Patenting Diagnostic Methods – Part 1

Written By: Dr. Angela Keuling, Patent Agent

The COVID-19 pandemic has illustrated the importance of fast and accurate diagnostic testing. It is clear that novel diagnostic methods have the potential to provide significant economic and social value. Often, new diagnostic methods are based not on novel equipment or reagents but on a newly discovered relationship between a biological marker and a disease or health condition. This is particularly common in the “omics” fields (e.g. genomics, proteomics, and metabolomics) where specific biological profiles may be found predict a person’s risk for developing a certain health condition.  Whether such diagnostic methods are eligible for patent protection has been a subject of some controversy in both Canada and the United States.

Part 1 of this article will look at the patent eligibility of diagnostic methods in Canada and Part 2 (coming the week of August 3…) will look at the United States.

Canadian Approach to Patent Eligibility

There has been little case law in Canada to specifically address whether or not diagnostic methods are patent eligible. Instead, the Canadian Patent Office has developed their own approach, outlined in the Manual of Patent Office Practice (MOPOP), that Canadian Patent Examiners follow when examining patent applications relating to diagnostic methods.

In general, the Canadian Patent Office use an approach that first involves determining what problem is being addressed by the patent application. For diagnostic method inventions, the Patent Office considers that there are two main types of problems that can be solved: i) a data acquisition problem; or ii) a data analysis problem. Once the problem has been identified, Examiners will look for the essential elements of the solution to the problem and determine if these elements are tangible steps or just abstract ideas or mental processes.

Diagnostic method inventions that are based on the discovery of a novel biomarker (or combination of biomarkers), or that use novel or unconventional laboratory techniques for detecting or quantifying a known biomarker, may be found to solve a data acquisition problem. Patent Examiners tend to find these types of inventions to be patent eligible if their “essential elements” are tangible steps to acquire data about the biomarker(s) of interest.

On the other hand, diagnostic methods that are based on a newly discovered relationship between known biomarker and a health condition will likely be found to solve a data analysis problem. Patent Examiners tend to find these types of diagnostic methods patent ineligible if their “essential elements” only involve mental steps for making a correlation between the biomarker(s) and the health condition of interest.

The end result is that a diagnostic method based on a novel correlation between one or more biological markers and a health condition, if the markers are detected by known or standard techniques, tend to be difficult to patent in Canada.

Patenting Diagnostic Methods in Canada

Although the Canadian Patent Office’s approach to patent eligibility presents a significant hurdle, it is still possible to obtain strong patent protection for some diagnostic method inventions. To increase the likelihood of obtaining an issued patent, patent applications need to be drafted carefully to position the application as solving a “data acquisition problem” instead of a “data analysis problem” and provide the necessary details to support such a position.

Thus, patenting diagnostic methods in Canada is complex and requires careful consideration. If you are interested in potentially patenting a diagnostic invention, our intellectual property team is happy to help you navigate this space.

Disclaimer: This article is to be used for educational and non-commercial purposes only. Parlee McLaws LLP does not intend for this article to be a source of legal advice. Please seek the advice of a lawyer before choosing to act on any of the information contained in this article.