G2/21 – Plausibility is not a distinctive legal concept or requirement
Patent proprietors and invalidators/opponents have eagerly awaited the “Plausibility” decision G2/21 of the Enlarged Board of Appeal of the European Patent Office which has been published yesterday.
Headnotes 1 and 2:
1.????????????Evidence submitted by a patent applicant or proprietor to prove a technical effect relied upon for acknowledgement of inventive step of the claimed subject-matter may not be disregarded solely on the ground that such evidence, on which the effect rests, had not been public before the filing date of the patent in suit and was filed after that date.
2.????????????A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
Regarding Headnote 1, it is not coming as a surprise that post-published evidence (i.e. evidence available only after the filing date) cannot be disregarded per se. The principle of free evaluation of evidence is universally applicable and each case is decided on its own merits.
Assessing the impact of Headnote 2 is more difficult and the Enlarged Board admitted that it only provides abstract criteria to be applied by the appeal boards considering the pertinent circumstances.
First of all, we learn from G2/21 that “plausibility” is not a distinctive legal concept or requirement. In particular, none of the options suggested by the parties: i) “no requirement” ii) “effect at least not implausible” or iii) “effect must be plausible” was chosen as the standard for being allowed to rely on post-published evidence.
For inventive step (Article 56 EPC), G2/21 starts from the fundamental principle that the assessment has to be performed at the effective date of the patent (application) on the basis of the information in the patent together with common general knowledge.
“The technical problem must be derived from effects directly and causally related to the technical features of the claimed invention. An effect could not be validly used in the formulation of the technical problem if the effect required additional information not at the disposal of the skilled person even after taking into account the content of the application in question.”
It is a known requirement that there has to be a cause-effect relationship between the distinguishing feature(s) and their effect(s). Still, the question is whether the effect was encompassed by that technical teaching and embodies the same invention at the filing date or whether claiming the effect changes the nature of the invention and requires additional information which was not available at the filing date. ?
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The above guidance shall now be used by the appeal boards to decide each case on its own merits.
Regarding the drafting of patent applications, the following questions still remain:
Is it required that an effect is explicitly disclosed and taught to be linked to (a) specific feature(s)? Or is it sufficient that the application recites an generic effect such an “improvement”, wherein the teaching of this “improvement” encompasses any properties of the product - even if these were not mentioned? Is it detrimental if a list of effects was mentioned in the application wherein only some effects of said list turn out to be achieveable later?
The answers to the above questions will surely impact the way patent applications have to be drafted.
Finally, G2/21 rules in the context of enablement (Article 83 EPC) of second medical use claims that proof a claimed treatment therapeutic effect (which is a claim feature) has to provided in the application as filed. In particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that such effect is achieved, this lack cannot be remedied by post-published evidence.
Our guidance is that a patent application shall be filed once the effects as well as their boundaries have been identified. Evidence supporting the effects may then be supplemented later.
If you have any questions, please feel free to contact us!
Dr. Thomas Sonnenhauser and Dr. Hendrik Wichmann