Today's Billion Dollar Patent Question: Who Owns CRISPR?
Biotech is on the cusp of curing genetic disorders, curing aging, making disease-resistant crops, and giving us superhuman designer babies. If any of these miraculous promises come true, it will likely be thanks to CRISPR, the revolutionary gene editing technique. The billion dollar question is: who owns CRISPR?
On the one hand, there's UC Berkeley biochemist Jennifer Doudna, who first filed a patent application describing the CRISPR-Cas9 method and its application to bacteria.
On the other hand, there are the teams at the Massachusetts Institute of Technology and Harvard University who extended the biotechnology to mammals. Synthetic biologist Feng Zhang and the Broad Institute teams made CRISPR work on human cells, too.
With potentially billions of dollars in future licensing at stake, neither side has conceded the others' patent claims. And so the judges at the U.S. Patent & Trademark Office are deliberating over the biggest patent battle since Edison's time.
Gene-Editing Patents Could Be Split
In a packed hearing at the PTO board on Monday, lawyers and observers entertained arguments by both sides. Under pressure from the judges, Berkeley's lawyers seemed pressed to do most of the entertaining. They seemed to doubt that Zhang's development of CRISPR for use on mammalian cells was an obvious application of Doudna's original patent claim on bacteria.
The battle began in May 2012 after Doudna filed for a patent to alter specific strands of bacterial DNA. In December 2012, Zhang filed a patent claim using the gene-editing technique in more complex cells, including humans. Zhang asked for an expedited review for his patent, which was granted in 2014.
Berkeley then filed a "patent interference" action, asking the PTO to decide who first invented the gene-editing technique. That review began in January 2016, and resulted in the hearing on December 5.
"My impression is both will end up with something," says legal scholar Robert Cook-Deegan of Arizona State University's campus in Washington DC.
Not in My GMO
Gene editing is being used, among other things, to produce plants that can resist drought and disease more effectively. Research shows that these plants have no traces of foreign DNA, making it possible to avoid regulations governing genetically modified organisms (GMOs).
"It takes millions of dollars and many years of work to go through the regulatory process," says Sophien Kamoun, who leads research at the Sainsbury Lab in Norwich, England, that is applying the CRISPR to potatoes, tomatoes, and other crops to fight fungal diseases.
The CRISPR applications and the patent battle are occurring at a time when many consumers have expressed concerns over GMOs. Over decades of research, however, GMOs haven't been shown to adversely affect human health. At this point, it's anyone's guess what kind of miracle crops (and miracle humans) the CRISPR gene editing techniques will develop.
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Related Resources:
- Gene-edited CRISPR Mushroom Escapes US Regulation (Nature)
- CRISPR Lawsuit: The Biggest Gene Patent Pre-Suit of All Time Hit PTAB (FindLaw's Technologist)
- Growing Trends in Agricultural Law, From GMOs to Totally Organic (FindLaw's Technologist)
- Can Big Data Help Fight Human Trafficking? (FindLaw's Technologist)
- How Government Lawyers Are Using Data Analytics (FindLaw's Technologist)
