Clarification as to the patentability of surgical methods
The much anticipated decision G1/07 of the Enlarged Board of Appeal (EBA) of the European Patent Office has issued, which provides guidance as to how the exclusion from patentability of treatment by surgery should be interpreted under European law. Regrettably, the EBA has chosen to provide answers to the referred questions that are fairly specific to the case under consideration, rather than a set of definitive rules for all cases. However, in the reasoning behind the decision some useful pointers have still been provided.
The EBA noted that the exclusion was not just for surgery that had a therapeutic purpose; this would not reflect the purpose of the exclusion, which was to free the medical profession from being hampered by patents. Non-therapeutic surgery such as cosmetic surgery and sterilisation still required considerable medical expertise due to the serious nature of the physical intervention and practitioners should be free to carry out such work.
However, a definition of surgery as any non-insignificant physical intervention was broader than required to achieve the purpose of the exclusion. Procedures such as hair removal by optical radiation and microdermabrasion were routinely carried out in cosmetic salons. Equally, safe and routine procedures for obtaining diagnostic data, potentially by an invasive step such as injection, did not require exclusion from patentability, when considering the public health interest.
The EBA therefore indicated that the exclusion should cover interventions that are the core of the medical profession’s activities, for which its members are specifically trained. Interventions of the kind that involve a health risk, even when carried out with professional care and expertise, should be excluded, whereas those that are “uncritical”, involving minor intervention and not normally presenting any significant health risk, should be open to patentability. When the intervention involves administration of a potentially risky substance, there would be an exclusion from patentability only where a health risk is associated with the actual method of administration.
It was stressed that the technical reality of the method must be assessed on a case by case basis to decide whether the exclusion applies. The specific case in question involved the injection of a contrast agent into the heart, and the EBA found that “A claimed imaging method in which, when carried out, maintaining the life and health of the subject is important and 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, is excluded from patentability…”.
It was indicated that a claimed method does not escape the exclusion by the inclusion of additional, non-surgical, steps. However, the use of a disclaimer to the excluded subject matter is possible, provided the established rules on disclaimers are met. Equally, an amendment could be made to remove the excluded matter, subject to the relevant requirements being met, such as basis for the amendment and the claim not becoming so broad that its scope is not supported or lacks clarity due to not setting out the essential features of the invention.
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