About the authors:
Claire Devine is a patent attorney at Appleyard Lees IP LLP. Claire has worked with a range of clients in the biotechnology and pharmaceutical areas, on applications related to a broad range of technologies, including antibodies, industrial biotechnology, gene therapies, RNA therapies, new chemical entities and drug repurposing.
David Walsh is a partner at Appleyard Lees IP LLP. He is a UK and European Patent Attorney specialising in the fields of polymers, pharmaceuticals, catalysis, process technology, sealing technology and industrial biotechnology. David has a PhD in surface chemistry from UCL.
A new EPO referral to the enlarged BoA will determine whether post-filed data can be used to support inventive step
Supporting data can be crucial to a patent application 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. However, it has been established in the Case Law of the Boards of Appeal that this additional data must relate to a technical effect that was at least “plausible” at the filing date of the application taking into account the common general knowledge at that date and the disclosure in the application.
There have been a number of recent decisions (previously discussed here), that have indicated that a lower bar has been set for the assessment of plausibility at the effective date of the application. However, the present referral now aims to determine whether post-published evidence should be disregarded for the assessment of inventive step, in the event that proof of a technical effect relies exclusively on this post-published evidence and the technical effect was otherwise implausible at the filing date. In addition, the referral asks whether the skilled person needs to consider the effect plausible at the filing date or merely not implausible.
This referral has arisen from the Opposition proceedings on EP2484209 (T0116/18). The decision to refer the question of post-published evidence to the EBA was provided in the minutes of oral proceedings of the appeal case (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 a synergistic effect. Therefore, the post-filed data submitted by the patentee was key to the determination of inventive step.
The Board highlighted divergent strains of Case Law related to the use of post published data. There were two extremes highlighted by the BoA. The first being the requirement of ab initio plausibility, wherein post-published evidence can be taken into account only if, given the application as filed and the common general knowledge at the filing date, the skilled person would have had reason to assume the purported technical effect to be achieved. The second being where plausibility is disregarded entirely. In these cases, it was found that the requirement for plausibility was incompatible with the assessment of inventive step according to the problem solution approach. It particular was not possible for a patent application to include experimental evidence necessary to demonstrate a technical effect in view of a prior art document that had not been or perhaps could not have been considered by the applicant at the time of filing.
Therefore, the Board of Appeal considered that it was necessary to refer the question of whether post-published data could be relied on to satisfy the requirement of plausibility of a technical effect. The following questions are referred to the Enlarged Board of Appeal for decision.
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 (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?
- 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 established Case Law, it seems likely that the EBA will confirm that post-published evidence should be disregarded under the circumstances set out in Question 1. Therefore, the decision may centre on where the burden of proof of implausibility lies, i.e. whether the opponent needs to establish reasons for implausibility at the filing date, or whether the patentee must demonstrate plausibility at the filing date. Indeed, the patentee considered that a further question should be included explicitly addressing where the burden of proof lies in establishing whether or not a technical effect has been achieved. However, the BoA considered that this was encompassed by the above questions.
The outcome of this referral is likely to have significant implications for the assessment of inventive step at the EPO and for the burden of proof of implausibility at the EPO.