The development of novel chemical or medicinal substances, as well as the creation of sophisticated clinical treatment schemes, necessitate large investments and take a long period.
The filing of patent applications is a critical aspect of safeguarding these sorts of enterprises, and there are frequently asked questions about when to file. Many applicants are eager to file their patent applications as soon as possible in order to avoid being scooped by competitors, reduce the risk of having their own published prior art used against them, or establish a legal foundation for their businesses in order to attract the significant funding required for, say, clinical trial development.
Evidence to Support Patent Claims After Filing
Technical evidence, on the other hand, is an important aspect of supporting patent claims, since it is utilized to prove the sufficiency of disclosure and to justify an inventive step. Many applicants rely on the opportunity to file late-filed material in order to file as soon as feasible. Clinical outcomes for patients, which might take years, or proving that particular substances are superior to others, are examples of such evidence.
The European Patent Office (EPO) has been focusing on late-filed information to support an earlier-filed patent application in recent years. The EPO’s Boards of Appeal have reviewed several cases. (BoA). Individual rulings are usually focused on specific situations, but the BoA has opted to send core questions to the Enlarged Board of Appeal in this case (EBA). The lawsuit revolves around the late filing of data showing a synergistic impact resulting from the combination of specific pesticide chemicals. Even though the synergistic impact was not demonstrated in the patent application, it was regarded as unanticipated and so may be utilized to support the inventive steps.
The appellant, however, maintained that the evidence was filed too late and did not fulfill the criteria of the plausibility of the technical impact because of its late submission. The criteria for plausibility is important to the EPO’s consideration of patent applications because an invention can only exist if the applicant shows that its instruction addresses the issue it claims to answer. In this case, the submission of post-published material is considered if it is already credible based on the patent disclosure. To put it another way, extra post-publication data may not be sufficient to show inventive step support for a claimed invention.
The BoA proposed significant referral questions to be addressed throughout the hearings, and all parties had the opportunity to respond and recommend changes. The appellant asked that the effective date be defined more explicitly in the questions, and a follow-up question should address the burden of evidence for (not) attaining the technical impact, according to the respondent.
The questions for the EBA have been determined by the BoA in its decision:
If for acknowledgment 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 a suit or the common general knowledge, the skilled person at the filing date of the patent application in the 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 a suit or the common general knowledge, the skilled person at the filing date of the patent application in the suit would have seen no reason to consider the effect implausible (ab initio implausibility)?
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