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G 2/21: Is the technical effect embodied by the invention as originally disclosed?

  • Sector: Biotechnology, Patent law
  • 19th April 2024
The Enlarged Board of Appeal (EBA) has released its written decision in G 2/21 on the question of post-published evidence. In G 2/21, the EBA consciously avoids the rabbit hole of plausibility, dismissing it as a generic catch word that does not amount to a distinctive legal concept.
 

Originally posted on IPKat.

For the EBA, the substantive question at the heart of G 2/21 is a familiar one that needs no reference to plausibility. In order to understand whether a purported technical effect may be relied on for inventive step, the EBA concludes that the substantive question remains that of what the skilled person would understand from the application as filed.

The referring case: Moths, moths and more moths

The referral in G 2/21 related to whether the evidence needed to support a purported technical effect can be provided after an application is filed. The referring decision related to the validity of patent EP2484209 claiming an insecticide made up of a combination of compounds. The purported technical effect of the insecticide was the synergistic effect of the compounds against certain species of moth.

The patent included data demonstrating the synergistic effect of example compounds falling under the scope of the claim against two different species of moth. At Opposition, the Opponent submitted contradictory data, showing that example compounds did not in fact have a synergistic effect against one of these moth species. In response, the Patentee submitted additional data showing a synergistic effect of the example compounds against a third species of moth. The Opponent argued that the synergistic effect of the compounds against the third moth species was not plausible from the application as filed, and so the post-published evidence should not be taken into account.

The post-published data submitted by the patentee were considered fundamental to deciding the question of inventive step. Without the additional data, the Board of Appeal found that the problem solved by the invention was the provision of a synergistic insecticide activity against the first two species of moth for which data were provided in the patent. Without the additional data, the Board of Appeal found that the claimed invention did not plausibly solve this problem, given that the data provided by the Opponent convincingly contradicted the data in the patent. Although notably, the Opponent’s data was also post-published.  

Conversely, if the patentee’s additional data were taken into account, the Board of Appeal found that the objective technical problem to be solved in view of the prior art could be revised as the provision of an synergistic insecticide activity against the third moth species, i.e. the moth species to which the new data related. None of the data submitted by the Opponent contradicted the Patentee’s post-published data relating to this moth species. 

The Board of Appeal’s questions to the EBA essentially asked a) if post-published evidence could be taken into account if an effect was plausible from the application as filed (“ab initio plausibility”), and b) if post-published evidence could be taken into account if there would have been no reason to consider an effect implausible from the application as filed (“lack of ab initio implausibility”). 

The decision in G 2/21: Is the technical effect embodied by the invention as originally disclosed 

With regards to the referred questions, the EBA considered the important test to be what a skilled person, in view of common general knowledge, would understand from the application as filed. Thus, for inventive step, what matters is whether the purported technical effect “is encompassed by the teaching” of the application as filed. Therefore, on the question of whether a patentee may rely on post-published evidence to support a technical effect, the EBA concluded: 

“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.”

A question raised by the EBA decision is what it means for an effect to be “encompassed by the technical teaching” and to be “embodied by the same invention” as originally disclosed in the application as filed. The EBA does not provide any guidance on this, and even acknowledges that its decision has a certain degree of “abstractness”. G 2/21 is therefore open to a certain degree of interpretation. 

With these caveats, this Kat reads the EBA’s conclusion as permitting inventive step based on a technical effect that is not explicitly described as the inventive contribution in the application as filed. However, it is also clear from G 2/21 that in order to rely on such an effect for inventive step, a skilled person must be free from doubt in view of the application as filed that the invention as claimed has the purported effect. If, for example, a claimed insecticide is purported to work against a species of moth, a skilled person must be able to understand that the invention as originally disclosed would have worked against the species of moth, once they are provided with the hindsight knowledge of the purported technical effect as the inventive contribution. As the EBA points out, the purported technical effect cannot and “does not change the nature of the invention” (r. 93). 

This reading of the EBA is supported by the acknowledged structure of the problem-solution approach, by which the closest prior art, and therefore the objective technical problem to be solved and the inventions purported technical effect, can only be identified with hindsight (see T 0605/20). 

Once we are at the point of assessing whether an invention originally disclosed does or does not have a certain technical effect, the standard test for the standard of evidence can then be applied, namely whether there are substantiated doubts, supported by verifiable facts, that the invention embodies the technical effect (for more on why this is the appropriate test). In the insecticide example, we are left with the question of how much a skilled person would doubt that the insecticide compounds would have a synergistic effect against the third species of moth for which data was not provided in the application as filed. 

It now remains for the Board of Appeal in the referring case to apply the EBA’s reasoning to the case in question, and this interpretation will help clarify the issues. 

What happened to plausibility?

The referring decision and the amicus curiae in G 2/21 discuss at length the concepts of “ab initio plausibility” and “ab initio implausibility”. By contrast, the EBA refocuses the debate away from plausibility as a concept. G 2/21 refers to “plausibility”, but only to dismiss it as not being useful to the legal question at issue. The EBA particularly finds plausibility to be a term that “does not amount to a distinctive legal concept or a specific patent law requirement under the EPC“, whether under inventive step (Article 56 EPC) or sufficiency (Article 83 EPC). To the EBA, plausibility is nothing more than a “generic catchword” used by the Boards of Appeal, national courts and users of the European patent system (r.92). 

The EBA reasoning in G 2/21, and its dismissal of plausibility, is aligned with how the term plausibility is used by the EPO. The concept of plausibility is merely the way in which the Boards of Appeal have signalled cases for which more evidence is needed to overcome the standard sufficiency bar of lack of substantiated doubt. In some technical fields (such as therapeutic use), there is a higher level of underlying doubt about whether an invention has actually solved the problem it purports to solve. In order to overcome the higher level of underlying doubt, a patentee must provide enough evidence to render the invention or its technical effect plausible (Evolve Insights). In some cases, plausibility will be relevant to whether a skilled person would derive that an technical effect is embodied by an invention as originally disclosed, in some cases it will not, depending on the technical field. At the EPO, plausibility was thus never a new or additional requirement for patentability. In G 2/21, the EBA supports and confirms this view. 

If, however, we wanted to translate the EBA’s decision in G 2/21 into the language of plausibility, it could be argued that the EBA has arrived at an ab initio lack of implausibility test. The requirement for a lack of ab initio implausibility is in line with the established standard of evidence for both sufficiency and inventive step, namely the lack of substantiated doubts, supported by verifiable facts, about the invention or its purported technical effect at the filing date. Importantly, this is not a lowering of the bar for evidence, but is in-line with previous Boards of Appeal case law. Put another way, “lack of ab initio implausibility” is just another way of phrasing the standard sufficiency test for lack of substantiated doubt, potentially as applied to therapeutic use inventions and invention in other challenging technical fields. 

Final thoughts 

The decision in G 2/21 is a long one, and raises more topics for discussion than can be covered in a single blog post. We also suspect that the “abstractness” of G 2/21 may lead to some differing views as to its interpretation.

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