Impacts Of TheAmazon.ComDecisions On Medical
Use Claims In Canada
Methods of medical treatment and surgery are not statutory
subject matter in Canada. Medical use claims, however, (similar to
the "Swiss-type" claims of Europe) are permitted as long
as they do not equate to medical or surgical methods (which involve
the professional skill of a medical practitioner) and that they
satisfy all the other statutory requirements (novel, inventive,
useful and sufficiently disclosed).
This has been the position in Canada following the decision of
the Supreme Court of Canada in the Tennessee Eastman (1972) case
and its subsequent decisions in Shell Oil (1982) and Apotex v.
Wellcome Foundation (2002).
However, in a recent series of decisions involving
Amazon.com's "one-click" patent, the approach to
determine what constitutes statutory subject matter has been
reconsidered. Although the subject matter of the Amazon.com cases
was primarily directed at the patent eligibility of business
methods and computer implemented inventions, the decisions have had
an impact on the way the Canadian Intellectual Property Office
(CIPO) purports to determine the validity of medical use claims in
In the Amazon.com cases, CIPO applied a test for assessing
patent eligibility by determining the "actual
contribution," which was independent of the construction of
the patent claims. CIPO's approach was to identify what the
inventor claimed to have invented, the "actual
contribution," and to determine whether it fell within the
statutory definition of "invention." If the actual
contribution was considered to lie in non-statutory subject matter,
the claim would be rejected. Amazon.com objected to this method of
assessment, alleging that it was contrary to case law of the
Supreme Court of Canada that requires, when assessing the validity
of a claim, the claim as a whole be purposively construed.
When the Amazon.com case was heard in the Federal Court of
Canada, the judge confirmed that the proper analysis was one of
purposive construction, and that the whole claim must be
interpreted and assessed for patent eligibility. A parsing of the
claim into different elements was not legally valid. However, even
after the Federal Court rejected CIPO's "actual
contribution" approach, objections to medical use claims
involving a determination of the "actual contribution"
were made by examiners.
The objections raised depended on the subject matter of the
specific medical use claims at issue but they usually followed a
similar argument. Although a claim may be written in an acceptable
format (i.e. a claim to a medical use, not a method of medical
treatment) if on considering its inventive concept the examiner
found that the actual contribution to the art required an element
of professional skill (such as targeting the use to a
pre-identified patient population, e.g., a diabetic) then that
claim was patent ineligible as a method of medical treatment.
CIPO appealed the Federal Court decision. In November 2011, the
Federal Court of Appeal held that the judge was correct. The
assessment of validity was to be based on a purposive construction
of the whole claim. However, even after the Federal Court of Appeal
had confirmed that "in determining subject matter solely on
the basis of inventive concept, [CIPO] adopted an analysis that is
incorrect in law," objections by examiners to medical use
claims based on the "actual contribution" analysis were
Given these court decisions, it was anticipated CIPO would
modify its approach. In April 2012, CIPO issued three draft
practice notices for public consultation, one of which, Office
Practice Respecting Claims to Diagnostic Methods and Medical Uses,
describes CIPO's approach to examining patent applications
containing claims to diagnostic methods and medical uses.
In the draft notice, CIPO appears to be returning to its
rejected approach for evaluating patent eligibility, but re-stating
it as a search for "inventive concept." The new proposed
approach appears to be a substantially similar concept to the
"actual contribution" analysis described earlier.
However, the authors of this article agree with the part of the
proposed notice that directs examiners to object to use claims that
define "when" or "how" a medicament is to be
delivered (as this requires professional skill); whereas use claims
that define "what" medicament is to be used may be
If CIPO continues to parse use claims using an "inventive
concept" approach rather than purposive construction, then it
is likely that further court decisions objecting to CIPO's
approach will be required to address the issue. For now, patentees
will have to be prepared to deal with objections reminiscent of the
"actual contribution" approach.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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