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This is part of a series of posts reviewing common Canadian
Patent Office objections to patent applications and claimed
inventions and providing some insight into how these objections may
be addressed.
The Objection
In a typical objection, the patent examiner asserts that the
claimed medical treatment with dosing elements is unpatentable
subject matter falling outside the definition of
"invention" in section 2 of the Patent Act. The
examiner may state that:
the "inventive concept" identified from the
disclosure is a patent-ineligible dosing regimen;
the applicant relies on a patent-ineligible dosing regimen to
distinguish the claimed treatment from the prior art; and/or
the dosing elements render the claimed treatment
patent-ineligible because they restrain a physician's
conduct.
This objection – and the provision on which it is
based – relate to the nature of the invention for which
patent protection is sought, rather than the patent application
that describes and claims the invention.
The Statutory Provision
Section 2 of the Patent Act defines the term
"invention":
2. "invention" means any new and useful art, process,
machine, manufacture or composition of matter, or any new and
useful improvement in any art, process, machine, manufacture or
composition of matter.
Since this term is used in the Act's patentability
provisions, courts treat section 2 as a statutory identification of
patentable subject matter. Thus, the definition of
"invention" is the Canadian equivalent of 35 U.S.C.
§101.
Section 2 must be read with the statutory exclusions to
patentability in subsection 27(8):
27. (8) No patent shall be granted for any mere scientific
principle or abstract theorem.
If subject matter falls within the definition of
"invention", and is neither a scientific principle nor an
abstract theorem, it is patent-eligible according to the terms of
the Act.
Addressing the Objection
Here are some reasons why you should consider arguing in
traverse of a section 2 objection to the claimed invention on the
basis that it relates to a dosing regimen:
The subject matter of the "invention" in section 2
(and elsewhere in the Patent Act) is identified by
construing the claims at the end of the specification, as mandated
by subsection 27(4):
27. (4) The specification must end
with a claim or claims defining distinctly and in explicit terms
the subject-matter of the invention for which an
exclusive privilege or property is claimed.
Since the "invention" is defined by the claims alone,
it cannot be identified by reading the disclosure or by construing
only selected claim limitations.
The Patent Act confines all patentability requirements
to the subject matter of the claimed "invention", not the
vague notion of "inventive concept".
By law, the examiner must assess the claimed subject matter for
patent-eligibility before considering
patentability.
The statutory framework does not support a determination of
patent eligibility based on a comparison with the prior art.
If the examiner is concerned that the claimed medical treatment
is similar to known treatments, the issue is novelty or
obviousness, not patent eligibility.
The subject matter of a claim cannot be impacted by the
potential actions of a physician.
Claims are construed within the four corners of the
specification, without resort to extrinsic evidence.
Physicians review product monographs or drug labels, not
patents, when deciding how to treat patients.
The Patent Office's recent stance against dosing
regimens is said to be based on case law.
Most cases on which the Patent Office relies were abbreviated
proceedings, not full patent trials, and their precedential value
is unclear.
The cases do not appear to adhere strictly to the Patent
Act, even though it provides a complete code for granting
patents in Canada per subsection 27(1):
27. (1) The Commissioner shall grant
a patent for an invention to the inventor or the inventor's
legal representative if an application for the patent in Canada is
filed in accordance with this Act and all other requirements for
the issuance of a patent under this Act are met.
The Patent Office's current policy can lead to logical
inconsistencies.
While a claim to "Use of x to treat y" is
patent-eligible, a dependent claim restricting the claimed use to
25-30 mg of x to treat y within time period z may be deemed
unpatentable, even though the narrower use falls within the broader
patentable use.
Next up: Responding to an objection to the description under
s. 2 of thePatent Acton the basis that it fails
to demonstrate, or provide a sound prediction of, utility of the
claimed invention.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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Given that many Canadian Internet web sites do receive U.S. visitors and many also utilize a DMCA safe-harbour provision, understanding the scope of protection that the safe harbour provides can be important to Canadians.
ICANN (the entity that essentially controls the worldwide domain name system) is in the final stages of processing approximately 1,900 applications for new gTLDs (generic Top Level Domains – like ".com") many of which are expected to come online in 2013.
In this case, Apotex claimed damages pursuant to s. 8 of the NOC Regulations, and Pfizer alleged that Apotex should not be entitled to damages, due to the principles of ex turpi causa relating to its alleged infringement of the relevant patent.
In a recent judgment, the Federal Court of Canada, granted Apotex's claim against Pfizer for section 8 damages under Canada's Patented Medicines Regulations, SOR/93-133.
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