The Canadian Intellectual Property Office has released revised guidance on examination of medical use claims:  PN 2015-01 “Revised Examination Practice Respecting Medical Uses” . This follows a court decision in AbbVie Biotechnology Ltd v Canada (Attorney General) (“AbbVie”), 2014 FC 1251.

As reported in our January 22, 2015 IP Update, in the AbbVie case, the Federal Court found the Commissioner of Patent erred in interpreting the jurisprudence and in finding that AbbVie’s claims claimed a method of medical treatment.  The Court found the claims, which relate to use of a known compound for a known purpose, at a fixed dosage amount and on a fixed schedule (bi-weekly), are patentable subject-matter. The reasoning was that, if the claimed use is prescribed, no skill or judgment would be expected to be exercised within the claim. The bi-weekly dosage was fixed and precise.

The new guidance supersedes the previous practice notice released June 10, 2013 (reported in our June 10, 2013 IP Update), with the following key changes made in light of AbbVie.

The new guidance expressly considers that fixed dosages and fixed dosage regimens do not point to professional skill or judgment. In addition, the Patent Office no longer considers patient sub-populations or administration sites to point to professional skill or judgment. PN 2015-01 states:

Essential elements that point to a limitation of a physician’s professional skill or judgment include those that provide details of a dosing schedule encompassing a range and those that represent a range of potential dosages that a patient may receive (as distinct from a range of dosage forms).  In contrast, essential elements that narrow treatment to a fixed dosage, a fixed dosage regimen, a patient sub-population or to a particular administration site are not considered to point to a limitation of a physician’s professional skill or judgment. [Emphasis added.]

The Patent Office continues to distinguish essential elements that instruct a physician on “how” versus “what” to use to treat a patient. However, the revised guidance no longer states that the former will lead to the conclusion that the claimed use encompasses a method of medical treatment. Instead, PN 2015-01 states that an inquiry as to the involvement of professional skill must first be met:

[I]t must be determined whether the essential element prevents, interferes with or requires the professional skill of a physician.  If the answer is “yes”, this will lead to the conclusion that the claimed use encompasses a method of medical treatment. [Emphasis added.]

The new practice notice provides welcome clarification on the examination of medical use claims.