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 Canada.
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 falls 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 long-standing case law of the Supreme Court of Canada which requires, when assessing the validity of a claim, that 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 that involved 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 still issued.
Given these court decisions, it was anticipated that 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 substantially similar in 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 acceptable.
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.
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