In a recent post I have discussed a case where a Swiss-type claim was used outside the medical realm. I have recently come across the present decision, which also deals with such a situation. It is neither brand new nor completely unknown (e.g. it has been cited in Mrs Brimelow’s statement concerning G 2/08), but I think it is worth recalling.
Independent claim 1 is drawn up in the form of a “second (further) medical use claim” as defined in G 5/83.
However, in spite of the chosen format, this claim does not in fact reflect a second (further) medical use, as the feature “for substantially reducing the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil” clearly defines a non-therapeutic use. Although the reduction of the inhibitory effect of the hydrophilic surfactant on the in vivo lipolysis of the digestible oil has a significant influence on the bioavailability of the hydrophobic drug, which in its turn is an important factor for the administration of the drug, it does not per se involve the treatment or alleviation of an illness or of any pathological condition and is therefore non-therapeutic.
As a consequence, it has to be established how a claim drawn up in the second medical use format but relating to a non-therapeutic activity has to be read for the assessment of novelty. [2.1]
Example 2a of D1 discloses the preparation of a pharmaceutical composition comprising a lipophilic surfactant, a hydrophobic drug, a digestible oil and a hydrophilic surfactant. These compositions are characterised by enhanced resorption/bioavailability levels and/or a reduced variability in resorption/bioavailability levels. D1 does not mention the effect of the lipophilic surfactant in terms of a reduction of the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil. As a consequence, with all other features already being disclosed in D1, the non-therapeutic use (“for substantially reducing the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil”) is the only potentially distinguishing feature of present claim 1. [2.2]
In G 5/83, the novelty derived from a new therapeutic use of a medicament in a “Swiss-type” claim, which relates to the use of a compound for the preparation of a medicament, was acknowledged by making reference to A 54(5) EPC 1973, according to which known substances or compositions used for the first time in a method as defined in A 52(4) EPC 1973 are novel. However, it was made clear that this special approach to the derivation of novelty can only be applied to claims to the use of substances or compositions intended for use in a method referred to in A 52(4) EPC 1973 (see G 5/83 [21]). [2.3]
As a consequence, this special approach to the derivation of novelty cannot be applied to present claim 1, which has to be interpreted as a claim defining a conventional process of preparation. In this context, it is emphasised that the claim format “the use of a lipophilic surfactant component for the manufacture of a pharmaceutical composition (for a non-therapeutic use)…” is equivalent to a claim directed to a “process of preparing a pharmaceutical composition comprising a lipophilic surfactant component …”. In the present claim 1, the indication of an additional non-therapeutic effect (“for substantially reducing the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil”) of one of the components in the finished composition has a merely illustrative character and thus no influence whatsoever on the process of preparing the composition. Therefore, it is not suitable for establishing novelty over example 2a of D1.
It is additionally noted that the present claim 1 - as is frequently the case with “Swiss-type” claims - does not specifically mention any process steps. Therefore, any non-naturally occurring product comprising all the features of the composition resulting from the process of preparation as claimed, such as e.g. the composition according to example 2a of D1, is detrimental for the novelty of the subject-matter claimed therein. As a consequence, the subject-matter of claim 1 of the main request does not meet the requirements of A 54. [2.4]
The board is aware of the fact that according to G 2/88 novelty over D1 could in principle be established by reformulating claim 1 into a conventional non-medical use claim, as in such a claim the feature “for substantially reducing the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil” would refer to a technical effect which is not disclosed in D1. However, the board sees no possibility for such a reformulation without offending against the provisions of A 123(3), as the change from the only independent claim of the patent as granted relating to a process of preparation (“Use of a lipophilic surfactant component for the manufacture of a pharmaceutical composition …”) to a claim referring to a use for achieving a particular effect (“Use of a lipophilic surfactant component for reducing the inhibitory effect of the hydrophilic surfactant …”) would extend the protection conferred. [2.5]
In other words, the patentee, when climbing in the Swiss alps, has fallen into an inescapable crevasse which opens between G 5/83 and A 123(3).
It is additionally noted that the present claim 1 - as is frequently the case with “Swiss-type” claims - does not specifically mention any process steps. Therefore, any non-naturally occurring product comprising all the features of the composition resulting from the process of preparation as claimed, such as e.g. the composition according to example 2a of D1, is detrimental for the novelty of the subject-matter claimed therein. As a consequence, the subject-matter of claim 1 of the main request does not meet the requirements of A 54. [2.4]
The board is aware of the fact that according to G 2/88 novelty over D1 could in principle be established by reformulating claim 1 into a conventional non-medical use claim, as in such a claim the feature “for substantially reducing the inhibitory effect of the hydrophilic surfactant component on the in vivo lipolysis of the digestible oil” would refer to a technical effect which is not disclosed in D1. However, the board sees no possibility for such a reformulation without offending against the provisions of A 123(3), as the change from the only independent claim of the patent as granted relating to a process of preparation (“Use of a lipophilic surfactant component for the manufacture of a pharmaceutical composition …”) to a claim referring to a use for achieving a particular effect (“Use of a lipophilic surfactant component for reducing the inhibitory effect of the hydrophilic surfactant …”) would extend the protection conferred. [2.5]
In other words, the patentee, when climbing in the Swiss alps, has fallen into an inescapable crevasse which opens between G 5/83 and A 123(3).
To read the whole decision, click here.
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