Responding to Canadian Patent Office Objections: Dosing Regimens
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.
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 the Patent Act on the basis that it fails to demonstrate, or provide a sound prediction of, utility of the claimed invention.
Canadian Patent Office claimed inventions disclosure dosing regimen objections Patent Act patent applications patent examiner Patent Office patent protection patent-eligibility patentability