T 2988/18 (Hyaluronic acid-based gels including lidocaine Hydrochloride/ALLERGAN) 21-04-2021

Reasons for the Decision

1. Admission of late filed arguments

1.1 In its submissions dated 26 March 2021 the appellant presented two arguments to meet the objection that the amendment to claim 1 of the main request, whereby the amounts of uncrosslinked hyaluronic acids were amounts expressed in percent "by volume", did not comply with Article 123(2) EPC. The first one was that this amendment did not add new technical teaching. The second was that even if the feature was not derivable from the application as filed it would nevertheless comply with Article 123(2) EPC in view of decision G 1/93. It is this second argument that was objected to by the respondent 01. Respondent 01 requested that it was not admitted into the proceedings.

1.2 In the present case the Board issued the summons to oral proceedings in July 2020. Notification of the summons occurred before the appellant filed its argument based on G 1/93. This means that Article 13(2) RPBA 2020 is relevant (Article 25(3) RPBA 2020). That provision suggests that: "Any amendment to a party's appeal case made...after notification of a summons to oral proceedings shall, in principle, not be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned."

The Board concurs with the interpretation of Article 13(2) EPC given in decision T 247/20 (Reasons 1.3) as summarised below.

The test under Article 13(2) RPBA 2020 is a two-fold one. The first question is whether the submission objected to (the argument based on G 1/93) is an amendment to a party's appeal case. If that question is answered in the negative, then the Board has no discretion not to admit the submission. If, however, that question is answered in the positive, then the Board needs to decide whether there are exceptional circumstances, justified by cogent reasons, why the submission is to be taken into account.

An amendment to a party's appeal case is a submission which is not directed to the requests, facts, objections, arguments and evidence relied on by the party in its statement of grounds of appeal or its reply. In other words: it goes beyond the framework established therein. As there was no argument based on G 1/93 in the statement of grounds of appeal the question arises whether this argument is an amendment to the appellant's appeal case. The Board considers that it is not for the reasons set out below.

1.3 There is no definition of the term "argument" in the RPBA 2020. In G 4/92 the Enlarged Board contrasted arguments to grounds or evidence and suggested that arguments "are reasons based on the facts and evidence which have already been put forward" (Reasons 10). This leaves open the question whether the type of argument made by the appellant, namely one where the Enlarged Board interpreted Article 123(2) EPC (the argument based on G 1/93), also falls under the ambit of Article 13(2) RPBA 2020.

1.4 Arguments pertaining to the interpretation of law are arguments generally accepted at any stage of the proceedings (see e.g. for German nullity proceedings Hall/Nobbe in Benkard, PatG, 11**(th) edition, § 83 Rz. 14 and Voit in Schulte, Patentgesetz mit EPÜ, 10**(th) edition, § 83 PatG, Rz. 20, for German civil proceedings Saenger, Zivilprozessordnung, Nomos, 8**(th) edition, § 282, Rz.12; for English civil proceedings Pittalis v Grant [1989 QB 605], at p.611). This has been recognised in the explanatory remarks to the RPBA 2020 according to which submissions of a party which concern the interpretation of law are not an amendment (Supplementary publication 1, OJ EPO 2020, p.218). The Board concurs with this view.

Respondent 01 submitted that the argument based on G 1/93 was not limited to a reference to the case law, but that a new argument had been developed on the basis of this case law. This constituted a new line of argument which amounted to an amendment to the appellant's appeal case. The Board is not convinced. The appellant's argument based on G 1/93 is essentially that G 1/93 permits an undisclosed feature to be added to a claim in certain limited circumstances, and that these circumstances existed in the present case. In short:**()the principle set out in headnote 2 of G 1/93 applied to the present case. The Board is of the opinion that this argument is precisely what was meant by the passage of the explanatory remarks to the RPBA 2020 referred to above, because an argument about the interpretation of law will naturally concern how that interpretation applies to the facts of the case before the Board.

2. Main request - Amendments

2.1 Claim 1 as granted differs from claim 1 as originally filed by inter alia the introduction of the feature "wherein the hyaluronic acid component comprises greater than 10% uncrosslinked hyaluronic acid by volume".

As also argued by the appellant, said feature originates from original dependent claim 7 which reads:

"7. The method of claim 1 wherein the HA component comprises greater than about 10% uncrosslinked HA".

Original claim 8 related to the same subject-matter and disclosed a more restricted range of concentration of uncrosslinked HA, namely:

"8. The method of claim 1 wherein the HA component comprises at least about 20% uncrosslinked HA".

None of original dependent claims 7 and 8 indicate however the nature of the concentration unit of uncrosslinked HA, which is given in "% ...by volume" in claim 1 of the main request. The introduction of the concentration in "% ... by volume" is therefore not derivable directly or unambiguously from the original claims, in particular original dependent claims 7 or 8.

2.2 In view of the absence of any indication of the nature of the concentration unit in original dependent claims 7 and 8, i.e. in % "by volume", there remains the possibility of turning to the description as originally filed to determine a possible basis or correspondence for said concentration unit in % "by volume". For the sake of clarification, this feature of % "by volume" corresponds to a concentration of "volume/volume %" or "v/v %.

2.2.1 In the description as originally filed, the concrete concentration of HA is given in several different units, namely:

- in % without further specification, in paragraphs [0018], [0019], [0026] and [0048],

- in weight by volume %, i.e. w/v%, in paragraph [0043] and paragraph [0096] of example 2,

- in weight by weight %, i.e w/w%, in paragraphs [0050], [0052] or [0097],

- in % by volume, in paragraphs [0048], [0049] or [0086].

Consequently, there is no uniform disclosure in the description of the application as filed regarding the unit concentration of HA, and the skilled person is not in a position to deduce therefrom that the concentration of "uncrosslinked HA" should be unambiguously in % "by volume".

2.2.2 Moreover, none of the passages cited above, namely paragraphs [0018], [0019], [0026], [0043], [0048], [0049], [0050], [0052], [0086] and [0097], refers explicitly to the concentration of specifically "uncrosslinked HA" as disclosed in claim 1 of the main request or original dependent claims 7 and 8.

All passages refer indeed to the concentration of "free HA", with the exception of paragraph [0043] which refers to the concentration of "free or lightly crosslinked HA" and not to "uncrosslinked HA".

The application as filed makes though a clear distinction between what is meant by "free HA" and by "uncrosslinked HA"."Free HA" is defined as "uncrosslinked HA as well as lightly crosslinked HA chains and fragments" in paragraph [0018]. In paragraph [0036] the term "free HA" refers to "individual HA polymer molecules that are not crosslinked to, or very lightly crosslinked". In the same paragraph it is stated that "free HA" can be defined as "the uncrosslinked, or lightly crosslinked component of the macromolecular component". In view of this distinction made in the description the Board does not accept the appellant's argument that the skilled person, relying on his common general knowledge, would use free and uncrosslinked HA interchangeably.

Consequently, the skilled person is neither in a position to deduce immediately that the concentration of "uncrosslinked HA" used in claim 1 of the main request or in orignal dependent claims 7 and 8 should unambiguously correspond to the concentration of "free HA" disclosed in the description.

2.2.3 The Board can also not follow the appellant's argument that paragraphs [0049] and [0086] were the only passages of the description which provided a directly identifiable counterpart to both of original claims 7 and 8 and which elaborated on the manner in which the percent values were to be calculated, namely "by volume".

Paragraphs [0049] and [0086] disclose respectively that "the composition can include about 10% to about 20% or greater of free HA by volume" and "the precursor gel is a relatively less cohesive gel comprising at least 10% to about 20% free HA by volume".

However, said passages neither relate to the concentration of "uncrosslinked HA" nor to a general "soft tissue filler composition" as given in claim 1. Both paragraphs [0049] and [0086] relate indeed to the concentration of free HA rather than uncrosslinked HA. Moreover, they concern specific forms of the precursor composition, i.e a dispersion of a solid phase in a fluidic phase in paragraph [0049], and a "relatively less cohesive gel" in paragraph [0086]. Instead, claim 1 of the main request relates very generally to a "soft tissue filler composition" without any further specification of the type of composition.

Furthermore, the circumstance that in paragraphs [0049] and [0086] the percentage is expressed by volume does not remedy the general confusion with regard to the concentration of HA in the description as a whole. For instance, the disclosure of paragraph [0049] is immediately followed by two paragraphs, which give the concentration of free HA in another concentration unit, i.e in "% by weight" (cf. par. [0050] and [0052]). Paragraph [0052] states in particular that "the free HA makes up greater than about 20% by weight of the HA component", and this specific passage could also have be seen as an identifiable counterpart to at least original claim 8.

It follows that the skilled person cannot consider the disclosure of paragraphs [0049] and [0086] as a directly identifiable counterpart to both of original claims 7 and 8.

2.3 The Board can also not follow the appellant's argument that, even if the wording "by volume" would not be derivable from the application as filed, the main request would nevertheless comply with Article 123(2) EPC in view of the findings in G 1/93 regarding the addition to a claim of an undisclosed limiting feature.

2.3.1 In this decision, it was acknowledged that a feature which was not disclosed in the application as filed but which was added to a claim during examination was not to be considered as contravening Article 123(2) EPC if it merely limited the protection conferred by the patent as granted by excluding protection for part of the subject matter of the claimed invention as covered by the application as filed, without providing a technical contribution to the subject matter of the claimed invention. These principles were confirmed by the Enlarged Board in its decision G 2/10 (see point 4.3 of the reasons).

2.3.2 Hence, according to the appellant, the wording "by volume" was introduced into the claims during examination of the application for the patent and it would have been clear to a skilled reader that said wording "by volume" merely had the effect of excluding protection for part of the subject matter of the claimed invention as covered by the application as filed. Said feature did furthermore not provide for a technical contribution to the subject matter of the invention claimed therein, which was concerned with the provision of a method of manufacture of a HA-based soft tissue filler compositions which overcome problems of degradation caused by anesthetic agents such as lidocaine (see, e.g., paragraphs [0012]-[0014] of the application as filed). There was nothing in the application as filed to indicate that the use of uncrosslinked hyaluronic acid in these amounts when calculated on a percent by volume basis provides a technical contribution to the invention claimed therein.

For this reason, this feature could not to be considered as subject-matter which extends beyond the content of the application as filed in the sense of Article 123(2) EPC.

2.3.3 In the present case, as pointed out by the respondents, the concentration level of free HA affects several technical effects, such as the kinetics of release of lidocaine from the composition (see paragraph [0097]), and the general cohesive level of the soft filler tissue composition which can be a highly cohesive gel with an amount of free HA not greater than 10% by volume, or a less cohesive gel when the free HA is over 10 % by volume (see par. [0086]). The cohesive level has very likely an impact on the stability of the composition, as was argued by the respondents. Thus, it directly affects one of the technical contributions provided by the invention as defined by the appellant, namely overcoming the problems of soft-tissue filler composition degradation caused by anesthetic agents such as lidocaine.

Thus the concentration "greater than 10% uncrosslinked hyaluronic acid by volume" is clearly a feature having a technical effect and providing a technical contribution to the claimed invention, contrary to the argument presented by the appellant.

Moreover, the application as originally filed mentions several technical objectives, such as a long term stability, a good usability in vivo, an absence of allergic reactions in patients and a good biocompatibility (see par. [0012]-[0014]). All these technical objectives play a role when determining the technical contribution of the application as filed. In the Board's view it cannot be excluded that the amount of free HA has an impact of the effects underlying these objectives.

2.3.4 Consequently, the conclusion reached in G 1/93 in relation to the addition to a claim of an undisclosed limiting feature cannot apply to the present case, since the feature "by volume" provides a technical contribution to the subject-matter of the claimed invention.

In the present case, the relevant question for the purposes of Article 123(2) EPC remains therefore whether an amendment made to the claims remains within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, from the whole of the application as filed (according to the "gold standard" of G 2/10, OJ 2012, 376). This is not the case with the feature "by volume" in claim 1.

2.4 Hence, the main request does not meet the requirements of Article 123(2) EPC for this reason.

3. Auxiliary Request - Amendments

The auxiliary request differs from the main request only in that claim 2 has been deleted, while claim 1 remains unchanged; the conclusion reached for claim 1 of the main request applies therefore also to claim 1 of the auxiliary request.

The introduction of the concentration in % "by volume" in claim 1 of the auxiliary request is therefore not derivable directly or unambiguously from the original application and the auxiliary request does not meet the requirements of Article 123(2) EPC for this reason.