Study on the Status of Patent Protection for Diagnostic Methods in Europe

Diagnostic methods that are practiced on the human or animal body have been explicitly excluded from patentability in most countries’ patent laws including European Patent Convention. However, rapid advances in science and technology, and consequently, the emergence of wide and diverse range of inventions in medical fields, have given rise to the difficulty and complexity of determining the scope of excluded diagnostic methods. Here, the approach of Technical Boards of Appeal to three issues has been controversial. First, what is the definition of “diagnostic method” as intended by the European lawmaker? Whether a claimed method is a “diagnostic method” only if it involves participation of a physician? What criteria can make a claimed method “practiced on the human or animal body” as it is required by the European Patent Convention? The response to these questions has been challenging and caused inconsistency and in some cases contradiction in European case-law. This Article tries to study and analyze the approach of Technical and Enlarged Boards of Appeal in a few key cases toward the patentability of diagnostic methods in Europe.