The patent relates to the field of orally administrable pharmaceutical dosage units such as soft chews, especially for administration to non-human animals.
Chews comprising pamoic acid or a pharmaceutically acceptable salt thereof can be easily processed in forming machines and therefore facilitates manufacturing such soft chews on an industrial scale.
Brief outline of the case
The patent was revoked as the OD came to the conclusion that claim 1 of the MR filed during opposition was infringing Art 123(2). Claim 1 of the MR is identical to claim 1 as granted.
AR 1 did not meet the requirements of Art 84. AR 2-10 were considered infringing Art 123(2) for the same reasons as the MR.
The proprietor appealed the decision.
The board held that the MR did not infringe Art 123(2) and remitted the case to the OD for further prosecution.
The claims at stake
Claim 1 as filed comprised the following proviso in the composition of the soft chewable veterinary pharmaceutical product:
A soft chewable veterinary pharmaceutical product comprising….
– “pamoic acid or a pharmaceutically acceptable salt thereof, provided that such pamoic acid or pharmaceutically acceptable salt thereof is not an active pharmaceutical ingredient”
Claim 2/1 as filed specified that the chewable composition comprises sodium pamoate.
In claim 1 as granted, the pamoic acid or a pharmaceutically acceptable salt thereof with the proviso was replaced by sodium pamoate. This claim was also in the MR before the board.
As the disclaimer/proviso was disclosed in the application as filed, it can be considered as a disclosed disclaimer and does not fall under G 1/3-G 1/16 or G 2-10.
However, removing a disclaimer can in general have two effects
- end up with an extension of object not allowable under Art 123(2)
- increase the scope of protection under Art 11223(3)
Here board found that removing the disclaimer/proviso did not infringe Art 123(2).
The opponent’s position
With the deletion of the feature and its proviso, claim 1 of the MR now also covered a soft chewable product comprising not only sodium pamoate but also for example pyrantel pamoate and/or pamoate oxantel. These possibilities were expressly excluded throughout the application filed by the proviso “provided that such pamoic acid or pharmaceutically acceptable salt thereof is not an active pharmaceutical ingredient”.
Furthermore, several documents D18 to D20 and also D22 had been provided, showing that sodium pamoate is a pharmaceutical active ingredient. Therefore, it was clear that sodium pamoate could not fall within the class of non-active pamoic acid derived ingredients of claim 1 as filed.
The opponents also argued that the omission of the proviso in the claims changed the scope of claim 1, resulting that the claimed object was contrary to Art 123(2).
The proprietor’s position
For the proprietor, the application as filed directly and unambiguously disclosed sodium pamoate as ingredient of the soft chewable veterinary pharmaceutical product, being a preferred embodiment of “pamoic acid or a pharmaceutically acceptable salt thereof” as compound per se for use as an ingredient in the soft chewable veterinary product of the invention, without any indication of its role as active or non-active ingredient, see e.g., page 7, lines 7-16.
The term “sodium pamoate” could thus replace the whole deleted expression in claim 1 as filed including the proviso.
The OD’s position
The OD agreed with the opponents and held that the MR did not meet the requirements of Article 123(2) EPC in view of the deletion of the feature “pamoic acid or a pharmaceutically acceptable salt thereof, and the corresponding proviso.
The board’s position
A direct basis for the sodium salt of pamoate is disclosed in original dependent claim 2. Sodium pamoate is also present in all examples and is presented several times as the preferred salt in the description of the application as filed, see page 3, line 11; page 7, lines 10-11 and 21.
The subject-matter of claim 1 of the MR results from the deletion of the proviso present in original claim 1.
The deletion of a proviso/disclaimer explicitly disclosed in the application as originally filed as “not forming part” of the invention might not be admissible if the deletion results in the “non-part” being still partially claimed or if there is no disclosure in the original application as a whole which renders the remaining claimed subject-matter directly and unambiguously derivable therefrom.
For the board, claim 1 of the original application makes a distinction between the presence of “one or more active pharmaceutical ingredients” and the remaining components of the product, including pamoic acid, even if the original proviso is not taken into consideration. The wording of the term “one or more active pharmaceutical ingredients” suggests indeed that the remaining components of the product including pamoic acid or a salt thereof are not considered as active pharmaceutical ingredients.
Moreover, the description discloses, on page 2, lines 15-20, the presence of pamoic acid or its salt in the soft chewable veterinary product without specification of its function and all examples according to the claimed invention comprise an active ingredient and sodium pamoate, without specification of the function of the latter.
A specific passage on page 7, lines 17-21 of the description states furthermore explicitly that “In one aspect…and pamoic acid or salts are included in the soft chew composition as an (non-active) ingredient or excipient”.
From this passage on page 7 it follows that the specific sodium pamoate was considered in the application as filed as a non-active ingredient and this passage appears to constitute a direct basis for the omission of the proviso and its replacement by the disclosed equivalent feature and specific compound “sodium pamoate”.
The board also found that the fact that pamoate salts, such as in particular the sodium salt, are presented in some prior art documents as pharmaceutical active ingredients, such as in D18-D20 or D22 as argued by the respondents, is irrelevant to the present case.
For the board, this argument appears to be irrelevant for the assessment of the requirements of Art 123(2), since the relevant question for the purposes of Art 123(2) is whether the amendments remain within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, from the whole of the application as filed, cf. the “gold standard” of G 2/10, OJ 2012, 376.
The board held that the interpretation of the OD and of the opponents is inconsistent with the subject-matter of original claim 1 in combination with claim 2, which encompasses this possible combination.
The board disagreed with the opponents as far as the scope of the claim was concerned. In the board’s view, such criteria relating to the scope of the originally filed claim is inappropriate for the assessment of compliance with Art 123(2), which refers explicitly to the content of the application as filed, and not to the scope of the claims. Here again, the board referred to the “gold standard” of G 2/10, OJ 2012, 376.
In the present file the disclosed disclaimer/proviso has been deleted.
The proviso has been replaced by a positive statement. The deletion remains problematic as the reason for the proviso has indirectly been deleted.
The applicant made clear in the application as filed that pamoic acid helps in the manufacture of soft chewable veterinary pharmaceutical products, although it can be considered, as such, as a medicine.
This does not seem known from the prior art and might warrant a patent, but with the proviso.
Whether keeping silent on a well-known property of an ingredient, as considered by the board, is really making a difference is debatable. The decision could, and probably should, have been different.
The reason of the proviso is found for example in §  which reads: “It has now been found that the soft chews that comprise sodium pamoate can be easily processed in a forming machine and that sodium pamoate facilitates manufacturing of such soft chews on an industrial scale using a forming machine”. Used in this way, sodium pamoate is indeed meant to have no therapeutic effect.
Sodium pamoate is, as shown by the opponents, a product which can have a therapeutic effect. In the claim accepted by the board, the proviso has been removed. The medical use of sodium pamoate is thus not excluded by the claim as it stands.
Therefore, a feeling of unease remains as the proviso is completely removed and it cannot be concluded from the wording of the claim that the sodium pamoate does not have any therapeutic effect.
When looking at the disclosure as a whole, the addition of sodium pamoate might not have the effect it normally has, that is a therapeutic effect, but it has the effect of allowing easy processing of the chew.
There are lots of decisions of the boards saying that when a claim is clear as such and makes technical sense, the description cannot be taken into account in order to imply a limitation of what is clearly expressed in the claim.
It can be agreed with the board that sodium pamoate is present in all the examples, but with the effect of easing manufacture. Here the board has looked at the description, but has overlooked the effect achieved by the presence of sodium pamoate when it comes to the manufacture.
It remains thus doubtful that the deletion of the proviso is acceptable when looking at the disclosure as a whole.
As the file has been remitted for further prosecution, the OD is bound by the ratio decidendi of the decision, but the patent is not yet saved.
It seems that a minimum amount of sodium pamoate (1,5%) is necessary to avoid clogging of the manufacturing machine , cf. Claim 2 as granted. The effect not being claimed, avoiding clogging of the manufacturing machine, the applicable objection is then not a lack of sufficiency, but a lack of IS, see for instance T 2001/12, catchword.
It will thus be interesting to see what happens under Art 100(a) when the procedure is reopened before the OD.