PATENTS: Patentability of Diagnostic Method

13 Sep 2022 | 2022 World Congress

By Ralph Nack, AIPPIĀ Second Deputy Reporter General

The last Plenary Session of this Congress will concern the issues of patentability of inventions regarding the diagnosis of diseases or disorders. This is a very current topic, as Ralph Nack, the responsible reporter of this Study Question, agrees: “As was, unfortunately, well illustrated by the global COVID pandemic, an accurate and quick diagnosis of diseases and disorders has become increasingly important. Also, the development and evolution of personalized medicine has led to an increasing use of diagnosing disease or medical conditions.

Out of the 36 reports received from AIPPI’s National and Regional Groups and Independent Members, it follows that a clear majority (95%) of the responding Groups consider harmonisation regarding the patentability of Diagnostic Methods as desirable. Ralph Nack is not surprised: “From a patentability perspective, it is important to adopt a consistent and predictable treatment of Diagnostic Methods as this will be important for growing investment in research and development.

The reports indicate support for Diagnostic Methods to be generally patent eligible, as long as medical practitioners are allowed to diagnose a patient without having to worry about patent infringement. More specifically, a novel diagnostic apparatus or machine, whose only or primary purpose is diagnostic testing, should generally be patentable subject matter according to the responses as summarized in the Summary Report (available at The same goes for a novel diagnostic technique or method.

The answers from the Groups to the questions asking what claims should be considered patentable eligible from a subject matter perspective, however vary. This means that proposals for harmonisation drawn from them need to be carefully evaluated. Also, it appears that the implementation of changes may be complex for many jurisdictions, which is why flexibility (e.g. in the form of a transitional period, or by taking into consideration specific circumstances such as a difference in access to medical care) for countries should be considered.

Following the informal Online Study Committee meeting that took place prior the Congress, a revised draft resolution was circulated and discussed in the in-person Study Committee meeting here in San Francisco on Saturday. Nicolaj Bording, chair of the Study Committee, says: “The additional meeting prior to the Congress really helped in this particular matter; it allowed discussion on a number of fundamental points pre-Congress, allowing us to circulate a further developed draft for discussion during the Congress“.

Today, the draft resolution will be further discussed during a Plenary Session chaired by Thierry Calame, and in the afternoon it will be presented to ExCo for approval. Ralph Nack says: “I am very much looking forward to today’s further discussions and conclusion of the debate on this important topic!