Key points
- The present decision deals with clarity of the term 'therapeutic agent', but first provides a useful summary of the rules for admissibility of amended claims filed during oral proceedings before the OD.
- " Auxiliary Request 1 was filed and admitted during the oral proceedings in Opposition (see decision under appeal item 3.3.1). The amendments required no undue evaluation and complied with the requirements of Rule 80 EPC. Since the opposition division departed from its provisional opinion set out in the annex to the summons and finding on the novelty of the main request during the oral proceedings and concluded that the patent could not be maintained as granted, the filing of an auxiliary request, which intended to overcome the novelty objection, seemed justified as the subject of the proceedings had surprisingly changed for the patentee at a late stage of the proceedings."
- " In principle, a decision taken by a department of first instance in the exercise of its discretion may be overruled by a Board of Appeal only if it is concluded that the department exercised its discretion in accordance with the wrong principles, without taking the right principles into account or in an arbitrarily or unreasonable way, thereby exceeding the proper limits of its discretion (see Case Law of the Boards of Appeal of the EPO, 9th edition, 2019, in the following "Case Law", V.A.3.5.1.b), and in particular decision G 7/93, OJ EPO 1994, 775, reasons 2.6)."
- " In exercising its discretion, the division had first to consider the reasons for filing the request at such a late stage in the proceedings, the allowability of the late-filed amendments, on a prima facie basis, and whether the parties and the opposition division could reasonably be expected to familiarise themselves with the proposed amendments in the time available. Since the amendments introduced in claim 1 of the auxiliary request 1 were filed in reaction to a change of the opposition division's opinion regarding novelty, were intended to overcome a novelty objection, did not require any further extensive assessment for both the opposition division and the opponent, and were "prima facie" allowable, they were admitted."
- italics added. A pertinent question may be whether "the time available" is simply the time scheduled for the oral proceedings before the opposition division or something else.
- " Hence the board fails to see why the opposition division had exercised its discretion according to the wrong principles or in an unreasonable way."
- " For this reason, it will not overrule the way in which the first instance has exercised its discretion. Furthermore, since the auxiliary request 1 was admitted by the opposition division in the proper exercise of its discretion and was decided upon by the opposition division, the board fails to see a legal basis for disregarding this request (see also Case Law, supra, V.A.3.5.4). It follows that since the aim of appeal proceedings is to review the decision under appeal in a judicial manner (Article 12(2) RPBA 2020), auxiliary request 1, the only request now on file, forms part of the appeal proceedings."
- The duty of the Board to review decisions to admit a case amendment was also acknowledged in T 0960/15.
- However, the amendment is found to be unclear. " Since the term "therapeutic agent" is open to interpretation or ambiguous, claim 1 lacks clarity within the meaning of Article 84 EPC."
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" Although a skilled person is able in most cases to decide whether a certain amount of a specifically defined product has a therapeutic effect or not (see decision T 151/01 of 9 February 2006, reasons 2.1), the "therapeutic agent" used in claim 1 defines far more than a specific class of compounds in a specific quantity having a therapeutic effect for a disease. It defines any known or yet unknown biologically active compound capable of treating or alleviating at least one disease state or condition. It is not limited to agents that are approved by a competent regulatory authority and/or are on a publicly available list of therapeutics. Hence, the respondent's argument that the skilled person would be able to determine from a list of approved therapeutic products whether any agent is a therapeutic agent or not, is not decisive in resolving the present clarity issue."
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The claim is directed to a delivery vehicle for a medicament, as I understand it, and reads: "1. A fully intact eubacterial minicell derived from a eubacterial parent cell, wherein the minicell comprises biologically active compound which is a therapeutic agent and displays an antibody or antibody derivative directed to a surface antigen of a cell for cell- or tissue-specific targeting of said eubacterial minicell, wherein the biologically active compound and the antibody or antibody derivative are exogenous to the parent cell and distinct from each other."
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/08/t-026718-term-therapeutic-agent-is.html
