Activity report for the Canadian Intellectual Property Office (CIPO)/Intellectual Property Institute of Canada (IPIC) Diagnostic Methods Working Group


(Ottawa); (Toronto); (teleconference)


Peter Wilcox (Partner, Belmore Neidrauer); Micheline Gravelle (Managing Partner, Bereskin & Parr); Neena Kushwaha (Acting Director, Biotechnology, CIPO); Jeremy McLean (Acting Program Manager, CIPO); Anne-Marie Monteith (Senior Director, CIPO); Kathleen Murphy (Director, Biotechnology, CIPO; only)


To review the issues and jurisprudence regarding the statutory subject matter of medical diagnostic methods.


In 2015, a Practice Notice concerning the examination of medical diagnostic methods was issued by CIPO. The Practice Notice has given rise to the identification by CIPO examiners of alleged defects relating to non-statutory subject matter for a subset of claims to diagnostic methods that would not have been so identified prior to the Practice Notice. Furthermore, due to various constraints, the CIPO Practice Notice is also fairly complex which has led to a long period of adjustment for applicants, agents and patent examiners. The CIPO Practice Notice has been the subject of some debate: a number of articles and blog postings discussing the CIPO Practice Notice and whether it adhered to the jurisprudence have been published. Against this backdrop, the President of IPIC approached the Commissioner of Patents at CIPO to see whether a collaboration intended to conduct an in depth discussion of the examination of medical diagnostic method patent applications and the Practice Notice might be a useful way to work together on this issue.


Clarification of practice

There was agreement that the CIPO Practice Notice was complicated and difficult to understand, especially when first encountered. According to the CIPO representatives, this complexity was a necessary outcome of the dual requirements of consistency of examination and the jurisprudence as interpreted by CIPO. Despite the complex nature of the Practice Notice, attention was drawn to the section of MOPOP on medical diagnostic methods published in late 2017 that expands on the Practice Notice in highlighting elements that might render a diagnostic method claim statutory such as distinct subpopulations and combinations of markers and/or tests.

Consistency of practice

CIPO has dedicated significant resources to ensuring examination of medical diagnostic method claims is consistent and would welcome the identification, through the use of the online feedback mechanism, of any applications for which examinations do not seem to adhere to published practice. (Please note: this mechanism cannot be used for the prosecution of the patent applications.)

Statistics: CIPO gathered and presented data for International Patent Classifications linked to medical diagnostic methods with the disclaimer that this data does not reflect all applications claiming such methods and also includes applications that were not claiming such methods. This data showed that the percentage of applications being allowed in these classifications is generally increasing with no significant changes in trends following the introduction of the Practice Notice.


The working group discussed in depth the significance and interpretation of a number of decided cases including, Inc v. Canada 2011 FCA 328; Shell Oil Co. v. Commissioner of Patents [1982] 2 S.C.R. 536; Free World Trust v. Électro Santé Inc. 2000 SCC 66; Whirlpool Corp. v. Camco Inc. 2000 SCC 67; and Schlumberger Canada Ltd. v. Commissioner of Patents [1981] 56 C.P.R. (2d) 204. Though a greater appreciation of the reasoning behind the differing interpretations was shared, no consensus interpretation of the relevant cases was attained. CIPO interprets the teachings of Amazon and Schlumberger to be relevant to diagnostic methods and Shell Oil was distinguished and interpreted by CIPO relatively narrowly.


The working group engaged in informative discussions. No further regular meetings will be scheduled, however the working group members have agreed to meet on an as-needed basis should one party have a topic to discuss. Working collaboratively, a better understanding of the differing perspectives was achieved by all participants. This understanding will be a useful foundation of knowledge in the event that any change to the diagnostic method Practice Notice is required. Furthermore, the engagement allowed for the provision of better information sharing regarding details of a published practice. The composition of the working group, both in terms of the relatively small size and the mixture of subject-matter expertise and strategic vision, allowed for discussions that were engaging, informative, constructive and non-confrontational.