The Canadian Intellectual Property Office (CIPO) has today issued guidelines concerning the examination of patent claims relating to medical uses, providing a framework by which examiners are to analyze such claims. This guidance follows CIPO’s recent guidelines concerning the requirement for a “purposive construction” of the claims during examination.

CIPO considers methods of medical treatment to be unpatentable, falling outside the definition of “invention” in section 2 of the Patent Act. In contrast, claims to uses of medicines may be patented. The guidelines focus on the examination of claims reciting dosage regimens or dosage ranges and confirm that claims are to be construed using principles of purposive construction, including the identification of claim elements that are essential. If it is found that “an essential element only serves to instruct a medical professional ‘how’ to treat a patient, rather than ‘what’ to use to treat the patient, this will lead to a conclusion that the claimed use encompasses a method of medical treatment.”

For performing the claim analysis, the new guidelines focus on the identification of the problem and solution based on the teachings of the description and common general knowledge in the art, whereby “[a]fter 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.” If an element that is deemed essential to the solution relates to “how” to administer or refine a treatment, the guidelines direct the examiner to object to the claim for lack of compliance with section 2 of the Patent Act.

The issuance of the new guidelines represents a further development in CIPO’s examination practice respecting methods of medical treatment.

To view the full text of CIPO’s medical use guidelines, click here.