T 3227/19 (Rotigotine patch / LTS LOHMANN) 24-06-2022

Main request

1. Article 123(2) EPC

1.1 Claim 1 of the main request defines:

"Transdermal therapeutic system, comprising

(a) a backing layer,

(b) a solvent-based self-adhesive matrix layer containing rotigotine as active ingredient, and

(c) a release liner,

wherein the self-adhesive matrix layer [deleted: has a coating weight of about 75-400 g/m2 and] comprises a reservoir layer [deleted: containing about 9-25 wt.-% rotigotine based on the weight of the reservoir layer], the reservoir layer has a coating weight of 150 g/m2 and contains 9 wt.-% or 18 wt.-% rotigotine based on the weight of the reservoir layer, and the reservoir layer further contains polyvinylpyrrolidone and the rotigotine to polyvinylpyrrolidone weight ratio in the layer is 9:2 to 9:5 or multiples thereof."

The Board's underlining and striking of definitions identify the amendments with respect to claim 1 as originally filed.

1.2 Request regarding the admittance of the objection

The argument that claim 1 of the main request comprised subject-matter extending beyond the content of the application as originally filed, because this claim defined the coating weight of the reservoir layer, but not the matrix layer as a whole, had been presented by appellant-opponent 1 in its statement of grounds of appeal (see pages 7-8 section II.1.2).

The respondent contested this objection on substantial grounds in the reply to the appeals and only questioned the admittance of the objection in the letter of 31 May 2022. At that time the Board had already issued the summons to oral proceedings and its communication pursuant to Article 15(1) RPBA 2020. The respondent's request not to admit the objection therefore represents an amendment to the respondent's appeal case which is in accordance with Article 13(2) RPBA 2020, in principle, not to be taken into account unless cogent reasons justify exceptional circumstances for consideration of the late amendment. The Board does not recognize any such justification in the respondent's submissions. The circumstance that in line with the argument in the statement of grounds of appeal filed by opponent respondent 1 the Board questioned in its communication the correctness of the finding in the decision under appeal can in this context not be qualified as exceptional.

The Board further observes that according to the minutes of the oral proceedings before the opposition division (see page 1, lines 18-20) appellant-opponent 2 objected that claim 1 of the auxiliary request 1 as filed in preparation of the oral proceedings before the opposition division, corresponding to the main request in appeal, comprised added subject-matter and that in particular the feature of the weight ratio of the PVP and rotigotine in the reservoir ratio was discussed. In the decision under appeal the opposition division concluded, however, that the defined subject-matter was adequately based on originally disclosed convergent limitations representing a restriction towards the original core invention (see pages 6-7, section 3.1). In this context the Board considers the argument regarding the coating weight of the matrix layer in the statement of grounds of appeal filed by appellant-opponent 1 not as an amendment of the opponents' case, but as a development of the objection as already raised before the opposition division in reaction to the findings in the decision under appeal.

Accordingly, even if the question of admittance raised by the respondent is taken into account, the Board still considers the relevant argument to be part of the appeal proceedings under Article 12(2) RPBA 2020.

1.3 Assessment of the basis for the amendments

1.3.1 As indicated in section 1.1 above, the amendment in claim 1 of the main request involves with respect to claim 1 as originally filed the omission of the definition of the coating weight of 75-400 g/m**(2)for the entire self-adhesive matrix layer and the introduction of definitions regarding the constitution of the reservoir layer, including its coating weight.

The definition of a coating weight of 150 g/m**(2)for the reservoir layer in claim 1 of the main request does not imply a corresponding restriction of the coating weight of the self-adhesive matrix layer as a whole. In fact, this matrix layer may in addition to the defined reservoir layer with a coating weight of 150 g/m**(2) contain additional layers, including further reservoir layers or a skin adhesive layer (see the patent, paragraphs [0071] and [0076], see also claim 2 of the main request). Accordingly for claim 1 of the main request to comply with Article 123(2) EPC an adequate basis for both the omission and the introduction of the indicated features must be identifiable in the application as originally filed.

1.3.2 According to the respondent the following passages in the original disclosure describe a TTS with a reservoir layer as defined in claim 1 of the main request without requiring a particular limitation of the coating weight of the matrix layer:

"In one embodiment, the self-adhesive matrix layer comprises a reservoir layer. The reservoir layer represents a matrix layer and is formed by a solid dispersion in terms of the foregoing. In a preferred embodiment, the self-adhesive matrix layer only comprises one reservoir layer and does not contain any additional matrix layer, i.e., in a preferred embodiment, the self-adhesive matrix layer represents a "mono -layer" matrix."(see page 17, lines 29-36)

"In a further embodiment, the reservoir layer of the transdermal therapeutic system has a coating weight of about 75-300 g/m2, preferably about 75-200 g/m2, more preferably about 100-150 g/m2 and most preferably about 150 g/m 2 and contains about 9-25 wt.-% rotigotine, preferably about 9-20 wt.-% rotigotine, more preferably about 9 wt.-% or about 18 wt.-% rotigotine based on the weight of the reservoir layer." (see page 18, lines 15-21)

"In a preferred embodiment, the self-adhesive matrix layer of the transdermal therapeutic system of the present invention comprises a reservoir layer and the reservoir layer contains rotigotine and polyvinylpyrrolidone and the rotigotine to polyvinylpyrrolidone weight ratio in the reservoir layer is 9:2 to 9:5, preferably 9:3 to 9:5, and particularly preferred 9:4, or multiples thereof." (see page 31, lines 1-8)

1.3.3 The Board notes that the passages cited by the respondent explicitly concern embodiments involving a particular constitution of the "the self-adhesive matrix layer" and "the reservoir layer" and thereby evidently refer to a generic antecedent in the disclosure.

According to the respondent the skilled person would recognize that the mentioned embodiments refer to the generic definition of a TTS requiring no particular range for the coating weight of the matrix layer presented in the following passage of the application as originally filed:

"The term "transdermal therapeutic system" (TTS) as used herein refers to a matrix-type patch having a continuous self-adhesive matrix layer in its centre portion. Such a patch consists of a backing layer, the self-adhesive matrix layer and a release liner, which is removed before use. In the present application, the terms "transdermal therapeutic system" , "TTS" and "patch" are equivalently used in order to describe the transdermal therapeutic system of the present invention" (see pages 13-14, bridging paragraph) "

The Board observes, however, that this passage presents merely the definition of what is intended with the term "transdermal therapeutic system" (TTS) in the context of the original disclosure. This definition provides information concerning the TTS described in the application as filed, but does as such not represent itself the generic antecedent for the subsequently disclosed embodiments. According to the Board the actually disclosed generic antecedent for the mentioned embodiments is to be found in the presentation of the invention preceding the definition of the used terminology (see page 13, lines 14-23), which recites the very same features as claim 1 as originally filed, including the feature limiting the coating weight of the matrix layer to 75-400 g/m**(2).

The Board therefore considers that the TTS defined in claim 1 of the main request without specific limitation of the coating weight of the matrix layer cannot be directly and unambiguously derived from the application as originally filed. Accordingly, the Board concludes that claim 1 of the main request does not comply with Article 123(2) EPC.

Auxiliary requests 1-18

2. Auxiliary requests 1, 2, 4-6, 8-10, 12-14 and 16-18

The coating weight of the matrix layer as a whole is not further defined in claim 1 of any of auxiliary requests 1, 2, 4-6, 8-10, 12-14 and 16-18. These auxiliary requests do therefore not comply with Article 123(2) EPC for the same reason as explained above in section 1.3 in relation to the main request.

3. Auxiliary requests 3, 7, 11 and 15

The respondent has not filed an appeal of its own against the decision under appeal, in which the claims of the main request (then auxiliary request 1) were held allowable. In accordance with the principle of prohibition of reformatio in peius as recognized in G 9/92 and G 1/99 the respondent is therefore in principle restricted to defending the patent within the limits of the subject-matter as defined in the main request.

The subject-matter defined in accordance with the claims of auxiliary requests 3, 7, 11 and 15 is not restricted by the limiting features of the coating weight of the reservoir layer, the content of the rotigotine and the weight ratio between the rotigotine and PVP as defined in the in claim 1 of the main request. These requests thus include claims to subject-matter which extends at least partially beyond the subject-matter defined in the claims of the main request. Accordingly, these requests fall under the prohibition of reformatio in peius and are therefore not admitted into the appeal proceedings.

The Board observes in this context that the exception to the prohibition of reformatio in peius formulated in G 1/99 concerns a remedy in appeal proceedings in case of the introduction of an impermissible limiting amendment, which had been held allowable by the opposition division (see point 14 of the Reasons). In contrast, the amendment held allowable by the opposition division in the present case involves, as explained in section 1.3 above, the impermissible omission of a limiting feature. The exception formulated in G 1/99 does therefore not apply to the present case.

Accordingly, auxiliary requests 3, 7, 11 and 15 are not admitted into the appeal proceedings.

Auxiliary requests 19-33

4. Admittance under Article 13(2) RPBA 2020

4.1 Auxiliary requests 19-33 were filed with the respondent's letter of 31 May 2022 well after the Board had issued the summons to oral proceedings and its communication pursuant to Article 15(1) RPBA 2020.

The filing of auxiliary requests 19-33 thus represents an amendment to the respondent's case which is in accordance with Article 13(2) RPBA 2020 in principle not to be taken into account unless cogent reasons justify exceptional circumstances for taking these requests into consideration.

4.2 The respondent argued that auxiliary requests 19-33 were filed in reaction to the communication of 28 October 2021, in which the Board questioned whether the claims allowed by the opposition division complied with Article 123(2) EPC. The Board observes, however, that in section 2.1.3 of its communication the Board did not introduce any new argument, but merely expressed its preliminary assessment with respect to the objection under Article 123(2) as presented in the statement of grounds of appeal filed by appellant-opponent 1. The circumstance that in view of the arguments in the appellant's statement of grounds of appeal the Board questioned the correctness of the assessment of the opposition division cannot be regarded as exceptional.

4.3 The respondent further referred to the considerations in G 1/99, in which a request for an amendment introducing one or more originally disclosed features was exceptionally considered admissible in order to overcome an objection raised during the appeal proceedings. The Board observes, however, that the considerations in G 1/99 merely concern the exception to the principle of prohibition of reformatio in peius in appeal proceedings. This exception only relates to the content of requests intended to remedy the impermissible introduction of a limiting amendment and is therefore unrelated to the exceptional circumstances for the admittance of late amendments to a party's appeal case under Article 13(2) RBPA 2020.

4.4 For the sake of completeness the Board further notes that the feature of a coating weight of 100 to 400 g/m**(2) for the matrix layer as introduced in the independent claims of auxiliary requests 19-33 does not seem consistent with the feature that this matrix layer comprises a reservoir layer with a coating weight of 150 g/m**(2). Accordingly, auxiliary requests 19-33 do not prima facie overcome the objection under Article 123(2) EPC against the main request and auxiliary requests 1-2, 4-6, 8-10, 12-14 and 16-18 without giving rise to any new objection.

4.5 Accordingly, the Board concludes that the respondent has not presented cogent reasons for exceptional circumstances justifying the late submission of auxiliary requests 19-33. These requests are therefore not admitted into the appeal proceedings.