When can you use newly filed data to support inventive step at the EPO?
24
Mar
2023
The EPO’s highest court has issued its long-awaited decision in G2/21 regarding the use of post-published evidence to support inventive step

The EPO’s Enlarged Board of Appeal (EBA) has today issued its long-awaited decision on case G2/21. The Board confirms that data generated after the patent’s filing date can sometimes be relied upon when arguing that the claims are inventive, but it also notes that this practice is not always acceptable.

As we have reported previously here, the aim of this referral was to clarify what role, if any, the so-called “plausibility” requirement plays in determining whether post-published evidence may be relied on to support inventive step at the EPO.

As a reminder, the three questions referred to the EBA 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)?

The EBA seems to consider that question 1 should be answered in the negative. However, despite questions 2 and 3 being contingent on a positive answer to question 1, the EBA acknowledged the need to provide guidance on the issue of post-published evidence to support inventive step[1].

Plausibility and inventive step

The EBA analysed the three lines of case law referred to in the referring Board’s decision – so-called “Type I” case law imposing the stricter “ab initio plausibility” standard, “Type II” case law imposing the less strict “ab initio implausibility” standard, and “Type III” case law which rejects the plausibility requirement altogether[2]. Many attorneys had hoped for a decision that selected one of these approaches and so overturned some of the alternative case law. However, rather than endorse any of these approaches, the EBA found that:

“when analysing the case law in more detail and irrespective of the conceptual terminologies for what questions 2 and 3 refer to as two distinct plausibility approaches, the Enlarged Board understands from the case law of the boards of appeal as common ground that the core issue rests with the question of what the skilled person, with the common general knowledge in mind, understands at the filing date from the application as originally filed as the technical teaching of the claimed invention.

Applying this understanding to the aforementioned decisions, not in reviewing them but in an attempt to test the Enlarged Board’s understanding, the Enlarged Board is satisfied that the outcome in each particular case would not have been different from the actual finding of the respective board of appeal. Irrespective of the use of the terminological notion of plausibility, the cited decisions appear to show that the particular board of appeal focussed on the question whether or not the technical effect relied upon by the patent applicant or proprietor was derivable for the person skilled in the art from the technical teaching of the application documents.”[3]

Thus, the EBA appears to imply that the “plausibility” requirement is a distraction, and that the main issue here is what the skilled person would derive from the application as filed. In fact, the EBA arguably criticises the amount of attention the “plausibility” debate has attracted:

“The term “plausibility” … does not amount to a distinctive legal concept or a specific patent law requirement under the EPC, in particular under Article 56 and 83 EPC. It rather describes a generic catchword seized in the jurisprudence of the boards of appeal, by some national courts and by users of the European patent system.”[4]

The EBA goes on to summarise that:

The relevant standard … concerns the question of what the skilled person, with the common general knowledge in mind, would understand at the filing date from the application as originally filed as 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 and to embody the same invention, because such an effect does not change the nature of the claimed invention.

Hence, 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 consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention.[5]

It is interesting to note that that the EBA explicitly acknowledged the “abstractness” of its decision on this point[6].

In practice, the EBA’s decision confirms that post-filed data can sometimes be used when assessing inventive step, but the Board offers relatively little concrete guidance about when this approach is acceptable.

Answers to the referred questions

“1. Evidence submitted … to prove a technical effect relied upon for acknowledgement of inventive step … may not be disregarded solely on the ground that such evidence…  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.” [emphasis added]

An aside – plausibility and sufficiency

Contrary to the sentiment expressed in the EBA’s preliminary opinion, the EBA’s decision also opines on the issue of plausibility in the context of Article 83 EPC (sufficiency of disclosure). This is often relevant to medical use claims, in which a therapeutic effect is recited as a functional feature of the claim. Here, following an analysis of the relevant case law, the EBA found 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). In order to meet the requirement that the disclosure of the invention be 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 to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence.[7]

The EBA’s decision on this point arguably endorses earlier decisions which apply the so-called “ab initio plausibility” standard to the assessment of Article 83 EPC (e.g., T2059/13).

Conclusion

The EBA’s decision in G2/21 will likely come as a disappointment to stakeholders seeking to obtain certainty on when it is permissible to rely on post-published data to support inventive step. In particular, it could be argued that EBA’s ruling merely replaces one seemingly abstract standard (“plausibility”) with another (“encompassed by the technical teaching and embodied by the same originally disclosed invention”). Thus, it is likely that the fundamental point at issue in G2/21 – the circumstances under which post-published evidence may be relied on to support inventive step – will continue to be a significant area of future debate.

[1] G2/21, r55-59.

[2] G2/21, r60-69.

[3] G2/21, r71-72, emphasis added.

[4] G2/21, r92, emphasis added.

[5] G2/21, r93-94.

[6] G2/21, r95.

[7] G2/21, r77, emphasis added.