Medical treatment assessed

01 September 2010

Where is the line between patent-protectable new medical indications and ineffective dietary supplements (the latter not being eligible for use-restricted product protection under the EPC)?

This case (17 Ob 35/09k, February 2 2010) concerned the infringement of a Swiss-type claim: "The use of an isoflavone phyto-oestrogen extract of soy or clover, for the manufacture of a medicament for administration in unit dosage form for the treatment of pre-menstrual syndrome, symptoms associated with menopause, or prostate cancer."

The defendant sold a product that contained 8% red clover extract with isoflavone phyto-estrogens as dietary supplement. The product leaflet informed that the product provided relief from menstrual or menopausal symptoms due to the red clover isoflavones contained, among other things. The defendant argued, however, that the product sold is not a drug, but a food supplement without therapeutic healing effects.

The court of first instance granted an injunction. The appellate court upheld that ruling.

Hearing the case, the Austrian Supreme Court (OGH) dealt for the first time in any depth with the definition of "medicine" in patent law. It based the judgment on the – liberal – interpretation as developed in practice before the EPO: the concept of therapeutic treatment for the purposes of Art 52 (4) EPC (now Art 53c EPC 2000) at heart is the restoration of health through treatment of diseases and the alleviation of suffering, but also comprises methods to maintain health by prophylactic treatments. The restoration of physical capacity, even if the reduction thereof is not caused by disease, must also be considered as a therapeutic treatment according to this provision. Even if the malaise has natural causes (such as menstruation, pregnancy, age), this is still covered with illness and injury symptoms and is often difficult to distinguish from them. It is difficult to distinguish and not appropriate in this connection to differentiate between treatments and causes or symptoms.

The OGH also clarified that procedures that only serve to improve the general well-being, such as the use of healthy foods (health nutrition) or dosage of vitamins not specifically indicated by a physician, are below the borderline for medical prophylaxis.

In cases of a use-limited product protection (see also: G 2/08), stating the intended use in the patent claims restricts the scope of the patent. Whether a third party makes use of the teaching of such a patent primarily depends on whether the same material is used for the same purpose. This has to be proven by the claimant, although here prima facie evidence can be sufficient. The OGH remanded to gain further evidence.