by Julian Cockbain[1] and Sigrid Sterckx[2]
In a target article in this Journal in 2018, for which we were two of the co-authors, we discussed the problematic nature of the patenting of foundational (bio)technological processes, in particular the CRISPR-Cas9 (CRISPR) gene-editing technique. This note is intended to bring the Journal’s readers up to speed on a couple of important recent developments in the CRISPR patent sphere.
In the case of CRISPR, the patent situation is complicated by the sheer number of parties seeking patents, as a result of which any entity seeking to use or develop CRISPR faces a forest of patent claims, and thus the task of negotiating multiple licenses and/or the prospect of mouth-wateringly expensive patent litigation. However, there are two key holders of potentially unescapable patents, each with its own licensing entities, the University of California Berkeley (UCB) and The Broad Institute (Broad). Put simply, UCB has patents for CRISPR simpliciter and Broad has patents for the use of CRISPR on eukaryotes (i.e. organisms, such as plants and animals that have nuclei in their cells), the societally and commercially most important and lucrative targets for this technology. UCB filed its initial US patent application in 2012 first, but Broad had its US patent granted first and thus the question arose as to which, if either, would capture the lion’s share of the licensing revenues.
Our target article in this Journal mentioned the first major skirmish in the struggle between UCB and Broad to establish a dominant patent position, the declaration in the US of an ‘interference’ (Interference No. 106048) between the two in order to determine whether Broad’s use of CRISPR on eukaryotes was obvious in view of UCB’s use of CRISPR on extracellular DNA: if it was, then Broad’s US patent would have been invalid and UCB’s patent position would have been strengthened. However, the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) decided that it was not, and in September 2018 this was confirmed by the US Court of Appeals for the Federal Circuit. UCB’s attempt to take this up to the US Supreme Court was rejected.
Since our target article was published, there have been two major developments with potentially significant effects on the relative strengths of the CRISPR patent portfolios of UCB and Broad, and hence on the likely development of their licensing strategies.
On 25 June 2019, the PTAB declared a second interference (Interference No. 106115) between UCB and Broad, this time focused on the question of which was the first to invent the use of CRISPR on eukaryotes, and thus again on whether Broad is entitled to its ‘broad’ US patents. The process is still ongoing, but it is the authors’ personal opinion that UCB may again fall short of victory.
In the meantime, one of Broad’s ‘broad’ European patents, EP-B-2771468, has been opposed by several parties on what seems on first sight to be pretty much of a formality – that Broad’s ‘priority claim’ was not valid.
Under the ‘Paris Convention’ of 1883, if a party files a patent application in one country, then a patent application for the same invention filed in another country within one year can be treated as if it were filed on the same date as the first application. Filing the first application gives its applicants the right to ‘claim priority’ from the first application, a right that can be assigned. Since the subject matter of a patent application must generally be new and inventive as of the application’s filing date, claiming priority ‘immunises’ the later application against material published between the first and the later applications.
Unusually, US patent applications must be filed by the inventors, and thus the priority right is vested in them rather than in the actual owners of the rights to the invention, e.g. their employers. Companies, shortly after filing patent applications in the US in the inventors’ names, thus routinely have the inventors execute assignments transferring to the company the ownership of the invention, of the US application, and of the right to claim priority.
The dominant European patent law, the European Patent Convention (EPC), requires that, for a priority claim to be valid, all the relevant priority-claiming rights must have been assigned to the European applicant before the European application was filed.[3] Broad failed to achieve this – not all of the US applicants for the relevant US application had assigned their rights in time.
This is not in fact a trivial matter. If Smith and Jones file a US patent application A describing three inventions, one (s) made by Smith, a second (j) made by Jones, and a third (sj) made by both and, within a year, Smith files a European patent application B describing only invention s but claiming priority from A, then, about 18 months after A’s filing, B will be published and the copy of A on the patent office file for B is open to public inspection. If thereafter Jones files a patent application C in Europe or elsewhere outside the US for invention j, that application C will be rejected for lack of novelty. In agreeing to file A, Jones had not necessarily agreed to the publication of A, other than on the grant of a US patent on A. Thus, if B was filed without Jones’ knowledge, her interests are harmed.
The position of the European Patent Office (EPO) in the opposition to Broad’s patent was thus that the priority claim was invalid. Broad appealed, and on 16 January 2020, in decision T-844/18, the EPO Board of Appeal affirmed and revoked the patent. The written version of the decision is not yet available, but the minutes of the hearing are accessible on the EPO’s website, www.epo.org.
There is no further appeal possible from EPO Board of Appeal decisions, only an almost-worthless right to ‘petition’ for the appeal decision to be reviewed – a procedure that only seems to work when the EPO has committed a procedural fault and that is not applicable where the objection is that the Board of Appeal has misinterpreted the law (see for example Cockbain, 2013). Most of Broad’s other broad European Patents suffer from the same problem, and so Broad’s patent position in Europe has been seriously degraded. Since filing a patent application outside the US, which claims priority from a US patent application which named inventors who were not involved in the foreign patent application, seems to breech the confidentiality of the non-involved inventors (unless they had agreed to the foreign filing), it is difficult to see that the entity filing such applications outside the US indeed had the right to claim priority. Claiming priority in this instance results in a breech of a duty of confidentiality. Simply put, ‘have you the right to publish something that someone told you in confidence?’ Thus, Broad’s patent portfolio outside the US is perhaps more broadly damaged than in Europe alone.
With the possibility of a distinct asymmetry in the relative strengths of the patent portfolios of Broad and UCB in the US and outside the US, it seems likely that the commercial pressure on the two to create a joint patent pool for licensing to third parties will increase. This holds out the chance that the barriers to access to CRISPR for others may reduce somewhat. However, even if a pragmatic attitude of seeking to maximize overall joint revenues prevails, the question of which of the scientists may be awarded any future Nobel Prize would still remain unsettled. Prof. Doudna, at least, seems already to have staked her claim in her wittily titled book A crack in creation (Doudna and Sternberg, 2017 – for non-native English speakers: the word ‘cracking’ is often used to mean ‘terrific’ or ‘superb’).
[1] European Patent Attorney, member of Bioethics Institute Gent, Gent, Belgium.
[2] Professor of Ethics, Ghent University, Gent, Belgium.
[3] This is not in fact a trivial matter. If Smith and Jones file a US patent application A describing three inventions, one (s) made by Smith, a second (j) made by Jones, and a third (sj) made by both and, within a year, Smith files a European patent application B describing only invention s but claiming priority from A, then, about 18 months after A’s filing, B will be published and the copy of A on the patent office file for B is open to public inspection. If thereafter Jones files a patent application C in Europe or elsewhere outside the US for invention j, that application C will be rejected for lack of novelty. In agreeing to file A, Jones had not necessarily agreed to the publication of A, other than on the grant of a US patent on A. Thus, if B was filed without Jones’ knowledge, her interests are harmed.