If you haven’t heard about CRISPR, you need to hear about CRISPR. It’s a new method for modifying the genes of bacteria, plants and humans alike, making it easier, cheaper and safer than it has ever been. CRISPR is expected to make cures for Huntington’s, Cystic Fibrosis, Leukaemia and HIV a reality, and a Nobel prize is not unexpected.
This method is adapted from a naturally occurring system in bacteria, and though its discovery as a genetic-scissor is generally attributed to Doudna and Charpentier of UC Berkley (among many others), the method is currently the subject of one big legal dispute; who has the right to patent CRISPR?
There is a sea of potential uses for CRISPR, in healthcare, agriculture and bioremediation, but who will be able to make money off of CRISPR, and will the new invention reach the people who need it?
What is the CRISPR patent dispute?
UC Berkeley filed for a patent on their ground-breaking discovery, and they got a patent encompassing the use of CRISPR in all kinds of cells. However, Professor Zhang and the Broad Institute of MIT and Harvard also have a patent for CRISPR, although their patent is specifically for the use of CRISPR in mammalian cells. The basis of the dispute is basically that Berkeley thinks that since their patent covers use in all cell types, the Broad institutes patent overlaps with theirs, and should be revoked. However, Berkeley hadn’t proven that CRISPR could be used in mammals at the time when they field for the patent, and the Broad Institute thinks that Berkeley could not patent what they had not proven. The United States Patent and trademark Office agreed with the Broad institute, and Berkeley are currently appealing this ruling.
The problem here is that the Berkeley patent was very broad, though (ironically) the Broad institutes patent was not. It is tempting when applying for a patent to want it to encompass as much as possible, but that also makes it tricky to tell where your patent ends and begins. This is why it’s up for debate if the Broad institute patent was an invention in itself, or if it falls within the terms of the Berkeley patent.
CRISPR comes with many potential uses, not least in human medicine and thus it comes with a massive market. Whoever holds the patent can control that market, which is perhaps illustrated by the fact that both institutes have given exclusive licences to use the CRISPR method for human therapies to two separate companies; Berkeley to Caribou Biosciences and the Broad institute to Editas. One of these companies will end up with the lone rights to sell CRISPR therapeutics acting on any gene in the human genome. That’s a lot of potential therapies, and a lot of potential money. They will also hold the power to decide which diseases to target and how much to charge for the therapies.
This situation is very similar to a case where a company (Myriad genetics) owned single rights to gene-testing for a very common cancer-gene, which lead to high prices of the test and the inability of patients to get second opinions in the testing.
This exclusive licensing is atypical of patents from academia, which are usually licence to many different companies, creating a more open market and a more available product. Why then have both Berkeley and the Broad Institute chosen to go against that tradition? Perhaps because of the massive potential of CRISPR? However, that massive potential could also be an argument as to why it ought to be more freely available.
Both the Broad institutes and Berkeley’s CRISPR research was government funded, and the reason it’s open to be patented at all is because of a law from 1980 called the Bayh-Dole Act which was meant to incentivise research by allowing researchers at universities to monetise their discoveries. But shouldn’t government-funded work be government property and thus belong to the people? One condition of the law states that the research must be “reasonably available to the public”, and considering the current exclusive rights to Editas and Caribou for CRISPR therapies, one can question if those terms are really met. However, both Berkeley and Broad have given free rights to non-commercial users and institutions to use CRISPR, which should mean that academic research can go un-hindered.
Regarding weather patents in general really do incentivise or hinder research is also a question hotly debated. A patent and the promise of exclusive rights can on one hand secure investors to companies, but on the other hand expensive patent licences can keep smaller companies out of the market.
Right now, Berkeley is appealing the court’s decision to grant the Broad Institute their patent, and both parties are still acting as though they have the sole rights to use CRISPR in humans. Interestingly, the people behind the research, Doudna and Zhang, are both co-founders of Caribou and Editas, meaning that both the institutions and the researchers will stand to stand to gain immensely off the success of these companies. So whoever wins the patent battle in the end will be making an awful lot of money and will have an awful lot of power over this new ground-breaking technology.
Unless the government thinks it’s not in the best interest of society. Under the Bayh-Dole Act, the government have so called “march-in rights” to control the patent of a government funded technology. If the publics petition that this restrictive licensing makes the technology too inaccessible, like the cancer-gene test case, the government can change that. Although, it’s probably fair to mention that the government has used this right exactly zero times since it was established.
Though the current CRISPR situation in the bio economy looks centralised and exclusive, Caribou and Editas might give sub-licences to other companies in the future, and the current patents are only US issued, and rulings in Europe and Asia could differ. This is a complex situation, and it is one that will affect modern medicine and biotechnology companies big and small.
More about the patent dispute.