R 0013/09 (Fundamental violation of Article 113 EPC/ALCON) 22-10-2009

1. Admissibility of the petition for review

1.1 The petitioner is adversely affected by the decision T 15/07 revoking its patent. The petition for review was filed on the ground referred to in Article 112a(2)(c) EPC. The petition therefore complies with the provisions of Article 112a(1) and (2) EPC.

1.2 The written decision was notified to the parties by registered letter posted on 5 June 2009. The two month period for filing the petition for review expired on 15 August 2009. As the petition was filed and the fee was paid on 14 August 2009, it also complies with Article 112a(4) EPC.

1.3 Finally, the exception mentioned in Rule 106 EPC applies in the present case as the objection concerns the written decision and could not be raised during the appeal proceedings.

1.4 The petition for review is therefore at least not clearly inadmissible.

2. Allowability of the petition for review

2.1 The petition for review is based on an alleged fundamental violation of Article 113 EPC. In its decision R 1/08, point 3 of the reasons, the Enlarged Board of Appeal found that a petitioner, to succeed with this objection, had to establish (a) that the contested decision was based on an assessment or on reasoning relating to grounds or evidence which the petitioner was not aware of and had no opportunity to comment upon and (b) that a causal link existed between this procedural defect and the final decision, otherwise the alleged defect could not be considered decisive and hence not fundamental.

2.2 The petition for review is clearly not a means to review the application of substantive law. A review of the application of substantive law would mean adding a third instance to the procedure before the EPO (see CA/PL 17/00 of 27 March 2000, point 11). The petitioner's submissions are therefore to be considered strictly and exclusively under the aspect of the right to be heard. For this purpose, in the present case, it is nonetheless necessary to consider the discussion of inventive step during the proceedings in some detail.

2.3 As follows from points X and XI of the decision under review the main dispute between the parties concerned the assessment of inventive step using the problem-solution approach based on the prior art documents (3) and (18). It was common ground that document (3), proposing ciprofloxacin as active agent for antibacterial ophthalmic compositions, represented the closest prior art. The additional document (18) is a scientific paper comparing the in vitro activity of ciprofloxacin and moxifloxacin (designated as "BAY 12-8039") against a number of bacteria strains including Pseudomonas aeruginosa, MSSA(= Methicillin sensitive staphylococcus aureus), MRSA(= Methicillin resistant staphylococcus aureus) and others. It was also common ground between the parties that, according to document (18), ciprofloxacin was much more active in vitro against Pseudomonas aeruginosa, which was an important ophthalmic pathogen, whereas moxifloxacin was more active against other bacteria such as e.g. MSSA and MRSA which, according to the patent (see table in paragraph [0010]), were also important ophthalmic pathogens.

2.4 In point 3.4.1 of the decision under review, the Board assessed the inventive step of the claimed subject-matter using the problem-solution approach based on the facts referred to above. In particular, it identified the technical problem with regard to document (3) as follows: "provision of a topical composition for treating or preventing ophthalmic infections which is more effective against key ophthalmic pathogens". It then came to the conclusion that for solving this problem the skilled person would select moxifloxacin to replace ciprofloxacin as the active agent since from document (18) it appeared to be more potent than ciprofloxacin against some of the key ophthalmic pathogens, as had been argued by the opponent/appellant.

2.5 As the petitioner has not objected to the statements and findings in point 3.4.1, the Enlarged Board of Appeal is satisfied that this part of the decision, in particular the definition of the problem to be solved, is based on grounds and evidence both parties were aware of and had opportunity to comment upon before the decision was taken. Thus, for this part of the decision, requirement (a) for a successful petition for review referred to in point 2.1, supra, is clearly not met.

2.6 Turning now to point 3.4.2 entitled "Additional arguments of the respondent", the question arises whether the findings objected to by the petitioner in this part of the decision fundamentally violated Article 113 EPC and, if so, had any influence on the Board's assessment of inventive step in point 3.4.1 (requirement (b) of point 2.1, supra).

2.6.1 Point 3.4.2 of the decision concerns the petitioner's additional argument that an ophthalmologist "did not in general identify the pathogens but treated them empirically" and that, therefore, "a topical ophthalmological composition had to be effective against all the relevant ocular pathogens and certainly against Pseudomonas aeruginosa". Consequently, the skilled person would not have considered to substitute moxifloxacin for ciprofloxacin as the active agent in antibiotic ophthalmic compositions (see point IV(b), supra).

2.6.2 The reason for which the Board rejected this argument was that "it is not in line with the problem as defined in the original application" since the formulation of the problem leaves it open against which "key ophthalmic pathogens" the improved composition should be more effective than existing antibiotics.

2.6.3 As stated at point 3.1 of decision R 1/08 of the Enlarged Board of Appeal, the EPC does not require that a Board of Appeal must provide a party with all foreseeable arguments in favour of or against a request in advance.

2.6.4 Even if the parties had not been informed in advance of the Board's view referred to above, it was nonetheless foreseeable that the additional argument of the petitioner could be used to support the presence of an inventive step only if it served to rebut some aspect of the specific chain of reasoning based on the problem-solution approach discussed at the oral proceedings. The petitioner could therefore not be surprised by the fact that the Board examined whether the additional argument was really relevant to the reasoning already presented. Nor could the petitioner be surprised by the conclusion of the Board that the additional argument was not in line with the stated problem and, as a consequence, could not succeed. As follows from uncontested point 3.4.1 of the decision under review and the patent itself the problem refers neither to improved efficacy against "all the relevant" ophthalmic pathogens nor to improved efficacy against specific ones, such as, in particular, Pseudomonas aeruginosa: the stated problem clearly remains unspecific in this respect. Thus, the conclusion reached by the Board in the objected part of the decision under review was based on a fact - the formulation of the problem - which the parties must have been aware of.

2.6.5 In this context the statement of the Board in point 3.4.2 that "there are situations where he [i.e. the ophthalmologist] may want to specifically treat infections caused by MSSA or MRSA rather than by Pseudomonas aeruginosa" did not add a new assessment or reasoning but illustrated the fact referred to above that the formulation of the relevant problem leaves open against which of the numerous possible key ophthalmic pathogens the improved composition should be more effective, whether it be against MSSA and/or MRSA and/or Pseudomonas aeruginosa and/or any other bacteria.

2.6.6 Thus, the Enlarged Board of Appeal is satisfied that also the findings in point 3.4.2 of the decision clearly do not constitute a fundamental violation of Article 113 EPC. It is therefore not necessary to further examine whether, according to requirement (b) referred to in point 2.1, supra, a causal link existed between these findings and the final decision based on the findings in point 3.4.1 of the decision under review.