A recent decision of the European Patent Office (EPO) Boards of Appeal (T 1631/17) has led to the revocation of a European patent for possessing an implicit step of treatment by surgery. Even though the step was not part of the claimed invention, it was considered to breach Article 53(c) of the European Patent Convention (EPC), which prohibits the granting of a European patent for methods of treatment of the human or animal body by surgery.

Background

The patent in question (EP 1 901 676), which was granted in 2013, concerned a method and set of materials for manufacturing dental replacement parts.

An opposition was initially filed against the patent but was later withdrawn. The Opposition Division of the EPO, however, decided to proceed with the opposition of their own accord. They deemed the patent invalid due to its only independent method claim containing an implicit step of treatment by surgery. The implicit step referred to preparation work that needed to be carried out on the patient prior to manufacture of the dental replacement parts; namely, taking an impression of the patient’s teeth.

The patentee appealed the decision of the Opposition Division.

Board of Appeal’s Decision

The patentee argued that the step of taking impressions of a patient’s teeth should be viewed as being separate to the claimed method of manufacturing the dental replacement parts. They argued that their claimed method did not relate to a method of treatment by surgery, because it could be performed in a laboratory without a patient needing to be present.

Although the Board of Appeal agreed that there was no explicit step involving methods for treatment by surgery in the patent’s independent claim, they declared with reference to the ruling of the Enlarged Board of Appeal (G 1/07) that even an implicit surgical step was sufficient for a patent to violate Art. 53(c) EPC, and that the patent in question inevitably included such a step.

The Board of Appeal held that the preparation step, which involved temporarily filling the gap left behind by a patient’s missing tooth and subsequently taking an impression of the teeth, was an essential element of the invention that had to be interpreted into the independent claim of the patent. The Board noted that, despite the patentee’s arguments to the contrary, the invention could not be performed entirely in a laboratory and required a patient to be present. For these reasons, the Board decided to uphold the decision of the Opposition Division and revoked the patent.

Headnote 1 of the decision of the Enlarged Board of Appeal G 1/07, which was referred to by the Board of Appeal in this decision, sets out the criteria for a method of treatment by surgery as being a method which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise.

It is not entirely apparent how the preparatory step of temporarily filling in the gap in a patient’s teeth followed by taking an impression meets such criteria of representing a substantial physical intervention on the body and entailing a substantial health risk. Nevertheless, this was accepted by the patentee and the patent was revoked.

This decision appears to expand the prohibition of medical treatment inventions to methods, which even though not claiming any steps performed on the human (or animal) body per se, inherently include such a step upstream of the claimed method; and consequently, inventors and applicants should carefully consider whether a treatment step is inherently part of any new inventive method, before considering patent protection in Europe.

At Wilson Gunn we are experienced in advising clients in the healthcare sector. If you have any questions regarding this decision, or about intellectual property protection for medical inventions, please get in touch to speak to one of our team.