A new subsection has been added to the EPO Guidelines on obviousness in the field of biotechnology (G-VII, 13: Inventive step assessment in the field of biotechnology). The new Guidelines apply as from 1 November 2019.
This new subsection imports especially Boards of Appeal case law from T 296/93 on the meaning of “reasonable expectation of success” in the context of an obviousness analysis. According to the new Guidelines, “in the field of biotechnology obviousness is considered at hand not only when results are clearly predictable, but also when there is a reasonable expectation of success.” Thus, for rendering a technical solution obvious, it will now be sufficient pursuant to the new Guidelines, “to establish that the skilled person would have followed the teaching of the prior art with a reasonable expectation of success.” The Guidelines point out that the “mere ‘try and see’ attitude in light of the closest prior art does not necessarily render the solution inventive.”
Further, the updated Guidelines emphasize that “reasonable expectation of success“ must not be confused with the “hope to succeed”. In the new subsection of the Guidelines, the foregoing is exemplified by the case where researchers know beforehand that, when attempting to reach a technical solution, they will need “not only technical skill but also the ability to make the right non-trivial decisions along the way”, then this hope should not be considered to amount to a “reasonable expectation of success”.