In my preceding post, I announced another decision on Swiss-type claims. Indeed, the claim under consideration is a very particular and rather unusual Swiss-type claim:
1. Use of at least one vital dye for the manufacture of a composition for staining a retinal membrane in an eye to visually distinguish the retinal membrane from the underlying retina in a method for performing retinal membrane removal.
Applicable law
[3.1] The present decision was taken after the revised EPC entered into force on 13 December 2007. Since the European patent in suit was granted before that date, A 53(c) applies and A 54(5) does not apply to it, in accordance with Article 7(1), second sentence, of the Act revising the EPC […] and Article 1 Nos. 1 and 3 of the Decision of the Administrative Council of 28 June 2001 on the transitional provisions under Article 7 of the Act revising the EPC […].
[3.2] According to decision G 5/83 [point 2 of the order], a European patent may be granted with so-called Swiss-type claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application. This approach was a “special approach to the derivation of novelty” (see G 5/83 [21]) and therefore constituted a narrow exception to the principles governing the novelty requirements which was not intended to be applied in other fields of technology (see G 2/08 [7.1.1]). Since the intention of the legislator was clearly not to exclude second therapeutic indications of a known medicament from the field of patentability the so-called Swiss-type claim constituted the adequate but exceptional solution (see G 2/08 [7.1.1]). In view of these considerations, the board takes the view that this exception to the general novelty requirement is only justified if a claim is indeed drafted in a clear Swiss-type format.
The abolition of Swiss-type claims as decided by the Enlarged Board of Appeal in its decision G 2/08 has no retroactive effect (see G 2/08 [7.1.4]) and does therefore not apply in the present case. Moreover, the board notes that A 54(5) does not apply to the present patent (see point [3.1] above).
Claim 1 of the main request is drafted as a Swiss-type claim, but differs from the Swiss-type format adopted by the Enlarged Board of Appeal in its decision G 5/83 in that it comprises several applications: the composition manufactured by using at least one vital dye is to be used
(a) for staining a retinal membrane in an eye
(b) for distinguishing the retinal membrane from the underlying retina
(c) in a method for performing retinal membrane removal. It therefore has to be evaluated how the various applications are related to each other and to the composition manufactured from the vital dye.
[3.3] The board is of the opinion that there is a causal link between features (a) and (b) in that feature (b) further specifies the staining of the retinal membrane. The combination of features (a) and (b) defines a single staining method, in which the retinal membrane is stained but the retina or the adjacent tissue in general is either not stained or stained with a different intensity and/or a different hue. Identical staining of the retinal membrane and the adjacent tissue, which would inhibit differentiation, is thereby excluded.
[3.4] As regards the interrelationship of features (a)/(b) on the one hand and feature (c) on the other hand, the respondent argued that claims had to be read in a reasonable way taking into account the technical teaching of the patent and the general knowledge of the skilled person. The technical teaching of the contested patent excluded the concept of two separate methods, i.e. a diagnostic method followed by a separate method of surgery, for the following reasons:
[3.4.1] The staining of the retinal membrane could not be carried out for purely diagnostic purposes, as the diagnosis, i.e. the verification of the presence of a retinal membrane, had already been made before.
The board wants to point out that [the] fact that the presence of the retinal membrane had already been established does not exclude a second diagnostic step by means of staining. According to the patent […] the vital dye to be applied provides sufficient staining for a useful colouring to be visible, which means that the staining step allows a better view of the retinal membrane and thus a better identification of its form and structure, which constitutes a method of diagnosis.
[3.4.2] The vital dyes used in the present invention were not suitable for purely diagnostic purposes, as a visual distinction could only be made during retinal membrane peeling.
The board notes that this argument of the respondent is not in line with the technical teaching of the contested patent. Again, reference is made to the passage in column 3, lines 2-8 (“ … the minimum amount of dye which is necessary to provide sufficient staining for a useful coloring to be visible should be so low …” [emphasis by the board]). The board therefore concludes that the staining may be performed in order to increase visibility of the retinal membrane.
The respondent further explained that in view of its position between the vitreous and the retina, the retinal membrane covered and therefore hid the retina and that was the reason why a differentiation between the stained retinal membrane and the unstained or differently stained retina was possible only during retinal membrane peeling.
This argument is not convincing, as, firstly, there are retinal membranes which do not completely cover the retina and, secondly, even if they do, the staining nevertheless improves their visibility, even if the underlying retina is not discernible in this case.
[3.4.3] The respondent further reasoned that the staining step is technically not separable from the membrane removal step, as the dye is in a preferred embodiment directly applied onto the retinal membrane after removal of the vitreous.
It is correct that example 2 of the contested patent describes such a staining technique, which is, however, as correctly pointed out by the respondent, a preferred embodiment of the invention. The subject-matter of claim 1 is not restricted to a specific method of applying the vital dye. As a consequence, other methods conventionally used such as intravenous or intravitreal injection, which allow a separation between staining of the retinal membrane and its removal, are included.
Finally, reference is made to column 4, lines 53-56 of the contested patent, which indicates that retinal membrane staining is preferably [emphasis by the board] employed as part of a vitreo-retinal surgical procedure, which means that separate staining, e.g. for diagnostic purposes, is envisaged as a less preferred embodiment.
[3.5] As a consequence, the board concludes that it is reasonable, both technically and in view of the teaching of the contested patent, to regard the staining procedure as a first activity, which is then followed by a second surgical method.
[3.6] Moreover, the concept of two separate subsequent methods is not excluded by the wording of claim 1. In this context, the term “in a method …”, which forms the link between staining and membrane removal but does not precisely define the nature of said link, is of particular interest. In the board’s view, the term “in a method …” may imply that the staining procedure is embedded in the membrane removal procedure, but it also has the meaning that the staining of the retinal membrane is simply carried out in the larger context of membrane removal surgery. Thus, the wording of claim 1 includes the situation that a retinal membrane, whose presence has already been diagnosed, is stained in order to improve its visibility so that more details can be recognised, which is a further diagnostic step. Then, in the light of these results, the ophthalmologist can decide whether or not to remove it. In view of the fact that the dye can be applied intraveneously or intravitreously, there is no obligation to perform the membrane removal right after the staining procedure.
[3.7] To summarise:
[3.7.1] In the light of the teaching of the contested patent two options are technically reasonable. The present invention may relate to (a) a single method comprising both staining of the retinal membrane and its removal; or (b) a first method of staining the retinal membrane followed by a separate method of its removal.
[3.7.2] In connection with the wording of present claim 1, it was concluded in point [3.6] above that the link between staining and membrane removal (“in a method …”) also includes both options (a) and (b).
[3.8] For determining whether the skilled person would read present claim 1 as a single method or as a sequence of two independent activities, the purpose defined in the Swiss-type wording is of critical importance: claim 1 is directed to the “use of at least one vital dye for the manufacture of a composition for staining a retinal membrane …” [emphasis by the board]. The indication of the purpose “for staining a retinal membrane” defines the activities encompassed by the Swiss-type format: all steps relating to the staining are comprised. The removal of the retinal membrane is not part of the staining procedure. It would therefore not be reasonable to include the important step of retinal membrane removal in a method defined as “use of at least one vital dye for the manufacture of a composition for staining a retinal membrane …”. The inclusion of this step would even be contradictory to the purpose mentioned above.
[3.9] The board therefore had to conclude that present claim 1 has to be read as a sequence of two separate activities: a use of at least one vital dye for the manufacture of a composition for staining a retinal membrane, drafted in the Swiss-type format and therefore not in conflict with A 53(c), followed by a separate surgical method of removing the retinal membrane, which is not drafted in the Swiss-type format and is therefore excluded from patentability pursuant to A 53(c).
Cited decisions
[3.10.1] The respondent cited decision T 1020/03 in support of the allowability of present claim 1 under A 53(c). In said decision (point [79]) the case was remitted to the first instance “for further consideration of novelty and inventive step, depending on whether the intended method of therapy was itself novel and inventive, taking into account all the features of the use in the claim …” [emphasis by the board].
The board is of the opinion that decision T 1020/03 is not relevant for the subject-matter as claimed in claim 1 of the present main request, as the claim which was the subject of said decision was a Swiss-type claim defining a single method of therapy which apart from the therapeutic indication comprised the dosage regimen as an additional feature. The same applied in decision G 2/08, also cited by the respondent in this context. However, neither of these two decisions concerned a claim including two separate sequential activities, one of which is excluded from patentability pursuant to A 53(c).
[3.10.2] A further decision cited by the respondent in this context was decision G 1/07. However, this decision is not relevant for the present case for the same reasons as outlined above in point [3.10.1]. It does not relate to a situation, where a claim refers to two separate sequential activities, one of which is excluded from patentability pursuant to A 53(c).
[3.11] As claim 1 includes a separate method of surgery, the claim as a whole is excluded from patentability pursuant to A 53(c).
[3.12] In view of the board’s finding as regards claim 1, an evaluation of the dependent claims is not necessary.
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