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Methods of medical treatment

Therapy

8.34 Therapy refers to any treatment designed to cure, alleviate, remove or lessen the symptoms of, or prevent or reduce the possibility of contracting any disorder or malfunction of the human or animal body (T 24/91 THOMPSON/Cornea OJEPO 1995, 512; T 58/87 SALMINEN/Pigs III [1989] EPOR 125; T 1599/09 COVIDIEN).

8.35 The following methods will generally constitute methods of therapy, and Examiners should have particular regard to such claims (Unilever (Davis’s) Application [1983] RPC 21):

(i) Preventative treatment, including vaccination of healthy individuals;
(ii) Methods to alleviate disease symptoms;
(iii) Curative treatment; and
(iv) Veterinary treatment of a diseased or injured animal, including prophylactic and immunotherapeutic treatment.

8.36 The key consideration here is if it is possible to establish a direct link between the treatment and the disease being cured, prevented or alleviated (Commonwealth Scientific and Industrial Research Organization’s Application BL O/248/04; Pfizer Inc v Commissioner of Patents [2004] NZCA 104). If a link can be established then a method falls within the “treatment by therapy”.

8.37 In addition, any medical treatment of a disease, ailment, injury or disability, i.e. anything that is ailing a patient and for which a doctor or veterinarian would be consulted would generally be regarded as therapy. This may be a Western trained doctor/therapist or a Traditional Chinese Medical physician. Similarly prophylactic or preventative treatments by such practitioners may be regarded as constituting therapy for the purposes of Section 16(2).

8.38 However, whether a medical practitioner or a veterinarian performs the method is not the only consideration. As long as the treatment cures, prevents or alleviates a disease, the treatment would constitute a method of therapy whether the treatment is performed by the patient (such as the administration of a medicament), by an automated system (see T 1599/09), or by a farmer (such as treatment of farm animals, see T 116/85 WELLCOME/Pigs I OJEPO 1989, 13). This is also consistent with the Borad of Appeal decision in T 245/87 SIEMENS/Flow measurement OJEPO 1989, 171 a method of stimulating a limb during blood collection in order to facilitate the flow of blood, where the Board noted that:

“The need for a medical practitioner to perform a measure on the human body or supervise such an operation is not the sole criterion by which a method step has to be assessed with regard to the exclusion of subject-matter from patenting under Art. 52(4) EPC. The purpose and inevitable effect of the step at issue are much more important.”

8.39 In this regard, it is more important for the Examiner to consider the purpose and inevitable effects of the invention. The Board of Appeal further noted that:

“If the claimed subject-matter is actually confined to operating an apparatus for performing a method with the technical aim of facilitating blood flow towards a blood extraction point, the operating method has no therapeutic purpose or effect and, therefore, is not excluded from patentability.”

8.40 On the other hand, if a method has no therapeutic purpose or effect, then the mere fact that an invention may be carried out by a medical practitioner does not render it incapable of industrial application. For example, in Schering A.G.’s Application [1971] RPC 337 it was held that claims that are directed solely to non therapeutic medical treatments will be generally accepted.

8.41 A method claim would also fall under the prohibition of Section 1 (2) even if it contains only one step that defines a therapeutic activity. For instance, including a step of “administering a substance for prophylactic reasons” in a method claim would likely render the method claim incapable of industial application (see G 01/04 Diagnostic methods OJEPO 2006, 334).