Canada: Responding To A Difficult Diagnosis: Strategies For Addressing Objections Based On New Canadian Examination Guidelines For Medical Diagnostic Methods

It bears repeating that the recent Practice Notice1 issued by the Canadian Intellectual Property Office (CIPO) on the subject of medical diagnostic methods is contrary to Canadian jurisprudence. Based on CIPO policy of tenuous legal basis (to put it mildly), the situation for diagnostic-related applications in Canada is markedly different from the court-created state of affairs in the U.S. However, past experience with other CIPO examining policies suggests that legal argument alone is unlikely to be successful in overcoming Practice Notice-based objections at the examining level, until CIPO is corrected by the courts. Best practices for addressing subject matter objections based on PN2015-02 are difficult to discern at this early stage, and there is certainly no obvious one-size-fits-all claim format, for example, that would circumvent current issues. This article aims to outline a few possible courses of action.

In its practicalities, there are similarities in how diagnostic claims are treated in both jurisdictions. What has been deemed "conventional" or the "particular technical environment" in precedential U.S. decisions has some correspondence to what Canadian examiners now call "common general knowledge (CGK) features" and subtract away during the assessment of subject matter eligibility.

Applicants wishing to take a pragmatic approach may wish to consider attempting to work within the confines of PN2015-02, legally unsound as it may be. To this end, receptive examiners may be open to reframing the problem and solution that underpins the analysis of the claims. It may be possible to explain to such an examiner that a diagnostic invention also addresses a data acquisition problem, and hence includes essential data acquisition features.

Since the PN2015-02 indicates that common general knowledge is to be considered in establishing essentiality, it may be possible to explain to an examiner that a body of literature pertaining to a particular analyte (and methods for its detection) was not common general knowledge that a skilled person studying a particular disease could be expected to possess or pursue, if no link between the two had ever been made before. After all, the Supreme Court has indicated that a skilled person is only expected to be "reasonably diligent in keeping up with advances in the field to which the patent relate[s]".2 Information drawn from a seemingly irrelevant field is arguably not the sort of common general knowledge the skilled person would possess, and only becomes relevant with the benefit of hindsight.

The nature of what constitutes a "new analyte" is not defined PN2015-02, and may also provide some leeway to negotiate with receptive examiners. If the detection steps involve a new mutation, fragment, isoform, degradation product, or post-translational modification, these would seem to qualify as a "new analyte" on a plain reading of the term. Applicants may also be able to assert that a combination of known analytes – perhaps even a combination of known variants therein – effectively constitutes a "new analyte".

It may also be helpful to reassure an examiner that an applicant is not seeking to monopolize a mere correlation. To this end, broad steps of "determining" could be refined to state something more explicitly physical, e.g., to define reagents or to specify binding and/or reacting steps. That said, the rather slapdash treatment of technically limited dependent claims to date raises questions of if and how added features of this sort will be assessed under the Practice Notice.

The author has seen some diagnostic-type method claims culminating in a step of "selecting a treatment" allowed in a small number of applications, though it is unclear at the present time if this represents a trend. This could be a viable course of action for some applications, for example with companion diagnostics resulting from diagnostic/drug co-development.

Finally, some applicants may wish to take advantage of abandonment and reinstatement provisions to defer examination in the hope that CIPO will be forced to correct its policies in the meantime. Reinstatement is available as of right in Canada at the time of writing, upon payment of the required government fee. The reinstatement period effectively extends Office Action deadlines one year beyond the initial deadline.


1 CIPO, "Examination Practice Respecting Medical Diagnostic Methods", Practice Notice 2015-02 (Ottawa: Industry Canada, 29 June 2015) [PN2015-02].

Whirlpool Corporation v Camco Inc, 2000 SCC 67 at para 74.

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