Patenting Diagnostic Methods In Canada: A Glimmer Of Light From Our Southern Neighbours?

Personalized medicine, where prevention, diagnosis, and/or treatment of disease is tailored to a particular individual, is becoming more and more prevalent as scientists uncover new connections between biomarkers and illnesses. However, developments in the Canadian Intellectual Property Office (CIPO) over the last several years have made it increasingly difficult to patent technologies related to molecular diagnostics. This article reviews the current position of CIPO with respect to diagnostic patent claims and looks at recent developments in the United States.

At issue are patent claims directed to methods of diagnosing a particular disease in a subject where the inventors have identified a new association between a known biomarker and the disease. Such claims are now routinely objected to by Canadian patent examiners as being directed to non-patentable subject matter, despite meeting the other requirements for patentability, namely novelty, non-obviousness and utility.

The Canadian Patent Act defines an invention in section 2 as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”. A statutory exception is set out in section 27(8) of the Patent Act, which provides that a patent shall not be granted for “any mere scientific principle or abstract theorem”.

The patent eligibility of various types of subject matter has also been considered by the Canadian courts over the years. However, there have been no decisions specifically speaking to the patent eligibility of molecular diagnostic methods. Rather, current Canadian Examination practice with respect to diagnostic methods is based on a series of Practice Notices released by CIPO starting in 2013.

Practice Notice 2013-02 was published in 2013 following a Federal Court of Appeal case related to the patent eligibility of business methods (Amazon.com v. Attorney General (Amazon.com), and provides guidance on the purposive construction of patent claims. The 2013 Practice Notice describes using a “problem-solution” approach to inform a purposive construction of the claims, including limiting the essential elements of the claims to those that solve the identified problem.

In June 2015, CIPO published a Practice Notice setting out procedures for examiners to follow when considering the patent eligibility of diagnostic method claims (Practice Notice 2015-02). This...