The decision under appeal is the opposition division's decision rejecting the eight oppositions filed against European patent No. 2 269 604.
The patent in suit stems from European patent application 10 1749 85.1, which was filed as a divisional application of the earlier European patent application 02 719 864.7.
Claim 1 as granted reads as follows:
"40-O-(2-hydroxyethyl)-rapamycin for use in the treatment of solid tumors other than lymphatic cancer, wherein the solid tumor is a kidney tumor and 40-O-(2-hydroxyethyl)-rapamycin is administered as the sole active ingredient."
Under Article 100(c) EPC, the subject-matter of a European patent which was granted on a divisional application may not extend beyond the content of the earlier application as filed. In the present proceedings the parties disputed, among other things, whether claim 1 as granted met this requirement. In particular, the parties disputed whether the earlier application as filed directly and unambiguously disclosed the combination of features in claim 1: "everolimus as the sole active ingredient" and "solid kidney tumours".
The opponents' arguments are that claim 1 as granted added subject-matter because the earlier application as filed disclosed neither explicitly nor implicitly the combination of everolimus monotherapy with the treatment of solid kidney tumours: the earlier application did not individualise this specific combination of features, did not present general preferences that could lead to their combination, and did not contain any pointer to linking the two choices. Thus, claim 1 resulted from at least two selections: kidney as the solid tumour type and everolimus monotherapy as the treatment type.
The respondent argued that the issue of added subject-matter needed to be examined using the "gold standard" rather than by looking at selections from lists; the latter principle was allegedly not suitable for assessing the present case.
The board agrees with the respondent that the principle to be applied for the assessment of added subject-matter is the so-called "gold standard", i.e. the claimed subject-matter must remain within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of the application as filed - in the case in hand, the earlier application as filed. Nevertheless, this does not rule out the principle of selection from different lists, although not compulsory, being a useful tool for assessing whether the earlier application as filed discloses a direct link between features in the claims, especially in the absence of generally preferred embodiments or allowable generalisations.
In the case in hand, claim 1 as granted adds subject-matter when the gold standard is applied, and this conclusion is confirmed by the principle of selection from different lists.
The board disagrees with the respondent's argument that the disclosure that everolimus is suitable for treating solid tumours is necessarily an implicit disclosure of everolimus monotherapy. The description and the examples fail to establish a link between solid kidney tumours and everolimus monotherapy.
Thus, the application of the gold standard leads to the conclusion that claim 1 as granted adds subject-matter beyond the content of the earlier application as filed.
This conclusion is confirmed by the principle of selection from different lists.
It was common ground among the parties that the treatment of solid kidney tumours constitutes a selection from the passage bridging pages 2 and 3. Thus, the ground for opposition under Article 100(c) EPC would not prejudice the maintenance of the patent as granted if the subject-matter of claim 1 could be derived from the earlier application as filed without having to make an additional selection. However, as argued by the appellant-opponents, the administration of everolimus as monotherapy constitutes an additional selection.
The board concurs with the appellant-opponents that the general disclosure and the examples of the earlier application disclose mono- and combination therapy without giving preference to either of them. There is no indication that one of the two options is preferred; both therapies are equally disclosed and illustrated in the examples, such that a selection is unavoidable to arrive at monotherapy.
Hence, the combination of everolimus monotherapy with solid kidney tumours requires a selection from two different lists and would present the skilled person with new technical information.
In conclusion, the earlier application as filed does not directly and unambiguously disclose a link between the treatment of solid kidney tumours and everolimus as the sole active agent. Therefore, the subject-matter of claim 1 as granted extends beyond the content of the earlier application as filed.
Claim 1 of each of auxiliary requests 1 to 14 contains the combination of features "everolimus as the sole active agent" (or "everolimus as monotherapy") and "solid kidney tumours". As outlined above, this combination of features was not directly and unambiguously disclosed in the earlier application as filed.
Hence, none of auxiliary requests 1 to 14 meets the requirements of Article 76(1) EPC.
The patent is revoked.