T 0267/18 - The term therapeutic agent is unclear

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."

• " 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." 

•  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.

T 0267/18 -

Main request

4. Appellant [opponent] raised objections under Articles 54, 56, 83, 84, 76(1) and 123(2) EPC and Rule 80 EPC. In view of the board's conclusion on Rule 80 and Article 84 EPC of the main and sole request (infra), there is no need to enter into a discussion of all the objections.

Exercise of discretion to admit a claim request with amended claims by the opposition division

5. 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.

6. Appellant considered that the amendments introduced in claim 1 contravened Rule 80 EPC, Article 84 EPC and Articles 76(1) and 123(2) EPC. Auxiliary Request 1, should not have been admitted into the proceedings as it was not "clearly allowable" in accordance with the EPO Guidelines for Examination.

7. The board cannot share appellant's view for the following reasons:

7.1 Decision T 1273/04 of 16 November 2007, mentioned by the appellant, is concerned with late amendments submitted in ex parte appeal proceedings and their admission under the RPBA, while the admission of auxiliary request 1 by the opposition division during the opposition proceedings need not to comply with the Rules of Procedure of the Boards of Appeal (RPBA). The findings on this issue in that decision are therefore not applicable to the present case.

7.2 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).

7.2.1 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.

7.3 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.

Rule 80 EPC

8. Even though the introduction of "which is a therapeutic agent" was intended to overcome a novelty objection in view of document D1 (see decision under appeal, item 2.2.2, last paragraph and reasoning on page 15, item 3.3.6), appellant contended that the introduction of the term "directed to a surface antigen of a cell for cell- or tissue-specific targeting of said minicell" served no purpose. This latter amendment was superfluous and not occasioned by a ground of opposition. It violated the provisions of Rule 80 EPC. Reference was made to decision T 2526/11 of 9 January 2013, reasons 3.1 to 3.4.

8.1 The board considers that the amendments in claim 1 consisting of

(a) a biologically active compound which is a therapeutic agent and

(b) displays an antibody or antibody derivative directed to a surface antigen of a cell for cell- or tissue-specific targeting of said eubacterial minicell, (amendments in italic and underlined)

are amendments which limit and define first the biologically active compound and second the antibody or antibody derivative displayed.

8.1.1 They represent a bona fide attempt to overcome the novelty objection raised under Article 54 EPC.

8.1.2 Amendment (b) introduced in claim 1 restricts the function of the displayed antibodies. It does not amount to a mere reformulation of the characterizing part of claim 1. Thus, the conclusion of decision T 2526/11 not to allow a claim 1 which was also amended by completely reformulating the characterising part apparently to render the claim clearer and more concise, albeit without providing a reason for it, is as such not applicable.

9. The board considers that the amendments introduced in claim 1 satisfy the requirements of Rule 80 EPC.

Clarity (Article 84 EPC)

10. Appellant contended that the introduction into claim 1 of both terms "which is a therapeutic agent" and "directed to a surface antigen of a cell for cell- or tissue-specific targeting of said eubacterial minicell" led to a lack of clarity, since the claim no longer defined in an unambiguous manner the matter for which protection was sought (Article 84 EPC).

11. The respondent contended that the skilled person did not have to determine the therapeutic efficacy of each and every agent in order to determine whether it fell within the scope of protection of claim 1 or not, as it was well-known that a competent regulatory authority had to grant its approval before a therapeutic product might be released on the market in Europe. Thus, the skilled person was able to determine with ease, from a publicly available list of approved therapeutic products, whether any agent was a therapeutic agent or not.

12. The board considers that the term "therapeutic agent" defines an agent both by its intended use and effect. A "therapeutic agent" defines a chemical substance that may be used for the treatment or mitigation of a disease condition or ailment.

12.1 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. Indeed, for most of the therapeutic agents, a therapeutic effect is usually first demonstrated using experimental in vitro and/or in vivo assays, long before clinical trials begin and the agent gets regulatory approval. Given the diverging definitions provided by the parties, the board must conclude that the skilled person is not in a position to establish whether the vast majority of biologically active compounds, e.g. peptides, oligonucleotides, proteins etc... are therapeutic or not and ultimately whether a fully intact eubacterial minicell comprising such an agent falls under the scope of the claim or not.

12.2 Since the term "therapeutic agent" is open to interpretation or ambiguous, claim 1 lacks clarity within the meaning of Article 84 EPC.

13. The board concludes that the main request contravenes the requirements of Article 84 EPC.

14. In the absence of an allowable request, the decision under appeal is set aside.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.