March 18, 2015
To all examiners:
The practice notice document PN 2013-04 Examination Practice Respecting Medical Uses published on June 10, 2013, is being revised following the recent Federal Court decision, AbbVie Biotechnology Ltd. v. The Attorney General of Canada, 2014 FC 1251. This document supersedes the previous practice notice.
MOPOP 17.02.03 (Medical and surgical methods) can generally be relied on for guidance, however, the examination of medical use claims, including dosage regimens and dosage ranges, requires specific guidance in order to ensure efficient, predictable and reproducible examination of applications. The guidance in the present notice applies to a claim in the form "use of product X for treating disease Y" and may apply to claims such as "use of product X for the manufacture of a medicament for treating disease Y", or "product X for treating disease Y…", or a claim having similar language when construed to be a claim to the use per se.
To reflect decisions of the courts on medical use claims,Footnote 1 the emphasis of the guidance provided herein relates to the examination of claims that recite dosage regimens or dosage ranges.
A) Claim analysis
Practice notice PN 2013-02 (Examination Practice Respecting Purposive Construction) mandates the use of purposive construction in place of other approaches to claim analysis.Footnote 2
To perform a purposive construction, an examiner identifies the problem the inventors set out to address and the solution disclosed. This exercise generally must be performed considering the specification as a whole, recognizing that the description guides the identification of the problem and solution.
While an applicant is entitled to claim less than the entire invention if so desired,Footnote 3 a proper identification of the actual invention, grounded in a purposive construction of the claims, is nevertheless necessary in order to assess whether the claim is patentable.
Identifying the problem and solution
The identification of the problem faced by the inventors is guided by the examiner's understanding of the common general knowledge in the art and by the teachings of the description.
The solution is the element or set of elements essential to the successful resolution of the problem. Depending on what was disclosed in the description and what was commonly known in the art, the solution could be, for example, a new compound or new use of a compound; or it could be an improvement (e.g. refinement) of a known use.
It must be borne in mind that the applicant is not required to explicitly state the problem and solution as long as the description allows for their understanding (see paragraph 80(1)(d) of the Patent Rules). Where the applicant is explicit as to the nature of the problem, examination should generally proceed accordingly unless doing so would be unreasonable on an informed reading of the application in light of the common general knowledge.
In identifying the problem faced by the inventors, the examiner will consider what the inventors state about the background of the invention, their objectives ("objects of the invention"), any specific problems, needs, limitations or disadvantages known in the art or discovered by the inventors, etc.
After identifying the problem and solution, a proper construction of the claims includes a determination of which elements in the claims are essential and non-essential to the solution. Having identified the essential elements, the subject-matter of the claim isthen assessed for patentability.
Section 2 of the Patent Act requires the subject-matter of an invention to fall within one of the categories of invention, i.e. an art, process, machine, manufacture, composition of matter, or an improvement in one of the foregoing.
Medical inventions, in particular, have been subject to a number of jurisprudential interpretations whereby certain types of matter have been found to fall outside the scope of section 2. For instance, it is well established that methods of medical treatment and surgery are not statutory subject-matter and are excluded from the definition of invention.Footnote 4
Medical use claims, however, are generally permitted as long as they do not equate to medical or surgical methods (e.g. do not include an active treatment or surgical step) and they satisfy all other requirements of patentability. The Federal Court has concluded, however, that inventions preventing physicians from exercising their skill and judgment in using a known compound for an established purpose effectively cover a method of medical treatment.Footnote 5
In order to determine whether the subject-matter of a claim is statutory, examiners must take into account the guidance outlined in PN 2013-02, which provides that an assessment for section 2 compliance should be based on the essential elements of the claim as determined by a purposive construction as outlined in Part A of this document.
For medical inventions, the problem faced by the inventor may relate to "what" to use for treatment. Generally the solution to such a problem will be provided by an element or set of elements in a claim that embody a treatment tool. This tool may include a compound, composition, formulation, or a dosage unit form.
The importance of a purposive construction approach is highlighted when assessing the patentability of claims that recite a dosage regimen or dosage range since the mere recitation of either of these does not necessarily mean the claim is non-statutory. However, if it is determined after a purposive construction that a dosage range, or dosage regimen that includes a range, is an essential element of a claim encompassing the use of a known compound in an established treatment, then the claim may cover a method of medical treatment. Where an essential element only serves to instruct a medical professional "how" to treat a patient,Footnote 6 rather than "what" to use to treat the patient, it 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 that does not comply with section 2 of the Patent Act.Footnote 7
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.Footnote 8