Excluded Subject Matter (4) – Methods of treatment by surgery

The European Patent Convention prohibits the grant of patents to "methods for treatment of the human or animal body by surgery..." (Article 53(c) EPC). Similar to the exclusion of methods of treatment by therapy (discussed in our previous article "Excluded Subject Matter (3) - Methods of treatment by therapy"), surgical methods are excluded from patentability for public policy reasons to free from restraint non-commercial and non-industrial medical and veterinary activities. However, the implementation and extent of these exclusions differ in significant ways. 

Most importantly, surgical methods are excluded from patentability regardless of whether they are therapeutic in nature. For this reason, cosmetic surgery or embryo transfer are excluded from patentability as surgical methods, despite being non-therapeutic. 

The term "surgery" is not precisely defined, because the field of methods which potentially involves surgical steps is vast. However, "surgery" is intended to cover the kind of interventions which constitute the core of the medical profession's activities, being substantial physical interventions on the body which require professional medical expertise to be carried out and which entail a substantial health risk. Each case is therefore considered on its own merits, based on the following factors: 

• Invasiveness of method
• Required level of medical expertise
• Health risk
• Complexity of operation

Taken alone, any one of the above factors may not be enough to exclude the method as surgical, meaning the factors need to be weighed as a whole. For example, the mere fact that a method is invasive is not enough in itself to be excluded as surgical. Routine interventions, even if invasive, that are of a routine character and performed on uncritical body parts and carried out in a non-medical, commercial environment without substantial health risks are not excluded from patentability as surgical methods. Examples of non-excluded invasive methods might include tattooing, piercing, hair removal by optical radiation and micro-abrasion of the skin. 

Similarly, while the exclusion does not solely depend on the person carrying out the method, the level of required medical expertise will need to be considered as a factor. For example, it has been found that injecting a contrast agent into a vein remote from the artery is not a method of surgery, because the injection could be delegated by a physician to a qualified paramedical professional and was thus considered a minor routine intervention which did not imply a substantial health risk. However, venipuncture of blood donors and the extraction of blood from a donor's body has been excluded from patentability, because it represented a substantial physical intervention on the body which required professional medical expertise and entailed substantial health risk. 

In order to be excluded, a surgical method must be carried out on a living human or animal body. A surgical method practised on a cadaver would not be excluded. Similarly, manipulation of body tissues or fluids after they have been removed from the human or animal body, are not excluded from patentability, provided these tissues or fluids are not returned to the same body.  

A multi-step method is excluded from patentability if it encompasses at least one step of surgical nature, as defined by the above factors. 

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 surgery. For example, a claim to a visual prosthesis "suitable to be located implanted in the eye behind the iris" has been found not excluded. The fact that features of the claimed product were functionally defined in relation to the body of the patient did not, in itself, transform the product claim into an excluded method claim. 

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