24/03/2023
The Enlarged Board of Appeal’s (EBA) ʺPlausibilityʺ decision (G 2/21) was issued on 23 March 2023 just 4-months after the hearing which took place on 24 November 2022.
The referral aimed to clarify whether a technical effect can be relied on to argue inventive step when proof for that effect rests solely in post-published evidence. It also looked at what role, if any, plausibility should play in this assessment.
The EBA was asked to consider an approach which lay between the two extremes of excluding post-filed data completely and not taking “plausibility” into account at all in deciding whether to admit post-filed data.
The referred questions were:
1. Should an exception to the principle of free evaluation of evidence (see e.g. G 3/97, Reasons 5, and G 1/12, Reasons 31) be accepted in that post-published evidence must be disregarded on the ground that the proof of the effect rests exclusively on the post-published evidence?
2. If the answer is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have considered the effect plausible (ab initio plausibility)?
3. If the answer to the first question is yes (the post-published evidence must be disregarded if the proof of the effect rests exclusively on this evidence), can the post-published evidence be taken into consideration if, based on the information in the patent application in suit or the common general knowledge, the skilled person at the filing date of the patent application in suit would have seen no reason to consider the effect implausible (ab initio implausibility)?
Existing practices and Case Law
According to the established jurisprudence of the boards of appeal, the assessment of inventive step is to be made at the effective filing date of the patent on the basis of the information in the patent together with the common general knowledge available to the skilled person.
The objective 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 that effect required additional information that was not at the disposal of the skilled person after taking into account the content of the application in question.
In order to determine the objective technical problem, the technical results and effects achieved by the claimed invention, as compared with the closest prior art, must be assessed. According to the established case law of the boards of appeal, it rests with the patent applicant or proprietor to properly demonstrate that the purported advantages of the claimed invention have successfully been achieved.
It is also established that the proceedings before the EPO are conducted in accordance with the principle of free evaluation of evidence; a principle accepted in various EPC Contracting States with a civil law system.
In accordance with this principle, any kind of evidence, regardless of its nature, is admissible (see T 482/89 and T 558/95).
The Decision
In assessing question 1, the EBA concluded that the principle of free evaluation of evidence qualifies as a universally applicable principle of both procedural and substantive law in assessing any means of evidence submitted by a party in proceedings under the EPC, be it an administrative department of the EPO or a board of appeal. Hence, 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.
Interestingly, the EBA also stressed that the scope of reliance on post published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC).
Referring specifically to pharmaceutical patents, the EBA stated that in order to meet the requirement that the disclosure of an invention is sufficiently clear and complete for it to be carried out by the person skilled in the art, the proof of a claimed therapeutic effect has to be 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 (they do not use the word “plausible”!) to the skilled person that the therapeutic effect is achieved. A lack of sufficiency in such a case cannot be remedied by post-published evidence.
Ultimately, the EBA concluded that:
- Evidence submitted by a patent applicant or proprietor to prove a purported 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
But …
- A patent applicant or proprietor may [only] rely upon a [purported] 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 consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.
The relevant standard for being able to rely on a purported technical effect requires an assessment of what the skilled person, with the common general knowledge in mind, would understand at the filing date from the application as originally filed to be the technical teaching of the claimed invention. The technical effect relied upon, even at a later stage, needs to be encompassed by that technical teaching of the application as filed, and to embody the same invention. The purported technical effect, even if developed at a later stage, should not change the nature of the claimed invention.
Conclusions
Anyone hoping to gain clarity on the role of post-published data in assessing inventive step is likely to be disappointed by G2/21. It could be contended that the ruling merely substitutes one abstract standard, “plausibility”, with another, “encompassed by the technical teaching and embodied by the same originally disclosed invention”.
On the other hand, the EBA have identified (without defining) two standards for assessing whether post-filed data can be used to support sufficiency or inventive step. For sufficiency, the technical effect must be “credible” but for inventive step, it must “only” be “encompassed by the technical teaching and embodied by the same originally disclosed invention”.
What is certain is that G2/21 raises as many questions as it solves and the question of when post-published evidence may be relied on to support inventive step (and sufficiency), will continue to be hotly debated.
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.
