In the patent application for Method and apparatus for measuring enzymatic activity by use of laser/Sony Corporation T 1213/10, a European Patent Office (EPO) Appeal Board has determined that a method of measuring enzymatic activity using a penetrating instrument is excluded from patentability under Article 53(c) of the European Patent Convention (EPC) on the basis that it is a method for surgical treatment of humans or animals.
Sony Corporation applied to the EPO for a patent for
a Method of measuring an enzymatic activity comprising measuring the quantity of a substrate metabolite produced upon metabolism of a substrate by an enzyme, ... [wherein] the substrate is caused by a penetration device to penetrate to a site where said enzyme is present.
On 21 January 2010, the EPO Examining Division refused the application on the grounds that the claimed process was a method of surgery and a method of therapy within the meaning of Article 53(c) EPC. Sony lodged an appeal against the decision.
The EPO Appeal Board referred to case G 1/07, which states that
A method claim falls under the prohibition of patenting methods for treatment by therapy or surgery now under Article 53(c) EPC if it comprises or encompasses at least one feature defining a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery or therapy.
Upon analysing the examples included in the patent description, which embodied endoscopic manipulations of viscous tissue, the Appeal Board held that the claim was excluded from patentability.
Sony argued that its method was patentable since it was not directed to measuring an enzymatic activity for any specific purpose but, rather, was of general scientific and analytical application. Further, the method had no curative benefits for, and did not improve, the immediate health of a patient. In addition, Sony argued that amended auxiliary claim requests made were exclusively directed to performance in vitro. The method was not, therefore performed on the human or animal body.
In considering these arguments, the Appeal Board again referred to case G 1/07, which clearly states that “neither the legal history nor the object and purpose (ratio legis) of the exclusions from patentability in Article 53(c) EPC justify a limitation of the term “treatment by surgery” to curative surgery”. In respect of the in vitro limitation introduced into the auxiliary requests, the Appeal Board found there was no basis in the original application to support the limitation. Consequently, the in vitro amendment was not permissible according to Article 123(2) EPC, as the amendment extended the subject matter of the claims beyond the content of the application as filed. The in vitro argument was consequently irrelevant to the issue of patentability.
This decision serves as a reminder of the wide and flexible meaning of “treatment by surgery” in Article 53(c) of the EPC. As exceptions to patentability exclusions under this rule are discrete, applicants should attempt to construct claims that sit outside the broad interpretation employed by the EPO.