In a press release on 10 July 2017, the Broad Institute announced that is has, with joint patent owners Harvard University, the Massachusetts Institute of Technology and the Rockefeller University, entered discussions about a potential CRISPR patent pool. The institutions collectively submitted 22 patents (from 10 patent families) for consideration to be included in a CRISPR-Cas9 joint patent pool. The proposed patent pool is being coordinated by MPEG LA, an organisation that coordinates various other patent pools in a variety of different fields, predominantly in the video technology space. The Broad Institute’s letter submitting these patents for eligibility evaluation can be accessed here.
Discussion eligibility requirements
Earlier this year, MPEG LA issued an
invitation to CRISPR-Cas9 patent holders to participate in a global CRISPR-Cas9 Joint Licensing Platform to create “
a single nonexclusive, cost-effective, transparent license” which would “
allow the market to focus on the creation of new products and therapies that accelerate and expand CRISPR’s deployment”.
MPEG LA has the following eligibility requirements to qualify to participate in discussions regarding the creation of a CRISPR-Cas9 Joint Licensing Platform:
eligible patent assets will consist of issued patents or published patent applications having one or more claims directed to:
· a composition of matter containing the CRISPR-Cas9 System or any of its elements;
· a composition of matter derived from use of the CRISPR-Cas9 system or any of its elements; or
· a method of use, or a method of manufacture, pertaining to any of the foregoing.
Only one patent need be submitted and considered eligible according to the above requirements to qualify the patent holder(s) to participate in patent pool discussions. Submitting a patent and qualifying to participate in the discussions does not oblige the patent holder to participate in the CRISPR-Cas9 Joint Licensing Platform – this only occurs when a patent holder executes agreements governing the terms and conditions under which the patent(s) will be included in the patent pool. Any discussions that take place after the eligibility criteria have been satisfied are entirely confidential and there is no obligation on a patent holder to disclose the fact that they have submitted any patent(s) to be considered against the eligibility requirements nor that they are participating in pooling discussions.
What can be made of the Broad’s participation?
The Broad Institute has said that “[a] patent pool would create a one-stop shop for commercial users to license CRISPR patents without needing to navigate a complex patent and licensing landscape”. MPEG LA has described a CRISPR patent pool as “a voluntary market-based business solution to the patent access problem tailored to balance, incentivize and resolve competing market and public interests”.
The Broad Institute’s and its joint patent owners’ decision to participate in discussions concerning a CRISPR patent pool and to disclose this fact is perhaps both surprising and unsurprising.
The institutions already make CRISPR tools freely available to academic and non-profit communities and issue non-exclusive licences for most types of commercial research, except human therapeutics (for further information on the CRISPR licensing landscape, visit our microsite
here and for our licensing landscape diagram, click
here).
In relation to human therapeutics, the Broad Institute puts limits on exclusivity through its ‘Inclusive Innovation’ model.
This model allows one licensee exclusive use of the technology for a defined period of time (two years), this is then followed by an open-call for applications by other groups.
In the case of CRISPR-Cas9, the two year exclusivity period has ended and the Broad Institute are inviting other groups to apply for use of the technology through their website.
As far as we are aware, the Broad Institute and their joint patent owners are the only key players as of yet to enter into discussions relating to a CRISPR patent pool. However, as mentioned above, there is no obligation on those entering into confidential discussions with MPEG LA to disclose the fact that they are doing so.
The fact that the Broad Institute decided to make its participation in CRISPR patent pool discussions public and its submission of 22 patents for eligibility consideration (when only one is necessary to enter into discussions) sends a strong message to the marketplace and other CRISPR patent holders. It could be seen as a strategic move to corral other patent holders to move towards patent pooling to ensure more open access to CRISPR tools. Despite these key players’ participation in patent pooling discussions seeming to move towards more openness in relation to CRISPR technology, the patent pool could be beset with many issues and may never actually come to fruition.
What issues will the patent pool need to overcome before it can effectively launch?
The current
CRISPR licensing landscape is already fairly complicated.
All of the main CRISPR players/patent holders have entered into exclusive licence agreements with spin-out companies in the area of human therapeutics.
Others have also entered into exclusive licences in other fields besides human therapeutics (for example, UC Berkeley and the University of Vienna have an exclusive licence in relation to all fields with Caribou Biosciences, who in turn has an exclusive licence relating to human therapeutics with Intellia Therapeutics).
Depending on the terms of these exclusive licences, it might be difficult for a patent pool to get up and running with the aim of offering global non-exclusive licences.
However, given that these spin-out companies are largely made up of researchers from the key patent holders/institutions, the terms might be such that it is relatively easy to terminate them in order to enter into a patent pool.
Furthermore, although MPEG LA has released fairly broad eligibility criteria to qualify to participate in patent pool discussions, these are not necessarily indicative of the eventual requirements necessary to qualify to actually participate in the pool. Key players with ‘essential’ patents are likely to want there to be some sort of essentiality requirement or at least for essentiality to be reflected in the royalties that are received by participants. Key players will unlikely want peripheral CRISPR patent holders to participate in the pool at all or, if they do participate, to receive the same level of royalties as those with patents essential to the CRISPR technology.
The terms of any patent holders’ participation in the patent pool will need to be negotiated, along with the terms of the non-exclusive licence that will actually be offered by the pool. This could be a drawn-out and hard fought negotiation depending on the parties eventually involved. For example, parties such as the Broad Institute currently impose certain terms on their licensees (e.g. no terminator crops, no use for tobacco and no gene drives) and it remains to be seen whether such policy conditions would be imposed via the patent pool licence.
Additionally, it is worth noting that MPEG LA predominantly manages patent pools in relation to the video, computer and gaming sphere. It may well be that its usual approach to patent pooling and discussions might need to be altered in some way to better cater for a technology such as CRISPR-Cas9. These adjustments, too, could take time.
Thoughts on what lies ahead
Although at first glance the Broad Institute’s and its fellow joint patent owners’ announcement of their participation in CRISPR patent pooling discussions would appear to be a big step towards opening up access to CRISPR technology and simplifying the licensing landscape, there is a long way to go before a CRISPR patent pool may actually come into existence. The certainty that a patent pool will be created is by no means guaranteed. Ultimately, the success of a patent pool depends on the number of key participants that are willing to be involved in it in order to incentivise licensees to obtain a licence through the pool. We are at the early stages of potentially creating a patent pool and, at this stage, we do not even know which other CRISPR patent holders might also be in discussions. Furthermore, negotiations on royalty rates and the actual terms of the non-exclusive licence to be offered by the pool will need to take place. The complexity and length of these negotiations should not be underestimated.
