G2/21 Plausibility – the decision

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Sarah Gibbs: Sarah is a senior associate and patent attorney. Sarah helps clients protect their inventions in both the chemical and biochemical fields. As a result of working with a wide variety of clients in these sectors, she has experience and understanding of the challenges faced by different companies.

Sarah’s work includes providing patentability advice, drafting patent applications, prosecuting patent applications in the UK, Europe and worldwide and handling large international portfolios. Sarah also has experience conducting and providing freedom to operate advice as well as advising on patent infringement and validity matters.

The Enlarged Board of Appeal has decided that post-published evidence can be used to prove a technical effect for the assessment of inventive step if the technical effect is “encompassed by the technical teaching” of the application at the original filing date.

 

Background

As we previously reported (here), post-published evidence can be crucial to establishing patentability, especially in the pharmaceutical and biotechnology fields. As such, applicants will often provide additional data during prosecution in order to support the patentability of an invention.

The referral in G2/21 arose from opposition and related appeal proceedings on EP2484209 (T0116/18). EP2484209 relates to an insecticide comprising two compounds which provided a synergistic effect.

In order to establish inventive step, the patentee relied upon post-published evidence of the alleged synergistic effect. Therefore, the post-published evidence was key to the determination of inventive step. However, divergent strands of case law were highlighted by the Board of Appeal when considering whether the post-published evidence could be taken into account. For this reason, the Board of Appeal referred the following questions to the Enlarged Board of Appeal:

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):

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)?

 

Decision

As mentioned above, the Enlarged Board of Appeal held that post-published evidence can be used to prove a technical effect for the assessment of patentability. The order reads as follows:

1). 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.

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.

The Enlarged Board of Appeal has therefore qualified that the principle of free evaluation of evidence is universally applicable under the EPC. In other words, evidence submitted to prove an alleged technical effect, where such evidence is crucial for the assessment 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.

Although “plausibility” is not mentioned in the headnotes of the order, in the decision the Enlarged Board of Appeal did consider that the term is not “a distinct condition of patentability and patent validity” under the EPC and go on to say that it is “rather an assertion of fact and something that a patent applicant or proprietor must demonstrate in order to validly rely on an asserted but contested technical effect”.

According to the Enlarged Board of Appeal, the core issue rests with the question of what the skilled person, taking into account the common general knowledge, would understand at the filing date of the application as the technical teaching of the claimed invention. Accordingly, a technical effect relied upon to support an inventive step, even if provided at a later stage, needs to be encompassed by the technical teaching of the application as filed.

It was held that these guiding principles would allow relevant “deciding bodies” of the EPO to take a decision as to whether or not post-published evidence may or may not be relied upon to prove an alleged technical effect when assessing inventive step.

 

Implications

In view of the Board’s decision, it has been clarified that the EPO may not reject an invention solely on the basis that evidence supporting a technical effect was not available at the time of filing the application. Rather, the EPO must decide on a case-by-case basis whether the alleged technical effect is “plausible”, i.e., whether it is encompassed by the technical teaching of the application as filed, or not.

Although applicable across all technical fields, the implications of the decision are likely to be greater in the pharmaceutical and biotechnology fields where the question of plausibility more frequently arises. Indeed, the Enlarged Board of Appeal note that a stricter standard applies for second medical use claims because “it is necessary that the patent at the date of its filing renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application”.

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