In AbbVie Biotechnology Ltd v Canada (Attorney
General),2014 FC 1251, rendered December 22, 2014, the
Federal Court allowed AbbVie's appeal from a refusal of the
Commissioner of Patents to grant Canadian Patent Application No.
2,385,745. The refusal was on the basis that the claims at issue
cover a method of medical treatment (Decision #1362). The Court held the
claims – for use of a known drug, HUMIRA (anti-TNF alpha
antibodies) at a specified fixed amount (40 mg) and fixed interval
(bi-weekly) – were patentable.
As no facts or claim construction were in dispute, the issue was
solely a question of law, namely the Commissioner's
determination of "the statutory limits of patentable subject
matter... – that is, the nature and extent of the prohibition
against methods of medical treatment", and more specifically,
the application of principles derived from the
The prohibition against claims to methods of medical treatment,
and the principle that claims to the exercise of professional skill
are not inventions and cannot be patented and monopolized, can be
traced back to the Supreme Court of Canada's decision in
Tennessee Eastman Co v Commissioner of Patents,  SCR 111 ("Tennessee
Eastman"). The Court found that the principle in
Tennessee Eastman has been applied consistently by the
courts to the facts before them.
In particular, the Court noted that in three decisions,
Merck & Co Inc v Apotex Inc, 2005 FC 755, Merck & Co Inc v
Pharmascience Inc, 2010 FC 510, and Bayer Inc v Cobalt
Pharmaceuticals Company, 2013 FC 1061, claims analogous to AbbVie's
claims have been found to be patentable.
The Commissioner, however, relied upon Janssen Inc v Mylan
Pharmaceuticals ULC, 2010 FC 1123 ("Janssen").
In that decision, the judge commented on a "concern in a case
like this where the '950 Patent effectively blocks the use of a
known compound (galantamine) for an established purpose (treating
Alzheimer's disease) using a well-known treatment methodology
The Commissioner interpreted Janssen as establishing a
broad prohibition against any patenting of the "how and
when" in the administration of a drug. This interpretation is
reflected in the Canadian Patent Office's practice notice PN
2013-04 issued June 10, 2013, entitled Examination Practice Respecting Medical
The Court concluded that the Commissioner erred in interpreting
Janssen as a change in the law rather than an application
of the prevailing jurisprudence to the particular claims and the
evidence. Noting that in Janssen the claims involved a
dosage range with several variables, and a known approach (a
titration regimen) requiring a physician to monitor the patient and
make adjustments, and thus covered a "pure form of medical
treatment", the Court found that the comments in
Janssen arose from the specific facts in that case and do
not support the Commissioner's broader position that a dosage
regimen in a claim is contrary to policy.
The Court accordingly found the claims at issue to be
patentable. There was no evidence to suggest that the bi-weekly
dosage is not fixed and precise and that further skill and judgment
would be expected to be exercised. Unlike Janssen, it does
not seek to claim a known approach (titration). It does not
restrict the physician's skill and judgment to determine if the
claimed use is appropriate for the patient: the physician decides
to prescribe it as is or not at all.
This decision offers further clarification in the area of dosage
claims and methods of medical treatment. The Commissioner may yet
appeal as of right.
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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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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