T 2614/11 (STABLE BEADLETS OF LIPOPHILIC NUTRIENTS/Omniactive Health Technologies) 16-10-2014

1. Main request - Inventive step

1.1 The invention relates to stable and usable formulations of lipophilic nutrients in the form of beadlets comprising an inert spherical core and a coating comprising a stabilizing antioxidant and said lipohilic nutrient.

The beadlets ensure stability of the lipophilic nutrient when formulated in the beadlet form itself, or when formulated in tablets. Moreover, said beadlets, which are obtained by a process of fluidized bed, are spherical, free flowing and suitable for tabletting or capsule filling (see par. [0001] and [0015]).

1.2 Documents (1), (2), (3), (4), (7) and (8) were considered as potential closest prior arts by the parties.

(a) Documents (1), (7) or (8) relate all to the same commercial product, namely Rovimix® E-50 Adsorbate. Document (7) shows in particular that this product consists of a lipophilic nutrient, namely DL-alpha-tocopheryl acetate, adsorbed on the surface of spherical silicic acid particles, without antioxidant (see document (7), first page). The external layer of DL-alpha-tocopheryl acetate covers furthermore only partially the spherical silicic acid particles, as shown by the experiments of document (12) (see document (12), point 5.2).

Document (8) mentions further the good flowability of the Rovimix® E-50 Adsorbate powder as expressed by an angle of repose of the beadlets of 30° (see document (8), "Flowability").

(b) Document (2) relates to a method of producing dry, fre-flowing mixtures of vitamin powders, obtained in the examples by high speed mixing of a tocopherols blend with silica. This document does not give further indications on the final structure obtained by said process.

(c) The date of publication of document (3) was posterior to the priority date of the contested patent, and this document is thus not relevant for the assessment of inventive step.

(d) Document (4) discloses the preparation of granulates by spray drying a carrier, tocopherol and a stabilizing agent to stabilize the potency of the tocopherol in the composition (see page 3, lines 9-12). The stabilizing agent is chosen among known antioxidants, namely ascorbic acid, citric acid, cysteine or methionine (see page 3, lines 22-27).

The process of preparation consists in forming an emulsion or slurry of all components followed by spray drying (see page 3, lines 40-44). The result of the spray-drying process is a composition in the form of a stabilized powder with a carrier supporting the tocopherol.

Document (4) further discloses in its examples the preparation of particulates by coating of tocopherol and an antioxidant onto silica gel by using a laboratory evaporator and a drying step (see for instance example 1). This document does not give more details on the structure of the particulates obtained by the method of the example, in particular if this coating was complete and uniform.

The document (4) is the document presenting the most common technical features with the subject-matter of claim 1. The subject-matter of claim 1 of the main request differ indeed from the compositions disclosed in document (4) only by the structure, namely an uniform layered structure in claim 1 of the main request instead of a granulate structure or a non uniform layered coated structure in document (4).

Consequently, document (4) is seen as the closest prior art.

1.3 The problem as set out in the description of the contested patent may be seen in the provision of beadlets with excellent free flowing properties which are appropriate for making tablets (see par. [0015], [0028]).

1.4 As a solution to this alleged problem, claim 1 of the main request proposes beadlets comprising an inert spherical core and a uniform coating comprising a stabilizing antioxydant and a lipophilic nutrient, formed from a colloidal suspension of said lipophilic nutrient and of said antioxidant by diluting a solution of said lipophilic nutrient in a non-polar solvent with a polar solvent and by subjecting the colloidal suspension to fluidisation using a fluidised bed system employing said inert core.

1.5 It has to be investigated whether there is sufficient evidence supporting the alleged effect.

1.5.1 The patent in suit provides 9 examples of compositions, all made from non-pareil sugar seeds uniformly and completely coated with a layer of a lipophilic nutrient and an antioxidant. The loaded non-pareil seeds were further coated by two protective layers acting as oxygen and moisture barrier (see par. [0039]-[0040]), such as in examples 1-8 by a first layer comprising essentially ethyl cellulose and hydroxypropyl methyl cellulose and a second layer comprising essentially sodium carboxymethyl cellulose or polyvinyl alcohol.

The flow property of the beadlets was assessed in example 9 by determining the angle of repose which was comprised between 23 and 25 degrees (see par. [0101]). The tablets obtained with the beadlets showed good properties, namely disintegration times of less than 2 minutes and friabilities of less than 1% (see par. 0102] and Table 1 of example 9).

1.5.2 The examples of the contested patent show undoubtedly an effect linked to the specific beadlets disclosed therein, an effect whose merits would deserve to be rewarded.

Said effect shown in the examples can however not be taken in consideration in the assessment of inventive step of the invention as claimed for following reasons:

(a) First, the specific compositions of the examples of the contested patent are not representative of the claimed object.

Said compositions of the examples have indeed their inert spherical core made from non-pareil sugar seeds, which structure and properties are particular and not necessarily shared by any "inert spherical core" in general.

The term "inert spherical core" of claim 1 of the main request is not limited to sugar non-pareil seeds and encompasses indeed any kind of carrier, including porous inert carriers, such as those of document (4) made from porous silica.

Moreover, the compositions of the examples present two further external coating layers which may have an essential impact on the effect observed and which are absent from the subject-matter of claim 1.

The effect observed with the compositions of the examples of the contested patent cannot thus be extrapolated to the whole subject-matter of claim 1.

(b) Secondly, the examples of the contested patent do not provide a comparison between the compositions according to present invention and compositions according to document (4), in particular regarding the flowability of the powders or the properties of tablets obtained with the beadlets.

According to the case law of the boards of appeal, alleged advantages to which the patent proprietor merely refers, without offering sufficient evidence to support the comparison with the closest prior art, cannot be taken into consideration in determining the problem underlying the invention and therefore in assessing inventive step (see for instance T 20/81). Said technical effect must be established in a plausible way over the closest state of the art.

The board does not see any reason to deviate from this case law as it was based on the understandable rule that a patent can only properly be granted for a solution claimed as non-obvious if it actually has the alleged effect.

1.5.3 It is thus not possible to conclude to the existence of an improvement over the prior art.

1.6 Consequently, in the absence of any experimental evidence or arguments establishing a minimum plausibility, the presence of an improvement of the flowability and tabletting properties of the claimed beadlets over the beadlets of document (4) has not been credibly demonstrated and the technical problem must be reformulated as the provision of alternative beadlets.

In view of the information found in the examples of the contested patent, the board is convinced that the problem has been plausibly solved.

1.7 Since the problem consists the provision of alternative beadlets, it belongs to the skilled person to modify the existing beadlets as part of its normal activity.

The production of uniformly coated beadlets is commonly known by the skilled person and the process of fluidized bed is an applicable method known in the art to produce such coated product.

The production of beadlets with an uniform coating can only be seen as an arbitrary choice that would be made as a matter of routine by a skilled person.

1.8 Further arguments from the respondent

1.8.1 The respondent argued that the problem of the provision of beadlets which are appropriate for making tablets was neither known nor deductible from any cited prior art document. It constituted therefore a newly identified problem, namely a problem-invention, which the skilled person would not have tried to solve.

Moreover, according to the appellant, beadlets formed from silica particles are not capable to provide powders with good flowability properties; the beadlets of the invention offered thus in any case an advantage over the prior art, which related only to silica particles.

Said silica particles could also not be classified as inert and spherical.

1.8.2 The Board could not share this opinion.

It is true that the discovery of an unrecognised problem may in certain circumstances give rise to patentable subject-matter in spite of the fact that the claimed solution is retrospectively banal and in itself obvious ("problem-inventions").

The need for the provision of free-flowing particulates is however already known from document (4) which mentions this property (see page 2, lines 7-9; page 3, lines 9-12). Document (4) mentions in particular the unsuitability of the tocopherol and their esters for certain pharmaceutical applications, "particularly those in which a powder is required, such as in tablets or capsules" (see page 2, lines 15-17). It follows that the problems of powder flowability and tabletting are related and intrinsically linked together, and as such recognized in the prior art.

Under these circumstances the arguments of the respondent appellant that the claimed invention was inventive since the problem was unrecognized before are not relevant.

As to the argument of the respondent regarding the poor flowability generally obtainable with powders made from inert cores of porous silica, it has not been substantiated or evidenced by the respondent.

This argument is furthermore not credible in view of the angle of repose obtained with porous silica for the product Rovimix® E-50 Adsorbate, showing namely an angle of repose of 30 degree (see document (8), "Flowability tests"), which is similar to the goal of the present invention to provide powders with an angle of repose between 20 and 30 degrees (see par. [0035]), This argument thus cannot form the basis of a comparison between the compositions of the present invention and composition according to document (4) having also porous silica as inert carrier.

As to the spherical aspect of silica particles, the general sphericity of silica particles was demonstrated by the pictures or drawings of documents (1), (7), (8) or (12) and was confirmed by the measurement of the angle of repose given in document (8).

Moreover, silica is a common excipient and as such has to be considered as inert. On a chemical point of view, it is obvious that silica is as at least as inert as the preferred excipients used in the contested patent, namely sugar, mannitol, starch, sago, and microcrystalline cellulose (see par. [0031]).

1.9 Thus, the subject-matter of claim 1 of the main request is obvious vis-à-vis document (4).

Consequently, the main request does not meet the requirements of Article 56 EPC.

2. Auxiliary request 1 - Inventive step

The subject-matter of claim 1 of auxiliary request 1 has been amended by the further presence of "a binding agent" in the coating.

According to the appellant of the contested patent, the binding agents are added for enhancing the efficiency of the coating, involving a positive effect on the friability of the tablets obtainable and not impairing the disintegration rate of said tablets obtainable from the beadlets (see par. [0052]).

An effect linked with the binder has however not be shown in the examples of the contested patent and is thus not credibly demonstrated. As for the main request the technical problem must be reformulated as the provision of alternative beadlets.

The use of a binding agent is commonly known by the skilled person and can only be seen as an arbitrary choice that would be made as a matter of routine by a skilled person.

The subject-matter of claim 1 of the auxiliary request 1 is not inventive over document (4).

Consequently, auxiliary request 1 does not meet the requirements of Article 56 EPC.

3. Auxiliary request 2 - Inventive step

The subject-matter of claim 1 of auxiliary request 2 has been restricted by the feature regarding the inert spherical core namely "comprising a carbohydrate that does not react with the lipophilic nutrient, said carbohydrate comprising a carbohydrate selected from the group consisting of sugar, mannitol, starch, sago, and microcrystalline cellulose".

This feature does not constitute a further distinction over the prior art. Although document (4) indeed discloses as preferred carrier carrier silica, it also teaches that alternative carriers might be starch or sugar (see page 3, lines 28-33). The solution was therefore known and taught in document (4).

The subject-matter of claim 1 of the auxiliary request 2 is not inventive over document (4).

Consequently, the auxiliary request 2 does not meet the requirements of Article 56 EPC.

4. Auxiliary request 3 - Admissibility of the appeal

The subject-matter of the process claims 1-29 of auxiliary request 3 corresponds to the process claims 19-47 of the request maintained by the opposition division or of the claims as granted.

The statement of grounds of appeal of the appellant-opponent contains objections regarding insufficient disclosure against the invention claimed in claim 19 of the request maintained by the opposition division, as well as objections regarding inventive step of process claims 19-47 as maintained by the opposition division.

The subject-matter of the process claims 19-47 as maintained or granted did however not form part of the opposition, which was limited to the product claims 1-18 as granted, as correctly decided by the opposition division.

Although the opposition had been filed on the grounds of Articles 100(a) and (b) EPC against the patent as a

whole, the statement of grounds of opposition contained

indeed objections and arguments relating exclusively to the product claims 1-18 as granted.

None of the subsequent mail of the opponent, namely the responses of the opponent to the summons to oral proceedings before the opposition division and to the

letter of the patent proprietor, which both mentioned

the point of the admissibility of the opposition

against the process claims 19-47, contained

further comments or arguments than those relating to

the product claims 1-18.

The opposition was thus found inadmissible by the opposition division insofar the subject-matter of the process claims 19-47 claims as granted was concerned.

There is thus no reason to deviate from the decision of the opposition division. The appeal proceedings accordingly are limited to the product claims, as was the opposition and the appealed decision.

The argument of the appellant that the mere objection on lack of disclosure raised in the statement of grounds of opposition against some terms of claim 1 as granted, such as "lipophilic nutrient" or "inert core" could form a basis for the extent of the opposition to the process claims 19-47, since said terms were also present in claim 19, cannot be accepted. The mentioned objections were indeed explicitly directed to the independent product claim 1, and thus the examination of the opposition was limited by the extent to which the patent was opposed.

As the subject-matter of the process claims 19-47 as maintained by the opposition or as granted does not form part of the opposition, the case is remitted to the department of first instance on the basis of the third auxiliary request which corresponds to said claims 19-47.