In Germany, as in the UK and other countries party to the European Patent Convention, methods of diagnosis or treatment by surgery or therapy practised on the human or animal body are not patentable. This exclusion is made in the interests of public policy, as it is considered that the act of treating a patient should not put a medical professional at risk of infringing a patent.
The Federal Court of Justice in Germany (the Bundesgerichtshof, or BGH) has recently issued an interesting decision on the scope of this exclusion from patentability.
Their decision overturned an earlier decision by the Federal Patent Court. The patent application in question, which was filed by Siemens, claims a method of combining images to guide a surgeon during heart surgery. It was initially refused by both the Patent Office and the German Federal Patent Court in Germany as they held that it claimed a method for the surgical treatment of the human body.
The applicant appealed the decision of the Federal Patent Court, and the case was considered by the BGH.
When considering their decision, the BGH referred to decision G1/07 of the Enlarged Board of Appeal (EBA) of the European Patent Office. In that decision (which related to the patentability of methods for imaging pulmonary and cardiac vasculature and evaluating blood flow), the EBA had stated that, provided that the imaging method was a complete invention in itself, the fact that it could be used in a potentially advantageous way in the course of a surgical intervention did not prevent the imaging method itself from being claimed. The EBA went on to say that, even if it is used in the course of a surgical intervention, this does not alter the fact that the imaging method is not a surgical step in itself.
The EBA stressed that the claim to the imaging method cannot rely on a method of treatment to make it patentable, but that the imaging method must be patentable in itself (ie it must be novel, inventive and capable of industrial application). The fact that one of the possible and described uses of the imaging method is the use by a surgeon during a surgical intervention, allowing the surgeon to decide on the course of action to be taken by using the instantly produced images, does not exclude that imaging method from patentability.
Following on from this decision, the BGH concluded that the claimed invention in Siemens’ application did not fall into the category of a “method of treatment” as, though the claimed method presupposes the introduction of a catheter into the heart, it only claims the imaging method itself. The method supports diagnosis but is not a method of diagnosis in itself, and it does not inform the skilled person how to reach a diagnosis.
This decision is consistent with the general principle that exclusions from patentability, such as the exclusion of methods of treatment or diagnosis, are to be construed narrowly. If claims are drafted in appropriate terms, patent protection can be often be obtained for methods that are useful in medical treatment, notwithstanding the exclusion. A method, even if clearly intended for use during treatment or diagnosis of a human or animal, may still be patented, provided that it does not depend on its use in a medical situation to make it novel or inventive.
25 November 2010