Canada: CIPO's Examination Guidelines For Medical Diagnostic Methods Turn Three

This article provides a retrospective on three years of experience with the examination guidelines established by the Canadian Intellectual Property Office for patent applications filed for medical diagnostics inventions, including personalized medicine and precision medicine technologies.

June 29, 2018 marked three years from the publication of PN2015-02, a practice notice that established new examination guidelines to be followed by patent examiners of the Canadian Intellectual Property Office (CIPO) for the assessment of claims to medical diagnostic methods, including personalized medicine and precision medicine technologies.1 According to the practice

notice, the so-called "essential elements" of a diagnostic claim are determined based on the identification of either a data acquisition problem or a data analysis problem in the state of the art. This problem is identified retroactively by an examiner, and only claim features that solve the delimited problem are deemed essential.

Thus, if the biomarker and the way of measuring it are determined to be "common general knowledge" (CGK) and the correlation is discovered, CIPO states that there was no preexisting problem relating to data acquisition. CIPO then finds that a data analysis problem was addressed, and limits the essential elements of the claim to the correlative features that directly address this problem. These are then said to be patent-ineligible mental steps.

In the alternative, CIPO will assert that a data acquisition problem was addressed, thereafter disregarding the correlation as supposedly "non-essential". In this case, patent-eligible subject matter will be found, but, unless the analyte or means for its measurement are independently novel and inventive, what is left is the step of measuring a known analyte in a conventional way, unlimited by application. As will be seen, objections for lack of novelty and/or inventive step follow.

CIPO's approach completely subordinates the claim language to a hindsight assessment of the point of discovery. This is

inconsistent with jurisprudence from the Supreme Court of Canada (SCC) concerning claims construction, which acknowledges the primacy of the claim language, and which determines essentiality based on material effects to the working of the invention.2,3 The approach contravenes the SCC on subject matter eligibility, and its pronouncement that the Commissioner of Patents is not permitted to refuse patents on the basis of public policy considerations independent of the Patent Act.4,5

The examination guidelines use the SCC-endorsed term "purposive construction" as labelling. The actual approach bears no resemblance whatsoever to the SCC's purposive construction.6 As discussed by UNB Professor of Law Norman Siebrasse in his blog post " Diagnostic Methods at CIPO", the meaning ascribed to a diagnostic claim by CIPO changes based on the inventive concept and therefore equates, in practical terms, to an older contribution analysis approach. This is starkly evident when one considers that two identically worded claims will be given interpretations that do not even overlap if the analyte is novel in one case, and known in the other.

The change in examination practice was not based on any change in the law, and has come in for criticism recently in the national press, including the National Post and The Globe and Mail.

Despite this, the examination guidelines were codified into Chapter 17 of CIPO's examination manual, the Manual of Patent Office Practice (MOPOP) in November 2017.

Lessons from the Past Three Years

Three years have taught us a great deal about CIPO's examination guidelines, including many details that are not apparent in official published texts.

Office actions have provided information about the practical application of the guidelines. One 2016 webinar involving CIPO representatives explained how some decisions about the analyte are made. In addition to this, material concerning the examination guidelines has been obtained through Canada's Access to Information Act and has been posted online anonymously.7 This includes CIPO training presentations, training manuals, bulletins, and internal emails, which together have illuminated many more aspects of the practice. Some of these points are discussed below, with hyperlinks to relevant source documents.

Footnotes

1 The term "diagnostic method" will be used throughout as an umbrella term to encompass any claim involving measurement of an analyte and correlation to a

biological trait.

2 Whirlpool Corp. v. Camco Inc., 2000 SCC 67 [Whirpool ].

3 Free World Trust v. Électro Santé Inc., 2000 SCC 66 [Free World Trust].

4 Shell Oil Co. v. Commissioner of Patents, [1982] 2 SCR 536.

5 Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76 at par 144.

6 The author's review article is available at https://ssrn.com/abstract=2809891

7 https://ipflyonthewall.wordpress.com/

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