Paris, October 6, 2021 – In vitro diagnostic methods are generally characterized by a physical step of detection or quantification of one or more analytes and a step of correlation with a pathology or predisposition. For a long time, the Canadian Intellectual Property Office (CIPO) focused its analysis on the second step, thereby reducing diagnostic methods to a simple mental process (e.g., abstract idea) and inevitably bringing such methods into the category of inventions “excluded from patentability.”
Following a decision rendered in 2020 by the Federal Court in the Choueifaty case (Choueifaty v Attorney General of Canada, 2020 FC 837), which removed certain obstacles on the patentability of inventions implemented by a computer, the CIPO has published new Guidelines for Examiners in which the patentability of in vitro diagnostic methods are also addressed.
According to these recent guidelines, each element of a claim is presumed to be an essential element and any essential element is assessed as to whether the element cooperates with the other elements of the claimed invention (concept of “actual invention”).
In practice, these new guidelines give an example of a claim considered to relate to a patentable invention (subject to meeting the other patentability criteria of course, including inventive step):
Since the release of these guidelines, recent decisions by the Patent Appeal Board (PAB), Re Antibodyshop A / S (2021 CACP35), Re Abbott Molecular Inc. (2021 CACP19) and Re Genentech, Inc. (2021 CACP20) have overturned previous decisions rejecting patent applications on diagnostic methods (for the first decision) and methods for predicting a drug response (for the two other decisions).
These decisions confirm that the claims are now assessed as a whole consistent with the new guidance. Therefore, method claims comprising both a step of measuring and acquiring in vitro data and a step of analyzing such data which cooperate to lead to a result (predisposition/pathology, prediction of response, and probably also prognosis) should now be considered patentable.
This is encouraging news for applicants in an era in which there is an upsurge in the development of diagnostic methods, especially since the appearance of Covid-19.
There is more to come on the same subject focusing on the situation in Australia.
