The legislator has left the task of construing the legal concept of “invention” and “technical” to the case law of the EPO Boards of Appeal so as to allow for developments in technology to still be taken into account when assessing patentability. 52(2) EPC provides a non-exhaustive list of “non-inventions,” but they are excluded from patentability only when claimed “as such.” It should also be noted that although the term “technical” is used frequently by the EPO when commenting on patentability, the term is not defined in the EPC. The EPC does not provide a positive definition of “invention,” nor does it prescribe statutory categories (compared to e.g., 35 U.S.C. The most relevant articles of the EPC that will apply to software in the medical device field are Articles 52, 53, 54, and 56 EPC. The EPO assesses the patentability of inventions according to the European Patent Convention (EPC). The software-related invention must also possess eligibility, novelty, and an inventive step. As is common for all fields for Japanese applications, an invention (including a medical software-related invention) under Japanese law must be sufficiently enabled and have clarity. The JPO defines a “software-related invention” as “an invention that uses software to carry out the invention.” Id. See JPO Examination Handbook, Computer Software-Related Inventions. The Japanese Patent Office (JPO)’s Examination Handbook includes a section dedicated to the field of software-related inventions. The former do not typically present significant challenges for protecting software medical devices, but the latter introduce explicit challenges to Chinese practice. Specifically, CNIPA has guidelines for applications relating to Computer Programs and the Diagnosis or Treatment of Diseases. The China National Intellectual Property Administration (CNIPA) has two sets of guidelines that are potentially relevant to inventions that use software as or part of a medical device. A brief summary introduction follows for each section, each of which relates to a country or legal jurisdiction the white paper covers (for specific information for a given country, please see the white paper): The white paper may be found here and covers various best practices for protecting software and medical device inventions around the globe. The authors include Christopher George, Christoper Karlen, John Kind, Anne Lejeune, Charlotte Leleu, Nikesh Patel, and Ryan Phelan. I had the privilege of co-authoring this paper with my fellow IPO committee colleagues, whom each provided perspectives on software and medical device IP law from around the globe. The Subcommittee reports to the IPO’s Software Committee. The paper was authored by the IPO’s Software and Medical Device Subcommittee, which I had the honor and pleasure of leading in 2022. I am excited to announce the publication of the Intellectual Property Owner (IPO)’s white paper on “ Software and Medical Device Guidance: A Global Perspective.”
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