This article now* provides parameters for subject matter eligibility of diagnostic methods in ex-U.S. jurisdictions, which may provide guidance for applicants and practitioners. Generally, many jurisdictions explicitly exclude diagnostic methods by statute, particularly in vivo diagnostic methods. However, some of these jurisdictions do provide exceptions. Namely, some jurisdictions permit in vitro and ex vivo methods and/or methods that merely provide intermediate results.


The intellectual property (IP) laws of some jurisdictions have drastically different approaches towards diagnostic methods, which can be challenging for applicants and practitioners. Israel, for example, allows diagnostic methods to be patented, subject to certain exceptions. By contrast, China, Europe, and Japan exclude diagnostic methods from patentability by statute. A nuanced understanding of ex-U.S. laws, along with care-fully drafted claims, can help applicants protect their IP abroad.

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*Note: This article is the second in a two-part series; view the first article Patentability of Diagnostic Methods in the United States and Abroad – Part I.


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