Patenting personalized medicine in Canada is a growth industry right now. In a recent article in IAM’s Life Science 2020, two of our Oyen Wiggs lawyers, Jennifer A Marles and Christina SW Kwok, provided their insights into what the future holds for this emerging area of medicine as it gains more traction. Below is a summary of that article or you can download the full article as published.
Personalized medicine holds the future for healthcare delivery. Underpinning most personalized medicines are diagnostic methods, which rely on establishing a correlation between one or more biological markers and the existence of a specific disease or a response to a particular treatment. Current administrative patent examination guidelines published by the Canadian Intellectual Property Office (the “CIPO”) create an obstacle for patenting certain diagnostic methods in Canada, and this has led to uncertainty as to the patentability of such technologies in Canada notwithstanding that there is no provision of Canadian law and no court decision that precludes patents from being awarded for such inventions.
Under the CIPO’s guidelines, whether a claim is considered patentable subject matter depends on how an examiner characterizes the problem that the claimed invention sets out to solve. In brief, if an examiner considers that the essential elements of a claim solve a “data acquisition problem”, then the claim is considered directed to patentable subject matter. If an examiner considers that the essential elements of a claim solve a “data analysis problem”, then the claim is refused for being directed to non-patentable subject matter.
To avoid the negative outcomes created by the current guidelines, the best option for patent applicants is to try (where feasible) to characterize the problem to be solved as a data acquisition problem, rather than a problem that relates to how the data is analyzed or how insights obtained from the data are applied. The disclosure of a new analyte, or a new method of acquiring data about a particular analyte, are examples of a data acquisition problem. The CIPO has, following these administrative guidelines, allowed patents for certain technologies in the diagnostics space that are aimed at addressing such data acquisition problems, demonstrating that with strategic crafting of the claims there may be some chance of obtaining a granted patent directed to certain diagnostic methods in light of these guidelines.
While the CIPO’s administrative guidelines are not considered to be in line with Canadian law and future guidance from Canadian courts will be required to gain further clarity as to the true patentability of such innovations in Canada, the recent Federal Court decision in Choueifaty v. Canada (Attorney General), 2020 FC 837 at the very least confirms that the CIPO’s guidelines are in error to the extent that they utilize a problem-solution approach to define the essential elements of the claims. Thus, the process of challenging CIPO’s administrative guidelines is already underway.
For a more in-depth overview of CIPO’s current guidance on the examination of medical diagnostic methods and for some tips on how to draft claims most likely to be found patentable under the current guidance, you can download the full article below.