In January this year, we wrote about the initiation of US ‘Interference’ proceedings at the US Patent & Trademark Office (USPTO) involving US patents and applications relating to the ‘CRISPR-Cas’ system of programmable gene editing. The opposing parties are the Doudna group (led by Jennifer Doudna at the University of California, Berkeley, and Emmanuelle Charpentier at the Max Planck Institute for Infection Biology, Berlin) and the Zhang group (led by Feng Zhang at the Broad Institute). The US battle still rages; this report focusses on the European patent battle front.
As in the US, the Zhang group has an extensive European patent family relating to CRISPR-Cas technology. As classified by the European Patent Register of the European Patent Office (EPO), the Zhang group’s main patent family currently includes seven granted patents and nineteen pending published patent applications (plus at least one as yet unpublished divisional application). The granted European patents are: EP2771468B1 (granted 11 February 2015), EP2784162B1 (granted 8 April 2015), EP2764103B1 (granted 19 August 2015), EP2896697B1 (granted 2 September 2015), EP2931898B1 (granted 9 March 2016), EP2898075B1 (also granted 9 March 2016) and EP2921557B1 (granted 13 July 2016). The Zhang group European patent family members contrast in number (which is not necessarily correlated with quality or valid scope of protection) with a single pending European patent application and no grant European patents in the Doudna group’s main patent family covering CRISPR-Cas technology.
However, for a period of nine months after grant of a European patent, any party can oppose the grant on grounds of lack of novelty, lack of inventive step, unpatentable subject-matter, added matter and/or insufficiency. Filing an opposition triggers a review proceedings before an Opposition Division panel of three experienced EPO patent examiners, often including the primary examiner who granted the patent. Opposition proceedings usually take between 19 and 27 months to complete, although a new streamlined procedure expected by EPO to cut the duration to around 15 months came into effect on 1 July 2016. At the end of the Opposition proceedings, a decision is issued on whether to revoke the patent or uphold it in its granted or an amended form. Any party to an Opposition disadvantaged by the decision can file an appeal which is heard before an Appeal Board of the EPO. Appeal proceedings currently take on average about 36 months to complete (2015 data).
So what’s happening with the Zhang group’s European patents? Given the potential control that could be exerted against other parties wishing operate in the CRISPR-Cas space covered by the patent claims, it should be no surprise that all of the seven granted patents have been opposed. EP2771468B1 has been opposed by nine parties, EP2784162B1 by eight parties, EP2764103B1 by seven parties and EP2896697B1 by eight parties. Each of the remaining three patents have (already) been opposed by one party but each is still within the nine month post-grant period for filing an opposition, so more opposing parties can be expected to come forward. It will be some months before any of the appointed Opposition Divisions issue a decision, and all such decisions are likely to be appealed.
It will accordingly be some years before the battle for key early stage European patents covering CRISPR-Cas technology is over. Subsequent European patents relating to patentable improvements or modifications of the basic CRISPR-Cas technology will also be of potential relevance to players in this field. Continuous focussed monitoring is advisable.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.