The present decision deals with an appeal against the decision of the Opposition Division to revoke the opposed patent. Claims 1, 8 and 9 of the patent as granted read:
1. A transdermal therapeutic system (ITS) consisting of an active compound-impermeable back layer, at least one matrix layer based on polyacrylate and comprising fentanyl, and a protective layer to be removed before use, characterized in that the polyacrylate is self-adhesive and free of carboxyl groups, is synthesized only from monomeric esters of alcohols comprising 1 to 8 C atoms, the alcohols having optionally a hydroxyl group, and of acrylic and/or methacrylic acid and, if appropriate, vinyl acetate in an amount of up to 50 percent by weight, and has a saturation solubility for fentanyl of between 3 and 20 percent by weight, and in that the active compound-containing layers contain at least 5 percent by weight of the incorporated fentanyl (und daß die wirkstoffhaltigen Schichten mindestens 5 Gewichtsprozent des eingearbeiteten Fentanyls enthalten), 80 percent by weight thereof being in molecularly disperse dissolved form.
8. The ITS as claimed in any of claims 1 to 7, characterized in that it additionally contains a control membrane as a further layer.
9. The ITS as claimed in claim 8, characterized in that it additionally contains a self-adhesive layer situated toward the skin on the control membrane for fixing to the skin.
The patent proprietor requested a correction of claim 1 under R 139: the word “incorporated” (eingearbeitet) was to be displaced so that “the active compound-containing layers contain at least 5 percent by weight of the incorporated fentanyl” (und daß die wirkstoffhaltigen Schichten mindestens 5 Gewichtsprozent des eingearbeiteten Fentanyls enthalten) would read “at least 5 percent by weight of the fentanyl are incorporated in the active compound-containing layers” (und daß die wirkstoffhaltigen Schichten mindestens 5 Gewichtsprozent des Fentanyls eingearbeitet enthalten). According to the patent proprietor, this amendment qualified as correction under R 139 because it was clear from the application as filed that the active compound was only incorporated into the glue from which the compound-containing layer was made.
The Board will not allow this correction:
*** Translated from the German ***
[3] In the present case the proposed correction concerns the feature “and in that the active compound-containing layers contain at least 5 percent by weight of the incorporated fentanyl” (“und daß die wirkstoffhaltigen Schichten mindestens 5 Gewichtsprozent des eingearbeiteten Fentanyls enthalten”; see claim 1 as granted). According to the [patent proprietor] this feature is to be amended such that the word “incorporated” follows the word “fentanyl”, so that the following feature is obtained “in that at least 5 percent by weight of the fentanyl are incorporated in the active compound-containing layers” (“und daß die wirkstoffhaltigen Schichten mindestens 5 Gewichtsprozent des Fentanyls eingearbeitet enthalten”). However, when a request for correction is filed, it has to be examined whether the part of the European patent concerned by the request contains such an obvious error that a skilled person is in no doubt that this information cannot be meant to read as such (see G 3/89 and G 11/91).
Pursuant to R 139, linguistic errors, errors of transcription and mistakes in any document filed with the EPO may be corrected on request. If the request for such correction concerns the description, claims or drawings, the correction must be obvious in the sense that it is immediately evident that nothing else would have been intended than what is offered as the correction. This requirement is not fulfilled in the present case.
It is true that when reading claim 1 as granted, one notes that not all of the fentanyl is found in the at least one matrix layer, although the ITS only consists of an active compound-impermeable back layer, at least one matrix layer comprising active substances, and a protective layer, wherein, according to the [patent proprietor] neither the back layer nor the protective layer contain active substances.
However, the skilled person, when reading the claims as granted, comes to the conclusion that the ITS may contain further layers besides the three layers that have already been mentioned, i.e. a control membrane and another self-adhesive layer (see claims 8 and 9 as granted).
Therefore, the skilled person concludes that in the present case the expression “consisting of” has no exclusive meaning but has to be understood as a synonym for “comprising”, so that fentanyl may be found within the ITS in the form of further layers or, as there is a control layer, even in the form of a reservoir.
Consequently, there is no obvious error which could be corrected under R 139. Therefore, the displacement of the word [“incorporated”] mentioned above is to be seen as an amendment that has to comply with A 123.
As a matter of fact, A 123 proved fatal to the requests on file.
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4 comments:
Is a correction under R. 139 EPC of the text of the granted patent at all possible? I would say this text (the Druckexemplar) is part of the decision of the ED and can no longer be regarded as a "document filed with the EPO".
According to J 3/01:
"Correction under Rule 88 EPC does not reverse the effect of decisions already taken on the basis of the uncorrected document (...)". So in the present case, if the proprietor had succeeded in getting a correction of the application documents filed by him as applicant during the examination phase, this would have had no effect on the grant decision. The request for correction under R. 139 EPC was hence useless (at least from the point of view of Art. 123(3)).
What he should have requested is a correction under R. 140 EPC, and maybe the Board should have interpreted the request that way. We then get the situation that is the subject of upcoming decision G 1/10.
According to G 3/89 and G 11/91, a patent may be corrected (during opposition) under R. 139 EPC. However, it seems clear to me that such corrections do not affect the text of the patent as granted (which is the base point for Art. 123(3)), but only the proposed text for maintenance in amended form.
Personally I have doubts as to whether the Druckexemplar (DE) is part of the decision of the ED and can be corrected under R140. Before the decision is taken, the DE is submitted to the applicant who gives his consent to it. So in reality it is a document submitted by the the applicant to the EPO...But this is another story which will be clarified with G1/10 (hopefully, because it is not directly part of the question asked).
On the other hand, I do not see a problem with the application of R 139. If the correction is allowed, the the Board will have to decide with the text at hand at that time, i.e the corrected text. J3/01 says that it is not acceptable to use a correction to go back to a procedural state that has already been terminated. In this case, if the correction would have been accepted, it would not mean that the application would go back to examination to get re-granted, possibly re-opposed etc. The Board would - for example - have decided to set the revocation aside because the grounds of opposition did not prejudice the patent (with the corrected text). And may be to send the case back to the OD. Something that is part of the normal procedure of the appeal.
I would think that Manolis is right. That corrections under R 139 (R 88 EPC 1973) are possible has been acknowledged, for instance, in J 42/92 ("A request under R 88 for amendments to the description or claims can only be filed during the pendency of application or opposition proceedings").
I do not think that a correction under R 140 (R 89 EPC) is possible because the text granted was the text the ED intended to grant (cf. T 805/95).
E-X 10 of the Guidelines is very explicit:
"Correction of errors in decisions must be clearly distinguished from correction of errors in documents filed by the applicant (or patentee) pursuant to R 139. [...] Correction of errors made by the applicant (or patentee) in application (or patent) documents cannot be arrived at in a roundabout manner through correction of the decision to grant (or maintain in amended form).
Correction of a decision is admissible only if the text of the decision is manifestly other than intended by the department concerned."
I agree that requesting correction under R. 139 is possible during opposition, but that does not necessarily imply that an allowed correction of e.g. the originally filed application documents has an effect on the patent as (already) granted (e.g. in case the opposition is rejected, or for the application of A. 123(3) in opposition proceedings).
Now maybe it does not really matter for A. 123(3) if the text of the patent as granted is changed, since allowance of the correction more or less implies the recognition that the text as granted should be read as if it was corrected. However, it might still be possible to think of cases where an allowable correction extends the scope of protection as compared to the uncorrected claims as granted.
@Manolis:
If your view is correct that the text of the granted patent is not part of the decision to grant, but is merely referenced by it, then I would agree that correction of this text is not possible under R. 140, but possible under R. 139. (However, I prefer the view that the text of the granted patent is part of the decision to grant.)
If the text is part of the decision to grant, then I still don't see how a correction under R. 139 could affect either form or content of a decision already taken, even though admittedly the situation in J 3/01 is somewhat different.
A situation that is somewhat similar to a request under R. 139 after grant is a request under R. 139 after a decision of the Board to remit to the ED with an order to grant / order to adapt the description. If the text fixed by the Board's decision is to be considered part of the decision of the Board, correction under R. 139 should not be possible (or rather, will/should not affect the text to be granted). If only the references to the documents on file form part of the decision, correction under R. 139 is probably possible (and effective).
@oliver:
I agree that a request under R. 140 would most likely not be allowed, but imho procedurally it is the only option to get the text of the granted patent corrected (apart from an appeal). I fully agree with E-X, 10 and would add that a correction of a decision cannot be arrived at through a correction under R. 139.
If Manolis is right that the text of the granted patent is not part of the grant decision, then correction of an unopposed granted patent seems not possible at all (not under R. 140 since it is not part of the decision and not under R. 139 since no proceedings are pending).
Are requests under R. 139 possible during limitation proceedings?
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