Methods of treatment of the human or animal body by surgery or therapy are not allowable according to European patent law. Some recent decisions from the Technical Boards of Appeal explain how this exclusion is to be applied narrowly, and indicate possible approaches to successfully overcome objections from the European Patent Office (EPO) to achieve patent grants.
Technical Board of Appeal decision T1526/17
In the Technical Board of Appeal decision T1526/17, the applicant appealed the original decision from the EPO Examining Division to refuse the European patent application. This invention related to determining the mechanical axis of a bone for diagnostic purposes and for preparing subsequent surgical steps. The invention used a medical navigation system with a stationary marker device and an electronic device with a camera rigidly attached to the bone.
Despite arguments from the applicant, the Board of Appeal considered that the output signal of the camera could only be analysed if the camera assumes different positions during bone movement, and so that movement of the bone with the attached electronic device must be an integral part of the claimed method. As a result the Board of Appeal decided that the claimed method did include the step of pivoting the bone and this pivoting equated to a surgical step. The Board also found that pivoting the exposed bone involves substantial health risks for the patient and so again must be considered a surgical step. As an additional confirmation, the Board decided that attaching the electronic device to the bone is also a surgical step.
Although the Board decided that the claimed method was excluded from patentability as a method for treating the human body by surgery, the applicant filed a further auxiliary request with amended claims. Interestingly this request was already filed during the examination proceedings but the Examining Division did not admit it. In Europe we are now accustomed to the Boards of Appeal adopting increasingly strict criteria when it comes to exercising discretion whether to admit late filed requests into the proceedings. This case is a welcome example of an instance where the Board exercised its discretion in favour of the applicant and did admit the auxiliary request.
The EPO exclusion relating to treatment of the human or animal body by surgery or therapy only applies to method claims, and does not apply to device, product, or system claims. Because the claims of the auxiliary request included claims to an electronic device, a navigation system and a computer program, no objections were raised. This is a clear example of how applicants can avoid method of treatment objections by careful choice of the category of claims before the EPO.
The final outcome of the appeal was that the Board remitted the case back to the Examining Division for further prosecution because the issues of novelty and inventive step had not yet been considered.
The same applicant, Brainlab AG, enjoyed another successful outing before the Boards of Appeal in decision T2136/19. This appeal again originated from an Examining Division decision to refuse a European patent application. The invention related to a computer-implemented data processing method for positioning a medical implant or surgical instrument relative to a bone of a patient.
Even when the claim category is that of a method claim, it may still be possible to convince the Boards of Appeal and the EPO that the method does not qualify as a method of treatment of a human or animal body by surgery or therapy. In this decision, the Board was satisfied that the claim was strictly limited to a purely passive data processing method which is carried out entirely and exclusively within a computer without causing any effect on the patient's body. There was therefore no functional link between the claimed method and any effects of a surgical or therapeutic nature that would occur during the intervention. As a result, the claims did not recite any method step defining or encompassing a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy.
Similar to the other Board of Appeal case, the Examining Division had not yet dealt with novelty and inventive step, and so the Board remitted the case to the Examining Division for further prosecution.
Medical device innovators can successfully navigate around the EPO method of treatment exclusion by including appropriate claims to devices, systems and computer programs when preparing the patent application. There are also strong grounds available for arguing that some methods are merely directed to the operation of a device, and so do not fall under the exclusion of a method of treatment by surgery or therapy. The EPO jurisprudence provides clear guidelines of how to overcome objections from the EPO or the Boards of Appeal. MedTech inventors seeking patent protection in Europe will be encouraged by the positive outcome of these recent decisions despite both cases being initially refused. For more information, contact us at docketing@secerna.com.