Lauded as one of the biggest innovations since the dawn of the biotechnology age, CRISPR has set the biotechnology world ablaze with its potential to cure complex human diseases and generate a multi-billion dollar industry. This powerful technology is the topic of a contentious patent dispute between two research institutions that has revived pre-America Invents Act (AIA) procedure and highlights a patent-licensing trend in the biotechnology industry.
What is CRISPR?
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a gene-editing technology that is derived from the natural immune system of bacteria and allows for the recognition and destruction of viruses. Although known since the 1980s, it was not until 2012 that biologists demonstrated that CRISPR could hold the key to quick, efficient and highly specific removal and replacement of purified DNA segments. Gene editing is not a new field of science, but CRISPR vastly outperforms its expensive and inefficient predecessors. Scientists have already used CRISPR in mouse models to successfully fix the genetic mutations that lead to diseases such as sickle-cell anemia and cystic fibrosis.
Background of the Dispute
In May 2012, a team of University of California-Berkeley (Berkeley) biologists filed for a patent after using CRISPR to alter specific stretches of bacterial DNA. In December 2012, Dr. Feng Zhang, a biologist at the Broad Institute of MIT and Harvard (Broad), filed his own CRISPR patent after demonstrating a method to edit the genes of more complex eukaryotic cells (i.e. the cells of animals and humans). Zhang requested, and was granted, an expedited review of his application. The United States Patent and Trademark Office (USPTO) awarded Zhang patent rights in April 2014. Berkeley then petitioned the USPTO for a patent interference proceeding, which commenced in January 2016. An interference proceeding is a remnant of the “first-to-invent” patent system that existed in the U.S. prior to the passing of the AIA in 2013. In the interference proceeding, a panel of three USPTO judges will determine which team was first to invent the CRISPR system for gene editing.
Berkeley argues that once its researchers demonstrated the use of CRISPR to edit DNA in bacteria, any reasonably skilled biologist could have adapted the technique for more complex cells. If the panel accepts Berkeley’s argument, it would preclude the patentability of a CRISPR gene-editing method for other cell types and would most likely award priority to the Berkeley patent. Broad’s counterargument focuses on showing that (i) Zhang developed his CRISPR method before the Berkeley team, and (ii) various reports that quote one of the Berkeley biologists describing unsuccessful attempts to apply CRISPR to human cells. If the panel finds in favor of Broad’s argument that Zhang invented the technique first, the Berkeley patent would most likely be rejected under the “first-to-invent” standard that applied when the patents were filed. However, if the panel finds that Zhang’s CRISPR method in eukaryotic cells is a non-obvious improvement from the claims made in the Berkeley patent, both patents could be valid. As the proceeding nears its one-year anniversary in January 2017, there is no resolution in sight.
A Divergence from Theory
The patent system is based on the theory that granting an inventor patent rights for his/her invention should foster innovation and incentivize the creation of industrial products. The patent owner can use and license his/her patented invention to those who will commercialize it for the use and betterment of society. Patent licensing should theoretically follow the grant of a patent, however, the CRISPR patent dispute highlights a trend in the biotechnology industry that contravenes the theoretical framework of the patent system: “move first and sort out the licensing later.” Four companies have already been born out of the CRISPR revolution, having generated multi-million dollar IPOs without the assurance that their license to the technology, or its underlying patent, is valid. Only those who get the first seat at the table will be able to reap the benefits that CRISPR promises; there is no time to wait for the patent system to catch up. Despite the USPTO implementing new features to improve its efficiency, this dispute sheds light on the difficulty of maintaining pace with the rapid advancements of biotechnology and the need for companies to have the first bite of the apple.
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Written by Roger McLaughlin
Cover photo by cruxgazer. All rights reserved.
Body photo by gardnerstevens. All rights reserved.