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.”
The paper was authored by the IPO’s Software and Medical Device Subcommittee, which I had the honor and pleasure of leading in 2022. The Subcommittee reports to the IPO’s Software Committee.
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 authors include Christopher George, Christoper Karlen, John Kind, Anne Lejeune, Charlotte Leleu, Nikesh Patel, and Ryan Phelan.
The white paper may be found here and covers various best practices for protecting software and medical device inventions around the globe. 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):
- China (John Kind). 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. Specifically, CNIPA has guidelines for applications relating to Computer Programs and the Diagnosis or Treatment of Diseases. The former do not typically present significant challenges for protecting software medical devices, but the latter introduce explicit challenges to Chinese practice.
- Japan (Ryan Phelan). The Japanese Patent Office (JPO)’s Examination Handbook includes a section dedicated to the field of software-related inventions. See JPO Examination Handbook, Computer Software-Related Inventions. The JPO defines a “software-related invention” as “an invention that uses software to carry out the invention.” Id. at 1. 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. Id. The software-related invention must also possess eligibility, novelty, and an inventive step. Id.
- EPO (Nikesh Patel). The EPO assesses the patentability of inventions according to the European Patent Convention (EPC). 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 EPC does not provide a positive definition of “invention,” nor does it prescribe statutory categories (compared to e.g., 35 U.S.C. 101). Art. 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 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. The EPO adopts a “two-hurdle” approach for assessing inventions that may include a mix of technical and non-technical features. Typically, where an invention uses software, it may be considered to be such a mixed-type invention or a computer-implemented invention (CII), which are considerations that must be taken into account for software medical device-related inventions.
- France (Charlotee Leleu and Anne Lejeune). The convergence of French and European practices applies particularly to software which, according to Article L611-10 of the French patent law, cannot be considered an invention when the patent application concerns software “as such.” Similarly to the European practice, a computer program may be considered an invention if it produces a further technical effect beyond the standard technical effects involved in the operation of a computer. Accordingly, a software developed for medical purposes, comprising either the processing of data representing physiological quantities, or the control of a medical device, may be considered an invention. The same applies to artificial intelligence methods which, when applied to medical data such as medical imaging, are considered technical.
- U.S. (Christopher Goerge). A prior paper published from this subcommittee in 2021 analyzed a series of U.S. court decisions impacting medical device-related software inventions. Innovations related to medical device technology, medical data processing, output generation, etc., can be patentable but face a high level of scrutiny as related to both software (Alice) as well as medical diagnostics (Mayo). Claims directed to guiding human actions or reflecting laws of nature are very difficult to find patent eligible. If a computer is involved as a tool to merely leverage generic computing capabilities in a well-understood, routine, and conventional manner, then such claims are likely ineligible. In contrast, providing a high degree of specificity in the claim and using the computer to perform a particular action could be patent eligible. Similarly, simply observing, measuring, gathering, and/or storing data using general computer processing functionality is likely ineligible.
The white paper concludes with a useful comparison chart that provides a reference comparing the similarities/differences of laws of the above countries. The chart is reproduced below for reference, but please see white paper for additional details:
|Patent Eligibility /Industrial applicability||Inventive Step / Obviousness|
|China||Methods of diagnosis are not allowable||Identify the technical problem solved and evaluate whether the claimed technical solution is inventive over the prior art|
|Japan||Inventions of methods of surgery, therapy, or diagnosis of humans do not comply with the industrial applicability requirements. See JPO Guidelines, Section 3.1; However, a medical device or medicine is a product and is not considered to be a “method of surgery, therapy, or diagnosis of humans.” See id. at 3.2.1.||“normal creation” activity of a person of ordinary skill can lack an inventive step|
|EPO||Computer programs and mathematical methods, for example, are excluded from patentability when claimed as such. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body are excluded from patentability under Article 53(c) EPC. A medical product such as a device is not considered to be encompassed by this exclusion.||Only features contributing to a technical effect are considered for the assessment of the inventive step.|
|France||Software claimed as such are not considered inventions, but software involving a technical effect (e.g., such as processing of medical images or command of a medical device) is eligible. Methods for treatment of the living human or animal body by surgery or therapy and diagnostic methods are excluded from patentability. This does not apply to substances and compositions for use in such methods, but similarly to the EP practice, products such as devices are not encompassed by such a provision. Guidelines regarding acceptable claims may be stricter than before the EPO.||Only features contributing to a technical effect are considered to assess an inventive step.|
|U.S.||Software medical device inventions must meet both the statutory requirements of 35 U.S.C. § 101 (falling into one of four statutory categories) and those described by the Supreme Court in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), holding that a software-related invention must not be “directed to” an abstract idea without significantly more (i.e., without an “inventive concept”).||Under 35 U.S.C. § 103 (obviousness), a claimed invention cannot be previously recited in a combination of prior art references, where one skilled in the art would have had some motivation to combine those references in the same manner as claimed.|
I look forward to working on this year’s upcoming paper to advance these topics further.
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