A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded thereon, the method comprising:Although this is an oversimplification, a key dispute centers on whether Doudna is only entitled to patent rights on an in vitro CRISPR/Cas9 component system, while Zhang is entitled to patent rights on the use of CRISPR in eukaryotic cells (the most valuable application of the technology). In an interference, the first filer (Doudna) is deemed the senior party, while the second filer (Zhang) is the junior party, and thus has the burden of proof to establish an earlier date of invention. Invention requires conception of the inventive idea, as well as either actual or constructive reduction to practice (meaning actual work on the invention or the actual filing of a patent application). A judge from the PTO’s Patent Trial and Appeal Board (PTAB) will conduct the proceeding. The interference could be expected to take several years, at least. The parties could settle along the way, with priority conceded and possible licensing options established. Since U.S. patent interferences are phasing out of American law due to the changes instituted by the AIA, it is no small irony that one of the most high-profile interferences will occur 3 years after the statute took effect. In addition, the patent rights to one of the most important advances in biotechnology will be sorted out according to the now-discarded first inventor paradigm of U.S. patent law. The patent rights at stake are immensely valuable, and even with an uncertain IP landscape, gene editing startups are proliferating as well as investments from established pharmaeutical companies in gene editing ventures.
contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly lnterspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system comprising:
a) a DNA-targeting RNA comprising
i) a targeter-RNA or guide sequence that hybridizes with the target sequence, and
ii) an activator-RNA or tracr sequence that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment, 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 or transcription of at least one gene encoded by the target DNA molecule is modulated.
February 13, 2016
Patent Rights to CRISPR Gene Editing Technology Will Be Sorted Out by Interference Proceeding
The powerful gene editing technology, CRISPR/Cas9, is now the subject of debate over its uses and applications (see here), and whether any limits should be set on possible applications in reproductive medicine (see here). However, a wholly separate controversy has been circulating in the field, involving a messy patent dispute between two of the main players in the development of the technology. A patent application on the technology was filed by Jennifer Doudna and her colleagues (Doudna) (assigned to UC Berkeley). In the same time frame, CRISPR-related patent applications were also filed by Feng Zhang and his colleagues (Zhang) (assigned to MIT and its Broad Institute). Doudna filed in May, 2012, while Zhang filed in December, 2012. Doudna's application is still pending, while Zhang has a number of issued patents to date (e.g., U.S. Patent No. 8,607,359); Zhang requested an accelerated patent examination and thus received the earliest issued patents. U.S. patent law underwent a significant change in 2013 when the America Invents Act (AIA) came into force, establishing a first-inventor-to-file standard in the law. Until then, the U.S. required that a patent be awarded to the first inventor (in time); that individual might or might not be the first to file a patent application on the invention. U.S. patent law has had a mechanism for identifying the first inventor where two separate applicants file for a patent on overlapping subject matter, known as an interference proceeding. The U.S. Patent and Trademark Office (PTO) has issued a Declaration of interference between Doudna and Zhang, based on the sequence of the Doudna/Zhang patent filings, which both claim overlapping subject matter (since both were filed before the AIA took effect, the conflict will be settled under the old first-to-invent standard). The Administrative Patent Judge has issued a "count," which is a fictional claim that encompasses the conflicting subject matter: