T 1758/07 – Can’t Have ‘Em Both

As you certainly know, Swiss-type claims are a dying species (following G 2/08 ; some days ago, there was an EPO communication on that topic but it appears to have been deleted from the website since then). Decisions dealing with such claims are, therefore, of decreasing interest. Nevertheless, I have retained two recent decisions on claims of that kind. The first one discusses the possibility of co-existence of two types of claims for the same subject-matter. The outcome is not really a big surprise.

General remarks

The patent was granted before EPC 2000 entered into force. Therefore EPC 1973 applies for consideration of medical uses.

In the case of a first medical indication, it is permissible under A 54(5) EPC 1973 to grant a patent with claims directed to a substance/composition for the treatment by therapy according to A 52(4) EPC 1973, even if the additive as such belongs to the state of the art, provided that its use for the above therapy is not comprised in the state of the art.

Second and subsequent medical indications can be protected in accordance with decision G 1/83 by claims which are directed to the use of a substance/composition for the manufacture of a medicament for a specified new and inventive therapeutic application (headnote II in conjunction with [19]). Instead of use claims it is possible to formulate claims directed to a process for preparing the medicament which is characterised by the use of the substance/composition (e.g. T 958/94 [headnote]).

[3.2] … The set of claims of the first auxiliary request contains a Claim 2 directed to a “Procedure for preparing a feed additive, to be used for the prevention of gastric disorders and intestinal diseases … and the product obtained in the hydrolysis is used as such non-fractionated”, which is, in accordance with G 1/83 and T 958/94, in the form of a second medical use.

On the other hand, Claim 8 pertains to a “Feed additive for the prevention of intestinal diseases … and the additive comprises the non-fractionated product obtained as such” by analogy with A 54(5) EPC 1973.

Thus, in the first auxiliary request the same subject-matter is claimed both as a first medical use (Claim 8 as a purpose-related product claim) and as a second medical use (Claim 2 as a reformulated Swiss-type claim).

[3.3] It is uncontested that the prevention of gastric disorders and intestinal diseases by using the feed additive according to Claims 1 and 8 represents a method for treatment of the human or animal body by therapy within the meaning of A 52(4) EPC 1973.

G 1/83 only applies to second (and further) medical indications. From this it follows that the legal fiction behind G 1/83, namely that the therapeutic treatment according to A 52(4) EPC 1973 is a limiting feature, is applicable only if a therapeutic treatment is indeed a second (or further) medical indication. If, however, the claimed subject-matter relates to the first medical indication, G 1/83 provides no legal basis for additionally claiming the same subject-matter as a second medical indication.

[3.4] In the present case the question therefore arises whether Claim 8 has to be considered as representing a claim in accordance with A 54(5) EPC 1973 (first medical use claim).

In this context the following two questions have to be answered:

• (a) Is the feed additive as such (i.e. the additive resulting from hydrolytic treatment of a yeast raw material comprising the non-fractionated product obtained as such) comprised in the state of the art?
• (b) Is the use of the additive for the prevention of intestinal diseases and gastric disorders (i.e. the therapeutic treatment according to A 52(4) EPC 1973) comprised in the state of the art?

Novelty of the additive - Question (a)

[3.4.1] It is uncontested by the parties that [D14] discloses a feed additive which has been prepared by hydrolytically treating a yeast raw material with an acid [… ;] the hydrolysate is dried and concentrated.

The board does not agree with the respondent’s view as expressed at the oral proceedings […] that concentration is tantamount to fractionation. According to the patent in suit […] the term “concentration” is mentioned besides “fractionation”, from which it can be concluded that "concentration" and "fractionation" are distinguishable technical features within the meaning of the invention. Therefore, there is no reason to assume that a concentrated yeast hydrolysate according to [D14] is necessarily a fractionated product. Since there is no disclosure in [D14] that the acid-hydrolysed yeast product is fractionated, it is reasonable to assume that the additive according to [D14] comprises the non-fractionated yeast hydrolysate as such.

Thus, [D14] anticipates the feed additive according to Claims 2 and 8 and question (a) has to be answered in the affirmative.

Therapeutic use of the additive - Question (b)

[3.4.2] According to [D14], the yeast hydrolysate is used for improving the palatability of oral ingesta for animals, e.g. animal feed […]. The improvement in the palatability of a feed has as its aim to induce an animal to eat more of the feed and not the treatment of an actual disease. The second alternative for the additive according to [D14] is the improvement in the palatability of medicaments […]. In this case, the active component for treating a disease is the medicament and not the additive, which serves only as an aid to ease administration of an oral medicament to animals by improving its palatability. This is clearly indicated in […] the document.

Thus, [D14] does not disclose the use of the yeast hydrolysate as an active composition for therapy of a disease within the meaning of A 52(4) EPC 1973.

Question (b) has therefore to be answered in the negative.

Conclusion

[3.4.3] Since

• the feed additive as defined in Claims 2 and 8 belongs to the state of the art (question (a) to be answered in the affirmative); and
• its use for a therapeutic treatment within the meaning of A 52(4) EPC 1973, i.e. for the prevention of intestinal diseases and gastric disorders, is not comprised in the state of the art (question (b) to be answered in the negative),

the first medical indication applies in accordance with A 54(5) EPC 1973 and the feed additive can be protected by claims directed to a feed additive for the prevention of intestinal diseases and gastric disorders.

This means, however, that the legal fiction in G 1/83 relating to the second and further medical indications no longer applies. Consequently, there is no room to protect the feed additive once more by claims formulated as second medical use claims.

Therefore, the feature “to be used for the prevention of gastric disorders ...” in Claim 2 is not limiting, with the result that the subject-matter of Claim 2 is not novel because, as shown under point [3.4.1], the preparation of a feed additive by hydrolysis of a yeast raw material with an acid and its use in non-fractionated form is anticipated by [D14].

[3.5] In consequence, the first auxiliary request is not allowable.

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