The Enlarged Board of Appeal EBoA is the highest judicial authority under the European Patent Convention. It handles patent examination for about 37 member states including the EU. The EBoA has recently published its decision G2/21 dealing with the principle of free evaluation of evidence in the context of inventive step. This decision is relevant for patents in the pharma, biotech and life science field.

In general, a patent application must properly demonstrate that the technical effect of the claimed invention has been successfully accomplished. Ideally, this is shown by examples and test data included in the application as originally filed. However, particularly in technical fields with highly sophisticated and expensive laboratory tests and studies, not all data is available at the filing date. Often, pre-test results might indicate the technical effect of the invention. In such cases, post-published evidence might be allowed to be filed later to prove the technical effect. Decision G2/21 now defines the circumstances upon which such data is to be considered.

First, evidence proving a technical effect may not be disregarded for the sole reason that it was filed after the filing date of the patent. The principle of free evaluation of evidence applies for any means of evidence, also for post-published data.

Second, although used as defined term in many decisions of the Board of Appeal, the term “plausibility” does not define a distinctive legal concept allegedly required under the EPC.

Third, the relevant question in view of inventive step consists of what would the skilled person understand, with common general knowledge in mind, as the technical teaching of the claimed invention – at the filing date of the application. The technical effect for inventive step must be encompassed by this technical teaching and embodied by the same originally disclosed invention – even at a later date.

It seems that the EBoA has tried to define a test of implausibility ab initio which would be in line with the established case law. As the decision is very detailed and abstract, it might subject to further discussions in various following decisions.