This isn’t an everyday patent dispute.
This is a battle for who invented the powerful gene-editing technique that Science magazine named the Breakthrough of the Year for 2015: CRISPR-Cas9.
CRISPR is like a molecular scalpel that uses the enzyme Cas9 to locate and snip out bits of DNA. One day it could cut out and replace the tiny bit of mutant genetic material that contributes to disease.
The process could yield new therapies for certain cancers or genetic disorders.
Potentially, billions of dollars are at stake that could flow either to UC Berkeley or to the Broad Institute (rhymes with “road”) in Cambridge, Mass., jointly owned by Harvard University and the Massachusetts Institute of Technology.
The U.S. Patent and Trademark Office (USPTO) agreed this week to resolve the competing claims for the discovery of the revolutionary tool.
Whoever gets the patent will be an important player in university research and the future of medicine, because that institution will set the terms for how the technology is used.
But the case also raises serious questions about the ethics surrounding sole ownership of a life-saving device or technique.
A Tricky Timeline
Scientists at UC Berkeley and the Broad Institute were working on CRISPR simultaneously. Biologists Jennifer Doudna and Emmanuelle Charpentier led Berkeley’s research. Synthetic biologist Feng Zhang led research at Broad.
Each institution filed patent claims—UC Berkeley filed first—and while they were filing, the U.S. changed the terms of how it awards patents.
Before 2013, the U.S. operated under a “first to invent” rule: whomever developed the invention first was awarded the patent.
But when the Leahy-Smith America Invents Act took effect in March 2013, a “first-to-file” system became law.
Zhang’s team filed after the “first-to-file” rule was enacted and paid extra to have its application expedited. The average wait time for patent approval is three years but an expedited patent application takes around a year.
So while UC Berkeley’s application was under review the USPTO approved Zhang’s application, even though it was submitted later.
Now, having granted an interference, the USPTO will determine which team was the first to invent the gene-editing technique.
Each side will have to prove, via notes and lab records, that it was the first inventor.
If Doudna’s team wins, all 13 of the Broad’s CRISPR patents will be canceled.
Billions Riding on One Decision
Editas Medicine in Cambridge, which uses CRISPR to develop novel drugs, filed to go public late last year and set its initial public offering at $100 million.
“This patent is potentially worth billions of dollars,” says Stanford University bioethicist Mildred Cho. “Whoever has a patent on this could charge as much in royalties as they want and can set their price because they now have a monopoly.”
Some experts caution that the patent for CRISPR-Cas9 is just one of many possible CRISPR patents. Cas9 is an enzyme used in the gene-editing technique, and there are many enzymes that could be used. How lucrative any one patent is depends on how broadly or narrowly it’s written.
After the patent is awarded, a lot rides on how the patent is enforced. Cho says the patent holder may encourage other groups to use the technology for a small fee or it could assert its monopoly ownership and charge exorbitant fees for its use.
Universities across the country are watching this case, says New York Law School Associate Professor Jake Sherkow, both for what it will tell them about their own abilities to pursue similar research, or file for lucrative patent claims.
“Other universities may be more aggressive about pursuing patents because of this case,” Sherkow says.
But even bigger than this is the ethical question, according to Cho.
Should Life-Saving Health Tools Be Patented?
“If this biotech is going to cure previously incurable diseases through altering DNA, do we allow patent holders to collect royalties and if so how much?” Cho asks.
“Should they even be allowed to have those patents at all?” she continues. “Should we have the same considerations for patents used for health purposes as other types of patents that apply to phones and cars?”
The victor won’t be announced in 2016. Sherkow says the trial will take years. It could go all the way to the Supreme Court, but he says that’s not likely.
“The chances of it going to the Supreme Court are only slightly better than the Powerball we had [this week],” he says.
Three members of the Patent Appeals and Interferences Board will start discussing the case on March 9.