T 99/09 – Not Quite Invisible

This is a revocation appeal.

Claim 1 of the main request was identical to claim 1 as granted and read:

Immediate release fenofibrate composition with a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured in accordance with the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium consisting of water with 2% by weight of polysorbate 80 or 0.025M of sodium lauryl sulphate. (my emphasis)

The Board found this claim to extend beyond the content of the application as filed.

*** Translation of the French original ***

[5.1.1] Claim 1 of the main request is identical to claim 1 of the patent as granted.

This claim refers to an “immediate release” pharmaceutical fenofibrate composition having a certain in vitro dissolution profile. The application as filed did not contain this claim.

It turns out that the expression “immediate release” is disclosed in the application as filed only in exclusive association with other structural or functional features:

• first, in claim 1 as filed in correlation with other features, i.e. the presence of a “inert hydrosoluble carrier”, “a fenofibrate active ingredient in a micronized form having a particle size less than or equal to 20 µm”, and an in vitro dissolution profile such that it has “a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or 0.025M sodium lauryl sulphate”;

• then, in paragraph [0015] of the application as published […], in correlation with an “inert hydrosoluble carrier” coated with a layer containing “fenofibrate in a micronized form having a particle size less than 20 µm” and a “hydrophilic polymer”.

Thus the expression “immediate release” is never disclosed in isolation but always in association with certain technical features, in this instance always with at least an “inert hydrosoluble carrier” and “fenofibrate in a micronized form having a particle size less than or equal to 20 µm”.

These technical features are absent from the subject-matter of claim 1 of the main request, which, therefore, constitutes a generalisation with respect to the cited passages. The application as filed does not provide any basis for such a generalisation, in this instance for any “immediate release” composition whatsoever having the claimed dissolution profile.

Thus a fenofibrate composition according to claim 1 of the main request cannot be directly and unambiguously derived from the application as filed.

[5.1.2] According to the [patent proprietor] paragraph [0017] of the application as published […] provides a basis for claim 1 of the main request. This paragraph discloses that the invention also provides a composition comprising fenofibrate having the claimed dissolution profile.

[According to the patent proprietor,] the expression “immediate release”, therefore, had to be interpreted as an invisible limitation because the dissolution profile necessarily implied immediate release.

The Board agrees that paragraph [0017] of the application as published […] may serve as a basis for a composition claim that is exclusively based on the dissolution profile. However, this paragraph does not disclose that it is an immediate release composition.

Moreover, it is not possible to combine the functional feature of paragraph [0017] of the application as published […] with other structural or functional features isolated from the description when the latter are disclosed exclusively in association with other functional or technical features. This would be tantamount to being able to create a great number of compositions that have no basis whatsoever in the application as filed.

Incidentally, the Board cannot agree that the “immediate release” feature is synonymous with the claimed dissolution profile. As a matter of fact, this expression has a technical meaning that is common in the field of galenical pharmacology and allows to categorise the kind of composition to which it applies. In this instance, “immediate release” implies the release of a great quantity of active agent over a very short span of time, or even instantaneously, from a structured galenic formulation after its administration to a patient. This expression allows to distinguish the claimed compositions from compositions which allow to have a “delayed release” or an “extended release” of the active substance, and, therefore, implicitly implies the existence of a galenic formulation that allows immediate or instantaneous release. Although the expression is vague, the “immediate release” feature, therefore, has to be considered to be a functional feature expressing the fact that all the parameters of the fenofibrate composition have to be chosen such that the active substance is released immediately. Incidentally, immediate release does not necessarily imply that the active substance dissolves quickly, because the speed of dissolution depends on the degree of solubility of the active substance.

As a matter of fact, the in vitro dissolution profile that is disclosed in paragraph [0017] of the application as published […] defines the speed of dissolution of the fenofibrate and not its speed of release from a galenical formulation; this speed of release depends on the dissolution medium used for the measurement and of the degree of solubility of the active substance. The dissolution profile disclosed in this passage does not necessarily imply the existence of a particular galenic formulation because a pharmaceutical composition containing only fenofibrate, without any limitation as to the galenic formulation of the fenofibrate and/or the presence of excipients, may have this dissolution speed. Thus the dissolution profile cannot be considered to be a synonym of the release mode.

Therefore, the expression “immediate release” provides a technical contribution to the claimed subject-matter and cannot be considered to be “invisible”.

[5.1.3] As a consequence, claim 1 of the request extends beyond the content of the application as filed (A 100(c)).

Should you wish to download the whole decision (in French), just click here.

The file wrapper can be found here.