July 21, 2019 -- After many years of hearing about the ability to edit a genome, many of us (scientist or not) are finally getting used to the idea. However, in federal patent offices and research institutions, this topic has been and continues to be the subject of serious debate.
With great potential in research and commercial settings, many eager scientists and venture capitalists have been fighting to gain dominance in the field. In the United States Patent and Trademark Office (USPTO) the fight has been primarily between the Broad Institute at MIT (Broad) and The University of California, Berkeley (UCB). Here is a rundown on events leading up to the current set of interference proceedings.
May 2012: UCB applies for CRISPR-Cas9 patent (US Patent Application No. 61/652,086)
Dec 2012: Broad, MIT apply for fast-track patent for CRISPR-Cas9 system (US Patent Application No. 61/842,322).
April 2014: Broad receives first patent for CRISPR-Cas9 specific to eukaryotic cells US Patent No. 8,697,359
Jan 2016: USPTO announces interference proceeding between Broad and UCB No. 106,048
Feb 2017: The Patent Trial and Appeal Board (PTAB) finds no interference with UCB’s patient claims
October 2017: UCB appeals PTAB decision to the US Court of Appeals for the Federal Circuit
September 2018: US Court of Appeals for the Federal Circuit ruled that patents held by the Broad and Harvard University were not in conflict with previously submitted patents from the UCB. The decision affirms the decision by the PTAB in February 2017 that Broad’s patents don’t step on CRISPR applications that researchers from UCB had filed earlier. That means that Broad maintains the hold of intellectual property for the use of CRISPR gene editing in eukaryotes.
June 24, 2019: The PTAB initiated a new interference process involving the UCB patent estate (Interference 106,115). The process was initiated by the USPTO itself and challenges the validity of UCB’s eukaryotic claims. The USPTO designated Broad, MIT, and Harvard as Senior Parties (first to invent) and UCB as the Junior Party regarding the use of CRISPR system in eukaryotic cells. This proceeding could lead to a potential shift in rights among.
July 18, 2019: MilliporeSigma and the Broad Institute of MIT and Harvard announced an agreement to offer non-exclusive licenses to CRISPR intellectual property (IP) under control in commercial research and product development. The goal is to allow companies to apply CRISPR in their research and allow other patent holders to participate in the future.
July 19, 2019: Sigma Aldrich petitioned the USPTO to open an interference proceeding in parallel with the interference declared by the PTAB (UCB v. BROAD) regarding CRISPR-Cas9 technologies developed in 2012 (Patent applications: 15/188,911, 15/456,204, and 15/188,924).
Patents Around the Globe The US Patent and Trademark Office has issued more than 80 patents with claims to CRISPR and/or Cas9 to more than 300 inventors from nearly 60 applicant organizations. The European Patent Office (EPO) has issued more than 20 such patents to approximately 30 inventors from about ten applicant institutions. In addition, there are more than 1,500 applications filed (but not yet granted) around the world.
Beyond the academic debate it seems that a forerunner is appearing in the global CRISPR race. Millipore Sigma, globally known as Merck KGaA (EMD Group), and in the United States and Canada known as Sigma Aldrich holds CRISPR technology patents in Australia, Canada, Europe, Singapore, China, Israel, South Korea. Moreover, they have patent filings for insertion CRISPR method in the U.S., Brazil, India, and Japan. With their newfound partnership with Broad and Harvard, a more established framework and plan is being formed. This may be just the move that CRISPR needs to excel from a brilliant discovery to a practical application.