Posts Tagged: "CRISPR"

The U.S. Patent and Trademark Office (USPTO) ruled in an interference proceeding yesterday that The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (“Broad”) have priority over The Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (“CVC”) with respect to who was first to invent the use of single-guide CRISPR-Cas9 genome engineering technology in eukaryotic cells.

As society adjusts to a new world of social distance and remote everything, rapid advancements in the digital, physical, and biological spheres are accelerating fundamental changes to the way we live, work, and relate to one another. What Klaus Schwab prophesized in his 2015 book, The Fourth Industrial Revolution, is playing out before our very eyes. Quantum computing power, a network architecture that is moving function closer to the edge of our interconnected devices, bandwidth speeds of 5G and beyond, natural language processing, artificial intelligence, and machine learning are all working together to accelerate innovation in fundamental ways. Given the global pandemic, in the biological sphere, government industrial policy drives the public sector to work hand-in-glove with private industry and academia to develop new therapies and vaccines to treat and prevent COVID-19 and other lethal diseases. This post will envision the future of gene editing technologies and the legal and ethical challenges that could imperil their mission of saving lives.

On Tuesday, June 24, the Patent Trial and Appeal Board (PTAB) declared an interference proceeding  between a collection of entities that are on opposing sides in the race to commercialize CRISPR-Cas9 genomic editing technologies. The patent interference will decide if inventors from the Regents of the University of California, the University of Vienna and the Umea University of Sweden were the first to invent certain methods for gene editing in eukaryotic cells, or plant and animal cells, that are covered by patent claims which have been issued to the Broad Institute, the Massachusetts Institute of Technology (MIT) and Harvard College. The patent interference involves 10 patent applications that have been filed by the University of California group and 13 patents that have been filed by the Broad Institute group. These two groups have been facing off in a series of legal battles regarding which side can properly claim to be the rightful inventor of perhaps the world’s most widely applicable gene editing technology useful for treating diseases, improving life science research and increasing the rate of biotechnology innovations.

The Federal Circuit recently weighed in on an interference proceeding between the University of California (“UC”) and the Broad Institute over the use of CRISPR-Cas9 technology. The Court affirmed a Patent Trial and Appeal Board (“Board”) decision finding there was no interference-in-fact between UC’s patent application and the claims of twelve patents and one application owned by Institute… Considering the evidence of simultaneous invention, along with evidence regarding the state of the art, inventor statements, and application of similar technologies, the Court concluded the Board’s finding was supported by substantial evidence.

The University of California (“UC”) and The Broad Institute, Inc. (“Broad”) are among the leaders in the development of CRISPR technology.  Both UC and Broad filed patent applications for claims broadly drawn to CRISPR-Cas9 systems and methods of DNA editing.  These parties are currently engaged in litigation over patents concerning the potentially most lucrative application of CRISPR technology – the use of CRISPR-Cas9 in plant and animal (eukaryotic) cells.  The outcome of this litigation will affect control of the CRISPR platform and development of the technology.

I was just thinking how often someone teaching intellectual property law leads the attack on the patent system when “Racing for academic glory and patents: Lessons from CRISPR” appeared. It sounds a dire warning that “overly broad patents must be reined in” as the passage of the Bayh-Dole Act “invoking patents as a mechanism for promoting commercialization of federally funded research” set off an “often socially wasteful race…for glory in academic research and in the patent sphere.” What’s particularly striking is that neither the paper nor the articles hyping it provide any evidence the CRISPR patents are restricting research or blocking commercial development. Indeed, most signs point in the opposite direction… Doesn’t a finding by NIH that there’s no evidence of any problems with how universities are licensing their CRISPR patents deserve to be mentioned? It seems like a pretty important point.

On Wednesday, October 25th, the Cambridge, MA-based medical research center The Broad Institute filed a brief with the Court of Appeals for the Federal Circuit in response to an appeal filed by the University of California stemming from patent interference proceedings playing out at the Patent Trial and Appeal Board (PTAB). The Broad Institute’s filing is the latest salvo in a patent battle which has played out between developers of a gene editing technology, which could prove to be very important to the future of fighting disease in humans.

The PTAB concluded: “Based on our determination that the preponderance of the evidence shows there is no interference-in-fact between the parties’ claims, we need not decide the other pending motions.”… Yesterday the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) issued a decision in the CRISPR patent interference pending between The Broad Institute, Inc. (the Junior Party; second filer) and The Regents of the University of California (the Senior Party; first filer)… This ruling is a victory for The Broad Institute, who had filed a motion arguing that the interference should never have been declared because there is no intereference-in-fact between the claims being made by the parties.

The alliance is composed of firms that have a vested interest in the outcomes of a CRISPR patent interference case currently in front of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). The interference proceeding specifically involves patents covering CRISPR/Cas9 gene editing technologies. The companies joining the alliance include Ireland-based ERS Genomics and Switzerland’s CRISPR Therapeutics (NASDAQ:CRSP) along with American biotech firms Caribou Biosciences and Intellia Therapeutics (NASDAQ:NTLA). These companies have all licensed CRIPSR/Cas9 technologies

Right now, behind the walls of the USPTO, there is a fiery interference battle occurring between two scientific teams over who created a groundbreaking, DNA altering technique first. The victor stands to receive incredible gains. In one corner is a team of scientists from UC Berkeley headed by biologist Jennifer Doudna from the University of California, Berkeley and microbiologist Emmanuelle Charpentier from Umeå University in Sweden and the Max Planck Institute for Infection Biology in Berlin. In the other, a group led by synthetic biologist Feng Zhang of the Broad Institute of the Massachusetts Institute of Technology and Harvard in Cambridge, Massachusetts.

England isn’t the only part of the world where embryonic gene editing research has been finding a foothold. In early 2015, researchers out of China published a paper reporting experiments in using CRISPR-Cas9 to edit a specific gene in an embryo’s genetic code responsible for a potentially life-threatening blood disorder. The research team found serious obstacles that need to be addressed before CRISPR-Cas9 can be used to edit genetic code in an embryo on a wide scale; these issues include low retention of genetic material and unintended mutations when a Cas9 enzyme misses its target.