Discovery of a previously unknown property of a compound underlying the known effect 

In T 254/93 (OJ 1998, 285) an application relating to the use of a retinoid compound in association with the use of corticosteroids in the prevention of skin atrophy was refused by the examining division. The board noted that it was a basic consideration in G 2/88 (OJ 1990, 93) that the recognition or discovery of a previously unknown property of a compound, such property providing a new technical effect, could involve a valuable and inventive contribution to the art. This was apparently the reason why the Enlarged Board of Appeal accepted that the use related to such a property could be regarded as a technical feature appropriate for establishing novelty. The board stated that it had no difficulty in accepting that the prevention of skin atrophy had to be regarded as a pharmaceutical feature and, following the conclusions of the Enlarged Board of Appeal, that the effect underlying this feature was not made available to the public in written form by any of the cited literature. Nevertheless, the question arose whether, in the case at issue, this effect was a technical effect within the meaning of decisions G 2/88 and G 6/88 (OJ 1990, 114), which was necessary to establish novelty, under Art. 54(1) EPC 1973, of the claimed subject-matter over the prior art. Although it concerned a specific aspect of the known use, the use specified in claim 1 (prevention of skin atrophy) was not actually different from the known use (treatment of dermatoses). The board observed that when a second medical indication was claimed in relation to the use of a constituent in the preparation of a known composition and the final effect was apparent in using the known composition for the known purpose, a technical problem could be seen neither in the obtaining of the final effect nor in the preparation of the composition. The only remaining question could be the explanation of the phenomenon underlying the treatment according to the known process. However, the mere explanation of an effect obtained when using a compound in a known composition, even if the explanation related to a pharmaceutical effect which was not known to be due to that compound in the known composition, could not confer novelty on a known process if the skilled person was already aware of the occurrence of the desired effect when applying the known process (see also T 669/01, T 605/09).

In T 605/09, claim 1, although drafted as a "method of improving activity in a pet", was undoubtedly framed so as to protect the "use" of a known nutritional agent "for improving activity in a pet", that is to say, the claim was to be understood as a second non-medical use claim. It was to be decided whether the claimed improvement of activity in a pet was a new technical effect in terms of G 2/88. The assessment of novelty depended on the answer to the question whether or not this effect, i.e. the capability of the nutritional agents to improve activity in a pet, which was not disclosed verbatim in the state of the art, could confer novelty on the subject-matter of claim 1 in view of G 2/88.

The board pointed out that there was undeniably a correlation between improving the health of a pet and its (physical) activity. As pointed out by the appellant, every dog or cat owner knew that a primary indicator of the health of a dog or a cat was its level of activity. In particular, it was well known that lethargy or inactivity were indicators of illness. In fact the alleged newly discovered effect of improving pet activity was necessarily correlated to the known one. Hence, the effect relating to improving pet activity was not a new technical effect in the sense of G 2/88 and could not confer novelty on the subject-matter of granted claim 1. The board noted that calling "improvement of health", which was disclosed in some prior art documents, "improving activity" was only paraphrasing a known effect. Specifically pointing to this effect could not be considered an additional piece of knowledge about the known use of the nutritional agents because it was only the rewording of a known effect. These considerations were in line with the conclusions in decision T 254/93.

Similarly, in T 486/01 the physiological effects highlighted by the patent proprietor were only regarded as additional items of knowledge about a further mechanism of action underlying the known therapeutic application.

In T 1001/01 the appellant had argued that decision T 1020/03 (OJ 2007, 204) had concluded that the specification of the "route of administration" was always a novelty-bringing feature for second medical use claims in the "Swiss-type form". (See G 2/08, OJ 2010, 456, above for the position on Swiss-type claims under the EPC 2000.)

The board noted that the appellant's argument that said decision was cited in the Case Law of the Boards of Appeal of the EPO, fifth edition, 2006, as taking "a new approach to the concept of "new therapy" "(page 109 of the Case law report) was not relevant, since the comments on novelty in decision T 1020/03, in the absence of a conclusion by Board 3.3.04 on Art. 54 EPC 1973, could only be taken as obiter dicta. The board stated that in fact, the assessment of novelty remained a decision to be taken on a case-by-case basis after making a careful and detailed technical (and not only linguistic) analysis of the features appearing in a particular claim and when the relevant piece of prior art was read by the skilled person. Indeed, the conclusions reached at by decision T 1020/03 were irrelevant for the claims on file, since the wording of the sets of claims serving as a basis for the present decision had not been challenged under Art. 52(4) EPC 1973 because they were medical use claims in an acceptable "Swiss-type form". (See G 2/08, OJ 2010, 456, above for the position on Swiss-type claims under the EPC 2000.)

In T 385/07 Claim 1 was drafted in the form of a second/further medical use of aplidine for making a medicament for the treatment of a mammal affected by pancreatic cancer. The relevant issue under the law in force was whether or not this use related to a novel medical use within the meaning of decision G 5/83 (OJ 1985, 64). The board found that, following decision T 158/96, the information in a citation that a medicament was undergoing a clinical phase evaluation for a specific therapeutic application was not prejudicial to the novelty of a claim directed to the same therapeutic application of the same medicament if the content of said citation did not allow any conclusion to be drawn with regard to the actual existence of a therapeutic effect or any pharmacological effect which directly and unambiguously underlay the claimed therapeutic application.

The board stated that failure in a patent application to provide a "new element" vis-à-vis the teaching of a prior art document may indeed lead to the lack of novelty of a claimed medical use (see e.g. decision T 919/99 of 7 April 2003, points 7 and 22 to 24 of the Reasons). However, the board did not adhere to the examining division's view that the present application had not really developed the subject-matter further compared to the teaching of document D1. Furthermore, it was true that the present application related to in vivo results in mice, not humans. However, it was an accepted principle of the case law that, for the purpose of patent protection of a medical application of a substance, a pharmacological effect or any other effect such as an effect observed on animal models was considered to provide sufficient evidence of a therapeutic application if, for the skilled person, this observed effect directly and unambiguously reflected such a therapeutic application (see e.g. T 241/95, OJ 2001, 103). Applying this principle, the board accepted in the case at issue that, in the absence of any data on human patients, the in vivo experiment was sufficiently predictive of the in vivo anti-tumour activity in humans.

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