To encompass and embody: Applying the abstract principles of G 2/21

It is now some weeks since we received the EBA's decision in G 2/21 on the standard of evidence required for inventive step (often referred to as the "plausibility" referral). As previously summarised (IPKat), G 2/21 does not change the evidence standard for inventive step. Instead, the main contribution of G 2/21 is the introduction of an additionally nuanced test for assessing the disclosure standard for a purported technical effect.  G 2/21 also does not provide practical guidance on how this test should be implemented and leaves a number of key questions for the Boards of Appeal to answer. 

G2/21: "Encompassing and embodying"

G 2/21 does not change the status quo with respect to the disclosure requirement for a technical effect relied on for inventive step. In G 2/21 the EBA confirms that, when relying on a technical effect for inventive step, it is necessary to ask what a skilled person would have understood from the application as filed in view of the common general knowledge (CGK) (r.93). This language mirrors the sufficiency requirement (Article 83 EPC) (IPKat).

On the question of whether post-filed evidence can be used to support inventive step, the EBA found that there was no bar to the submission of new evidence. However, once evidence has been submitted it can still be ignored as inconsequential to the question at hand. With regards to new evidence supporting a purported technical effect, the EBA found that new evidence could not alter the requirement for the technical effect to be understandable to a skilled person from the application as filed in view of CGK. Arguably, post-filed evidence of a fact that is neither disclosed in the application as filed, nor derivable from CGK, is definitionally irrelevant to the question of what a skilled person would understand from the application as filed in view of the CGK. The possible exception to this is new evidence pertaining to what the CGK would have been when the application was filed. 

Contemplating the abstract principles

G 2/21 then added some nuance to what it means for a technical effect to be understandable from the application as filed:

"The relevant standard for the reliance on a purported technical effect when assessing whether or not the claimed subject-matter involves an inventive step 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".

G 2/21 is not about plausibility

From G 2/21, it seems that the EBA dislikes the term "plausibility", or particularly its evolution into a catch-word that has gained a life of its own in the national courts and IP commentary (r.92).  However, despite being commonly referred to as the plausibility referral, G 2/21 is not really about plausibility. Whilst plausibility is mentioned throughout G 2/21, this is only because the terminology of plausibility is commonly used in connection with discussions about the standard of evidence for inventive step. A reference to "plausibility" is a way for Boards of Appeal to signal that there is a higher level of underlying doubt with regards to certain types of invention, particularly those defined by very broad claims and/or those in challenging technical fields (IPKat). In such cases, the Boards of Appeal assess whether the purported technical effect of a claimed invention would be "plausible" to a skilled person, from the application as filed and in view of common general knowledge. 

The question of whether or not "the terminological notion of plausibility" needs to be employed because of the breadth of the claim or the nature of the technical field, is separate to the question of the standard of disclosure required to support a technical effect (r.72) (IPKat). The disclosure standard remains the same regardless of the type of invention. Particularly, it is still necessary to ask what a skilled person would understand from the application as filed, in view of common general knowledge. From G 2/21, we now have the additionally nuanced requirement that the technical effect is encompassed by the technical teaching and embodies the same invention as the technical teaching of the invention, as understood by a skilled person from the application as filed at the filing date in view of CGK. 

Outstanding questions

The EBA provides no practical guidance as to what it means for a technical effect to be "encompassed by the technical teaching" and to "embody the same invention" as the application as originally filed. It is seemingly clear from this language that a technical effect relied on for inventive step cannot be completely divorced from the original technical teaching of the application as filed. What is not clear from the reasoning in G 2/21 is whether the application as filed must explicitly mention the technical effect. Would an implicit understanding that the claimed invention embodies the technical effect be sufficient? It is also not clear from G 2/21 how new data disproving a technical effect should be treated. 

Unknown prior art

The question at the heart of the referral in G 2/21 was whether a technical effect relied on for inventive step must be explicitly disclosed in the application as filed. A common scenario in which a patentee may want to rely on a technical effect that is not explicitly disclosed in the application as filed is when the closest prior art was not known to the patentee at the filing date. The EPO often requires direct comparisons to be made between the prior art and the claimed invention. For example, to support inventive step for a new antibody, it may be necessary to show that a claimed antibody has higher potency than prior art antibodies binding the same target. The EPO will also often require the potency of the claimed antibody and the prior art antibody to be measured by exactly the same assay, in order that they are directly comparable. However, if the prior art is obscure, the patentee may not have been aware of it at the time of filing. The question becomes whether the patentee can submit additional data directly comparing the antibodies in order to support inventive step. 

This Kat is not clear on how to assess whether new comparative data for e.g. an antibody, could be said to be "encompassed by the technical teaching" and to "embody the same invention" as the technical teaching understood by the skilled person from the application as filed. However, the EBA in G 2/21 does not state that an explicit disclosure of the technical effect is necessary. G 2/21 may be interpreted as permitting implicit disclosures of a purported technical effect, provided these could be understood by a skilled person from the application as filed in view of CGK. Crucial to this question is whether the skilled person is given hindsight knowledge of the technical effect (IPKat). 

The relevance of new negative data

In the referring decision in G 2/21, the Board of Appeal had to consider not just whether new data supporting a technical effect could be considered post-filing, but also whether new data disproving a technical effect could be similarly considered. The Opponent in the case in question submitted new evidence at opposition that contradicted the evidence provided in the application as filed. However, the EBA in G 2/21 did not directly address the question of how much weight should be given to this evidence. Nonetheless, from the EBA's reasoning, it appears to this Kat that post-filed negative evidence relating to a technical effect should face a similar test to positive data, and should be ignored if irrelevant to what a skilled person would understand from the application as filed in view of CGK at the filing date. In other words, the new data should not be considered if it would not be known or understood by a skilled person from the application as filed in view of CGK.

There may also be an interaction here with the evidence requirement in inventive step and sufficiency, that there are no substantiated doubts supported by verifiable facts about the invention. Can new data from an opponent provide substantiation to new doubts about an invention, or must these doubts already be inherent in the application as filed in view of CGK? The wording in G 2/21 suggests the EBA would favour the latter possibility. In other words, the opponent must demonstrate that a skilled person would have doubts about the purported technical effect based solely on the application as filed in view of CGK.   

Final thoughts

The Boards of Appeal are now faced with the unenviable task of implementing G 2/21. It will be interesting to see how Boards of Appeal tackle the issue of implicit technical effect in view of prior art not known to the patentee at the filing date, and the relevance of new negative data against a purported technical effect. Both of these questions were relevant in the referring decision in G 2/21T 0116/18. Will the Board of Appeal in this case now be any clearer as to how to proceed? 

Further reading

When generating antibodies for a target is more than routine (T 0435/20) (24 April 2023)

Plausibility demystified - a review of EPO case law before G 2/21 (24 Feb 2023)

To encompass and embody: Applying the abstract principles of G 2/21 To encompass and embody: Applying the abstract principles of G 2/21 Reviewed by Rose Hughes on Tuesday, May 02, 2023 Rating: 5

11 comments:

  1. Interesting article. The requirement of G 2/21 regarding the "technical effect to be "encompassed by the technical teaching" and to "embody the same invention" as the application as originally filed" is a necessary requirement for relying on a technical effect when formulating the objective technical problem, but not a sufficient one. My analysis is that under T 939/92 (and other decisions), the Board must also be convinced that the technical effect is actually achieved and that this is an independent requirement, not affected by G 2/21.

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    1. Hi Peter - I agree. The test of whether the Board is convinced (or put another, whether a skilled person would have serious doubts, substantiated by verifiable facts) that the technical effect is actually achieved [over the whole scope of the claim], is a separate question to that directly considered in G2/21. This is why G2/21 is not really about plausibility.

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    2. Dear Rose, I think that any date of the opponent showing that the asserted technical effect (invoked by the patentee) is not achieved in practice (or that there are many non-working embodiments in that respect) will be considered. It is like submitting experimental evidence that water boils at 100C at 1 bar: it concerns time-independent facts, unlike the requirement of G 2/21 which is tied to the (past) priority date.

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  2. There are 2 types of 'technical effect' which might need to be evaluated separately. One is the broad technical effect achieved by the teaching and data in the specification (e.g. showing drug X treats cancer), and then there is the specific, often narrower, technical effect relating to the problem to be solved in view of the prior art (e.g. showing drug X also has less side effects than drug Z disclosed in D1). It is this second type of 'narrower' technical effect where applicants/patentees get into trouble as they did not realise they needed to show it when drafting the specification, and so there needs to be some leeway in the system for the use of post-filing data to show the second type of technical effect. It is close to impossible to define the criteria for allowing use of post-filing data to show the second type of technical effect as it all depends on the relationship of the prior art to the invention, and in some sense how predictable it was that the second type of technical effect would need to be shown. The Enlarged Board was sensible in not setting strict rules for use of post filing data, but it does of course lead to uncertainty as whether or not post filing data can be used becomes problem-specific

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    1. Good comment from Santa. Curious whether Rose will comment on it. It brings to mind a comment in some other thread about what renowned judges (Wendell-Holmes included) have had to say about the need for wiggle room, leeway so they have room in their decisions to hold on to the interests of justice. And that in turn brings to mind the EPO determination to avoid being prescriptive in other areas, such as what "technical" means. Sometimes it is so, that the more prescriptive the law is, the better (I'm thinking here of the EPO's problem-solution approach, to frame the obviousness debate and stop it getting all hand-waving) but perhaps there are other areas where the opposite better serves the interests of justice, like being overly prescriptive about "conforming" the description under Art 84 EPC to a claim that is otherwise allowable.

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    2. Thanks Santa. Perhaps the distinction between these two types of technical effect you identify partly reflects the sufficiency/inventive step division? I agree with the challenge of defining criteria for allowing post-filed comparative data in a system that permits the use of hindsight to identify the problem to be solved in view of the closest prior art.

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    3. Thanks Rose. My comments really come from my experience of how effective an attack plausibility has become in EPO opposition. Previously, traditional lack of enablement attacks were difficult in chemical/pharma/biotech if you did not have any data to file to support them. Now you just have to attack the weak points in the data in the spec, and the patentee can be put in a very difficult situation if they cannot use post filing data. So I believe plausibility has become far more demanding than enablement because it is a test of your data under attack from a hostile party that can find many different holes in it if they wish. EPO case law is very very unclear as to how the burden of proof operates in this situation between patentee and opponent, but I have seen the patentee's getting a lot more burden than they would under traditional enablement. Plausibility requires very clear thinking in terms of which inventive concept needs to be shown using what form of data, and I think many opposition divisions struggle with the complexity of it. The reference to the Enlarged Board was perhaps for the purpose of seeking help for opposition divisions in particular, to give them a set of rules to follow, especially for use of post filing data. However the Enlarged Board instead, I think, realised it was better for things to play in the system for a while and let plausibility find its own way in terms of how examining and opposition divisions deal with it.

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  3. "What is not clear from the reasoning in G 2/21 is whether the application as filed must explicitly mention the technical effect. Would an implicit understanding that the claimed invention embodies the technical effect be sufficient?"

    My reading of headnote II. is that an explicit mentioning of the technical effect in the application as filed is not necessary.

    Otherwise, the Enlarged Board would not have formulated the requirement that the skilled person, having the *common general knowledge* in mind, and *based* on the application as originally filed, must be able to *derive* the technical effect as being encompassed as being encompassed by the technical teaching and embodied by the same originally disclosed invention.

    If it were necessary to have an explicit statement of the technical effect, neither would the common general knowledge come into play, nor would any act of derivation be allowed.

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  4. @Rose Hughes

    The system not only permits the use of hindsight, it is based on hindsight from day one. Hindsight is inevitable for a search of prior art to be carried out since the examiner c

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  5. Is not the fundamental challenge in any First to File jurisdiction to reward those who, in their application as filed, make a useful, new and not obvious contribution to the art with a scope of protection that is commensurate with the contribution but does not exceed it? What the contribution is will be dependent not only on what the inventor conceives but also on the skills of the drafter of the patent application, to capture that contribution in full. Good drafting keeps the case out of the courts; less good drafting results in litigation fests. Pemetrexed anyone?

    People like to decry it, whenever judges reveal that they rely on "I know it when I see it" gut feelings, but that is 1) the reality and 2) necessary to serve the interests of justice. Good drafting is the most important factor that will help judges to see "it", and act accordingly, case-by-case, as necessary. I think it right for the case law to evolve gradually: the flow of cases at the EPO is heavy enough to ensure that the case law will evolve rapidly. That's better than a Supreme Court laying down a binding prescription that cannot withstand critical commentary and comes to be widely disparaged.

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    1. Anonymous of Friday, 5 May 2023 at 13:12:00 GMT+1, it depends on what you mean by 'good drafting'. That could mean that the data in the spec is tightly focused on showing the technical effect or it could mean that the spec identifies all the possible technical effects that might be needed to overcome as yet unidentified prior art. The perceived and agreed upon contribution will be dependent on both these factors

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