T 0360/09 (Albumin fraction/OCTAPHARMA) 06-06-2013

Reasons for the decision

1. According to Article 108 EPC one requirement for the admissibility of an appeal is that "a statement setting out the grounds of appeal shall be filed in accordance with the Implementing Regulations". Rule 99(2) EPC stipulates that "[i]n the statement of grounds of appeal the appellant shall indicate the reasons for setting aside the decision impugned [...]".

1.1 In cases where the appeal is against the whole decision of the first instance the requirement to "indicate the reasons for setting aside the decision impugned" has been interpreted by the Boards of Appeal to mean that the statement of the grounds of appeal should analyse (a) the main reasons given in the contested decision and this (b) in sufficient detail, the latter requirement serving the purpose that the board and the other parties be put in a position to understand the reasons why the decision is alleged to be incorrect (Case Law of the Boards of Appeal, 6th edition 2010, VII.E.7.6.1, first and second paragraph). Thus where, as in the present case, the claims filed on appeal are different from those dealt with in the contested decision, it has to be derivable from the statement of grounds of appeal and the requests relied on, why the reasons in the contested decision for rejecting the claims then on file do not apply to the claims filed on appeal.

There may be cases where this is understandable merely on the face of the amended claims. However, if this is not so, it is necessary that the statement of grounds of appeal provides an analysis of the reasoning in the impugned decision with respect to the amended claims, it being the presence and not the persuasiveness of such an analysis which is required.

2. In the present case the opposition division gave a detailed reasoning in the decision under appeal why it had decided to reject the main request because (i) its method claim 1 contained subject-matter extending beyond the content of the application as filed and (ii) the subject-matter of its product claim 4 lacked novelty in view of the disclosure in documents E7 or E9 and also (iii) why it had decided to reject the two auxiliary requests because their method claims contained subject-matter extending beyond the application as filed. Hence, in the board's view, both added matter with regard to the method claims and novelty with regard to the product claims must be considered as the two "main" reasons relied on in the decision under appeal.

2.1 In its notice of appeal the appellant requested the board to set aside the decision of the opposition division and to reject the oppositions. The statement of appeal further contained a request for remittal to the first instance for examination of the issues of Article 54 and 56 EPC.

2.2 The amended main and auxiliary requests filed with the statement of grounds of appeal each contain three claims, namely, one amended claim to a method and two - by reference to the amended method - amended claims to products.

2.3 It thus follows that, as regards the extent to which the decision under appeal is appealed, the appellant, both of whose requests filed with the statement of grounds contain amended product claims, appeals not only against the decision of the opposition division to reject the main and the auxiliary requests for added matter, but also against the decision to reject claim 4 of the main request for lack of novelty. Hence, in the light of the observations in points 1.1 and 2 above, for the appeal to be admissible not only the issue of added matter with regard to the method claims, but also the issue of novelty of the amended product claims has to be addressed in a sufficient manner vis-à-vis the reasons set out in the decision under appeal, namely here lack of novelty with regard to the disclosure in documents E7 and E9.

3. In the statement of grounds of appeal detailed explanations are given where the basis in the application as filed is found for the amended method claims. Thus, one of the main reasons for revocation in the decision under appeal (see point 2 above), added matter, is sufficiently substantiated in the statement of grounds of appeal.

With regard to the issue of novelty it is stated in the statement that the subject-matter of the main request (which includes product claims) is new and also that the product is new (see section XII above). Thus, in contradiction to its argumentation (see sections XVI and XVII above), at the time of filing of the appeal the appellant itself had apparently considered novelty of the product claims to be an issue that needed to be dealt with.

The question in the present case is however the sufficient substantiation of this issue, i.e. whether or not it is understandable from the statement of grounds of appeal why the subject-matter of the amended product claims is novel over the disclosure in documents E7 or E9 (see point 2.3 above).

4. Claim 4 refused by the opposition division for lack of novelty read: "An albumin containing fraction having a reduced prekallikrein activator (PKA) content obtainable according to the method of claim 1 to 3." Thus, this claim is a so-called product-by-process claim, i.e. a claim which is directed to a product and which relies on process features for the definition of the product - here by reference back to the method defined in claims 1 to 3, a method which is according to the preamble of the claims for "manufacturing an albumin enriched fraction having a reduced prekallikrein activator (PKA) content".

4.1 With respect to the novelty of this claim 4 the

opposition division reasoned that (see section VII above):

- it should be kept in mind that a product characterized by a process has to be novel and inventive on its own regardless on how it is produced;

- the subject-matter of claim 4 as a product is only characterised to be an albumin composition with reduced PKA content;

- any albumin product with a PKA lower then normal is pertinent for novelty;

- albumin solutions for pharmaceutical use seem to be acceptable up to a PKA value of 35 IU/ml;

- the albumins produced by the methods taught in documents E7 or in E9 lead to a PKA activity even less then 10 IU/ml which is the preferred value in the contested patent;

- the subject-matter of claim 4 is therefore not novel over the disclosure in documents E7 and E9.

5. Claims 2 and 3 of the main and auxiliary request filed with the statement of grounds of appeal read:

"2. An albumin containing fraction having a reduced prekallikrein activator (PKA) [sic] obtainable according to the method of claim 1.

3. The albumin of claim 2 having a PKA content of less than 12 IU/ml, preferably 10 IU/ml, wherein the PKA is determined according to European Pharmacopeia, Fourth Edition."

5.1 Apart from the amended claim reference the only difference between claim 2 of both the main and auxiliary requests and claim 4 of the previous main request is that, by reference back to claim 1, claim 2 of the pending request characterizes the product by methods which are different from those characterizing the product of claim 4 of the previous main request. Essentially, the difference between the methods is that the methods according to claim 1 of the present main and auxiliary requests include more and even more precise steps, respectively. Present claim 3 is dependent on claim 2. Its wording is identical to that of claim 5 of the main request before the opposition division. Thus, these two claims only differ in respect of the method feature (see sections IV, IX and X above).

6. When considering the amended claims per se, it is not self-explanatory why the amendment - characterization by a different method - overcomes the reasons for finding that the subject-matter of claim 4 of the main request before the opposition division lacks novelty over the disclosure in documents E7 or E9. This is particularly so in the light of the opposition division's statement that it should be kept in mind that a product characterized by a process has to be novel and inventive on its own regardless on how it is produced. The board notes in this respect that the opposition division's view reflects established and consistently applied case law since the decision in case T 150/82 was issued in 1984 (see also Case Law of the Boards of Appeal, 10th edition, II.B.6.1 and 6.2). Further it is not prima facie apparent whether or not the additional method steps have an influence on the PKA content, and if they do, if the PKA level is reduced to such an extent that the claimed subject-matter differs from and is therefore novel over that disclosed in documents E7 and E9.

7. In its statement of grounds of appeal the appellant submits in support of the novelty of the product claims that:

- the subject-matter of the main request is new because the process characterized in the claims is different from the process disclosed in document E1;

- the product is new because it is the result of a new and inventive process;

- none of the other documents anticipates the subject-matter of the main request.

7.1 The first two arguments thus explain the novelty of the product merely by referring to the novelty (and inventiveness) of the process referred to in the product claim - generally and in relation to a process disclosed in document E1. However, the opposition division had expressly stated in the decision under appeal that this is per se not a sufficient reason. Thus, for the appellant's argument to be understood in the light of the reasoning in the decision under appeal, it should have explained why the product becomes new over the disclosures in documents E7 and E9 in view of the new process features.

7.2 The appellant's third argument mentioned in point 7 above neither takes account of documents E7 and E9 nor of the opposition division's reasoning that these documents disclose albumin-containing fractions with a PKA content of "even less than 10 IU/ml" and thus also does not elucidate why the amended product claims overcome the reasons in the decision under appeal for refusing the main request for lack of novelty of its product claim 4.

8. In summary, it is not understandable either when considering the claims per se or when considering them in the light of the written submissions in the statement of grounds of appeal why the subject-matter of the amended product claims is novel over the disclosures in documents E7 or E9. For this reason the statement of grounds of appeal is considered to insufficiently substantiate one of the two main reasons in the decision under appeal, i.e. the reason of lack of novelty (see points 2 and 2.3 above).

9. The appellant argued, that since it did not pursue the main request rejected for lack of novelty by the opposition division, but rather based its new main request on the first auxiliary request which was only rejected for added matter, the board could not deal with the novelty of the product claims of the new requests because the opposition division had not considered the novelty of the product claims of the this auxiliary request. It would therefore be premature and against the fundamental principle of procedural economy, if the appellant had to argue in the statement of grounds of appeal the issue of lack of novelty in relation to the product claims. The appellant referred to decision T 934/02 of 29 April 2004 to support its case.

10. Which of the reasons of the impugned decision have to be dealt with in the statement of the grounds of appeal is determined by considering an appellant's procedural and claim requests filed with the notice and the statement of grounds of appeal in the light of the contested decision as a whole. It is therefore not relevant which of the requests rejected at the first instance form the basis of the requests filed on appeal. In the present case the circumstances are such that it was necessary for the appellant to substantiate the issue of novelty in a sufficient manner in order for the appeal to be admissible (see point 2.3 above).

10.1 Proceedings before the Boards of Appeal of the EPO are not of a purely cassative nature, i.e. the contested decision can be challenged by filing of amended claims (Case Law of the Boards of Appeal, 6th edition 2010, VII.E.16). Article 111(2) EPC gives the Boards the discretion either to deal with these amended claims itself or to remit the case to the first instance. However, a decision pursuant to Article 111(2) EPC is only taken after the appeal has been held to be admissible which requires sufficient substantiation. Thus, sufficient substantiation is a prerequisite for the admissibility of an appeal and cannot, as the appellant's argument suggests, be premature nor can it, for reasons of procedural efficiency, be postponed to a later point in time.

10.2 In the case cited by the appellant, decision T 934/02 (supra), the opposition division had rejected the main request on the grounds that the subject-matter of claim 1 was not inventive over the combination of documents D1 and D6. With its statement of grounds of appeal the appellant-patent proprietor filed amended claims and explained in detail the reasons why their subject-matter should be considered inventive over the combination of documents D1 and D6.

The appellant-opponent challenged the admissibility of the appeal for the reason that it was based on new amended claims. In its view the purpose of the appeal was to review the decision on the rejected request and not to examine an entirely different request raising issues never considered by the opposition division.

The board did not agree with the appellant-opponent's view. It stated that there is nothing in the provisions of the EPC concerning the admissibility of an appeal "supporting the idea that the task of a Board should be strictly limited to considering the claims contained in the requests rejected by the opposition division." (see point 2 or the Reasons). Furthermore the board quoted from decision T 717/01 of 14 January 2003 which holds that an appeal of the patent proprietor is to be considered sufficiently substantiated if (i) there is a change in the subject of the proceedings due to the filing of new claims and (ii) the statement of grounds sets out in detail why the grounds of opposition do not prejudice the maintenance of the patent as amended on the basis of these new claims.

In the case under consideration in decision T 934/02, (supra) the statement of grounds gave detailed reasons why the subject-matter of claim 1 of the main request should be considered novel over documents D1 or D6 as well as inventive over the combination of these two citations. Therefore the appeal was held admissible.

Decision T 934/02 (supra) rather than helping the appellant's case, supports the opposite view, namely that amended claims may be filed in appeal proceedings (see point 10.1 above) and that for an appeal to be considered as sufficiently substantiated an explanation of why these amended claims overcome the decision under appeal is necessary (see point 1.1 above).

11. The board concludes in view of the observations in points 2 to 8 above that the statement of grounds of appeal cannot be considered as sufficiently substantiated within the meaning of Article 108 EPC in combination with Rule 99(2) EPC.