Excluded Subject Matter (3) - Methods of treatment by therapy

The European Patent Convention prohibits the grant of patents to "methods for treatment of the human or animal body by ... therapy" (Article 53(c) EPC). These methods are excluded from patentability for public policy reasons to free from restraint non-commercial and non-industrial medical and veterinary activities. 

Therapy is defined as the curing of a disease or malfunction of the body, as well as the alleviation of the symptoms of pain and suffering. This includes prophylactic treatment, aimed at maintaining health by preventing ill effects that would otherwise arise, such as immunisation against a certain disease or the removal of plaque.  

A method is excluded from patentability if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by therapy. However, the identity of the person carrying out the method (a doctor, nurse etc.) is not relevant. 

Purely non-therapeutic methods, such as purely cosmetic methods, may be patentable. However, where a method contains both non-therapeutic and therapeutic aspects, it will be excluded from patentability if the therapeutic effect is inextricably linked to the claimed method. If the therapeutic and non-therapeutic effects are distinguishable, it may be possible to claim the non-therapeutic method separately, such as with a disclaimer to a non-therapeutic method. 

In order to be excluded, the treatment method must be carried out on a living human or animal body. A treatment method practiced on a dead human or dead animal body would not be excluded. Similarly, treatment of body tissues or fluids after they have been removed from the human or animal body, are not excluded from patentability as long as these tissues or fluids are not returned to the same body. For example, the treatment of blood for storage in a blood bank or diagnostic testing of blood samples is not excluded, but treatment of blood by dialysis with the blood being returned to the same body would be excluded. 

Finally, only method claims are excluded. Claims to products, such as substances, compositions, medical devices, computer programs and storage media are not excluded, even if the product is intended for use in a method of therapy. This is important for patenting so-called 1st and 2nd medical use claims to substances or compositions for use in a method of therapy, which will be discussed in more detail in a future article. 

This article is a part of our EPO Practice and Peculiarities series. Click here to explore.