Berkeley vs. Boston. Jennifer Doudna vs. Feng Zhang. The patent battle on the technique that is revolutionizing life sciences has often been described as a duel between the group that first experimented the CRISPR platform on the genome of bacteria and the group that, a few months later, adapted the system for use in eukaryotic cells. But the patent landscape is more complicated than that, and there are worries that the stunning potential of this genetic modification technology may crumble under a mountain of intellectual property rights claims. The good news is that several patent holders are discussing how to merge their assets into a joint licensing pool, to allow interested researchers to deal with a single subject. But will this strategy be suffice to safeguard the common interest, which is to enable as many groups as possible to work to turn CRISPR promises into reality?
“They have a patent on green tennis balls; we will have a patent on all tennis balls,” Doudna said a few months ago, commenting on the point won by his arch-rival, who had just seen the validity of his foundational patent confirmed by judges. That decision is currently under appeal, but if the claims of both the opponents were granted as written, a researcher who wants to get into the CRISPR tournament and play on the court of multi-cellular organisms (encompassing all the plants and animals, man included) should get a license from both Boston and Berkeley. Keeping with Doudna’s metaphor, patents are now covering balls of many shapes and colors, cleverly modified to play in different ways, and the risk is that many players are forced to leave tennis. According to the latest figures, 18 organizations have already secured more than 60 patents related to this technology in the US, while in Europe there are over 20 patents granted to about ten organizations. And numbers are set to grow, as thousands of applications related to CRISPR are ready for examination.
It is a welcome step in the right direction, therefore, the move of the licensing company MPEG LA which has invited patent holders to collaborate and pool their rights under a single license. However, it is too soon to judge the initiative success. The terms of the agreement are still under negotiation, and a comprehensive list of merging patents is not yet publicly available. As for the two main contenders, we know that Boston has joined the effort, while Berkeley is said not to be involved. Jakob Sherkow from New York Law School has written about the issue in Science, together with Jorge Contreras, and reached by email explains his doubts to CRISPeR Frenzy: “The high cost of development of biopharmaceutical technologies typically requires some form of exclusive licensing of patents governing the application of such technologies. Usually, however, pool-based patents are licensed on non-exclusive bases. As a consequence, we are uncertain how a pool-based approach will work here. Pools have been used to great benefit in other areas of fundamental technology. Jorge and I thus remain skeptical–but ultimately hopeful–that pools will work for CRISPR as they have for, say, USB or Bluetooth technologies. We’ll see”.
CRISPR tools are being made freely available for academic researchers and hopefully will continue to be so in the future. But as research leads to the development of marketable products, intellectual property rights will become a serious problem. Massimo Facchinetti, a patent expert from the University of Padova, applauds the pool idea as a positive twist but agrees that Sherkow is right in thinking that “the greatest development of new CRISPR-based human therapies is likely to occur only if limited exclusive rights covering specific genes and diseases targets are granted.” Some of the patents issued so far are, however, far too wide in their claims, argues an analysis published in Nature Biotechnology in July. For example, both the foundational patent granted to Zhang in US and the rival patent obtained by Doudna in Europe are based on experiments performed with a DNA cutting enzyme (Cas9) from a single bacterium but aim to cover all systems based on similar enzymes, even if their potential for the use in genome editing has not been proven. “Given the importance and breadth of applications of the genome editing technology, which seems to set a new technical standard, interference between intellectual property and the antitrust law will solicit the intervention of regulatory authorities,” is Facchinetti’s guess.