Although not many outside the world of the biological sciences have heard of it yet, the CRISPR gene editing technique
may turn out to be one of the most important discoveries of recent years
-- if patent battles don't ruin it. Technology Review describes it as:
an invention that may be the most important new genetic engineering technique since the beginning of the biotechnology age in the 1970s. The CRISPR system, dubbed a "search and replace function" for DNA, lets scientists easily disable genes or change their function by replacing DNA letters. During the last few months, scientists have shown that it's possible to use CRISPR to rid mice of muscular dystrophy, cure them of a rare liver disease, make human cells immune to HIV, and genetically modify monkeys.
Unfortunately, rivalry between scientists claiming the credit for key parts of CRISPR threatens to spill over into patent litigation:
[A researcher at the MIT-Harvard Broad Institute, Feng] Zhang cofounded Editas Medicine, and this week the startup announced that it had licensed his patent from the Broad Institute. But Editas doesn't have CRISPR sewn up. That's because [Jennifer] Doudna, a structural biologist at the University of California, Berkeley, was a cofounder of Editas, too. And since Zhang's patent came out, she's broken off with the company, and her intellectual property -- in the form of her own pending patent -- has been licensed to Intellia, a competing startup unveiled only last month. Making matters still more complicated, [another CRISPR researcher, Emmanuelle] Charpentier sold her own rights in the same patent application to CRISPR Therapeutics.
Things are moving quickly on the patent front, not least because the Broad Institute paid extra to speed up its application, conscious of the high stakes at play here:
Along with the patent came more than 1,000 pages of documents. According to Zhang, Doudna's predictions in her own earlier patent application that her discovery would work in humans was "mere conjecture" and that, instead, he was the first to show it, in a separate and "surprising" act of invention.
The patent documents have caused consternation. The scientific literature shows that several scientists managed to get CRISPR to work in human cells. In fact, its easy reproducibility in different organisms is the technology's most exciting hallmark. That would suggest that, in patent terms, it was "obvious" that CRISPR would work in human cells, and that Zhang's invention might not be worthy of its own patent.
Whether obvious or not, it looks like the patent granted may complicate turning the undoubtedly important CRISPR technique into products. That, in its turn, will mean delays for life-changing and even life-saving therapies: for example, CRISPR could potentially allow the defective gene that causes serious problems for those with cystic fibrosis to be edited to produce normal proteins, thus eliminating those problems.
Although supporters of patents will argue as usual that they are necessary to encourage the discovery of new treatments, CRISPR is another example where patents simply get in the way. The discoveries were made by scientists in the course of their work in fundamental science at academic institutions, not because they were employed by a company to come up with a new product. According to some, the basic application of CRISPR to human cells that everyone is fighting over may even be obvious. The possibility of legal action will doubtless discourage investment in companies working in this area, and thus slow down the flow of new treatments. As usual, the only ones who win here are the lawyers.
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