Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3
This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here. Part 2 examined the patentability of diagnostic inventions in Europe and can be found here. Part 3 will examine the patentability of diagnostic inventions in Canada.
In Canada, the patentability of medical diagnostic methods is currently in a state of flux. The issues began with the decision in Amazon.com v. Attorney General (Amazon.com) 97 C.P.R. (4th) 171 (F.C.A). In Amazon.com, the Federal Court of Appeal identified three important elements for patentability subject matter: (i) it must not be a disembodied idea but have a method of practical application; (ii) it must be a new and inventive method of applying skill and knowledge; and (iii) it must have a commercially useful result. Additionally, the Court also ruled that “purposive construction” of patent claims must be performed prior to making a determination of subject matter eligibility, which involves identifying and assessing the essential and non-essential elements of the claims.
Moreover, in 2015, the Canadian Intellectual Property Office (CIPO) released patentability Examination Guidelines specific to diagnostic methods (Guidelines). These Guidelines have now been incorporated into the CIPO Manual of Patent Office Practice (MOPOP) and contain the following instructions for Examiners when approaching a claim directed to diagnostic methods:
(a) Identify the problem the inventors set out to solve and the solution provided by the invention, guided by the description and the Examiner’s understanding of the common general knowledge in the relevant art.
(b) Consider that for diagnostic methods, an inventor is generally looking to solve a data acquisition problem and/or a data analysis problem.
(c) Factors that may indicate a data acquisition problem include novel analytes or biomarkers and novel means of identifying or quantifying an analyte (regardless of whether the analyte is new).
(d) Factors that may indicate a data analysis problem include a new correlation between a condition and an analyte that is common general knowledge.
(e) Determine whether elements in the claims are essential (provide a solution to the identified problem) or non-essential (do not provide a solution to the identified problem).
(f) If the essential elements are required solely to solve a “data analysis problem” as opposed to a “data acquisition problem”, the claim will be refused as directed to non-statutory subject matter.
Practically, the Guidelines direct Examiners to reject patent claims where the subject matter of the claim is based only on the identification of new and non-obvious correlation, for example, between a disease state and a known biomarker. While some claims directed to diagnostic inventions have issued since the Guidelines were established, there has been a fair amount inconsistency at CIPO with respect to the application of the Guidelines. Canadian patent practitioners still determining types of claims which are currently allowable in Canada under CIPO policy, drawing on claim wording strategies similar to those used in the U.S.
To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions. You can register for the webinar at the following link: Link to webinar.
This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.