filing date provisional applications (Broad Motion 3) • Some of Broad’s claims don’t correspond to the count (Broad Motion 5) – U.C. • Change the count (U.C. Motion 3) • Entitled to filing date of provisional application (U.C. Motion 2)
  12. 12. What are the Parties Saying? • Broad says no interference because the count requires function in eukaryotes – U.C. did not invent such a system – they didn’t show CRISPR could cut DNA in a cell – This is a highly unpredictable art and scientists at the time would not expect U.C.’s molecule would work in a eukaroytic cell – Zhang’s work using CRISPR in eukaryotes was a breakthrough
  13. 13. What are the Parties Saying? • U.C. moved to change the count to – Remove Eukaryote requirement – Limit the count to a single-molecule DNA-targeting RNA – U.C.’s allowed claims are not limited to eukaryotes. • U.C. moved that its earlier provisionals support the count (limited to eukaryotes) – Example 1 shows the single molecule system in vitro and says it can be used in all types of cells – Extending example to eukaryotes is obvious and predictable • Other investigators quickly used the disclosed molecule of Example 1 in eukaryotes.
  14. 14. What are the Commercial Implications? • Genetic medicine – Duke, U. Tex. And Harvard report editing genes in a mouse to treat Duchene’s Muscular Dystrophy h • http://www.nytimes.com/2016/01/01/science/gene-therapy-muscular- dystrophy.html?_r=0 – Napster founder funds U.Penn. Effort to modify T-cells with CRIPSR to treat cancer • https://www.technologyreview.com/s/601742/money-behind-first-crispr- test-its-from-internet-billionaire-sean-parker/ • Bioengineering – DuPont announced new CRIPSR spliced corn hybrids – https://www.technologyreview.com/s/542311/dupont-predicts-crispr-plants-on-dinner- plates-in-five-years/
  15. 15. What are the Commercial Implications? • Doudna and Charpentier – Caribou Biosciences • Therapeutics, agriculture, and industrial bio production • $30 Million Series B in May 2016 – CRIPSR Therapeutics • In vivo and ex vivo therpies • Backed by Celgene, GSK Venture, • Raise $89 Million in 2014 – Intellia Therapeutics • T-cell based therapeutics • Backed by Novartis • Zhang – Editas Medicine • T-cell based therapeutics • IPO in February 2016 at $94 million

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