Taking care with CRISPR
With more than 2,000 patent families related to CRISPR technology, we are seeing more follow-on patent applications being examined before the European Patent Office (EPO). Inventive step objections being raised generally fall into two categories: that a technical problem is not credibly solved in the patent application as filed, or that it would at least be obvious to try to use CRISPR over other known gene-editing techniques.
Determination of inventive step before the EPO is based on a problem and solution approach. This requires an analysis of a technical contribution achieved by the claimed invention which is not found in the closest prior art. The technical contribution is then considered in formulating the objective technical problem to be solved over the prior art.
A technical problem put before the EPO may be regarded as being solved only if it is credible that substantially all claimed embodiments exhibit the technical effects upon which the invention is based. As stated in a decision of the Boards of Appeal of the EPO (T1329/04): “The definition of an invention as being a contribution to the art, ie, as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching indeed solves the problem it purports to solve.”
Post-published data is allowable only to confirm that the claimed subject matter solves the problem where it is already credible from the disclosure in the patent that the problem is indeed solved (see T1329/4 and T415/11).
A one-way street
With regard to “obvious to try” inventive step objections, in a recent examination report (issued in October 2017) on EP 3 019 595 the examiner summarised the use of CRISPR instead of other genome-editing techniques to correct known mutations leading to sickle cell disease as follows: “Of course applicant will try and argue that it was not a one-way street situation because he could have chosen other options … However, where one option is akin to a motorway while the other is winding unpaved roads, the applicant is presented with a clear one-way street situation.”
