T 2842/18 - Verbatim statement is no basis Art. 123(2) in pharma case

Key points

• The post title oversimplifies the decision at hand but indicates the point of contention.
•  “Claim 1 is drafted as a second medical use claim pursuant to Article 54(5) EPC, thus attaining the claimed therapeutic effect is a functional technical feature of the claim.”
• Under Art. 123(2), the question is whether the claim has basis in Example 3 of the application as filed.
• “In a first line of argument the appellants [patentees] put forward that the requirements of Article 123(2) EPC were met because the language "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" was disclosed verbatim in the application as filed.”
• The Board: “Claim 1 was amended during opposition proceedings to include the therapeutic effect of "[medical effect, see above]" as a technical feature of the claim. As a consequence, for the purpose of assessing the requirements of Article 123(2) EPC, it has to be examined whether or not there is a disclosure in the application as filed from which it is directly and unambiguously derivable that this is the effect achieved when the treatment is carried out as claimed.”
• “Example 3 of the application describes a phase III randomised, double-blind, placebo-controlled multicenter study of retreatment with rituximab in subjects with rheumatoid arthritis (RA) receiving background methotrexate ”
• “No results of the envisaged retreatment study are reported.”
• “while the wording "preventing or slowing down (...) rheumatoid arthritis" is disclosed in the application, see point 43., the board concludes that the skilled person does not derive from page 129, lines 20 to 22, when read alone or in the context of Example 3 as a whole, a clear and unambiguous disclosure that the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved when patients with active RA are retreated under the protocol described.”
• As a comment, I wonder how this analysis would work out if claim 1 at issue would have been included verbatim in the claims of the application as filed and was granted unamended.
• As a further comment, I do see that the concept of disclosure must be the same for novelty and Art. 123(2) and that for lack of novelty of second medical use claims, it is (under current case law) not sufficient that the cited prior art document verbatim discloses the claim wording if it does not make the medical effect plausible / demonstrate that the effect is actually achieved. 
• “The [pantentees submitted] that the board was wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. ...  the board's conclusion with respect to Article 123(2) EPC, see points 50. and 51., are not based on considerations of plausibility but on the established criteria for assessing the requirements of Article 123(2) EPC”

T 2842/18 - 

https://www.epo.org/law-practice/case-law-appeals/recent/t182842eu1.html

Claim construction

31. Claim 1 is drafted as a second medical use claim pursuant to Article 54(5) EPC, thus attaining the claimed therapeutic effect is a functional technical feature of the claim. The disease to be treated is "joint damage in a subject with rheumatoid arthritis (RA)", while the therapeutic effect achieved by the treatment is "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".

32. This was not disputed by the appellants.

Amendments (Article 123(2) EPC) - claim 1

33. This claim request was identical to the claim request of auxiliary request 14 in the proceedings before the opposition division. The opposition division held that the subject-matter of claim 1 derived "directly from Example 3" (see decision under appeal, page 23, point 4.1).

34. Respondents VI, VII, VIII contested this finding of the decision under appeal and submitted that the features "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis", "at least one prior course of treatment with rituximab and (...) at least one further course of treatment with rituximab" and "wherein the treatment comprises administration of rituximab and methotrexate" of claim 1 were not directly and unambiguously derivable from the application as filed (see section VI. for the complete wording of the claim).

35. As the board could arrive at a decision on the present case by considering the requirements of Article 123(2) EPC with respect to the first feature - "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" - this decision does not deal with the requirements of Article 123(2) EPC with respect to the other features.

36. The objection against the first feature was raised during opposition proceedings and maintained on appeal by respondent VI in reply to the statement of grounds of appeal, see section XLII. The appellants' objection that this objection had been introduced by the board is thus without merit.

Direct and unambiguous disclosure

37. In a first line of argument the appellants put forward that the requirements of Article 123(2) EPC were met because the language "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" was disclosed verbatim in the application as filed.

38. It is established jurisprudence of the boards of appeal that the standard for assessing compliance with the requirements of Article 123(2) EPC is the standard set out in decision G 2/10 (OJ EPO 2012, 376, point 4.3 of the Reasons), also known as the "gold standard". Amendments are only permitted 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. It is not permitted for the skilled person to be presented with new technical information after the amendment (see decision G 2/10, supra, points 4.3 and 4.5.1 of the Reasons; see also Case Law of the Boards of Appeal of the European Patent Office, "CLBA", 2019, 9th edition, II.E.1.1 and II.E.1.3.1).

39. Claim 1 was amended during opposition proceedings to include the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" as a technical feature of the claim. As a consequence, for the purpose of assessing the requirements of Article 123(2) EPC, it has to be examined whether or not there is a disclosure in the application as filed from which it is directly and unambiguously derivable that this is the effect achieved when the treatment is carried out as claimed.

40. It is undisputed that the claims as filed and the general part of the description of the application as filed do not disclose that administering at least one further course of treatment with rituximab to a subject who has received at least one prior course of treatment with rituximab (retreatment) is "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis".

41. Example 3 of the application describes a phase III randomised, double-blind, placebo-controlled multicenter study of retreatment with rituximab in subjects with rheumatoid arthritis (RA) receiving background methotrexate (see page 92, lines 29 to 32).

42. Example 3 begins with the statement that "[t]he primary objective of this study is to evaluate the efficacy of retreatment with rituximab in subjects with active RA who are receiving MTX [methotrexate] and who have had an inadequate response to TNF inhibitors" (emphasis added; see page 93, lines 1 to line 3). It is explained that subjects with active RA after a first course of rituximab will be treated with a single additional course of rituximab (see page 95, lines 5 to 8) and also that "[t]he purpose of retreatment with rituximab is to prevent flare, promote sustained control of disease, and potentially prevent disease progression" (emphasis added; see page 95, lines 9 and 10). Primary and secondary outcome measures as well as assessments to be performed during the treatment period are defined on page 95, line 30 to page 129, line 19 of the application.

No results of the envisaged retreatment study are reported.

43. Example 3 concludes with the statement that "[i]t is expected that re-treatment under the protocol herein (or with a different CD20 antibody) will be effective in preventing or slowing down the progression in structural joint damage and erosion caused by RA" (emphasis added; see page 129, lines 20 to 22).

44. According to the appellants, this concluding statement provides the basis for the feature "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" of claim 1.

45. The board agrees with the respondents that the statement on page 129, lines 20 to 22, of the application does not amount to an explicit disclosure that retreatment ("under the protocol...") does achieve the effect of "preventing or slowing down the progression...", but rather expresses an expectation of what the outcome of the clinical trial might be. It is the board's view that the skilled person would derive from the passage in question that the above mentioned effect might or might not be achieved. The skilled person would not conclude that the effect was definitely achieved.

46. It is also established jurisprudence of the boards of appeal that a disclosure can be implicit, where an implicit disclosure relates solely to matter which is not explicitly mentioned but is a clear and unambiguous consequence of what is explicitly mentioned (CLBA, supra, section II.E.1.3.3).

47. The board therefore considered the skilled person's understanding of the statement on page 129, lines 20 to 22 when read in the context of Example 3 as a whole, including any implicit disclosure.

48. The skilled person reading Example 3 in its entirety (see point 42. above) would immediately realise that this is in fact a protocol for a proposed clinical study that has yet to be carried out. More importantly, the skilled person would understand that the primary objective of the proposed study was "to evaluate the efficacy of retreatment with rituximab" and that the purpose of this retreatment was to "potentially prevent disease progression". These statements relating to the primary objective of the study and the purpose of the retreatment could not be taken by the skilled person as a clear and unambiguous disclosure that the effect mentioned on page 129, lines 20 to 22, would actually be achieved when retreatment is carried out under the protocol described. Rather, the skilled person would understand that there were uncertainties about whether or not the effects to be tested for were achievable and that these uncertainties made the study necessary.

49. Consideration of the entire disclosure of Example 3 therefore does not lead to a different conclusion with respect to the uncertainty about the outcome of the retreatment study conveyed to the skilled person by the concluding statement on page 129, lines 20 to 22, of the application. Rather, the skilled person's immediate understanding of the carefully worded phrase is confirmed.

50. Therefore, while the wording "preventing or slowing down (...) rheumatoid arthritis" is disclosed in the application, see point 43., the board concludes that the skilled person does not derive from page 129, lines 20 to 22, when read alone or in the context of Example 3 as a whole, a clear and unambiguous disclosure that the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved when patients with active RA are retreated under the protocol described.

51. That the therapeutic effect of "preventing or slowing down the progression in structural joint damage and erosion caused by rheumatoid arthritis" is achieved by following the steps of the claimed treatment thus provides the skilled person with technical information not disclosed in the application.

52. Consequently, the board comes to the conclusion that the subject-matter of claim 1 extends beyond the content of the application as filed and therefore that claim 1 does not meet the requirements of Article 123(2) EPC.

Plausibility

53. The appellants' further lines of argument may be summarised as considering that the board was wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. In addition, Example 1 rendered the effect plausible.

54. However, the board's conclusion with respect to Article 123(2) EPC, see points 50. and 51., are not based on considerations of plausibility but on the established criteria for assessing the requirements of Article 123(2) EPC, see points 37. to 49. above.

55. In the present case, these considerations include an assessment of the skilled person's understanding of the phrase "it is expected" since this is the wording used in the application, see point 43., in the passage relied on by the appellants as providing a basis for the amendment of claim 1.

56. The criteria for the assessment of direct and unambiguous disclosure of a claimed therapeutic effect are independent of, for example, the presence of data or the assessment of plausibility of the claimed effect. Indeed, there could be direct and unambiguous disclosure of a therapeutic effect that is not plausible at all.

57. Therefore, the board agrees with the appellants' submission that it would be wrong to include considerations of plausibility when assessing compliance with the requirements of Article 123(2) EPC. The appellants' further argument that the requirements of Article 123(2) EPC would be met since Example 1 renders the claimed therapeutic effect plausible, can thus not succeed for this reason alone.