On 17 January 2018, a panel of the European Patent Office (EPO) opposition division wholly revoked a patent co-owned by the Broad Institute (‘Broad’) relating to CRISPR/Cas9 ‘gene editing’ technology. The European patent in question, number EP2771468, is entitled ‘Engineering of systems, methods and optimized guide compositions for sequence manipulation’, and is a European equivalent to US patent no. 8,906,616, which is one of the key Broad patents involved in the US patent interference dispute with the University of California (UC) – which is currently on appeal to the US Court of Appeals for the Federal Circuit. As is usual with European opposition proceedings, the ruling was issued immediately at the hearing (which had originally been scheduled to continue for two further days). A full written decision providing detailed reasons is likely to be a few weeks away.
Technically, the basis for revocation in the final decision is likely to be lack of novelty and/or inventive step of all claims of the Broad patent. However, the underlying reason for Broad’s failure to defend its patent is a loss of priority. In particular, the EPO panel determined that Broad was not entitled to claim priority from four of its earlier US provisional applications, including the earliest filing, US provisional application no. 61/736,527, which was filed on 12 December 2012. This loss of priority was fatal to the patent, as a result of a number of publications – including Broad’s own – that occurred subsequently, but prior to the full application’s filing date of 12 December 2013.
While this decision is obviously pivotal in the ongoing disputes between Broad and UC over ownership of foundational patent rights relating to CRISPR/Cas9 technology, it also provides an object lesson and a timely reminder of essential requirements for valid priority claims for patent applicants around the world, in all fields of technology. While the circumstances of Broad’s case are somewhat more complex than most patent filings, what has happened to it here is not at all specific to the particular invention at issue. In a nutshell, the problem was that, at the time of filing international application no. PCT/US2013/074819 (from which the European patent is derived), the named applicants – Broad, MIT and Harvard – did not collectively own all of the rights necessary to claim priority from the earlier provisional applications. More particularly, the provisional applications named a researcher from Rockefeller University as a co-inventor/applicant, yet neither the researcher nor Rockefeller was named as an applicant on the international application. Nor had the named applicants received any assignment from Rockefeller of the right to claim priority in the international application.
In fairness to Broad, the US national law relating to ‘internal’ priority (i.e. claiming the benefit of a US provisional application in a subsequent non-provisional application) is less strict, and focusses on the substance of the invention actually claimed in the later application rather than on a distinct right of priority. But this can hardly be an excuse for ignorance of the international position, especially when the stakes are so high. Broad has issued a statement, arguing that the EPO decision is based on a technicality, and asserting that it is ‘inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe’. I disagree. Not only is this not the first time that the EPO has applied these rules in relation to priority claims, but it is not the only adjudicating body to have determined that they are, in fact, required by the international treaties in question.
Broad has vowed to appeal. In the meantime – and in anticipation of the likelihood that any appeal will fail – all international applicants would be well-advised to ensure that they are clear on the ownership of the right to priority at the time of filing. At the end of this article, I set out some guidelines for avoiding the troubles that Broad has encountered, not only at the EPO but at any international patent office.
Technically, the basis for revocation in the final decision is likely to be lack of novelty and/or inventive step of all claims of the Broad patent. However, the underlying reason for Broad’s failure to defend its patent is a loss of priority. In particular, the EPO panel determined that Broad was not entitled to claim priority from four of its earlier US provisional applications, including the earliest filing, US provisional application no. 61/736,527, which was filed on 12 December 2012. This loss of priority was fatal to the patent, as a result of a number of publications – including Broad’s own – that occurred subsequently, but prior to the full application’s filing date of 12 December 2013.
While this decision is obviously pivotal in the ongoing disputes between Broad and UC over ownership of foundational patent rights relating to CRISPR/Cas9 technology, it also provides an object lesson and a timely reminder of essential requirements for valid priority claims for patent applicants around the world, in all fields of technology. While the circumstances of Broad’s case are somewhat more complex than most patent filings, what has happened to it here is not at all specific to the particular invention at issue. In a nutshell, the problem was that, at the time of filing international application no. PCT/US2013/074819 (from which the European patent is derived), the named applicants – Broad, MIT and Harvard – did not collectively own all of the rights necessary to claim priority from the earlier provisional applications. More particularly, the provisional applications named a researcher from Rockefeller University as a co-inventor/applicant, yet neither the researcher nor Rockefeller was named as an applicant on the international application. Nor had the named applicants received any assignment from Rockefeller of the right to claim priority in the international application.
In fairness to Broad, the US national law relating to ‘internal’ priority (i.e. claiming the benefit of a US provisional application in a subsequent non-provisional application) is less strict, and focusses on the substance of the invention actually claimed in the later application rather than on a distinct right of priority. But this can hardly be an excuse for ignorance of the international position, especially when the stakes are so high. Broad has issued a statement, arguing that the EPO decision is based on a technicality, and asserting that it is ‘inconsistent with treaties designed to harmonize the international patent process, including that of the United States and Europe’. I disagree. Not only is this not the first time that the EPO has applied these rules in relation to priority claims, but it is not the only adjudicating body to have determined that they are, in fact, required by the international treaties in question.
Broad has vowed to appeal. In the meantime – and in anticipation of the likelihood that any appeal will fail – all international applicants would be well-advised to ensure that they are clear on the ownership of the right to priority at the time of filing. At the end of this article, I set out some guidelines for avoiding the troubles that Broad has encountered, not only at the EPO but at any international patent office.