Post-published evidence can be used to assess inventive step at the EPO. The use of such evidence has developed through the case law of the EPO and more recently in the “Dasatinib” cases (T488/16 & T950/13) issued in early 2017. In particular, the EPO generally considers such evidence can be used if the evidence demonstrates or supports a technical effect that is “plausible” from the application as originally filed.
The new referral to the Enlarged Board of Appeal on this point under G2/21 will have to weigh up the benefits of allowing further evidence to support an innovative finding based on preliminary results against the risks of allowing speculative patenting. This issue is particularly relevant in the chemistry and life sciences fields and oppositions in this area.
The case underlying the referral
The referral arises from T0116/18 relating to insecticide compositions. The application claimed the combinations of compounds provide a synergistic effect. However, the opponent provided post-‑published evidence (D23) to contest the examples in the patent and the patentee provided post-published evidence (D21) to demonstrate a synergistic effect against a specific insect species. The Board faced the conundrum that they considered that the claims would only be allowable if the patentee’s evidence (D21) was taken into account because it could establish a more ambitious technical problem.
Why the referral?
The Board considered that whether or not post-published evidence, such as D21, can be taken into account is a fundamental question of law for which diverging lines of case law exist. The diverging case law generally follows either the (i) “ab initio plausibility” or (ii) “ab initio implausibility” standard.
The “ab initio plausibility” standard that 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. Dastanib I (T488/16) followed this line of reasoning and the Board ultimately did not allow consideration of the post-published evidence.
The “ab initio implausibility” standard post-published evidence can only be disregarded if the skilled person would have had legitimate reasons to doubt that the purported technical effect would have been achieved on the filing date of the patent in suit. Recently, T2015/20 followed the ab initio implausibility standard and stated:
“Claims in patent applications typically involve generalisations which inherently include an aspect of speculation. Patent applications in the field of medicine represent in this respect no exception.
The approaches developed in the jurisprudence of the Boards of Appeal of the EPO for the assessment of sufficiency of disclosure and inventive step specifically take account of the technical contribution actually disclosed in a patent application to avoid patent protection resulting from unreasonable speculation on the basis of propositions that are prima facie implausible.”
The Board referred the following three 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):
- 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)?
The issues facing the Enlarged Board
The concept of plausibility is not codified in the Articles or Rules of the EPC, but rather is concept intended to prevent speculative patenting. However, the use of post-published evidence to confirm the inventiveness of an innovation based on preliminary findings is valuable to Patentees, especially in the fields of chemistry and life sciences.
The Enlarged Board will have to find the thin line that strikes the balance between the interests of patentees and third parties. It is hoped that the Enlarged Board will recognize the difficulties faced by patent applicants when providing initial data for the patent application (in particular balancing the desire to provide good proof of concept findings with not wanting to delay filing the application after a competitor). Patent applicants also face the difficulty of drafting the patent application without an exhaustive knowledge of the prior art. Post-published evidence is useful in particular when unknown prior art is revealed and reformulation of the technical problem is required.
The issue of plausibility is a thorny and complex issue that potentially affects many high value patents in the pharmaceutical and biopharmaceutical industry, and the decision will be keenly anticipated by many in those industries.
This is for general information only and does not constitute legal advice. Should you require advice on this or any other topic then please contact email@example.com or your usual Haseltine Lake Kempner advisor.