We reported last year the decision by the Federal Court in Choueifaty v Canada (Attorney General), 2020 FC 837 (hereinafter "Choueifaty"), which indicated that the Canadian Patent Intellectual Property Office (hereinafter "CIPO") and suggested that it may become easier for certain claims to be deemed patentable. At the time, many practitioners were doubtful that meaningful change would occur in CIPO practice, referring to the lack of change by CIPO after the decision of the Federal Court of Appeal in Canada (Attorney General) v. Amazon.com, Inc., 2011 FCA 328.
In November, CIPO issued a practice notice in response to Choueifaty. Many practitioners believe that this practice notice does not bring meaningful change to the practice of claim construction at CIPO. This belief was alluded to in the "25th Intellectual Property Law: The Year in Review" program hosted by the Law Society of Ontario. Some articles written by practitioners also reflect this belief.
However, we believe that this practice notice and the accompanying examples actually bring changes to CIPO practice that are beneficial to patent applicants.
The practice notice correctly notes that the determination of whether the claimed subject matter is patentable starts with a purposive construction, contrary to the problem-solution approach advocated in earlier practice notices, for example, PN 2015-01. Nonetheless, it is important to note that this practice notice states that "all elements set out in a claim are presumed essential," which was not the practice previously. The practice went on to state that "[w]here an actual invention consists of a combination of elements cooperating together, all of the elements of the combination must be considered as a whole when considering whether there is patentable subject-matter." It is noted, however, the practice notice still uses the problem-solution language in some instances, which may be the reason why some practitioners think that CIPO will stick to its old practice.
Applying the practices outlined in the practice notice, the example claims show that it will be easier for the subject matter of certain claims to be considered patentable.
For example, the following computer-related claim is considered to be directed to patentable subject matter:
A computer-implemented method of analysing data from seismic measurements comprising:
Performing seismic measurements;
Receiving the data from the seismic measurements;
Processing the data on a computer using algorithm X; and
Displaying the results of the analysis.
If one has dealt with Examiner's Report in the past several years, one would note that this claim will be rejected as being directed to unpatentable subject matter under the old practice. The Examiner most likely would consider step a to be non-essential because the problem is data analysis and step a is not essential to the solution and steps b-d are directed to data analysis, which is disembodied, thus rendering the claimed subject matter unpatentable.
Under the new practice, the claim is considered to be directed to patentable subject matter. CIPO reasons that step a is essential, which cooperates with steps b-d to solve a problem, and that step a involves discernible physical effects for the measurements, thus rendering the claimed subject matter patentable.
Similarly, the following claim is considered to be directed patentable subject matter:
A method of diagnosing whether a human subject is at risk for developing cancer, comprising:
measuring the level of X in a biological sample from the subject; and
comparing said level to the level of a non-cancerous reference sample, wherein an increase in the level of X relative to said reference indicates the subject is at risk for cancer.
In the past, this claim would be rejected for being directed to unpatentable subject matter because the Examiner would consider step a to be non-essential and step b to be directed to unpatentable disembodied idea, rendering the claimed subject matter unpatentable.
Under the new practice, CIPO considers the subject matter of this claim to be patentable because step a is essential, which cooperates with step b, and step a is "directed to physically measuring the level of X in the sample," thus rendering the claimed subject matter patentable.
Another point made in the practice notice regards dosage ranges in claims. The practice notice correctly states that "in cases where at least one of the essential elements of the actual invention limits the claimed use to a dosage, a range of potential dosages that a patient may receive, and/or a dosage regimen, regardless of whether these are fixed and/or cover a range, this fact alone is not determinative of whether the claim is patentable subject-matter" (emphasis added). This is consistent with the court decisions. For example, the Federal Court in AbbVie Biotechnology Ltd. v. Canada (Attorney General), 2014 FC 1251 indicated that the test should be whether "a claim directed to the exercise of professional skill or judgment" (see, e.g., para 114). However, the example claim 2 below is considered to be directed to unpatentable subject matter, without discussing the test:
Use of compound X to treat peptic ulcers.
The use of claim 1, wherein X is for administration at a first dosage of 6 to 8 mg/day for a period of about 2 to 10 weeks, and a final dosage of 16 to 24 mg/day.
This determination appears to suggest that dosage range necessarily requires professional skill and judgment. We do not necessarily agree with this determination without knowing the disclosure as a whole with respect to professional skill and judgment. In addition, it is noted that this claim depends from a "use" claim that is directed to patentable subject matter.
Fortunately, a recent Commissioner's decision, Amgen Research (Munich) GmbH (Re), 2021 CACP 2, appears to affirm the test as articulated in the court decisions. Here, claims reciting dosage ranges are deemed to be directed to patentable subject matter because any dosage within the range as claimed would be appropriate, rendering unnecessary the professional skill and judgment of the physicians.
In conclusion, we believe that the practice as updated in this practice notice will make it easier for claimed subject matter to qualify as patentable subject matter compared to past practices.