T 1870/22 (SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND A SALT OF N-(8-(2- HYDROXYBENZOYL)AMINO)CAPRYLIC ACID/Novo Nordisk A/S) 29-11-2024

Reasons for the Decision

1. Main request - Rule 80 EPC

1.1 The compliance of the main request with Rule 80 EPC has been contested by the respondents in view of the deletion of claim 3 as granted.

Claim 3 as granted read:

"3. The composition according to any of the preceding claims, wherein the molar ratio between semaglutide and said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid in the composition is less than 10, such as less than 5 or less than 1."

According to the respondents the patent proprietor deleted claim 3, in response to objections relating to Article 84 EPC and not in reply to the objections raised initially against claim 3 under Article 83 EPC. Since the respondents' objections are considered to be lack of clarity objections under Article 84 EPC, deletion of granted claim 3 should not be admissible under Rule 80 EPC.

1.2 The Board notes that the objections against claim 3 as granted were raised by the respondent 02 under Article 83 EPC in its notice of opposition. In response to this objection, the proprietor deleted dependent claim 3 in its main request. Hence, this deletion is in direct response to the objections made by respondent 02 under Article 100(b) EPC and is justified under Rule 80 EPC.

More specifically, the respondent 02 objected claim 3 under Article 83 EPC by arguing that the skilled person was not able to rework the invention over the entire molar ratio claimed. In view of the claimed percentage of "at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" in claim 1, the patent as defined in the preferred option of claim 3 was not re-workable for the range of from 0.05 to 1, and it could only be realized in the range of from 0.05 to (almost) 0. In other words, 95 % of the preferred range was not re-workable (see points 14 to 20 of the submissions of 3 December 2020).

The Board notes that the molar ratio reported in claim 3 as granted is also disclosed in the patent description (see par. [0030] of the specification). In the Board's view, if a claimed invention appears at first sight infeasible, due to technical incompatibilities with other parts of the claims or of the description, this may result simultaneously to a lack of clarity and insufficiency of disclosure which justifies the deletion of the claim under Rule 80 EPC.

2. Main request - Article 76(1) EPC

2.1 Claim 1 of the main request reads:

"1. A solid composition for oral administration comprising semaglutide and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, wherein said composition comprises at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid."

The subject-matter of claim 1 has been objected under Article 76(1) EPC under two points:

a) the claimed amount of "at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" has replaced the originally claimed amounts of the salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid (NAC) of "at least 0.6, or at least 0.8 mmol", and there was no indication in the parent application that an amount of "at least 60% (w/w)" could be used instead of "at least 0.6 mmol". The opposition division concluded in its decision that an amendment replacing or removing a feature presented as essential contravened the requirements of Article 76(1) EPC.

b) respondent 02 also considers that the subject-matter of claim 1 constitutes a selection from a threefold selection from lists, with regard to the claimed amount, semaglutide and the oral administration.

2.2 The description of the parent application specifies that the "salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" is used as delivery agent (see page 10, lines 24-28).

With regard to the claimed amount of the delivery agent (see point a) above), several parts of the parent application D20 mention it:

- page 13, lines 1 and 4;

- page 21, line 4;

- page 23, line 23.

2.2.1 The disclosure on the first paragraph of page 13, line 1, relates to the claimed composition and discloses that "in some embodiments the composition comprises at least 60% (w/w) delivery agent, less than 10% (w/w) binder, 5-40% (w/w) filler, and less than 10% (w/w) lubricant or glidant". In this first passage, the amount of "at least 60% (w/w)" is linked with amounts of other components of the composition, namely the amounts of binder, filler, lubricant or glidant. Therefore, the amount "at least 60% (w/w)"cannot be extracted in isolation of the other features.

In the second paragraph of the same page on line 4, the parent application further discloses that "in some embodiments the composition comprises at least 60% (w/w), such as at least 70% (w/w) or at least 75% (w/w), delivery agent". This disclosure appears to be independent from the previous paragraph of the same page given the way it is introduced by the terms "in some embodiments". Said paragraph relating to the delivery agent is furthermore followed by three distinct paragraphs relating to the presence and amounts, "in some embodiments", of respectively a a binder, a filler, and a lubricant and/or a glidant. The inconsistency in the last paragraph between the disclosed amount of lubricant and/or glidant, namely "0.1-10% (w/w)", and the amount of "less than 10% (w/w) lubricant or glidant" in the first paragraph suggests that each paragraph of page 13 must be seen as separate embodiments.

Consequently, the amount of the delivery agent in the second paragraph of page 13 is disclosed in isolation and represents a separate embodiment. Accordingly, it constitutes a valid basis for the feature "at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" of claim 1 of the main request.

2.2.2 The further disclosure on page 21, embodiment 15 relating to "15. A composition according to any one of the preceding embodiments, wherein said composition comprises at least 60% (w/w), such as at least 70% (w/ or at least 75% (w/w), of said salt of N-(8-(2- hydroxybenzoyl)amino)caprylic acid", cannot serve as basis for the feature of "at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" of claim 1, since it is clearly linked to compositions comprising the delivery agent in a minimal amount of at least 0.6 mmol (cf. embodiment 1 on page 19) or in the range of 0.6-2.1 mmol (cf. embodiment 11 on page 20).

The same conclusion applies with regard to the disclosure of page 23, i.e. "44. A composition according to any one of the preceding embodiments, wherein said composition comprises at least 60% (w/w) delivery agent, less than 10% (w/w) binder, 5-40% (w/w) filler, and less than 10% (w/w) lubricant and/or glidant.", since the disclosed amount of "at least 60% (w/w)" is linked with other amounts of the composition, namely the amounts of binder, filler, lubricant or glidant.

2.2.3 The Board could not follow the line of argumentation developed by the respondents and by the opposition division in its decision regarding the feature "at least 60% (w/w) of said salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" in claim 1 for the following reasons.

[deleted: ]

The respondents argued that the amounts of 0.6 mmol or 175 mg of the delivery agent are essential features of the disclosure of the parent application, especially in light of the technical problem to be solved, and that it is not possible to consider single statements in the application in isolation, said statements involving the presence of less than said 0.6 mmol or 175 mg of the delivery agent; the deletion of such essential features contravened Article 76(1). This argumentation was followed by the opposition division in its decision.

In more detail, the respondents consider that the replacement of the absolute amounts of 0.6 mmol or 175 mg of the delivery agent by the relative amount of 60% (w/w) is not possible, because the skilled person is taught by the parent application that a specific and minimal absolute amount of NAC is required to ensure bioavailability of the GLP-1 agonist, as demonstrated by the results of Table 1 of the patent, wherein 300 mg of SNAC (compositions B, D, E, F) led to a better bioavailability than 150 mg of SNAC (composition A), while bioavailability was not affected by the relative amounts which was over 60% (w/w) in all examples.

In the same context, the opposition division considers in its decision that the skilled person recognises that the only difference between the background art cited in the description of the contested patent and the proposed solution is the absolute amount of the salt of NAC, indicating that this feature represents the contribution to the state of the art.

In the Board's view, the only and fundamental test for determining whether the subject-matter of claim 1 meets the requirements of Article 76(1) EPC is the same adopted for assessing the requirement of Article 123(2) EPC, namely the "gold standard" disclosure test (see G 1/05 of 28 June 2007, point 5.1 of the reasons, and G 2/10, point 4.3 of the reasons). This standard requires that the subject-matter of a claim of a divisional application or patent remains 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 earlier application as filed. Moreover, the skilled person may not be presented with new technical information (see G 2/10, point 4.5.1 of the reasons).

While the points raised by the respondents or by the opposition division might be founded, these considerations or approaches are irrelevant to the assessment of added matter under Articles 76(1) or 123(2) EPC, and relate rather to the assessment of sufficiency of disclosure or inventive step. Under Articles 76(1) or 123(2) EPC, it is sufficient that a feature be derivable directly and unambiguously from the parent of patent application, which is the case here as shown above.

Moreover, there is no indication in the parent application that the minimum amount of 0.6 mmol of a NAC salt is essential. D20 states in several parts that "certain amounts" of a salt of NAC are necessary (e.g. page 1, line 33). Other parts of the description do not mention any minimum amount at all (e.g., page 1, lines 5-6).

The examples illustrate furthermore a composition that contains at least 60% (w/w) of a salt of NAC (SNAC), but contains less than 0.6 mmol of said salt of NAC, which is effective at delivering semaglutide to the blood stream by oral route, even if it is less effective than compositions comprising more than 0.6 mmol of SNAC (see composition A of Table 1).

Thus, the arguments of the respondents are not convincing.

2.3 With regard to point b), respondent 02 considers that the subject-matter of claim 1 constitutes a selection from a threefold selection from lists, with regard to the claimed amount, semaglutide and the oral administration.

The Board concurs with the decision of the opposition on this point (see points 2.5-2.7 of the decision ) and considers also that this objection is not founded.

The feature "oral administration" does not involve any selection. This route of administration was already part of original claim 1. Moreover, it is stated on page 12 (lines 5-6) that the composition is administered by the oral route.

Semaglutide is the preferred GLP-1 agonist as disclosed in original claim 11 and on page 4 (line 13). Moreover, all the examples relate to semaglutide.

The association between a GLP-1 agonist and "certain amounts of a salt of N-(8-(2-hydroxybenzoyl)-amino) caprylic acid" is disclosed directly and unambiguously in the parent application, such as on page 1, lines 31-35. The amount of the delivery agent has to be seen as a selection among several possibilities, namely the absolute values of at least 0.6 mmol or 175 mg, and the relative amount disclosed in the parent application on page 13, line 4, i.e. "in some embodiments the composition comprises at least 60% (w/w), such as at least 70% (w/w) or at least 75% (w/w), delivery agent".

Consequently, the Board agrees with the opposition division that only a single selection is necessary to arrive at the subject-matter of claim 1.

2.4 Consequently, the subject-matter of claim 1 is derivable directly and unambiguously from the parent application and the main request meets the requirements of Article 76(1) EPC.

3. Remittal to the opposition division

As mentioned above, the subject-matter of the main request meets the requirements of Article 76(1) EPC. However, the main request has not yet been examined with regard to other grounds of opposition, such as inter alia inventive step or sufficiency of disclosure or even Article 123(2) EPC.

Under Article 111(1) EPC, the Board may in the present case either proceed further with the examination of the other grounds of opposition, or remit the case to the opposition division for further prosecution.

Article 11 RPBA provides that the Board shall not remit a case to the department whose decision was appealed for further prosecution, unless special reasons present themselves for doing so. The Board holds that such special reasons are apparent in the present case.

The provision of Article 11 RPBA has indeed to be read in conjunction with Article 12(2) RPBA, which provides that it is the primary object of the appeal proceedings to review the decision under appeal in a judicial manner (see also T 1966/16, point 2.2 of the reasons, T 0547/14 points 7.1 and 7.2, and T 0275/15 point 4.). This principle would not be respected if the Board were to conduct a complete examination of the opposition grounds.

As discussed above, in the present case the opposition division division decided only on the question of Article 76(1) EPC and did not consider the further grounds of opposition. Under these circumstances, the Board considers it appropriate to exercise its discretion under Article 111(1) EPC and to remit the case to the department of first instance for further prosecution.