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USPTO Pro Bono Update

Members on the Move

BIPLA Third Annual Symposium

BIPLA and KAIPBA Joint Press Release

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G2/21 – “Plausibility”: using post-published evidence in Europe

BIPLA Writing Competition

USPTO Recognizes 2022 Patent Pro Bono Achievement Certificate Recipients

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2023 Ⓒ Boston Intellectual Property Law Association

NEWSLETTER ARCHIVE

Volume 54, Issue 2

G2/21 – “Plausibility”: Using Post-Published Evidence in Europe

By Natalia Wegner and Sam Sackville, Carpmaels & Ransford

Reliance on post-published evidence of an unexpected effect used to require “plausibility” at the EPO: a threshold test the Technical Boards of Appeal applied to many cases over the years, often leading to refusal or revocation due to a lack of inventive step. Recently, the EBA (Enlarged Board of Appeal), the EPO’s highest authority, stepped in and issued decision G2/21 in response to a perceived divergence in the case law.

The EBA’s decision – G2/21

In Headnote 1, the EBA confirmed that evidence cannot be disregarded purely because it is post--published, as doing so would contradict the principle of free evaluation of evidence (¶90):

Headnote 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. [emphasis added]

The EBA furthermore noted that the concept of “plausibility” is merely “a generic catchword” that “does not amount to a distinct legal concept” or “a specific patent law requirement” (¶90).

This seems like a win for patentees: G2/21 rejects the plausibility doctrine and clarifies that there are no limits on the evidence in support of inventive step. However, in Headnote 2 the EBA then limits the technical effect that can be relied on for inventive step, as one that must be “encompassed by the technical teaching and embodied by the same originally disclosed invention”:

Headnote 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]

What does the new test mean?

The EBA’s new test is difficult to interpret – an effect which is “encompassed by the technical teaching and embodied by the same originally disclosed invention” is a new concept under EPO law. The EBA’s decision itself provides little guidance; indeed, the EBA in ¶95 acknowledges the “abstractness” of its new criteria, noting that the outcome of future cases applying G2/21 will depend on, inter alia, the specific circumstances and technical field.

One view is that the EBA’s new test bears a resemblance to the EPO’s long-standing doctrine of allowing reformulation of the technical problem: this allows a “subjective technical problem” put forward in a patent specification (i.e. the technical effect as seen by its inventors at the time of filing) to be reformulated into an “objective technical problem” (i.e. the technical effect in light of the most relevant prior art, which may have been identified only later, during search). The case law sets out that the objective technical problem should be “derivable from the application as filed” (T386/89, T31/18); “implied by or related to the technical problem initially suggested” (T184/82); “within the framework of the invention” (T1422/12); and should not “change the nature of the invention” (T440/91, T344/89, T321/16).

These requirements are recognisable in the new test in G2/21, and as such we may see parties citing reformulation case law when arguing for (or against) reliance on a technical effect. While this may be a reasonable approach, particularly absent any other clear interpretation, it seems unlikely that the new test was intended to be identical to the reformulation test – the reformulation case law is not discussed in detail or put forward as basis for the new test in G2/21. Moreover, the EBA’s test includes a concept not found in the reformulation case law: the “technical teaching”.

This new concept of the “technical teaching” appears vital, since effects relied on must be “encompassed” by that technical teaching, according to G2/21. Indeed, G2/21 states that the technical teaching was also “the core issue” and was “focussed on” by the boards in the earlier plausibility cases (¶71, ¶72). Unfortunately, the EBA does not define what a technical teaching is.

Despite this lack of guidance, it seems uncontroversial that a technical teaching could be derived from experimental data in the application as originally filed and/or available from the common general knowledge. Additionally, statements might also qualify, considering one of the cases cited by the EBA (T2015/20):

“[…] the Board considers the statement in the application, that the treatment of respiratory disorders, particularly asthma and COPD, with aclidinium is most effective upon administration by inhalation in a dosage of about 400 µg metered nominal dose (paragraph [0003]) to represent a significant technical teaching, which is far from an invitation to perform a research programme and which does not prima facie lack plausibility. This teaching is as such falsifiable, in the sense that it is open to challenge, and is therefore considered to represent information in the form of a specific technical contribution which goes beyond some insufficient verbal statement.” [emphasis added]

So, statements of advantage might constitute a technical teaching in some cases. However, there are limits – it is clear from earlier case law that verbal statements can fail if they are: imprecise and/or need to support a broad disclosure (T488/16); contradicted by CGK and/or the application itself (T1329/04); and/or not clearly linked to the claimed invention. These requirements may be easier or harder to meet depending on the technical field.

Taking all this together, allowability of technical effects under G2/21 will likely focus on the technical contribution of the specification – not only on data, but also on statements of effect/advantage and other technical disclosures. When drafting new specifications, it is prudent to include as much experimental data as possible. This was sound advice before G2/21, as it is now. However, G2/21 has arguably placed more emphasis on the wording used to characterise the invention and its advantages. Precise, verifiable, statements of effect or advantage included in the specification at the drafting stage may make arguing a case under G2/21 easier.

Who does the decision benefit?

The months following the EBA’s decision look set to be a period of uncertainty in which the EPO and its users may take a heterogeneous approach to applying the EBA’s guidance. Things should settle once the boards apply the new test to specific cases and give their reasoning. In the meantime, G2/21 feels like a decision for everyone: patentees and opponents alike are already referring to it to support their case.

For instance, patentees may take comfort that the plausibility doctrine has gone – this may help to neutralise negative perceptions of past plausibility case law. Secondly, patentees may refer to the EBA’s comments that post-published evidence cannot be disregarded purely as a matter of principle – the fact that evidence must be considered may be advantageous if it is particularly convincing evidence of an effect. Thirdly, patentees may seek to rely on certain cases cited in G2/21 as an endorsement of helpful principles:

the EPC requires no experimental proof for patentability: T578/06, cited in the opening paragraph (¶60) of the EBA’s reasons
effects can be “derivable” from the patent, and not necessarily supported by evidence: T31/18, T2371/13 (¶65)
plausibility cannot be equated with obviousness: T184/16 (¶69)

Conversely, opponents could make hay with the EBA’s comment in ¶72 that the outcome of the earlier plausibility cases would not have been different if the G2/21 test had been applied – opponents may argue this means nothing has really changed. Indeed, the absence of any real guidance on the meaning of “technical teaching”, “encompassed” and “embodied” may lead some to the conclusion that the new test is “plausibility” by a different name.