T 0158/13 - Unallowable therapeutic use claim

Key points

• The claim at issue for a " non-therapeutic use of a stimulative perfume composition"  was held to violate Article 53(c) EPC, because the recited purpose of "for releasing persons from a physiological mental condition of sleepiness, sense of fatigue and inactivity in daily life, and for refreshing and activating their mental condition" did not allow for a "clear and unambiguous distinction" with a medical use. The feature "non-therapeutic"  does not help. 

EPO T 0158/13 - link

The wording of independent claims 1 and 6 of the 2nd auxiliary request on which the decision under appeal was based read as follows:

"1. A non-therapeutic use of a stimulative perfume composition including 0.01 wt% to 50 wt% anisaldehyde for releasing persons from a physiological mental condition of sleepiness, sense of fatigue and inactivity in daily life, and for refreshing and activating their mental condition, wherein said stimulative perfume composition further includes a perfume compound selected from the group consisting of cinnamic aldehyde, eugenol, carvone and heliotropin."
"6. A stimulative perfume composition comprising anisaldehyde as a stimulative agent and a perfume component selected from the group consisting of pepper, cardamom and nutmeg."

4. Article 53(c) EPC

4.1 In the decision under appeal the Opposition Division found that the subject-matter of claims 1 and 5 of the then pending 2**(nd)auxiliary request met the requirements of Article 53(c) EPC, since it was possible to clearly distinguish between a non-therapeutic and a therapeutic use of the stimulative perfume. The basic argument was that it was possible to distinguish between persons that only had little sleep and those who suffered from chronic fatigue or depression, and consequently the non-therapeutic use arose from a proper selection of persons on which the stimulative perfume was used.

4.2 However, in the statement setting out the grounds for appeal the Appellant pointed out that it was not possible to distinguish between a therapeutic or non-therapeutic use of the stimulative perfume composition, since the way of administering the composition is the same for a therapeutic and a non-therapeutic use. Moreover, the claimed use covered at least some mental conditions, such as sleepiness, that might or might not be of a pathological nature.

4.3 According to the case law of the Boards of appeal a clear distinction between a therapeutic and a non-therapeutic use is possible, if the group of persons treated can be clearly identified as healthy or as suffering from a pathological condition (see e.g. T 469/94, not published in the OJ EPO, point 4.4 of the reasons).

4.4 In the present case the claims were directed to the non-therapeutic use of a stimulative perfume composition "for releasing persons from a physiological mental condition of sleepiness, sense of fatigue and inactivity in daily life, and for refreshing and activating their mental condition". At least the sleepiness or inactivity in daily life may not only be a physiological condition, but may also arise from a pathological condition. For example, sleepiness or inactivity in daily life may be an early sign of a depression which cannot be clearly distinguished from a non-pathological condition.

Without a clear and unambiguous distinction between a physiological and a pathological nature of a persons mental condition a clear distinction between therapeutic and non-therapeutic use is also impossible. The mere reference to the claimed use being a "non-therapeutic" use does not, therefore, exclude the therapeutic use.

Even with the wording of the claim, which calls the claimed composition a "perfume" composition a therapeutic use is not excluded, since the patent in suit demonstrated that the administration of the perfume composition leads to a clearly measurable stimulative effect on the brain, as can be determined by an increase of the CNV value.

Since for the use for some of the claimed mental conditions a clear distinction between therapeutic and non-therapeutic use cannot be made the subject-matter of claims 1 and 5 does not fulfil the requirements of Article 53(c) EPC.

4.5 Consequently, the Respondent's main request, which was the maintenance of the patent in suit on the basis of claims 1 to 6 according to the 2**(nd)auxiliary request on which the decision under appeal was based, is not allowable.