On March 28, the latest round in the intellectual property battle over CRISPR/Cas9 ended with the European Patent Office (EPO) ruling in favor of the University of California / University of Vienna, the work of scientists Jennifer Doudna and Emmanuelle Charpentier, and licensee CRISPR Therapeutics. The EPO granted the University of California (UC) a wide-ranging patent on the gene-editing technology, covering non-cellular uses and cellular applications in multiple cell types, including human and other eukaryotic cells and granting patent rights in 40 countries. The United Kingdom Intellectual Property Office has followed suit, and granted a similarly broad patent.
This decision splits the battle over CRISPR intellectual property rights between the United States and the European Union, with the team of The Broad Institute of Massachusetts Institute of Technology / Harvard University, scientist Feng Zhang, and licensees including Editas Medicine coming out on top of a decision by the U.S. Patent and Trade Organization (USPTO), who ruled there was “no interference” between the two groups’ filings. The UC group has appealed the USPTO’s decision, and the Broad Institute group may appeal the EPO one. China and Japan have yet to make their own rulings in the IP battle.
CRISPR/Cas9 is fundamental technology that enables genes to be precisely edited. It is used to target and cut desired sequences of DNA, analogous to the use of a word processing program to cut and paste single letters or words from a document. Since its discovery, CRISPR/Cas9 has become an important tool for both fundamental biological research and increasingly for studies of genetic diseases and the development of potential new therapies for blood diseases, cancer and other illnesses.
While no one disputes that Doudna and Charpentier were the first to announce their discovery of the technology, at issue in the U.S. patent case is where they demonstrated CRISPR/Cas9’s utility — in bacteria — and what that implies. The women filed their patent application first, but Feng Zhang and the Broad Institute expedited their own application and have been awarded a U.S. patent for Zhang’s work, which extended CRISPR/Cas9 efforts to show how the technology could be used in more complex eukaryotic cells. The UC team filed an “interference” to invalidate Zhang’s claim, but in January the USPTO ruled against them. The January USPTO ruling effectively declared that Zhang’s application of the technique to human and mouse cells was a new and patentable invention, not an “obvious extension” of Doudna and Charpentier’s work.
The UC lawyers say that their patent application in the EU was substantially the same as the UC patent filed in the United States. The EU patent was the subject of numerous third party “observations” filed by the Broad Institute and others, objecting to issuance of an EU patent for the UC team, but these were all dismissed by the EPO as not altering patentability. While the January ruling against the UC team in the United States was a set-back, UC and CRISPR Therapeutics believe the EU patent opens the door to USPTO issuing a patent on their filing that backs CRISPR/Cas9’s use in all cells, leaving in place the Broad Institute patent covering its specific application to eukaryotic cells.
And so it goes…
Intellectual property battles on fundamental and financially valuable technology can take 10 years or longer before they are ultimately settled. And long IP fights can put a serious chill on scientific collaboration, as inventors are encourage to keep their advances a closely held secret until the potential financial value is sufficiently secured. The best outcome in this case is likely to be a near-term cross-licensing deal so that companies seeking to use the technology can get licenses to both group’s patents, enabling them to move forward with the certainty they won’t be sued.