T 1107/06 – The Relaxing Effect of Botox on G 1/03

I shall put a – provisional - end to my series of posts on disclaimers with this decision, which I consider to be of major interest.

The opposed patent claimed the use of a Botox for the manufacture of a medicament for the reduction of a cholinergic controlled secretion.

[…] Claim 1 of the first auxiliary request contains the disclaimer “wherein the secretion is not lacrimation”. The appellant maintains that this disclaimer does not comply with the requirements of A 123(2) EPC. [29]

[… T]here is a specific disclosure of the use of botulinum toxin in the treatment of lacrimation in the application as filed. However, this use is described in positive terms as part of the invention, not in negative terms as something to be excluded from it. Therefore the appellant argued that the disclaimer as such is not originally disclosed and could only be justified if it fell under any of the exceptions accepted in decisions G 1/03 and G 2/03. [30]

Prior to the above-cited decisions, it was widely accepted that a disclaimer could in principle be allowed when the subject-matter to be excluded was disclosed in the EP application as filed as an embodiment of the invention. This principle emerged from [T 4/80,]the very first decision allowing the introduction of a disclaimer into a claim. […] According to the understanding of the present board, this decision justified the allowability of the disclaimer not by its purpose, but by the fact that the subject-matter to be excluded was originally disclosed by the applicant as a possible embodiment of the invention. [31]

The principles developed in decision T 4/80 were applied or cited with approval in several other decisions (see e.g. T 80/85 [3]; T 98/94 [2.3]; T 673/94 of [3]; T 448/93 [2.2]). [32]

It is well-known that the European practice and case law concerning disclaimers in general was put into question by the decision T 323/97 which considered that all disclaimers have to strictly comply with the prohibition of adding subject-matter contained in A 123(2) EPC. However, even in this decision the principle that an embodiment “positively” disclosed in the application as filed can be disclaimed appears not to have been questioned as it follows from point 2.4.1 of the reasons. [33]

The strict approach adopted in decision T 323/97 with respect to disclaimers in general caused two other boards to refer questions of law to the Enlarged Board (EBA). T 507/99 submitted three questions to the EBA. Question 1 was worded as follows: “Is an amendment to a claim by the introduction of a disclaimer unallowable under Article 123(2) EPC for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of claim have a basis in the application as filed?” [emphasis added] It already follows from the wording of this question that the decision T 507/99 started from the premise that a disclaimer may only arguably infringe A 123(2) if the application as filed contains no basis for it, neither in negative terms (i.e. if it was disclosed as not being part of the invention) or in positive terms (i.e. if it was disclosed as an embodiment of the invention). The referral decision was therefore only made after ascertaining whether a basis, be it “negative” or “positive”, could be found in the case at hand. [34]

T 451/99 referred the following question to the EBA: “Is the introduction into a claim of a disclaimer not supported by the application as filed admissible, and therefore the claim allowable under A 123(2), when the purpose of the disclaimer is to meet a lack-of-novelty objection pursuant to 54(3)?” The term “not supported” appears to have been used in that decision in order to encompass both a negative and a positive disclosure of the subject-matter to be excluded. [35]

It follows from the above analysis that both referral decisions relied on the assumption that disclaiming subject-matter which was positively described as an embodiment of the invention in the application as filed may comply with the requirements of A 123(2). [36]

In the decisions G 1/03 and G 2/03 the EBA addressed the issue of disclaimers in the framework of the questions referred to it. This limitation clearly transpires from a passage contained in point 2 of the reasons of both decisions: “More specifically, the EBA has to deal with the allowability of disclaimers which have not been disclosed in the application as filed. […] The expression ‘unsupported’ is avoided in the following reasons, since the term ‘support’ in A 84 has a different meaning. Instead, the expression undisclosed is used.” [37]

It is thus apparent that the legal analysis of the EBA was not concerned with situations where the application as filed provides sufficient basis for the disclaimer nor did it need to elaborate on the precise conditions under which such basis would have to be accepted. The present board is unable to identify any passage in the EBA’s opinion which would indicate or imply that the premise on which the referring boards had framed their questions […] was put into question. In particular it is noted that, as the above-cited passage shows, the term “undisclosed” was substituted for the term “unsupported” used in decision T 451/99 only for the reason of avoiding any confusion with the requirements of A 84. The language chosen does therefore not imply that the term “undisclosed disclaimer” was meant to encompass situations where the subject-matter to be excluded was not disclosed negatively but only in positive terms, i.e. as an embodiment of the invention. [38]

This understanding of the EBA's opinion finds further support in the wording and the structure of the answers given to the questions referred: “1. An amendment to a claim by the introduction of a disclaimer may not be refused under A 123(2) for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of the claim have a basis in the application as filed. 2. The following criteria are to be applied for assessing the allowability of a disclaimer which is not disclosed in the application as filed: […]” (emphasis added) It is apparent that the answer no. 1 closely follows the wording of question no. 1 referred by decision T 507/99 and is therefore not concerned with a situation where the subject-matter to be excluded has a positive basis in the application. Furthermore, the necessary logical link between answer no. 1 and answer no. 2 implies that the term “disclaimer which is not disclosed” refers to the situation described in answer no. 1, i.e. to a situation where neither the disclaimer nor the subject-matter excluded by it has a basis in the application as filed. [39]

The above understanding of the EBA’s opinion is also reflected in the decision T 1139/00. [40]

The view that a disclaimer may be acceptable if the excluded subject-matter has been originally disclosed in positive terms as an embodiment is also embraced by the Guidelines for Examination in the EPO (C-III 4.20). [41]

The board is aware, however, that a more restrictive approach has recently emerged in the case law of the boards of appeal (see decisions T 1050/99 [2-7]; T 1102/00 [4]; T 236/01 [6]; T 868/04 [3.4]; T 795/05 [7.1]; T 1559/05 [2.1]). According to this approach disclaimers which exclude subject-matter disclosed as an embodiment of the invention are regarded as non-disclosed disclaimers and held unallowable unless they fall under one of the exceptions laid down in decisions G 1/03 and G 2/03. [42]

In T 1050/99 considerable weight is placed on a passage in G 1/03 [2.5] concerning disclaimers which exclude non-working embodiments. Nothing in this passage suggests that, as assumed in T 1050/99, it concerns the exclusion of non-working embodiments that were specifically disclosed in the application as filed. As already set out above, the EBA restricted its analysis to so-called undisclosed disclaimers which, in the light of the questions referred, were not meant to include disclaimers excluding subject-matter originally disclosed as embodiments in positive terms. [43]

A further argument made in order to support the restrictive approach is that in cases where a positively disclosed embodiment is later disclaimed it could not be inferred from the original disclosure that the applicant intended to exclude the subject-matter of the disclaimer from the scope of protection (see T 1102/00). Although this observation is correct in itself, it does not lead to the conclusion that the disclaimer necessarily fails for this reason to comply with A 123(2). The fact that the technical teaching of an application as filed discloses subject-matter as part of the invention which is not comprised in the amended claim does as such not justify an objection under A 123(2). To hold otherwise would be in sharp contrast to the established case law which e.g. accepts that an applicant or proprietor may under certain conditions amend Markush formulae by “shrinking” the definitions of substituent groups (see T 615/95; T 948/02 [2.4.1]). […] Thus, the mere fact that an amended claim encompasses less than what was originally disclosed as the subject-matter of the invention is per se not bad under A 123(2). [44]

The board therefore considers that the decisive question to ask in the present circumstances under A 123(2) is not whether the skilled person could infer from the original disclosure that the applicant intended to exclude the subject-matter of the disclaimer from the scope of protection. Rather it has to be ascertained whether there is a clear and unambiguous disclosure of the subject-matter remaining in the claim. Applying the established yardstick to be used in the framework of A 123(2), such disclosure may be explicit or implicit. Implicit disclosure includes what any person skilled in the art would consider necessarily implied by the patent application as a whole (see T 860/00 [1.1]) [45]

When there is a generic disclosure of the invention together with a specific disclosure of an illustrative or preferred embodiment falling under the generic disclosure, the skilled person will normally imply that all the other embodiments comprised in the generic disclosure without being mentioned specifically also form part of the invention. The non-exemplified or non-preferred embodiments are thus implicitly disclosed as the logical complement of the exemplified or preferred embodiments. [46]

[…] The view expressed in the present decision finds further support in a number of decisions dealing with amendments of applications where both a general and a preferred range were originally disclosed. In such a situation, a combination of the preferred disclosed narrower range and one of the part-ranges lying within the disclosed overall range on either side of the narrower range is considered to be unequivocally derivable from the original disclosure of the patent in suit and thus supported by it (see T 2/81). [48]

The board therefore comes to the conclusion that it should not embrace the restrictive approach adopted in the decisions cited above but should continue to follow the prior established case law. Claim 1 of the respondent’s first auxiliary request is thus considered to comply with the requirements of A 123(2). [49]

I find this decision (taken by a Board chaired by Mrs. Kinkeldey) highly interesting as it could open a way around G 1/03 for disclaiming elements that are disclosed in the application. We will now have to wait and see if this position is adopted by other Boards. I for one would welcome this evolution of the case law because I find it more in line with the traditional approach that authorises an applicant having claimed different alternatives to abandon some of them while limiting the claimed subject-matter to the remaining alternatives. 

NB : This decision has already been discussed here.

To read the whole decision, click here.