Last December, the Federal Court of Canada overturned a decision
of the Commissioner of Patents to refuse a patent claiming a fixed
dosage regimen for the drug Humira® (Adalimunab) used in
rheumatoid arthritis. The Court's decision1 is found
here: 2014 FC1251.
This Court decision was an appeal of Decision No. 1362 of the
Commissioner of Patents ("the Commissioner"), refusing to
grant Canadian Patent Application No. 2,385,745 ("the '745
application") to AbbVie Biotechnology Ltd.
("AbbVie") on the grounds that the claims at issue
encompass an unpatentable method of medical treatment.
The claims at issue, relating to the use of Humira® as a
treatment using a fixed dosage (40 mg) on a fixed (bi-weekly)
schedule, were deemed to be patentable by the Federal Court.
Before the PAB, AbbVie argued that because the claims defined a
fixed dose and a fixed dosing schedule, they avoided the exercise
of skill or judgment of a medical professional, and thus related to
patentable subject matter. However, the PAB interpreted the case
law, notably the decision of Janssen Inc. v Mylan
Pharmaceuticals ULC2 (Janssen), as having
established the rule "that the mere presence of these two
features [i.e., a fixed dosage and fixed dosing schedule] in a
claim is not always sufficient to avoid the method of medical
treatment prohibition", and asserted that the claims at issue,
by placing restrictions on "how and when" the drug is to
be administered, would interfere with the ability of physicians to
exercise their judgment in the administration of Humira® when
generic versions of this drug become available. The PAB thus
concluded that the claims encompassed an unpatentable method of
medical treatment. The Commissioner adopted the PAB's
recommendation, and issued a decision confirming the refusal to
grant the '745 application.
Federal Court Decision
AbbVie was successful upon appeal of the Commissioner's
Decision to the Federal Court of Canada, Trial Division. Justice
Kane of the Federal Court acknowledged that the prohibitions
against claims to methods of medical treatment and to claims
relating to the exercise of professional skill have been
consistently applied by Canadian Courts. However, Justice Kane
remarked that such decisions are based on the specific facts of
each case. Justice Kane referred to three decisions, Merck
& Co Inc v Apotex Inc.3, Merck & Co.
Inc. v Pharmascience Inc.4, and Bayer Inc. v
Cobalt Pharmaceuticals Company5, in which claims
comparable to AbbVie's claims had been found to be
patent-eligible on the basis that if no professional skill or
judgment is involved, the claimed invention is not a method of
The Court noted that the Commissioner overlooked the specific
facts of Janssen, more particularly that the
Janssen 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. Therefore
the Commissioner's reliance on the Janssen case was
The Federal Court thus drew a clear distinction between cases
where professional skill and judgment is exercised, for example
where adjustments by the physician would be required, and those
where no adjustments and therefore no professional skill and
judgement are required, such as in this case where the claims
recite a fixed dosage on a fixed
Revised Examination Guidelines
Taking into consideration the Federal Court Ruling, the Canadian
Intellectual Property Office recently issued revised Examination
practice guidelines6 and examples of patent-eligible and
patent-ineligible medical use claims7, confirming that
claims reciting features that do not involve a physician's
professional skill or judgment, such as a fixed dosage, a fixed
dosage regimen, a patient sub-population or a particular
administration site, are patent-eligible.
This decision and the new practice guidelines provides a welcome
clarification on the patent-eligibility of claims involving dosage
regimens, and indicates that medical use claims that do not entail
professional skill and judgment, including those defining fixed
dosages and/or dosing schedules, constitute patent-eligible subject
matter under Canadian Patent law.
Patent applicants would be well advised to consider this
important change to Canadian patent practice when seeking patent
protection in Canada.
1. AbbVie Biotechnology Ltd. v Canada (Attorney
General), 2014 FC1251.
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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