July 2010 Issue
The EPO Clarifies the “Methods of Treatment by Surgery” Exclusion
The Board’s conclusions offer insight on the interpretation of Article 53(c) EPC and set out new approaches for determining whether inventions are excluded from patentability as methods of surgery.
In the In re Medi-Physics case, the Board was asked to determine whether the claimed imaging method, which included a step of injecting a contrast agent into a patient’s heart, was eligible for patent protection. Based on the reasons discussed below, the Board held that the claimed method was excluded from patentability because it was a method for treatment by surgery within the meaning of Article 53(c) EPC.
In arriving at its decision, the Board refused to find that the exclusion of “treatment by surgery” is limited solely to purely therapeutic methods (i.e., directed to restoring or maintaining the health of the human or animal body). Id. at 47-48. Stated differently, the Board found that “surgery” may encompass traditionally nontherapeutic procedures, such as, for example, sex-change operations, sterilization, or the operative removal of wrinkles. Id. at 23. Similarly, the Board also refused to find that the exclusion applied broadly to any “non-insignificant intervention” performed on the structure of an organism. The Board found that such a broad exclusion is now unjustifiable due to advances in nonmedical technologies (e.g., cosmetic and hair-removal procedures, tattooing, and piercing) requiring contact with the human body. Id. at 58-59.
Having rejected the narrow and broad definitions, the Board then sought an appropriate definition that allowed the exclusion to be effective but not stifling. The Board reasoned that the exclusion was intended to “specifically [free] the medical profession from [the] constraints which would be imposed on them by patents granted on methods of surgical or therapeutic treatment.” Id. at 60. The Board concluded that “any definition of the term ‘treatment by surgery’ must cover the kind of interventions which represent the core of the medical profession’s activities, i.e., the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility.” Id. Thus, the Board held that methods involving “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 [are] excluded from patentability.” Id. at 74. The Board, however, was unwilling to provide “an authoritative once and for all definition of what the term ’treatment by surgery’ may comprise” because of the ever-changing nature of medical technology. Id. at 63.
Next, the Board confirmed that a multistep method may be ineligible for patent protection if the method contains a single step directed to “treatment by surgery,” as defined by the EPC. The Board, however, opined that exclusion under Article 53(c) EPC may be potentially avoided by specifically disclaiming any embodiments directed to “surgery” within the meaning of the EPC, provided the rest of the method claim complies with the requirements of the EPC. Id. at 68. The patentability of such inventions, however, must necessarily be decided on a case-by-case basis. In addition, the Board announced that methods having diagnostic purposes should not be automatically excluded from patent protection merely because the method may be used during surgery. Id. at 74.
The In re Medi-Physics case makes it clear that most standard surgical methods (i.e., methods involving an invasive physical intervention of the body by a medical expert) are still ineligible for patent protection. Methods involving only a minor intervention or no substantial health risk, however, may be eligible for patentability. The EPO’s treatment of such methods, however, has yet to be determined.