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
The new practice notice provides welcome clarification on the
examination of medical use claims.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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