T 0795/21 - Deleting alternative from Markush formula

Key points

• Claim 1 is directed to a class of compounds ("A chemical compound having formula I"). The Board finds that claim 1 of the main requests lacks an inventive step over D36 (after an extensive analysis).
• Claim 1 specifies as one of the features "X is independently selected from the group H, F, Cl, Br, I, OH and methyl (-CH3)" and "Y is F".  The embodiment wherein X is H is found to be obvious because of structural similarity with D36 (with further reasons).
• The Board turns to Auxiliary Request 4. Herein, H is deleted from the list of alternatives for X. 
• In the application as filed, the definition was: "X and Y are independently selected from the group comprising H, F, Cl, Br, I, OH and methyl (-CH3)". Hence, in AR-4, H is deleted from the list for X and Y is limited to F.
• The Board recalls that according to established case law, for this type of amendment, Article 123(2) requires that "the amendment may not lead to a particular combination which is not derivable from the original application and is therefore potentially suitable to provide a technical contribution to the originally disclosed subject-matter as opposed to a mere restriction of the required protection which does not result in the definition of a new sub-class of compounds and is therefore not potentially suitable to provide a technical contribution to the original subject-matter." (T 615/95, T 859/94, T 50/97, T 783/09, T 948/02 and T 801/02) 
• As the amendment is made to restore inventive step, the proprietor argues that this case law no longer applies after G 2/10: the proprietor argues that "with reference to G 2/10 and T 1937/17 that the notion of a technical contribution should actually not be taken into account at all"
• The Board:  "amendments by the deletion of options from multiple lists of separate characteristics inherently include an aspect of combination and potentially involve an aspect of arbitrariness, which may complicate the assessment of whether such amendments remain within the limits of what the skilled person would directly and unambiguously derive from the original disclosure."
• The Board recalls that G 2/10 referred to the "body of jurisprudence ... with respect to cases in which the limitation could lead to the singling out of compounds or sub-classes of compounds or other so-called intermediate generalisations not specifically mentioned nor implicitly disclosed in the application as filed" and indicated that this body of case law was to be applied (r.4.5.4). 
• Therefore, the notions used in the existing case law, namely "mere restriction of the required protection" versus "generating another invention" or "suitable to provide a technical contribution to the originally disclosed subject-matter" are to be applied as considerations which may arise from the application of [the gold standard test] when assessing amendments by deletion of options from multiple lists and which may affirm the result of such assessment.
• "the Board considers that the observation that the deletion of options for X and Y in accordance with claim 1 of auxiliary request 4 is suitable to provide a technical contribution to the originally disclosed subject-matter supports the assessment that this amendment is not in compliance with the "gold standard".
• The technical contribution is provided by the amendment omitting the alternative that overlapped substantially with D36 and was held to be obvious. 
• "The Board therefore concludes that auxiliary requests 4 does not comply with the requirement of Article 76(1) EPC."
• As a comment, I wonder whether the allowability of the amendment here depended on the content of D36 as prior art. 
• The decision was taken 24.03.2023. On that day, the stock price of the proprietor decreased from 1.24 USD to 0.80 USD. The patent is EP2955190, also at issue in [2023] EWHC 611 (Pat) of 21 March 2023. That decision states that Sofosbuvir falls in the Markush group of the claims of the patent (at 11).

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t210795eu1.html

4. Auxiliary requests excluding H for X

4.1 Auxiliary request 4 (filed as auxiliary request 5)

4.1.1 The parent application as originally filed (see page 3, line 12 to page 4, line 14, see also claim 1) defined the variables X and Y for the compounds of formula I as follows:

"X and Y are independently selected from the group comprising H, F, Cl, Br, I, OH and methyl (-CH3)".

It was not in dispute that the amendments in accordance with claim 1 of auxiliary request 4 include with respect to the definition of the compounds of formula I in the parent application as filed the limitation of the meaning of Y to F in combination with the deletion of H from the list of options for X.

4.1.2 As confirmed in G 2/10 (see inter alia section 4.5.4), the assessment of amendments is to be based on what a skilled person would derive directly and unambiguously, using common general knowledge, from the (parent) application as originally filed (the "gold standard").

The Board observes that in accordance with the established jurisprudence regarding the deletion of meanings from multiple lists defining variables in a generic formula (see Case Law of the Boards of Appeal, 10th Edition, II.E.1.6.3 with reference to T 615/95, T 859/94, T 50/97, T 783/09, T 948/02 and T 801/02) it is not sufficient that the remaining subject-matter still relates to a generically defined group of compounds. In order to comply with Article 123(2) the deletion must not result in a particular combination of specific meanings which was not originally disclosed and which thereby generates another invention. In other words the amendment may not lead to a particular combination which is not derivable from the original application and is therefore potentially suitable to provide a technical contribution to the originally disclosed subject-matter as opposed to a mere restriction of the required protection which does not result in the definition of a new sub-class of compounds and is therefore not potentially suitable to provide a technical contribution to the original subject-matter.

4.1.3 In the patent as granted the definition of the compounds of formula I had already been limited with respect to the originally disclosed group of compounds by restriction of Y to a single meaning. Whilst such limitation is not objectionable as sole amendment, the combination of this limitation of Y with the further deletion of H in the meaning of X as defined in claim 1 of auxiliary request 4 singles out those compounds which are characterized by the combination of the features that the 2-position of the sugar moiety carries a dual substitution and that at least one of these substitutions is a fluoro-substitution. The Board considers this combination of features to define a specific sub-group of compounds within the originally disclosed generic group of compounds, which is well suitable to provide for a technical contribution generating another invention.

The original disclosure does not provide any pointer to this sub-group of compounds. On the contrary, the parent application as filed (see page 9, line 16) explicitly includes in the defined preferred list of meanings for X and Y the option of H: "Preferably, X and Y are, independently, selected from the group consisting of F, H and OH". These preferred meanings for X and Y are also reflected by the examples in the original disclosure, which relate to compounds in which X and Y represent either both H or both F.

4.1.4 The appellant-patent proprietor argued that no technical contribution was associated with the amendments in auxiliary request 4, which would merely remove the overlap with the definition of compounds from document D36 without giving rise to improvements or effects for which the original disclosure provided no basis.

The appellant-patent proprietor does thereby not address the suitability of the sub-group of compounds resulting from the amendments to provide for a technical contribution that was not embodied by the originally described generic group of compounds, which to a substantial extent overlapped with the teaching in document D36.

4.1.5 The appellant-patent proprietor further argued with reference to G 2/10 and T 1937/17 that the notion of a technical contribution should actually not be taken into account at all.

The Board notes that in G 2/10 (see section 4.3) the Enlarged Board of Appeal explained that the notion of a "technical contribution", as referred to in G 1/93 (see section 16) in the context of conflicting requirements under Article 123(2) and (3) EPC and in G 1/03 (see sections 2.6 and 4) in the context of disclaimers for undisclosed subject-matter, was not intended to modify the "gold standard" for the assessment of amendments.

The Board agrees with the considerations in T 1937/17 (see sections 4.3 and 4.3.1) that, accordingly, in the context of an amendment which is found to be allowable or not allowable under the "gold standard" any investigation as to the potential for a technical contribution is without relevance.

However, amendments by the deletion of options from multiple lists of separate characteristics inherently include an aspect of combination and potentially involve an aspect of arbitrariness, which may complicate the assessment of whether such amendments remain within the limits of what the skilled person would directly and unambiguously derive from the original disclosure.

Following the explicit reference in G 2/10 to the applicability of the existing jurisprudence regarding the singling out of compounds or sub-classes of compounds or other so-called intermediate generalisations not specifically mentioned nor implicitly disclosed in the application as filed (see G 2/10, section 4.5.4), the Board understands in this context the notion of

"the remaining generic group of compounds differing from the original group only by its smaller size" versus "singling out an hitherto not specifically mentioned sub-class of compounds"

and the notion of

"mere restriction of the required protection" versus "generating another invention" or "suitable to provide a technical contribution to the originally disclosed subject-matter"

as developed in the jurisprudence (see in section Case Law of the Boards of Appeal, supra, section II.E.1.6.3) not as modifications of the "gold standard" for the assessment of amendments in the form of additional or alternative criteria, but rather as considerations which may arise from the application of this standard when assessing amendments by deletion of options from multiple lists and which may affirm the result of such assessment.

Accordingly, the Board considers that the observation that the deletion of options for X and Y in accordance with claim 1 of auxiliary request 4 is suitable to provide a technical contribution to the originally disclosed subject-matter supports the assessment that this amendment is not in compliance with the "gold standard".

4.1.6 The Board therefore concludes that auxiliary requests 4 does not comply with the requirement of Article 76(1) EPC.

4.2 The claims according to auxiliary requests 5-9, 14-23, 28-33, 38-47, 50-51, 54-59, 62-63, 66-71, 76-83, 88-95, 98-101 and 104-107 include the same limitation in the definition of X by the deletion of H as claim 1 of auxiliary request 4.

The same considerations as presented in section 4.1 above therefore apply with respect to these auxiliary requests.

Accordingly, the Board concludes that auxiliary requests 5-9, 14-23, 28-33, 38-47, 50-51, 54-59, 62-63, 66-71, 76-83, 88-95, 98-101 and 104-107 (filed as auxiliary requests 5-10, 15-24, 29-34, 39-48, 51-52, 55-60, 63-64, 67-72, 77-84, 89-96, 99-102 and 105-108) do not comply with the requirement of Article 76(1) EPC.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

https://www.epo.org/law-practice/case-law-appeals/recent/t210795eu1.html