T 454/08 – A Fake Swiss

Swiss-type claims are a dying species, but from time to time we still have decisions dealing with them.

Claim 1 of the main request before the Board read (in English translation):

Use of an active substance in the form of microcrystals or microgranules comprising a coating that masks their taste and a mixture of excipients, wherein the mixture of excipients comprises one or more disintegrating agents and one or more swelling agents or soluble agents, for the manufacture of a rapidly disintegratable multiparticulate tablet, wherein said tablet is intended for oral administration in the buccal cavity on the tongue, and wherein its disintegration speed is such that it disintegrates in less than 60 seconds, in order to provide with the saliva present a suspension easy to be swallowed.

In what follows, the Board examines the novelty of this claim and shows us that travelling with a fake Swiss passport is a dangerous activity.

*** Translation of the French original ***

[4] Claim 1 of the main request is essentially directed at:

• the use of an active substance in the form of microcrystals or microgranules comprising a coating that masks their taste and a mixture of excipients …
• for the manufacture of a rapidly disintegratable multiparticulate tablet …
• said tablet is intended for oral administration in the buccal cavity on the tongue …
• its disintegration speed is such that it disintegrates in less than 60 seconds, in order to provide with the saliva present a suspension easy to be swallowed.

Interpretation of claim 1

[4.1.1] According to decision G 6/83, a European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application.

Decision G 6/83 allowed the reformulation of claims for therapeutic methods referred to in A 52(4) EPC 1973 as so-called Swiss-type claims.

Thus the use of a composition for manufacturing a medicament to be used within the framework of a therapeutic or surgical activity is patentable for the implementation of any specific use in a given therapeutic method, within the framework of a further medical indication, provided that the other requirements of the EPC, and in particular novelty and inventive step, are satisfied.

However, if a claim drafted in the form of a Swiss-type claim does not refer to an implementation of any therapeutic method or de facto refers to a non-therapeutic use, then the feature defining the implementation is of purely illustrative character and cannot serve to establish novelty over the state of the art. As a matter of fact, this particular approach to novelty only applies to claims directed at the use of a substance or composition for a method within the meaning of A 52(4) EPC 1973 (now A 53(c)).

Claim 1 of the main request is drafted according to the model proposed by decision G 6/83, i.e. the use of a substance for the manufacture of a composition intended for a specific use.

However, none of the terms of claim 1, i.e. “active substance”, “multiparticulate tablet” and “intended for oral administration in the buccal cavity on the tongue” implies the implementation in any therapeutic method within the meaning of A 53(c).

As a matter of fact, the expressions “active substance”, “multiparticulate tablet” and “intended for oral administration in the buccal cavity on the tongue” cannot be considered to be limited to the therapeutic domain. In particular, one cannot assert that a “oral administration in the buccal cavity on the tongue” refers to a therapeutic use. Moreover, claim 1 does not contain any additional feature related to any implementation in a therapeutic method.

The particular approach to novelty created by decision G 6/83, therefore, does not apply to claim 1 of the main request, the subject-matter of which is equivalent to a process claim, i.e.  “process for manufacturing a rapidly disintegratable multiparticulate tablet by using an active substance in the form of microcrystals or microgranules comprising a coating that masks their taste and a mixture of excipients …”. The step where the tablet is administered, wherein “said tablet is intended for oral administration in the buccal cavity on the tongue” has to be understood as a feature that is illustrative of the tablet and not as a limiting feature concerning a specific way of administration.

[4.1.2] Moreover, the subject-matter of the claim comprises a functional feature defining the multiparticulate tablet, i.e. “its disintegration speed is such that it disintegrates in less than 60 seconds, in order to provide with the saliva present a suspension easy to be swallowed”.

This functional feature does not allow to define the subject-matter of claim 1 in a clear and unambiguous way. As a matter of fact, claim 1 does not contain any indication concerning the measuring method used for the measurement of the disintegration speed. In particular, claim 1 only defines the degree of disintegration via its capacity to form a suspension that can be swallowed easily. This capacity is a subjective concept. The level of disintegration can vary between a mere reduction of the size of the multiparticulate tablet and the achievement of a suspension of small particles. This variability has an impact on the claimed disintegration time, which makes it ambiguous.

The relevance of the state of the art has to be evaluated taking into account this ambiguity.

Document 4(3)

[4.2] Document 4(3) refers to pharmaceutical compositions for oral administration, comprising a medicament that is coated by a polymer which is soluble at pH values above 5 and an acid component intended to reduce or avoid the dissolution of the coating in the buccal cavity […]. It is the polymer coating, which is protected from dissolution by the acid component, that masks the taste […].

The compound can be a tablet that quickly disintegrates in the mouth […]. The tablets of example 1 comprise cellulose and reticulated polyvinylpyrrolidone. They disintegrate in the mouth in less than 30 seconds (see example 1).

Thus document 4(3) anticipates all the features of the subject-matter of claim 1 of the main request.

Document 2(3)

[4.3] Document 2(3) concerns tablets that are to be dispersed in water in order to be then swallowed in the form of a suspension […]. These tablets are made up of coated microparticles that are dispersed in at least one swelling agent and a disintegrating agent […]. Examples 1 and 3 comprise coated microparticles that are associated with guar gum, cellulose and reticulated polyvinylpyrrolidone.

The amounts of excipients and the final hardness of the tablets obtained in document 2(3) are identical or very similar to the amounts and the hardness obtained with the tablets of the preferred embodiment of the impugned patent […]. The speed of disintegration obtained with the tablets of document 2(3) is 1 minute in water. The skilled person can only conclude that these tablets have physical properties that are equivalent to those of the impugned patent and necessarily would have the same disintegration properties if they were administered in the mouth.

Incidentally, although these tablets are intended for a different use, they are appropriate and suitable “for oral administration in the buccal cavity on the tongue”.

Thus the subject-matter of claim 1 of the main request is not novel over the disclosure of document 2(3).
 

Document 2(2)

[4.4] Document 2(2) concerns a tablet that quickly disintegrates into several granules in the stomach […]. The granules are made up of an active substance that is coated with a mixture of acrylic polymers and ethyl cellulose (Eudragit® E30D and Aquacoat® ECD), which polymers are well known for masking the taste […] and which are also used in the impugned patent. These coated granules are blended with cellulose and reticulated polyvinylpyrrolidone, which are also cited among the preferred excipients of the embodiments of the impugned patent. These tablets are appropriate and suitable “for oral administration in the buccal cavity on the tongue”.

These tablets disintegrate in 37°C water in less than one minute […]. Although the disintegration time is measured in vitro, one may expect that the disintegration time is of the same order when it is measured in vivo, in presence of saliva. The skilled person can only conclude that these tablets have physical properties that are equivalent to those of the impugned patent and necessarily would have the same disintegration properties if they were administered in the mouth.

Thus document 2(2) destroys the novelty of claim 1 of the main request.

Document 4(6)

[4.5] Document 4(6) discloses tablets comprising pellets that are coated with a protective polymer. These tablets may be brought in contact with a small quantity of water […] and may be absorbed as they are or in drinkable form that is obtained using the liquid used for disintegrating the tablet […]. The tablet of example 1 discloses pellets coated with Eudragit® E30D and contains starch and reticulated polyvinylpyrrolidone as excipients. The quantities of excipients and the final hardness of the tablet are equivalent to the tablets of the impugned patent. One can only conclude that the tablet of document 4(6) is suitable for buccal administration on the tongue and that implicitly the disintegration speed would be identical to the embodiments of the present invention.

Thus claim 1 of the main request is not novel over document 4(6).

Additional arguments of the [patent proprietor]

[4.6] (a) The [patent proprietor] was of the opinion that claim 1 of the main request was drafted as a second therapeutic use related to a specific way of administration. Claim 1 of the main request has to be read in the light of the description, which makes it clear that the active substance can only be a therapeutic substance. As a matter of fact, the description uses expressions related to therapy such as “practitioner” […], “therapeutic substance” […], “medicament” […], therapeutic protection […] all along. Also, the examples contain therapeutic substances. Thus the skilled person cannot interpret the expression “active substance” in claim 1 to mean anything but a “therapeutic substance”. Consequently, the oral administration is to be considered as a feature to be taken into account for assessing novelty. However, this reasoning cannot be endorsed. Not only should it not be necessary to consult the description in order to interpret the subject-matter of a claim, but these expressions, in particular “active substance”, “therapeutic substance” or “medicament” are not sufficient for de facto implying a therapeutic method. A therapeutic use is not related to the nature of a substance that in itself possesses therapeutic properties, but it is related to the effective involvement of said substance in any therapeutic method within the meaning of A 53(c). As a matter of fact, one cannot exclude that a substance having therapeutic properties may be used in methods that are not methods within the meaning of A 53(c).

(b) According to the [patent proprietor], the claimed tablet has to have particular properties, i.e. it has to have satisfy conditions related to the disintegration time and masking of taste. In particular, the criterion according to which it has to disintegrate in less than 60 seconds has to be taken into account when novelty is assessed. The Board does not contest that the criterion of disintegration is a fundamental feature of the multiparticulate tablet according to the invention and agrees that it should be taken into account for the assessment of the novelty of claim 1. However, the ambiguity and the subjective nature of this functional feature does not allow for a restrictive interpretation. In particular, the interpretation of the disintegration level allows for many different ways of measuring the corresponding disintegration time. This variability has to be taken into account when comparing [the claimed subject-matter] with the state of the art (cf. point [4.1.2] above). The [patent proprietor] has provided Annexes 2 and 4 containing measurements of the disintegration time of the tablet according to example 3 of document 2(3) and a comparison between example 1 of document 4(6) and example 1 of the impugned patent. As far as Annex 2 is concerned, there is no explanation whatsoever in regard of the way in which the time of disintegration in the mouth is measured. Annex 4 advocates complete disintegration of the tablet, which is a particular method that is not mentioned in claim 1 or in the text of the description of the impugned patent. Thus these Annexes cannot be considered to be relevant for establishing an objective comparison with the state of the art.

Conclusions

[4.7] It follows [from the above] that the subject-matter of claim 1 of the main request is not novel (A 54).

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