R 0008/13 15-09-2015

Reasons for the Decision

1. Admissibility

The requirements of Article 112a (4) EPC, regarding the time limit and payment of the fee, are met.

As to the requirement of Rule 106 EPC, three objections under this rule were raised during the oral proceedings (X supra) which cover the alleged violations of the right to be heard.

The grounds linked to reasoning in the written decision could not be known during the oral proceedings.

The present petition for review is admissible.

2. Allowability

The petitioners’ grounds may be grouped in two categories which to some extent overlap:

- violations of their right to be heard (A); and

- other procedural defects (B).

Preliminary remarks about the principles to be applied: Article 113 EPC/ fair trial

1. The Enlarged Board of Appeal subscribes to the petitioners’ view that the right to be heard is not a mere formal concept for an opportunity to speak but a real right for a party to be aware of, and comment on, the decisive issue(s) on which the board is going to base its decision. In this respect the Enlarged Board fully endorses the analysis of decision R 16/13 of 8 December 2014 which in particular stated: "Demnach ist das Recht, gehört zu werden, gewahrt, wenn eine Partei die Gelegenheit erhalten hat, sich zu den entscheidungserheblichen Gesichtspunkten des Falles… zu äußern, wenngleich die Kammer aus der Erörterung der vorgebrachten Gründe letztlich ihre eigenen Schlüsse ziehen können muss (R 15/12 vom 11 März 2013 Nr.5a der Gründe). Dies bedeutet, dass die Kammer ihre Entscheidung nur auf Gründe stützen darf, die im Beschwerdeverfahren angesprochen worden sind und deshalb die Parteien nicht überrascht haben konnten” "So a party has been given the right to be heard, if it has had an opportunity to comment on the decisive aspects of the case…, even if, ultimately, the board must be able to draw its own conclusion from the discussion of the grounds put forward…. This means that the board may base its decision only on grounds which were addressed and thus could not come as a surprise to the parties” (Reasons point 3.3) (translation by the Enlarged Board).

The Enlarged Board also agrees that Article 13 RPBA which is to be applied in compliance with Article 114 EPC cannot thwart the application of Article 113 EPC.

2. On the other hand, according to established case law, the right to be heard does not go so far as to impose a legal obligation on a board of appeal (like any other judicial body) to disclose in advance to the parties, how and why, on the basis of the decisive issues under discussion - or at least those foreseeable as the core of the discussion (in this case: the different possible roles of the functional features) – it will come to its conclusion. This is part of the reasoning given in the written decision (R 1/08 of 15 July 2008, Reasons point 3.1; R 13/09 of 22 October 2009, Reasons point 2.6.3; R 16/10 of 20 December 2010, Reasons point 2.2.4; R 19/11 of 2 October 2012 Reasons point 2.2; R 15/12 of 20 December 2012 Reasons point 5; and also R 16/13 supra, Reasons point 3).

The Enlarged Board will first analyse the decision under review before examining complaints A and B

3. In point 8.3 of the reasons, the board indicated how it was applying the principles laid down in G 2/10. Starting from the Enlarged Board’s answers to the questions referred, the board explained that it had to evaluate the disclosure of the parent application as filed in comparison with the subject matter remaining in the claim after amendment due to the disclaimer (point 4.6 of G 2/10). In point 8.4 it then noted that a disclaimer introduced in a divisional application to avoid double patenting had been considered legitimate by decision G 2/10 (point 4.5.5 of the Reasons), and thus concluded (point 8.5) that the construction of claim 1 was a necessary step in order to assess what the subject-matter claimed was.

4. The board considered that claim 1 was a product claim defined by structural and functional features (points 8.5.1 to 8.5.4) and stated that the pharmacokinetic plasma profiles (also called "plasma feature” in the discussion) were attainable by means of any controlled release dosage matrix, which was not an acrylic resin matrix, and which did not cause pH-dependent dose dumping (points 8.5.2 and 8.5.4).

5. From point 8.6.1 to point 8.6.6 the board discussed different passages in the parent application which disclosed:

- the general principle but not the claimed values of oxycodome salt nor the Cmin and Cmax (corresponding to the plasma feature),

- a matrix which performed the required functions but in vitro (page 9 of the parent application),

- the possible materials of the matrix (page 10 of the parent application; claims 5 and 6 of the parent application).

6. The board concluded that it could not be derived from these passages that any of the controlled release matrices was able to provide the pharmacokinetic plasma profile required in claim 1 of the main request, or that any controlled release matrix could achieve the plasma profiles without the occurrence of an acrylic resin (point 8.6.4, last sentence). The parent application did not disclose the combination of features (a) the oxycodone salt (the active ingredient), (b) a controlled release dosage matrix providing a pH independent dissolution which was not an acrylic resin matrix and (c) the desired plasma concentration. Accordingly the subject-matter of claim 1 remaining after the introduction of the disclaimer extended beyond the content of the parent application (point 8.6.7).

(A) The alleged violations of the right to be heard

7. The core of the petition is that the decision came as a surprise because the specific construction of claim 1 which turned out to be the decisive and crucial element, on which the decision was based, was in fact raised ex officio by the board and never communicated to the parties. More precisely, the board singled out a specific feature, namely the functional plasma profiles, feature (c) of claim 1, and gave it a very specific meaning in combination with the controlled release matrix feature (feature (b) of claim 1), the latter feature being both structural and functional. This amounted to raising ex officio a new ground of opposition, the petitioners contended.

8. The argument that this conclusion was the result of an unexpected specific construction of the claim has two aspects:

(a) Such a construction had never been present in the debate since the outset of the opposition proceedings, as it had never been raised by any opponent. It was in contradiction with the previous construction of claim 1 by the opposition division and by the board in its first communication. It was not predictable. This line of argument requires looking into the file history.

(b) This objection is coupled with the contention that the specific claim construction had nothing to do with the debate, which was to be expected about the disclaimer and decision G 2/10. While the debate had been reopened precisely in order to discuss the admissibility of the disclaimer in view of G 2/10, the board in fact, under cover of remaining subject matter and G 2/10, took a general approach to the claim and dealt with its compliance with Articles 76(1) and 100(c) EPC on the basis of the interplay of structural and functional features which the petitioners had thought no longer relevant. This second aspect no longer concerns the facts but rather is the petitioners’ assessment of the merits of the analysis of the facts and of the correctness of the interpretation of the principles applied by the board.

As to the first aspect of the argument (a)

9. To determine which subject matter (grounds, facts and evidence) could have been expected to be discussed, and whether new facts and grounds were introduced ex officio by the board of appeal in its decision, the Enlarged Board has to check the file history.

9.1 The decision of the opposition division made clear that an amendment leading to claims being directed to all but an acrylic resin matrix in combination with the other claimed features was not directly or unambiguously derivable from the parent application (point 27.4 of the reasons and also supra point III). It is true that the decision was issued prior to G 2/10 but the construction of the claim expressed there was, in fact, irrespective of the principles developed by the case law. Furthermore, it anticipated the notion of "remaining subject matter” of G 2/10. ("… no matter whether the amendment is called disclaimer or not, the OD considers that its introduction leads to a specific scope which was not disclosed in the parent application”).

9.2 It must be borne in mind that the task of the board of appeal was firstly to check whether the reasons supporting the decision of the opposition division under appeal were cogent (R 16/13, supra, point 5). Therefore the subject-matter of the appeal was determined by the content of the decision under appeal.

9.3 In its first communication (24 March 2009) prior to the first oral proceedings the board also made clear that the introduction of the disclaimer created an artificial subgroup (supra VI) not disclosed as such in the parent application.

10. In this respect the petitioners counter-argued that the reasoning in the decision of the opposition division and the opinion of the board of appeal were of no relevance because they did not concern the feature of the plasma concentration (Cmin, Cmax) but only the pH independent feature and that for ten years the discussion had never concerned this feature. It is true, as appears from the file, that the relationship between the controlled matrix other than a resin matrix and the plasma profile feature had not been singled out, either by any opponent in their written submissions or by the board in its communication mentioned above.

It is also true that one cannot establish what exactly was discussed during the oral proceedings.

11. However, firstly, the general terms of the decision of the opposition division ("an amendment leading to claims being directed to all but an acrylic resin matrix in combination with the other claimed features”) and in the communication ("Hence this artificially created subgroup is limited by a certain functional definition which did not appear to configure a subgroup of controlled release polymeric materials but was a condition to be attained by the formulation”….”The definition in granted claim 1 introduces technically meaningful boundaries in the definition of the matrix component… " supra point VI - emphasis by the Enlarged Board) excludes the petitioners’ restrictive interpretation and leads to the conclusion that the scope of the appeal entailed a global evaluation of the claim. There was no reason for a non-biased reader to understand the functional features referred to as only the matrix defined by the pH-independent feature, and for not considering all the possible functional boundaries.

12. Secondly, even though no reasons were given at the end of the first oral proceedings, the logical conclusion to be drawn from the decision to close the debate on auxiliary requests I to Vb which contained the disclaimer, while continuing in writing with respect to auxiliary requests VI to VIb, is that the board stuck to its analysis set out in the communication (supra point 9.3).

13. Thirdly, it must be borne in mind that the appeal procedure is mainly in writing; the written submissions have also to be taken into account. In this respect the petitioners in their written submissions of 7 February 2012 in preparation of the oral proceedings, page 24 ff., referred expressly to the passage of G 2/10 where it was explained that the disclaimed subject matter should not lead to a particular meaning of the remaining subject-matter which was not originally disclosed. They contended that the remaining group of matrices was only a generic group limited in size, and the removal of the acrylic resin matrix did not lead to the combination of specific meanings attached to the remaining group of retardants created by the removal of acrylic resins from this group, and that specific retardants as such were not connected with the effects associated with the invention (paragraph bridging pages 26 and 27). The Enlarged Board reads these arguments, which were not limited to the pH-independent feature, as a rebuttal of the foreseeable analysis of the board, i.e the petitioners obviously had in mind the possible combinations of structural and functional features referred to so far by the opposition division in its decision and by the board in its communication, even if each of the possible combinations between structural and functional features had not been expressly addressed. It was indeed within the normal understanding of any qualified party to identify which kinds of combinations were at stake and needing to be interpreted, particularly bearing in mind the known concern of the board about the relationship between the different features (structural and functional). The declaration from Mr Van Nispen (Pet2) who, prior to the oral proceedings, tried to foresee the possible interpretations the board might come to, one of them being that the functional features played a role in the definition of the claim, and the request for referral to the Enlarged Board submitted by the petitioners during the appeal proceedings (Referral suggestion 1, supra point X(b)), are further evidence that the petitioners were aware of the issue related to the interplay of all the features.

14. Therefore the Enlarged Board cannot see anything in the decision of the opposition division, or in the first communication of the board and the whole proceedings, which could have caused the petitioners to think that the debate would be restricted to the "ph-independent feature” only, or that the interrelationship of the different structural and functional features was no longer a relevant issue.

15. Lastly it appears from the decision that the board was aware of the petitioners’ position and considered it (facts and submissions of the decision under review LIII under heading d) "the appellants’ claim requests” pages 39 ff.; and points 8.7 ff. of reasons). As reported by the board, the petitioners explained at length why the material of the matrix was irrelevant, what the core subject-matter of the invention was, and that any matrix could be taken provided it had all the required functionality. The petitioners also filed an auxiliary request 2a in response to the objection that the teaching in relation to the pharmacokinetic profile could not be combined (page 52, end of paragraph e) of the facts and submissions of the decision under review).

16. The Enlarged Board is aware of the petitioners’ objections that the facts and submissions summarised by the board in its decision are not all supported by the minutes of the oral proceedings, which, in the petitioners’ view, renders the board’s summary not reliable. However, the arguments brought forward by the petitioners during the review proceedings against the construction of the claim by the board - in line with the petitioners’ written submissions referred to supra point 13 – tally with the arguments taken into consideration in the decision and corroborate the correctness of the facts and submissions part of the decision in this respect. The board discussed these arguments, gave its own construction of the claim, which was indeed at variance with the petitioners’ position, and explained why, in view of G 2/10, the petitioners’ arguments were not accepted (8.7 ff.).

17. It follows from the above that the Enlarged Board cannot accept the contention that the claim construction and the consequences drawn from it came as a surprise, or that the petitioners were left in the dark. The board did not accept the petitioners’ analysis. While they contended that the matrix was necessarily limited by the functional plasma feature and the skilled person would know which matrices to choose, the board reasoned in terms of mere disclosure of the combination of all features, applying its interpretation of the principles of G 2/10 as shown below. It is indisputable that the petitioners, like the other parties (see the letter of opponent 4 of 14 October 2010; VII supra), were aware of what the crucial issues were, namely the disclosure of the combination of features (a), (b) and (c) wherein the controlled release dosage matrix was defined by functional features.

18. To conclude on this point, the Enlarged Board notes that what the petitioners expected from the board was that, after considering their arguments about the limiting effect of the plasma profiles feature (see the passage under facts and submissions paragraphs (d) and (e)) (already quoted in point 15 supra), it would explain to the parties how it had come to the conclusion that the combination was not disclosed and why it was not persuaded by the petitioners’ arguments. That is however beyond the right to be heard or the requirements of adversarial proceedings, and concerns the intellectual process of substantiating the decision, as explained in R 16/13 (supra 2)

19. In R 16/13, referred to by the petitioners, the Enlarged Board noted that the board, ex officio, had given an evaluation of the comparative tests, filed in order to show an improvement compared with the closest prior art which was at variance with the evaluation made hitherto by the examining division, the opposition division and both parties, and without giving the parties any opportunity for being acquainted with this evaluation nor for commenting on this new approach.

20. That situation is not comparable with the present one, where the interpretation of the combination claimed in claim 1 and the admissibility of the disclaimer with respect to Articles 76(1) and 100(c) EPC had been central to the case since the proceedings before the opposition division. The creation of a non-disclosed subgroup of matrices resulting from the introduction of the disclaimer had first been pointed out by the opposition division and was also mentioned by the board. From both the decision under appeal and the communication of the board drawing attention to the definition of the matrix component by functional features, a representative with normal experience and training could foresee what the crucial issues were for the board, and which features and possible combinations were at stake (R 16/13 point 3, last sentence).

21. It results from the above that the contention that the debate should have been limited to the pH-independent feature and that the discussion concerning the disclosure of the other features in the decision under review came as a surprise is belied by the file history.

As to the second aspect of the argument (b)

22. The petitioners also expressed their objection by saying that there were two periods in the appeal proceedings and two legal bases: at the beginning the board only considered G 1/03 and G 2/03 and later, once decision G 2/10 became known, the board changed its approach of the claim. In the end, instead of dealing with the subject-matter in the light of G 2/10, it went for the specific construction, based on a particular relationship between structural and functional features. The petitioners have repeatedly claimed that this specific construction corresponded to the particular legal issues the board had had in mind since announcing on 19 October 2010, in its three member composition, its intention to refer of its own motion a question to the Enlarged Board (supra point VIII).

23. As suggested by the other party, the petitioners have a reading of the decision which is not objective.

Without of course attempting any assessment of the substantive issues, it results from an objective reading of the decision (supra point 3) that the logic of the reasoning revolved around the application of Article 76(1) EPC: the board, according to the method taught in case G 2/10, construed claim 1 found not allowable by the opposition division in a way which did not deviate from its first communication and checked whether this claim was disclosed in the parent application (supra points 9.2,11 and 14).

24. The petitioners’ assertion that this analysis had nothing to do with G 2/10 is factually incorrect as shown below.

24.1 As analysed above in point 8 a distinction (that was not clear in the petitioners’ arguments) is to be made, between, on the one hand, the construction of the claim without the disclaimed subject matter (supra points 9 to 14) and, on the other hand, the legal approach under Articles 76(1) and 100(c) EPC to the subject-matter thus construed. Decision G 2/10 may have made it clear, adding to the existing case law, that a disclaimer in a divisional application is not inadmissible merely because it was introduced solely to avoid double patenting with the parent application. But this decision did not change the basic requirements of Articles 76(1) and 100(c) EPC in line with G 1/03 and G 2/03 (point 4.6 of G 2/10).

24.2 Furthermore, considering the history of the case and the issues under discussion so far (supra points 9 to 14), the Enlarged Board cannot see that G 2/10 started a de novo construction of the claim in the light of the notion of remaining subject matter which had always been present in the debate (see earlier the opposition division’s decision). The allegation that under the principles set out in G 2/10 the feature of Cmin and Cmax was immaterial is a personal view of the petitioners. The Enlarged Board sees in the decision under review no more than the application of G 2/10, particularly points 4.5.4 about the need for a technical assessment of the case and 4.6 about divisional applications and Article 76(1) EPC.

Reference is also made to pages 8 and 9 of the minutes as reviewed by the petitioners, according to which the respondent-opponent stated that the disclaimer always generated remaining subject matter which was a new subgroup, relying on the statement of the board in the communication issued in 2009 in its three-member composition (page 3).

The petitioners’ additional arguments in respect of the alleged procedural deficiencies (b), (e), and (f) of (ii) in point XIV supra are rendered moot by the conclusion above that no de novo construction has occurred (point 24.2 supra):

25. Ground (b) of (ii) in point XIV: The petitioners did not obtain further communications after the one issued prior to the first oral proceedings, despite their requests in writing (of 5 December 2011 and during the oral proceedings) and orally. This complaint fails because (i) apart from the fact that there was no obligation on the board to issue a communication (G 6/95, OJ EPO 1996, point 5, page 657), (ii) the communication of 18 January 2012 in reply to the petitioners’ request implicitly meant that the board had the same analysis about the scope created by the disclaimer, and (iii) the reasons set out in points 9 to 14 above apply.

26. The petitioners further complained that the board had withheld the technical information about this specific interpretation, despite their repeated requests for clarification, for hearing a technical expert (Pr. Lamprecht) or for referral to the Enlarged Board.

26.1 The petitioners criticised the board because it applied to the facts, grounds and evidence the principle set up by the Enlarged Board, in particular in R 6/11, according to which "the parties are not entitled to advance indications of the reason or reasons for a decision before it is taken….If that principle applies to the reasons for a decision generally, it must apply to a comment forming only a part of such reasons” (point 7.1 of the reasons).

26.2 In fact, in point 7.2, the board merely explained why it did not need an external expert to interpret the claim; a claim is construed by reference to the common general knowledge of the skilled person and does not need the competence of an expert (point 4.5.4 of G 2/10); in the board’s analysis, construing claim 1 did not go beyond the expertise of the three technical members of the board. It cannot be said that the board refrained from giving any information, since everything necessary to interpret the claim was clearly open to discussion (supra points 9 to 14). The Enlarged Board does not see any possible relevance here of Lawrence v The General Medical Council, High Court of England and Wales, case No. CO/11086/2010 cited. The general point made in this judgement was the need to avoid taking a decision on the basis of an expert opinion that has not been submitted to the parties as evidence or argument. In the present case the "evidence” boiled down to the disclosure of the combination of features and the choice between two claim constructions: the petitioners’ construction or, if that were not accepted, the construction hitherto found non-compliant with Articles 76(1)and 100(c) EPC by the opposition division and the board. Once again, there is nothing to support the petitioners’ complaint that they had no idea that the possible combination of features (a), (b) and (c) could result in the undisclosed subgroup according to a possible interpretation by the person skilled in the art.

26.3 The Enlarged Board therefore does not see that the board withheld technical information. So the refusal of all the requests in this respect does not amount to a procedural violation. Therefore there is nothing that might infringe Article 6 ECHR. This is different from the situation that was considered in R 16/13 to be a violation of the right to be heard (supra points 19 and 20).

27. Grounds (e) and (f) of (ii) under point XIV supra:

As to the refusal of the requests for referral to the Enlarged Board and the alleged refusal by the board to reveal the point of law regarding the interrelation of the structural and functional features it had previously intended to refer to the Enlarged Board, the Enlarged Board notes (i) that the board gave its reasons (points 10ff. of the reasons) and (ii) that it does not fall within the ambit of the petition for review proceedings to evaluate their merits,(iii) it results from the decision that the "point of law” applied was the interpretation of Articles 76(1) and 100(c) EPC in view of G 2/10 (supra points 22 to 24). Lastly the reasons set out under (A) supra, in particular in points 22 to 26, apply here.

(B) Other procedural defects (a), (c) and (d) of (ii) under point XIV supra

28. The petitioners cited the adage that "justice delayed is justice denied”. The delay in issuing the minutes and the written decision amounted to an unreasoned decision, according in particular to German case law, in the sense that the facts had to be reconstructed.

This alleged defect is not however one of those that can give rise to a petition for review.

In any case, the delays in sending both the minutes and the decision, a consequence of the length of proceedings and the quantity of submissions (see the facts and submissions), have no causal link with the decision issued at the end of oral proceedings. Nor has any procedural deficiency been identified as a consequence of this, admittedly, unsatisfactory situation.

29. The change of composition of the board and the abandonment of its intention to make a referral to the Enlarged Board are not per se procedural deficiencies. The petitioners themselves had requested an enlargement of the board, by letter of 5 October 2010. The fact that the board decided to enlarge later "for complexity of the case” does not change the background to the case, and this administrative measure had no detrimental consequences, in the light of the reasons given supra in points 9 to 14).

As to the change of mind regarding the referral to the Enlarged Board, the board explained the reasons and the present Enlarged Board cannot, in the light of the analysis supra, see any breach of the right to be heard or any violation, let alone a violation that might justify a petition for review.

30. The reasons set out in points 9 to 21 and 28 supra also apply to grounds (iii) of point XIV supra about the adversarial character of the proceedings, which overlapped with the grounds dealt with in these points.

31. It results from the above that the grounds for the petition based on the violations of the right to be heard are ill-founded because the petitioners relied on an overly broad definition of the right to be heard and (ii) the petitioners’ strong disagreement with the board’s construction of the claim in itself and with the whole decision (Pet6, analysis by Mr Kitzmantel), which, according to the petitioners, "nullified the gist of decision G 2/10” and is at odds with the established case law does not fall within the ambit of the petition for review procedure.

(i) The right to be heard, or the party’s rights in an adversarial litigation, does not encompass giving the parties the reasons why the board does not accept their arguments; that is part of the reasoning of the decision based on the arguments of the parties (supra point 18).

(ii) As made clear by the travaux préparatoires for Article 112a EPC, under no circumstances should the petition for review be a means to review the application of substantive law. A review of the application of the substantive law would mean adding a third instance to the procedure before the EPO (CA/PL 17/00 of 27 March 2000, point 11). Consequently the Enlarged Board cannot be requested to evaluate the construction of the claim and the application G 2/10.

32. It results from the above that the petition for review is unallowable.