• EUROPEAN PERSPECTIVES

    Patentability of Medical Methods 

    The medical industry is predicted to continue its impressive growth as the population enjoys greater longevity and innovation stimulates demand for new medical treatments. Patents are critical to investment in such innovation, especially where lead-times to market are long. The medical field of patents has its own set of exclusions to patentability for reasons of policy and ethics and the boundaries of patentability are constantly being tested. Here we review two recently reported cases where the EPO’s Technical Board of Appeal has addressed this issue.

     

    T1165/97 – ULTRAFEM / Feminine Hygiene Device

    A method of using a vaginal discharge collector is held not to be a method for treatment or a diagnostic method and is held to be industrially applicable if the claimed method can be performed by an enterprise, e.g. one aiming to assist women in collecting a sample of their discharge.

    The claims of concern related to a method of using a vaginal discharge collector and had been refused by the Examining Division on the basis of a lack of industrial applicability (Art 57 EPC). The Division’s refusal primarily relied on Decision T74/93 – BTG / Contraceptive Method (which held that a method of contraception which was to be applied in the private and personal sphere of a human being was not susceptible of industrial application). It was argued that even if the positioning of the device was performed by somebody other than the person in question (e.g. a nurse or a doctor), the claimed method would be excluded under Art. 52(4) EPC as a medical method (see above), rendering the subject-matter unpatentable for that reason. Furthermore, the claimed steps of holding the collector in place and collecting the discharge were individually and personally performed by the woman in question and hence not industrially applicable. Finally, the claimed step of disposing of the discharge collector had no relation to any industrial applicability.

    The applicant successfully appealed on the basis that the claimed method was not a method for treatment or a diagnostic method. Furthermore, it was considered to be industrially applicable because the claimed method could be performed by an enterprise.

    For industrial application, it is irrelevant whether the enterprise actually exists

    On the requirement of industrial applicability, the Board defined an invention as susceptible of industrial application if it could be made or used in any kind of industry. The claimed method could be performed by an enterprise aiming to assist women in collecting a sample of their discharge, such as for subsequent visual, chemical or bacterial inspection or for extraction of one or more of its components for use in industrial preparation of pharmaceutical compositions (NB it was considered irrelevant whether such an enterprise existed – what was significant was that there was the possibility that such a service could be offered by an enterprise).

    Moreover, it could be foreseen that application and retrieval of the discharge collector would be performed by a professional in the service of an enterprise. Furthermore, this service would not be one satisfying only the strictly personal needs of the woman in question because the collection of a sample may be caused by external reasons, e.g. the advice of a medical practitioner to have such a sample taken for further diagnosis. In addition to this, the person taking the sample would generally not be acting on the instructions of the woman in question (c.f. the contraceptive method in BTG), but on the basis of instructions supplied with the collector itself.

    The exclusion of industrial applicability under Art. 52(4) was held not to apply because there was no requisite act of surgery or preventative treatment of illness or any alleviation of the symptoms of pain and suffering. Also, there was no necessity of particular medical skills to work the invention. In this regard, the Board indicated that even if the claimed method were performed by a medically trained person or doctor, this would still not constitute a method of treatment of the human or animal body by surgery or therapy.

    The claimed method was not considered to be a diagnostic method because the Board considered the exclusion only to apply to diagnostic methods of which the results make it directly possible to decide on a particular course of medical treatment, i.e. only methods that contain all the steps involved in reaching a diagnosis should be excluded (see below on this point).

    Thus, the appeal was successful in respect of the method claims but the applicant was requested to make amendments to the description to remove references to methods of therapeutic treatment.

     

    T964/99 – CYGNUS / Device and method for sampling of substances using alternating polarity

    A claim to a method of diagnosis practiced on the human or animal body is not permitted where it includes a single precluded diagnosis step, even if the method includes other steps not in themselves precluded.

    In this case, the application was refused by the Examining Division because a step of iontophoretically sampling a substance from a living human or animal body (sampling a substance or substance metabolite from the surface of the body by conducting electrical current through the tissue) was considered to be a diagnostic method within the meaning of Art. 52(4) EPC.

    The applicant appealed, but the Board upheld the Examining Division’s decision and said it was immaterial that the claimed methods could be performed by a patient himself and that their execution would not have a significant impact on the human body, nor involve a serious health risk.

    The applicant had based arguments on the definition of diagnostic methods used in T385/86 – BRUKER / Non-Invasive Measurement which related to nuclear magnetic resonance (NMR) procedures. The applicant argued that:

    • the only diagnostic methods to be excluded were those whose results immediately made it possible to decide on a particular course of medical treatment (i.e. the method was required to contain all the listed steps required in reaching a medical diagnosis);
    • methods providing only interim results were not diagnostic methods;
    • the claimed step of analysing the sample chamber for the concentration of the extracted substance was performed by purely technical means outside of the body;
    • the application of electrodes to the skin and the passing of low iontophoretic currents through the skin had no lasting significant or lasting effect on the body; and
    • the claimed methods did not involve any risk for the health of the person treated, nor did it require any medical knowledge (i.e. the participation of a medically qualified professional was not required).

    The Board was not persuaded by these arguments, because it considered that a strict adoption of the principles set out in BRUKER would lead to the conclusion that typical diagnostic procedures practised on the body (e.g. percussion, auscultation or palpation) would, in principle, be patentable because they do not constitute a complete diagnosis.

    The Board also compared the exclusion for diagnostic methods to those for methods of surgery or therapy, where it had previously been established that a single step of a surgical or therapeutic nature would pose a bar to patentability. The Board could see no reason why there should be such a difference in interpretation.

    The Board did not contest that, in order to arrive at a medical diagnosis, all of the steps referred to in BRUKER were required, but considered that the exclusion applied even if not all of the steps were involved. Hence, the Board relied on alternative definitions of a “diagnostic method”, in particular, “methods pertaining to, or of value for the purposes of, diagnosis” (emphasis added). Within this meaning, any medical activity concerning the gathering of information in the course of establishing a diagnosis qualifies as a diagnostic method.

    Thus, it was decided that the term “diagnostic” could be interpreted as encompassing all steps required for reaching a medical diagnosis, or also, an individual step of a diagnostic examination. The Board considered that the intention of the legislator had been to distinguish between in vivo methods practised on the human or animal body, which would be excluded, and extra-corporeal (in vitro) laboratory tests, which would be patentable.

    It is important to bear in mind that this decision did not overturn previous case law. Instead, the Board factually distinguished this case from earlier ones. In particular, the nuclear magnetic resonance (NMR) procedures of BRUKER, although performed on a living body, were only considered to define steps which concerned the technical operation of exciting and detecting resonance signals and thus fell within terms of design and performance within the exclusive competence and responsibility of the technician skilled in NMR technology. Thus, the claimed steps of BRUKER amounted to nothing more than the (internal) operation of a technical device, and without exception, fell within the competence and under the exclusive control of a technician. The methods claimed in BRUKER were consequently not excluded from patentability even if they generated and detected physical signals on a living body and the results could be evaluated for diagnostic purposes. In conclusion, it was pointed out that the claims of BRUKER could have been drafted in such a manner as to only contain steps concerning the control and internal operation of a technical device.

     

    Summary

    A method of treatment that is not practiced on the human or animal body or that is not therapeutic is allowable, provided that it does not have both therapeutic and non-therapeutic effects, and provided it can be used in any kind of industry, e.g. it can be performed by an enterprise (other than a medical professional). If a method or use claim has a single impermissible treatment or diagnosis step, the entire claim will be refused.