• Surgery and Diagnosis and the Grey Area Therebetween

    Methods of surgery or therapy performed on the human or animal body are unpatentable under Article 53(c) EPC 2000, but the Board of Appeal in the case of T0992/03 has referred a question to the Enlarged Board of Appeal as to whether a process that is otherwise patentable is precluded from patentability on the grounds that it encompasses (without necessarily claiming) a surgical step.

    The invention in question relates to a method for MRI imaging that includes delivering an imaging enhancer (polarized 129Xe) to a region of the patient’s body prior to imaging. In some embodiments and claims, the enhancer is inhaled (a non-surgical step). In other embodiments, it is delivered to a region of the heart by injection, although these embodiments are not explicitly claimed.

    Does the possibility of such a step constitute a method of surgery? If so, must the claim be refused on the grounds that it encompasses such an embodiment? The Board of Appeal has referred questions along these lines to the Enlarged Board.

    Notably, the Board of Appeal does not have difficulty deciding that, but for the surgical step, the claims need not be refused on the grounds that they are directed to a method of diagnosis. This is in accordance with our practice note on Patenting Medical Methods (http://www.jenkins.eu/articles/patentingmedical-methods.asp), because the subject matter relates to the data gathering step of diagnosis, which in this case is technical in character (and not to the subsequent phases of (ii) comparing, or (iii) recording of a deviation from normal or (iv) attribution of the deviation to a particular clinical picture). The case is pending as reference G01/07 and the oral hearing is scheduled for 11 November 2009.

    Comment

    This is, perhaps, another of those cases in which less is more. If the draftsman had not over-egged the pudding by including embodiments that involve surgery, it seems the Board of Appeal (and perhaps the Examining Division) would have been happy to grant the patent. Unfortunately, however, one of the methods described involved injecting the contrast agent into the body, and the claims encompassed that method. Had the draftsman described only those methods that required no surgical intervention, there would be no need for further debate. But having described such methods, must the claims be restricted to exclude them?

    Of course, to say that more careful drafting would avoid the objection is a very unsatisfactory way to leave matters. Surely an unpatentable invention cannot be rendered patentable by hiding embodiments? But if the Enlarged Board were to decide that the claims must be restricted, would this not open up the possibility of attacking and revoking patents on the grounds that they encompass methods that might require surgery? And some will say “what is wrong with that”? After all, the Office disallows claims to methods that might be performed as mere mental acts, even if they are described as being performed by a computer or by hardware.

    The position taken by the Chartered Institute of Patent Attorneys in its amicus curiae brief is that a claim that does not recite a surgical step should not be considered treatment by surgery, even if it might encompass a surgical procedure.

    Surgery? Treatment?
    Just what is or is not “Treatment by surgery”?

    In considering whether a surgical treatment is precluded from patentability by Article 53(c), the Guidelines look to
    the nature to the treatment. Merely considering the nature of a treatment does not fully address the question in the
    case of a wide range of surgical treatments that are not necessary therapeutic in the curative sense, such as:

    • cosmetic treatments
    • termination of pregnancy
    • castration and sterilisation
    • artificial insemination
    • embryo transplants
    • treatments for experimental and research purposes
    • removal of organs, skin or bone marrow from a living donor.

    Accordingly, the general test applied by the Boards of Appeal in considering whether a particular surgical procedure is a method of treatment that is to be excluded, asks whether the method involves significant physical intervention that is suitable or potentially suitable for maintaining or restoring health, physical integrity or physical wellbeing. Treatments by surgery that are clearly neither suitable nor potentially suitable for maintaining or restoring health of humans or animals remain patentable. The referral to the Enlarged Board in case G01/07 asks whether the aim or purpose of the surgical step plays a role. The referring Board points out difficulties in taking account of any subjective purpose or intent, but raises the question in view of comments in an earlier decision of the Enlarged Board.