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