21 Jun Inventions with (in)credible effects
Plausibility, sufficiency, and inventive step in patents
In the field of intellectual property, the term “plausibility” is commonly used to refer to the “trustworthiness” or “credibility” of an invention claimed in a patent application.
While its origin is still in discussion among experts, the concept of “plausibility” appears in the Case Law of the European Patent Office (EPO) since years, often related to patents in the pharma and biotechnology fields.
Additionally, this concept is used in connection with two patentability requirements clearly defined in the European Patent Convention (EPC), i.e. sufficiency of disclosure and inventive step.
The “sufficiency” requirement, according to Article 83 EPC, implies that an invention has to be sufficiently described to allow the skilled person (legal figure often referred to in patent law) to carry it out based on what the patent application describes and the general common knowledge at the time of filing the application (again another concept in patent law referring to all knowledge available in textbooks and manuals in a particular technical field). As a minimum requirement, the application should contain at least one sufficiently detailed example of how the invention can be implemented to consider it sufficiently disclosed. However, the number of examples required depends on the case, particularly on the scope of protection requested by the claims.
The “inventive step” requirement, according to Article 56 EPC, implies that to be considered patentable, an invention should not be obvious for the skilled person in view of the state of the art.
It is worth highlighting that, despite the weight that the concept has acquired in the case law, “plausibility” is not mentioned in the legal text body of the European patent system, but only in the Guidelines of examination and with regards to the burden of proof in certain specific situations.
To believe or not to believe? Where does the problem arise?
The problem with “plausibility” often appears because, on the one side, there is the will to obtain the broadest scope of protection for a particular inventive concept, and on the other side, it is often not possible, or viable, to provide examples covering absolutely all the cases comprises within the scope of the claims. See, for example, chemical compounds o biologics (antibodies, recombinant proteins) for which the number of a priori functional variants is enormous. Testing all these variants in the laboratory in vitro (in test tubes or the like) or in vivo (in animal models or clinical trials) is very complex and costly.
In certain cases, doubts with regards to the “plausibility” of a claimed invention claim can arise. Is it possible that a specific therapeutic effect of a subgroup of variants (included, for example, in a dependent claim) of a compound or a composition is not supported in the description. This is due to the lack of a reference in the patent application to the technical effect that this subgroup of variants has, and/or due to the lack of examples that prove that the technical effect is achieved for these variants.
It is very often the case that the concept of “plausibility” appears with respect to a third-party action contesting the validity of the patent, for example during opposition proceedings or during the subsequent Appeal before the Boards of Appeal of the EPO. In these proceedings, a third party willing to invalidate or limit a granted patent can object lack of sufficiency of disclosure or lack of inventive step for one or more of the claims. These two concepts are related because inventive step requires that the invention has a technical effect (for example a therapeutic effect if a drug is claimed) and this technical effect must be plausible.
In any of these cases, it can be desirable, or even necessary to rely on data that was not available at the time of filing the application or that was not disclosed in that moment to further progress with the prosecution of the application or to maintain the patent alive.
The long awaited G2/21 decision
On the 23rd of March 2023, the awaited G2/21 decision of the Enlarged Board of Appeal (EBoA) of the EPO relating to the admissibility of these post-published evidence, was issued. Particularly, the decision was expected to shed light to the criterion to be applied with regards to the “plausibility” of a technical effect relied upon, for assessing whether a claim is inventive, when said technical effect was only supported by post-published evidence.
Omitting the references to the Case Law, given the educational character of this article, the questions referred to the EBoA had a logic order and read as follows:
If for acknowledgement of inventive step the patent proprietor relies on a technical effect and has submitted evidence, such as experimental data, to prove such an effect, this evidence not having been public before the filing date of the patent in suit and having been filed after that date (post-published evidence):
- Should an exception to the principle of free evaluation of evidence 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?
- 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)?
- 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)?
Based on the logic included in the questions, it is possible to think that the aim was to obtain a decision that would clearly guide with regards to:
- the admissibility of post-published evidence not included in a patent application with regards to an alleged technical effect.
- the criterion to accept such post-published evidence depending on whether the skilled person would have considered the technical effect to be credible, and/or whether the skilled person would not have considered the technical effect to be incredible, in both cases on the date of filing and considering the content of the patent application and the common general knowledge at that time.
The answers of the Enlarged Board of Appeal in G2/21:
After the decision has been issued, opinions up to now agree that, while the EBoA has provided a clear answer to question 1), the answer to questions 2) and 3) was not as direct as maybe some expected, and we will have to wait to see how it is interpreted in the upcoming decision of the Boards of Appeal.
The principle of free evaluation of evidence
To the first question, the Enlarged Board of Appeal replied that:
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.
In other words, that evidence provided by an applicant or a patent owner to prove a technical effect should not be ignored only because they have been submitted after the filing of the application.
To complete this answer, it is interesting to highlight the definition of “the principle of free evaluation of evidence” that the EBoA:
Said principle can be defined in abstract and general terms as allowing and, by the same token, requiring a judicial body, like the Boards of Appeal, to decide according to its own discretion and its own conviction, by taking account of the entire content of the parties’ submissions and, where appropriate, any evidence admissibly submitted or taken, without observing formal rules, whether a contested factual assertion is to be regarded as true or false (paragraph 30 of the G2/21 decision).
and the intermediate conclusion that the EBoA reaches after analysing both the EPO Case Law (its own and the BoA one) and the case law of the EPC Contracting States., is that:
[…] the principle of free evaluation of evidence qualifies as a universally applicable principle in assessing any means of evidence by a Board of Appeal. (paragraph 55 of the G2/21 decision).
In other words, that it must be analysed on a case-by-case manner, and that each Board of Appeal can and should decide taking all factors of each individual case into consideration.
Plausibility
With regards to questions 2 and 3, while both streams of the Case Law presented in the questions are acknowledged (ab initio plausibility or ab initio implausibility), the EBoA highlights, in its intermediate and final conclusions that the concept of “plausibility” does not have the consideration of a distinctive legal concept, and is not a requirement of patentability according to the EPC, particularly according to Articles 56 and 83 EPC, which correspond respectively to the inventive step and the sufficiency of disclosure requirements.
However, the EBoA does not establish in which specific cases post-published evidence should or should not be accepted.
In connection to “inventive step”, the EBoA acknowledges the need to provide guidance on the application of the principle of free evaluation of evidence in respect to post-published evidence when for the reliance of an asserted but contested technical effect. With this aim, after analysing the Case Law of the Boards of Appeal and the national courts of the Contracting States, the EboA goes beyond the original questions and takes a step back to consider when a technical effect should be relied upon to support inventive step.
Particularly, the EBoA concludes that:
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 (Answer to Questions 2 and 3 in the G2/21 decision).
Besides the “abstractness” of these criteria (citing the words of the decision) the EBoA considers that:
Irrespective of the actual circumstances of a particular case, the guiding principles set out above should allow the competent Board of Appeal or other deciding body to take a decision on whether post-published evidence may or may not be relied upon in support of an asserted technical effect when assessing whether or not the claimed subject-matter involves an inventive step (paragraph 95 of the G2/21 decision).
In other words, that for the assessment of inventive step, particularly in case there are doubts arising about the possibility to rely in a technical effect for which the only support is post-published evidence, the EBoA in its decision seems to want to take the concept of “plausibility” to a second plane. Else the EBoA has focused on a different concept that, based on its analysis and independently of the latter, has coherently guided the available Case Law, that is the concept of “technical teaching” of the claimed invention.
Practical implications of the G2/21 decision. So, now what?
As it happens after any decision of the EBoA, the question is what the practical implications of the content of the decision are. In this case, due to the complexity of the matter and the abstract character of many of the conclusions reached, it may be difficult to extract specific “take-home messages”.
On the one hand, it is worth highlighting that, with its decision, the EBoA, even without intending to review any decision, seems to validate the practice of the BoA in cases of inventive step in which “post-published evidence” and “plausibility” have been discussed, pointing out that the outcome in each particular case would not have been different from the actual finding of the respective Board of Appeal if the guiding principles of the G2/21 decision are taken into account (paragraph 72 of the decision). Therefore, as already pointed out in other articles on the topic, it seems reasonable to use the arguments presented in the cited decisions as a proxy to assess future cases in which post-published evidence may play an important role.
On the other hand, we will have to wait for pending or future cases before the Boards of Appeal to see how the abstract guiding principles are interpreted. It might not be too long as a preliminary opinion has been issued in the case that originated the questions addressed in G2/21 (Case T 0116/18, a summary of which can be found here), which will most likely be the first case where a more concrete guidance on this topic may be provided.
Finally, after the decision G2/21 it is worth to stop and consider the complexity involved in a patent application drafting project, particularly but not exclusively in the pharma and biotech fields. If the “Holy Grail” is (and has always been) the “technical teaching encompassed by the claimed invention”, it is of utmost importance to include in the patent application this technical teaching in the most clear and complete way. This with the aim to leave the door as wide open as possible for post-published evidence filings and to be able to rely upon technical effects that were originally either not apparent or that were not enough highlighted in the application as filed.
This is of special relevance in the fields of pharma and biotechnology, in which the ability to predict is very limited. Moreover, in these fields, factors like the degree of maturity of a technical development, the data available that can be included in the application, and the large amount of uncertainty intrinsic to the development of a drug, make the drafting of the claims and the inclusion of future fallback positions especially hard. All this considering that, it is not only whether data is available or not, but also that projects while it is advisable to protect them as soon as possible, usually take many years to reach the market and to produce critical data. Here, the teamwork between inventors and IP attorneys, and the ability of the latter to not only be able to understand and describe the invention as deeply as possible are key factors to maximize the chances of success of the patent application and to obtain effective protection for the invention.
Author: Ricard Valdés-Bango Curell; Ph. D in Biotech at Curell Suñol.
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