T 1259/16 (Glatiramer acetate III/TEVA) 12-09-2017

Reasons for the Decision

Admissibility of the appeals and the intervention; parties to the proceedings

1. The appeals of appellant I (patent proprietor) and of appellants II, III and IV (opponents 1, 3 and 4) are admissible. Furthermore, the intervention complies with the requirements of Article 105 EPC and is therefore admissible. Consequently, the intervener is a party to the appeal proceedings as of right.

Main request (set of claims as granted)

Admissibility

2. Appellant II requested that the main request be excluded from the appeal proceedings by virtue of Article 12(4) RPBA, and appellant III and the party as of right (hereinafter "intervener") requested that the main request be held inadmissible by virtue of

Article 12(2) RPBA for lack of substantiation in the statement of grounds of appeal for the subject-matter of claims 27, 28 and 32.

3. With regard to appellant II's request,

Article 12(4) RPBA stipulates that a board has the power to hold inadmissible requests which could have been presented or were not admitted in the first-instance proceedings.

The present main request had been dealt with in the first-instance proceedings, and it underlies the decision under appeal (see reasons, points 24 to 24.2.5). The request was maintained by appellant I in its statement of grounds of appeal (see pages 1 to 3) and thus forms part of appellant I's appeal (Article 12(1) RPBA). Accordingly, the board has no power to exclude this request from the appeal proceedings pursuant to Article 12(4) RPBA.

4. As to the request of appellant III and the intervener, the board observes that there are decisions, cited in the Case Law of the Boards of Appeal, 8th edition 2016, section IV.E. 4.2.4 under the heading "Unsubstantiated requests", in which auxiliary requests - filed during appeal proceedings without any substantiation and mostly at later stages of the proceedings - were held inadmissible by the boards. However, the circumstances underlying these decisions were different from the present circumstances, i.e. the admissibility of a

claim request dealt with in a decision under appeal and where substantiation is lacking for only some of the claims. Accordingly, the board decided to reject the request to hold the main request inadmissible.

Article 100(c) EPC - claim 32

5. The opposition division held that the subject-matter of claim 32 of the main request failed to meet the requirements of Articles 76(1) and 123(2) EPC (see decision under appeal, points 24.2.2 to 24.2.5). It considered that the (earlier) application as filed disclosed glatiramer acetate (GA) manufacturing processes which comprised the step of reacting trifluoroacetyl glatiramer acetate (TFA-GA) with aqueous piperidine. This step was not a feature of the subject-matter of claim 32, and the (earlier) application as filed did not disclose the general use of TFA-GA to manufacture GA in the absence of the reacting of TFA-GA with aqueous piperidine, and therefore this claim did not meet the requirements of Articles 76(1) and 123(2) EPC.

6. Appellant I's statement of grounds of appeal does not specifically address the issue of the basis for the subject-matter of claim 32 in the (earlier) application as filed. However, appellant I submitted that the reasoning provided in the statement of grounds of appeal with regard to the basis for the subject-matter of claim 22 of auxiliary request 1d also explained where the basis was to be found for the subject-matter of claim 32 of the main request.

7. Claim 22 of auxiliary request 1d relates to the use of TFA-GA in the manufacture of GA and comprises the step "wherein the trifluoroacetyl glatiramer acetate is treated with piperidine" (see section IV). The reasoning provided in the statement of grounds of appeal addresses the issue of why the subject-matter of claim 22 does not need to specify that the piperidine used in the conversion of TFA-GA to GA is "aqueous piperidine". Therefore, this argument does not address the objection raised by the opposition division against the subject-matter of claim 32 (see point 5).

8. Thus, the board finds that the reasons given for setting aside the decision under appeal as regards the finding of the opposition division of lack of a basis in the (earlier) application as filed for the subject-matter of claim 32 are not persuasive.

9. Consequently, the board decides that the ground for opposition under Article 100(c) EPC prejudices the maintenance of the patent as granted because at least claim 32 relates to subject-matter extending beyond the content of the (earlier) application as filed

(Articles 76(1) and 123(2) EPC).

Auxiliary requests 1 to 8

Article 123(2) EPC - claims corresponding to claim 20 of the main request

10. The opposition division held that minimum levels of ppm metal ion impurities had been disclosed in association with the HBr solution or the trifluoroacetyl polypeptide mixture, but not as features of the GA end product as such, and that therefore the subject-matter of claim 20 of the main request did not meet the requirements of Articles 76(1) and 123(2) EPC (see decision under appeal, point 24.2.3).

11. Auxiliary requests 1 to 8 all include a claim corresponding to claim 20 of the main request directed to (a mixture of) glatiramer acetate (GA) having a desired molecular weight (an average molecular weight between 4,700 and 11,000 dalton) and less than 100 ppm (20 ppm) metal ion impurities (see section IX).

12. Appellant I submitted that the basis for these claims was the same as that submitted for claim 20 of the main request.

13. It has been established (cf. decision G 2/10, OJ EPO 2012, 376) that the "gold standard" for assessing compliance with Article 123(2) EPC is that any amendment to the parts of a European patent application or of a European patent relating to the disclosure (the description, claims and drawings) can only be made 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 these documents as filed.

14. It was undisputed that GA containing less than 1000 (or 100 or 20) ppm metal ion impurities was not disclosed explicitly in the application as filed. However, appellant I submitted that the claimed GA was the direct product of several of the processes described in the application as filed and that it would be clear to the skilled person that the controlled levels of metal ion impurities applied not only to the TFA-GA precursor material but also to the GA product.

15. The board is not persuaded by this line of argument.

The application as filed discloses processes comprising the use of a solution of hydrobromic acid in acetic acid (HBr/AcOH) containing less than 1000 ppm of metal ion impurities (see paragraphs [0012], [0013] and [0064]). The application also discloses mixtures of trifluoroacetyl polypeptides comprising variable amounts of metal ion impurities, e.g. less than 1000 ppm, less than 100 ppm and less than 20 ppm (see paragraphs [0054] to [0060]).

16. However, in the application as filed it is not disclosed that the use of this HBr/AcOH solution and trifluoroacetyl polypeptides, respectively, necessarily leads to GA having a metal ion impurities content of less than 1000 ppm.

17. Moreover, there also appears to be no direct and unambiguous connection between the amount of metal ion impurities in the HBr/AcOH solution and the amount of metal ion impurities in the GA product, since on the one hand the processes are disclosed using open language such as "comprising the steps" and on the other hand the metal ion content of any possible other component used in the process for the production of GA is not specified in the application as filed (see paragraphs [0012], [0013] and [0064]).

For the same reasons there is also no direct and unambiguous connection between the amount of metal ion impurities in the TFA-GA precursor material and in the GA product.

18. In the board's judgement, the skilled person would therefore not derive directly and unambiguously from the application as filed, using common general knowledge, that the disclosed processes necessarily lead to GA having less than 1000 ppm metal ion impurities.

19. According to auxiliary requests 1 to 4, the level of metal ion impurities in GA is reduced to 100 ppm, and in auxiliary requests 5 to 8 it is further reduced to 20 ppm (see section IX). However, for the same reasons as set out above for the subject-matter of claim 20 of the main request (see points 13 to 18), it is not apparent that the processes disclosed in the application as filed necessarily lead to GA having an even lower content of metal ion impurities.

20. The board concludes from the above that the subject-matter of the claims of auxiliary requests 1 to 8 corresponding to claim 20 of the main request does not meet the requirements of Article 123(2) EPC. Therefore auxiliary requests 1 to 8 are not allowable.

Auxiliary request 9 - request corresponding to auxiliary request 1f maintained by the opposition division

Articles 123(2) EPC - claims 2, 3 and 4

21. The subject-matter of claims 2, 3 and 4 of auxiliary request 9 is directed to methods which comprise the use of "a solution of hydrobromic acid in acetic acid, which solution is free of free bromine and comprises less than 100 ppm of metal ion impurities".

22. The opposition division held that the application as filed provided a basis for the claimed subject-matter (see decision under appeal, point 27.2). The opponent-appellants and the intervener disagreed with this finding in the decision under appeal.

23. It was undisputed between the parties that the claimed combination of the features characterising the solution of hydrobromic acid in acetic acid - "free of free bromine" and "less than 100 ppm of metal ion impurities" - is not explicitly disclosed in the application as filed.

24. At issue is thus whether or not the claimed combination of features can be derived directly and unambiguously, using common general knowledge, from what is explicitly disclosed in the application as filed, i.e. whether the combination is implicitly disclosed.

25. It is established case law that the content of an application must not be considered to be a reservoir from which individual features pertaining to separate embodiments of the application can be combined in order to create a particular combination. In the absence of any pointer to that particular combination, this combined selection of features does not, for the person skilled in the art, emerge directly and unambiguously from the content of the application as filed. The fact that features in question have been mentioned in the description as "preferred" may act as a pointer (see Case Law of the Boards of Appeal, 8th edition 2016, section II.E.1.4.1 and the decisions cited there).

26. Appellant I submitted (i) that the preferred levels of free bromine and metal ion impurities were individualised preferences that were clearly understood as being applicable in combination, (ii) that the application as filed disclosed the levels of free bromine and metal ion impurities as narrowing cascades moving towards most preferred values, (iii) that example 4 provided a basis for the claimed combination and (iv) that case law such as in decisions T 1581/12,

T 2134/10, T 1241/03 and T 783/09 supported its case (see section XV).

27. The board will address appellant I's various lines of argument in turn.

28. As regards appellant I's first line of argument, the application as filed discloses "a solution of hydrobromic acid in acetic acid, which solution comprises less than 0.5% of free bromine and less than 1000 ppm of metal ion impurities" (see paragraphs [0009] and [0019] and similarly in paragraphs [0012] and [0013]) and thus a specific combination of levels of free bromine and metal ion impurities which differs from the claimed combination.

29. The levels of free bromine in the solution of hydrobromic acid in acetic acid (HBr/acetic acid) are set out individually in paragraphs [0020] to [0024] of the application as filed and range from "less than 0.1% of free bromine" to "free of free bromine".

30. In a separate list, the levels of metal ion impurities in the solution of HBr/acetic acid are set out individually in paragraphs [0025] to [0031] of the application as filed and range from "less than 1000 ppm of metal ion impurities" to "free of metal ion impurities".

31. None of these embodiments in paragraphs [0020] to [0031] of the application as filed is characterised explicitly as being preferred. Rather, these embodiments are characterised variously as "in one embodiment", "in another embodiment", "in a further embodiment" and "in yet another embodiment". Thus, in the board's judgement, all the various levels of free bromine and metal ion impurities have to be considered to represent equally suitable alternatives.

32. Furthermore, while the levels of free bromine and metal ion impurities are both features of the HBr/acetic acid solution, each of them in fact solves a different problem. Thus, free bromine leads to bromination of tyrosine residues in TFA-GA (see paragraph [0086] of the application as filed), while metal ion impurities in HBr are chelated by TFA-GA and GA and the resulting metal complexes contribute to coloration of the GA solution (see paragraphs [0090] to [0093] of the application as filed). Accordingly, in the board's view, the skilled person reading the application as filed as a whole has no reason to understand that the levels of free bromine and metal ion impurities of the HBr/acetic acid solution are connected and to be varied in combination. Therefore, the disclosure of one specific solution comprising a particular combination of levels of free bromine and metal ion impurities (see point 28) provides no pointer to all possible other such combinations.

33. In summary, appellant I's first line of argument thus fails since the claimed levels of free bromine and metal ion impurities are not disclosed as preferred embodiments, nor does the application as filed provide a pointer to the combination of any level of free bromine and metal ion impurities beyond the explicitly disclosed combinations (see point 28 above and point 36 below).

34. Appellant I's second line of argument hinges on the submission that the application as filed discloses the levels of free bromine and metal ion impurities as narrowing cascades moving towards most preferred values.

35. However, in the board's view, the skilled person reading the application as filed would not recognise from the mere depiction of the levels of free bromine and metal ion impurities as narrowing cascades that the lower values are necessarily more preferred or that the lowest level is the most preferred. This is because the skilled person is aware that, while the product produced, i.e. GA, has to be safe, reducing the levels of impurities can be time-consuming, difficult and expensive, and reducing impurities to as low a level as possible is both impractical and uneconomical (see declaration D69, point 10). Therefore, while the skilled person would want to control the level of impurities, this does not mean that, all things being considered, the lowest level of impurity is necessarily the most preferred. Hence, appellant I's second line of argument also fails.

36. As regards appellant I's third line of argument, Example 4 relates to the colour determination of HBr/acetic acid solutions and discloses that "the color of these batches of HBr/acetic acid indicated that they were essentially free of bromine and metal ion impurities" (see paragraph [0115] of the application as filed). Thus, in terms of levels of impurities

Example 4 discloses that the solution is "essentially free" of both free bromine and metal impurities. However, the disclosure of this combination in Example 4, i.e. the reduction of both types of impurity to the lowest level, does not provide a pointer to the claimed combination in which "free of free bromine" is combined - not with "essentially free of metal ion impurities" - but with "less than 100 ppm of metal ion impurities". Therefore, the board is also not persuaded by appellant I's third line of argument.

37. As regards appellant I's reliance on the case law, the board considers that the factual basis of decision

T 1581/12 of 15 September 2016 (see Reasons, point 7) and of decision T 2134/10 of 14 November 2013 (see Reasons, point 11) is not comparable to the factual basis of the present case. In the cited decisions, the combination of features was allowed because it was considered to be derived from two lists which were not independent of each other. In the present case, however, the lists relating to free bromine levels and metal ion impurities are fully independent (see also points 29, 30 and 32), and appellant I itself submits that the limits relating to free bromine and metal ion impurities can be varied independently (see

section XV). As acknowledged in decision T 1581/12 with reference to established case law, in such a situation, in the absence of a clear pointer, the association of one member of one list with another member of the other list results in a combination which is considered to create new subject-matter (see Reasons, point 7).

38. In decision T 783/09 of 25 January 2011 (see Reasons, points 5.7 to 6.2) the reference to particularly preferred combinations of features was explicitly disclosed in the application as filed, and no particular quality was attributed to any of the very preferred combinations, resulting in a list of forty-four qualitatively equal elements, of which forty-one

could be deleted. As pointed out above (see point 31), in the present case none of the impurity levels is characterised as being preferred, let alone as being very preferred.

39. Decision T 1241/03 of 1 September 2005 (see Reasons, points 6 and 7) also relates to a different situation, as there the application contained no lists of equally suitable parameters, and the preferred value for each parameter was indicated explicitly in the application as filed. In the light of this disclosure the board considered that the combination of compounds in specific concentrations found a basis in the application as filed.

40. As the present case is not comparable to cases such as those underlying decisions T 2134/10, T 1581/12,

T 1241/03 and T 783/09, appellant I's reliance on that case law does not help its case either.

41. The board concludes from the above that the claimed combination of features results from a selection from two fully independent lists. Since the application as filed does not provide a pointer to the claimed combination, the subject-matter of claims 2 to 4 of auxiliary request 9 does not meet the requirements of Article 123(2) EPC. Hence, auxiliary request 9 is not allowable.

Auxiliary requests 10 to 32

Article 123(2) EPC

42. Auxiliary requests 10 to 32 all contain at least one independent claim which includes a combination of a requirement that the solution of hydrobromic acid in acetic acid be free of free bromine and a threshold level of metal ion contamination (variously 100 ppm or 20 ppm), see section IX.

43. In the context of auxiliary request 9 the combination of the features "free of free bromine" and "less than 100 ppm of metal ion impurities" had been considered by the board (see points 21 to 41). In the board's opinion this analysis is equally applicable to the combination of the features "free of free bromine" and "less than 20 ppm of metal ion impurities". This was not disputed by appellant I.

44. Accordingly, the board decides that the subject-matter of claims 2 to 4 of auxiliary requests 10 to 24 and the subject-matter of claim 1 of auxiliary requests 25 to 32 do not meet the requirements of Article 123(2) EPC. These requests are therefore not allowable.

Auxiliary requests 33 and 34

Admissibility

45. In auxiliary request 33 the solution of hydrobromic acid in acetic acid is now characterised as comprising "less than 0.5% of free bromine and 100 ppm of metal ion impurities", while according to auxiliary

request 34 it comprises "less than 0.5% of free bromine and 20 ppm of metal ion impurities".

46. Auxiliary requests 33 and 34 were filed in reaction to the communication issued by the board pursuant to

Article 15(1) RPBA setting out its preliminary opinion on some of the issues in the appeal proceedings.

Moreover, the combinations of features now claimed had not been claimed before and thus represented an amendment to appellant I's case.

Consequently, under Article 114(2) EPC and Article 13(1) RPBA, the admission of these requests is at the board's discretion.

47. Appellant I submitted that auxiliary requests 33 and 34 had been submitted to take account of the board's preliminary opinion in the communication pursuant to Article 15(1) RPBA with regard to an objection under Article 123(2) EPC.

48. The board observes that the objection at issue here, which the amendments made in auxiliary requests 33

and 34 aimed to address, was not a new one. It had been raised by all opponent-appellants in their respective statements of grounds of appeal (see section VII) and was thus known to appellant I. In fact, the only new piece of information for appellant I was the board's indication that it was inclined to agree with the opponent-appellants' objection.

49. The board therefore considered that in these circumstances the board's communication and the preliminary opinion given therein cannot be taken as justification for the admissibility of new requests submitted only in reply to said opinion in the communication (see also Case Law of the Boards of Appeal, 8th edition 2016, section IV.E.4.4.12).

50. The board further considered that the suggested amendments would have added considerably to the complexity of the case, as the claimed combination of features had not been present in any of the granted claims or in any of the higher-ranking pending claim requests, but stemmed from the description and thus had not been considered before.

51. Moreover, the combination of features was unexpected. In fact, appellant I had not pursued the "less than 0.5% free bromine" feature before the opposition division, and the only claim request in the appeal proceedings containing this feature - albeit in combination with the feature "less than 1000 ppm metal ion impurities" - was the main request, while all 32 auxiliary requests filed in response to the opponent-appellants' statements of grounds of appeal contained the "free of free bromine" feature. The proposed amendments thus went beyond what had to be considered to be the framework of these appeal proceedings.

52. Finally, the board considered that no substantiation as to the novelty and inventive step of the claimed subject-matter was submitted when filing auxiliary requests 33 and 34, and so it was not immediately apparent to the board that these claim requests - in case they were found to fulfil the requirements of Article 123(2) EPC - could be dealt with without adjournment of the oral proceedings or remittal of the case. In the board's view, admitting these claim requests would thus not have served procedural economy.

53. Hence, the board decided to exercise its discretion not to admit auxiliary requests 33 and 34 into the proceedings in accordance with Article 114(2) EPC and

Article 13(1) RPBA.

Auxiliary request 35

Admissibility

54. This claim request is based on auxiliary request 9 with deletion of those claims that were considered by the board not to meet the requirements of

Article 123(2) EPC.

It was filed during the oral proceedings after the board had given its opinion on auxiliary requests 1 to 32 and had further decided not to admit auxiliary requests 33 and 34 into the appeal proceedings.

Thus, the filing of this request likewise constituted an amendment to appellant I's case, and its admission was at the board's discretion (Article 114(2) EPC and Article 13(1) RPBA).

55. The appellant submitted (i) that the filing of this request had been announced in advance in writing and (ii) that the request was clearly admissible, as the board in its communication pursuant to

Article 15(1) RPBA had not taken up any of the other added subject-matter objections raised by the opponent-appellants, and those which had been dealt with no longer applied.

56. As to the first argument, even though the filing of auxiliary request 35 had been announced in writing - albeit only as one of 16 possible auxiliary requests (see section XII) - this auxiliary request had in fact been filed only at the oral proceedings.

57. As regards appellant I's second argument that the board in its communication had not taken up any of the other objections raised by the opponent-appellants (which could potentially apply to the now claimed subject-matter), it is noted that a board is not obliged to give a preliminary opinion on each and every objection raised in the appeal proceedings. A communication under Article 15(1) RPBA serves as guidance for the oral proceedings. In accordance with this purpose a board may in such a communication (see Article 15(1) RPBA) draw "attention to matters which seem to be of special significance, or to the fact that questions appear no longer to be contentious, or containing other observations that may help concentration on essentials during the oral proceedings."

58. Furthermore, in addition to appellant I's arguments, the board, when deciding on the admissibility of auxiliary request 35, has taken into account criteria developed by the case law in relation to the admissibility of claims submitted for the first time during oral proceedings. For example, a claim request submitted at a late stage might be allowable if its submission can be considered an appropriate reaction to unforeseeable developments in the proceedings or if it would be immediately apparent to the board, with little or no investigative effort on its part, that the new request is clearly and obviously allowable (see Case Law of the Boards of Appeal, 8th edition 2016, section IV.E.4.2.6 a)).

59. In the present case, the filing of the auxiliary request was a reaction to the board's finding that the "combination feature" did not meet the requirements of Article 123(2) EPC. This finding however could not be considered unforeseeable or unexpected, given that it was in line with the board's preliminary opinion set out in its communication issued pursuant to

Article 15(1) RPBA.

60. Furthermore, it was in fact immediately apparent to the board that this request could not be considered clearly and obviously allowable, as there were a number of outstanding added subject-matter objections which had been raised by the opponent-appellants in their respective statements of grounds of appeal and which had not been addressed by the amendments made (see also section XII).

61. Lastly, the reasons why appellant I did not file (what is now) auxiliary request 35 with its reply to the statement of grounds of appeal, i.e. the wish to address the issues of the appeal with a reasonable number of claim requests and the wish to take account of added subject-matter issues that had been of concern to the board in the parent case T 1536/14 and of which the "combination" objection was not a part, can also not convince the board that the appropriate time for filing auxiliary request 35 would have been in reply to the board's communication. This is so in view of the fact that the "combination" objection was an issue in the present appeal from the beginning (see section VII).

62. Therefore, in view of all the above considerations, the board decided not to admit auxiliary request 35 into the proceedings in accordance with Article 114(2) EPC and Article 13(1) RPBA.

Conclusion

63. In the absence of an allowable claim request, the patent is to be revoked.