Jianming Jimmy Hao, Ph.D. writes:
A patent battle between University of California and MIT has casted clouds over the ownership of the CRISPR gene-editing technology potentially worth billions of dollars. Bio-pharma companies, investors, and researchers should use caution when navigating the complex intellectual property landscape.
The CRISPR gene-editing technology has created intense excitement in the community of bio-pharma and venture capital industry. It is believed that this technology will transform our ability to edit the genomes of all living organisms, including humans. “CRISPR is absolutely huge. It’s incredibly powerful and it has many applications, from agriculture to potential gene therapy in humans,” said Craig Mello of the University of Massachusetts, who shared the 2006 Nobel Prize for medicine for discovery of RNA interference. See the New York Times.
While venture capital funds and biotech-pharmaceutical companies are pouring money into companies developing CRISPR technology (see, e.g., FierceBiotech), University of California and MIT are entering into a fight for control of what could be hugely lucrative intellectual property rights to the technology. On April 15, 2014, the USPTO awarded the first CRISPR-related patent (US 8697359) to a group led by Dr. Feng Zhang at the Broad Institute of MIT and Harvard University. Since then a group of inventors led by Dr. Jennifer Doundna at University of California, Berkeley, who also filed their own patent applications, have submitted thousands of pages of documents to the USPTO challenging the patent. If the USPTO accepts the UC Berkeley group’s challenge, a so-called “interference” proceeding will be initiated to prove which group invented the claimed technology first.
Had any of the two groups filed their patent application after March 16, 2013, there would be no such fight as after that date the US patent system changed to a “first-to-file” system. Before that date, however, the US patent system was a “first-to-invent” system and, under that system, whoever invented a claimed technology first is entitled to the patent right. In this CRISPR fight, the UC Berkeley group actually filed their patent application about seven months earlier than the MIT group. Yet, the latter group secured a patent first as they took advantage of a so-called “fast track” practice, which allowed them to jump the queue at the USPTO. Despite the timing differences, both groups’ applications are assessed under the old system and the “interference” proceeding can be used to decide who invented what first.
Going forward, this legal battle could take several years to settle and either party may end up with significantly limited patent protection or even walk away empty-handed. Meanwhile, more and more patent applications have been filed in the field. As of May 26, 2015, there are about 787 published PCT applications (including some filed by Fox Rothschild for its clients) that are related to CRISPR. As more funds are pouring in, companies, investors, and researchers should use caution in their licensing, investing, collaboration, and R&D activities in connection with the technology and related intellectual property landscape.
Jianming Jimmy Hao, Ph.D. is an associate in Fox Rothschild’s Princeton office.