December 7th, 2016
Kristen V. Brown
On Tuesday, the two feuding parties of the CRISPR gene editing patent fight entered the boxing ring: Attorneys for each side made oral arguments before a three-judge panel, in a case that not only puts billions of potential dollars at stake, but could define the future of genetic engineering.
The dispute pits two groups of scientists against each other. In 2014, the Broad Institute of Harvard and MIT were awarded 13 patents for CRISPR, a genetic engineering breakthrough that brings the dream of fixing everything from deadly disease to environmental catastrophe into reach, simply by cutting and pasting bits of DNA. Scientists at UC Berkeley, however, also claim credit for some of CRISPR's foundational work. At the centre of this saga is sexism, scandal and a crusade for credit for one of the most important scientific discoveries of this century.
Wrapped up in the patent battle, along with lots and lots of money, is what will happen to the technology itself. Scientists don't always choose to enforce patents for their discoveries, and some never file for patents at all. But when they do, in some cases, patents can impede research by making new technologies unavailable to other researchers, or at the very least by making those technologies prohibitively expensive.
"This question has been of particular concern for the biological sciences, where production and exchange of biological 'research tools' are important for ongoing scientific progress," a group of scientists wrote in Nature Biotechnology back in 2009. "It is well known that biological scientists report increasing difficulties associated with access to research tools."
That was the case, for example, with patents on two human genes linked to breast cancer held by Myriad Genetics. Thanks to its patents, Myriad was the only company that could perform the genetic test determining whether a woman is at a high risk for the disease. In 2013, the Supreme Court issued a unanimous opinion finding that those particular patents were invalid because human genes are not patentable, but plenty of other scientific discoveries, like CRISPR, are still eligible for patents. And owning the patent for CRISPR is a pretty big deal: By giving scientists an unprecedented ability to decrypt and reorder genes, the enzyme-based system opens up a universe of possibilities that could drastically alter our world.
The fight is far from over — the patent judges must first decide whether the two side's claims are really in conflict. After that, probably sometime next year, the judges will determine who owns the commercial rights to CRISPR. But CRISPR has already spawned hundreds of millions in investments and countless breakthroughs. Last month, Chinese scientists undertook the first trial of CRISPR on a human, using it to treat patients with lung cancer. Other work has suggested the technology might be used to cure HIV, curb world hunger, end pesticide use and save endangered species. That's just the beginning.
Both parties had already licensed their technology to several firms, notably Editas and CRISP Therapeutics, and that research is on hold until the patent kerfuffle is cleared up, forcing companies to sit on technology they may or may not own the rights to. For those companies, worth a combined billions of dollars, the outcome of the trial could make or break them. In the end, whoever wins the patent debate will have the power to block technology from companies that did not licence the technology through them.
For academic researchers, the patent battle has fewer implications, as CRISPR will probably still be freely available for university labs to use. But the battle has resurfaced a debate on the negative impact that patents can have on biotechnology. In recent years, many in the community have critiqued their use, and argued in general for a scientific process that is more open and collaborative. At MIT, for example, synthetic biologist Kevin Esvelt is encouraging other scientists to share their experiments before they even get started, in order to promote faster progress and prevent an accidental genetically engineered catastrophe. Esvelt, who holds the patents for gene drive, a formidable tool that can be used to override natural gene selection, plans to use his own patents to force other scientists to share their work publicly.
"Neither Berkeley nor MIT should have patents on CRISPR, since it is a disservice to science and the public for academic scientists to ever claim intellectual property in their work," UC Berkeley biologist Michael Eisen, who would gain resources were Berkeley to win, wrote on his blog.
There's no hint as to what the eventual victor of the CRISPR patent battle might do with its winnings. But the stakes are high. On the table is who owns the rights to modify the biological code of our world.