Colonizing CRISPR: The Mapping and Warring over Gene Editing Technology

February 11, 2018

Intellectual property—a degree of ownership of knowledge or ideas—is, foremost, property. Patents are a kind of intellectual property where creators of new inventions receive a temporary monopoly over the use of those inventions. This may sound simple on its face, but lawmakers often struggle to define the scope of “new inventions.” Drawing out the boundaries between inventions involves a kind of intellectual cartography where abstract ideas are given concrete limits. The bigger the invention, the harder it can be to map.
When an invention is big enough, disputes over where boundaries lie can start a patent war. In patent wars, entities vie over huge tracts of intellectual property. These conflicts resemble historic efforts to colonize land.

Not only do the participants in a patent war seek to map the intellectual property; they want to claim it.

Battles in a patent war can last for years, and—much like colonization—they can be extremely detrimental to third-party research that had been going on in the field long before its “discovery” as a marketable intellectual property.
Enter: CRISPR. Standing for “clustered regularly interspaced short palindromic repeats,” CRISPR is a relatively recent gene-editing technique. The technique works like a miniature version of a supermarket label-maker. A protein, Cas-9, that holds onto a strand of DNA. The tip of that strand floats freely outside of the protein and corresponds to a specific length of DNA in the cell. This corresponding DNA guides the protein to its match in the cell, and then the Cas9 protein cleaves away that part of the cell’s DNA. The technique can be used to repair or replace the cleaved section with unprecedented precision. This technique is expected to have enormous economic and academic value.
So, we can figure out a technique for precisely editing a genome, but can we figure out who owns that technique? This important question has sparked patent wars in the U.S. and abroad. In 2012, with multiple communities studying the CRISPR technique, researchers at the University of California in Berkeley succeeded in applying CRISPR to prokaryotes. Unfortunately for them, prokaryotes are simple forms of life that are universally single-celled, and so they do not have any money. Eukaryotes, on the other hand, can be multi-cellular, and some of them, like humans, do have money. When researchers at Broad Institute at MIT developed a way to apply the CRISPR technique to eukaryotes, it raised an important question: did Berkley and Broad invent the same piece of intellectual property, or are their inventions different?
Courts in the U.S. have held that Berkley’s technique does not conflict with Broad’s because the Berkley technique only applies to prokaryotes whereas the Broad technique only applies to eukaryotes. This is a win for Broad and a loss for Berkley because it means that Broad has ownership over the valuable half of the CRISPR technique. Broad has already begun benefitting from this ownership by handing out licenses to use CRISPR in private sector research.
But Broad’s control of CRISPR might not hold up overseas. The European Patent Office (EPO) disagreed with U.S. courts’ about the novelty of Broad’s application of CRISPR to eukaryotic cells, and, based on technical errors in Broad’s European patent application, the EPO rejected Broad’s CRISPR patent. Instead, the entity MilliporeSigma has claimed a fairly sweeping patent for the CRISPR technique in Europe.
Meanwhile, as with most patent wars, researchers are caught in the crossfire. The confusion surrounding the ownership of CRISPR IP has left many independent researchers unsure about what they can research or who they would need to look to for a license. The differing patent right between nations have not helped to clear the air. Investing in a new biotechnology is already a risky prospect. Tacking on the risk of losing one’s research in litigation scares away investors and researchers.
Except in China, where loose regulations have allowed CRISPR research to skip all the way to human testing. Additionally, Chinese courts are already assigning patents to research companies, like Intellia Therapeutics, that are racing ahead in terms of CRISPR research.
The intellectual property landscape of CRISPR has not even been fully mapped, and different sovereigns are already dividing it up in different ways. In this age of multi-national research, these differences in the assignment of patents and the regulation of research will eventually come to a head. As a result, CRISPR may be the next great test for international patent law.