In AbbVie Biotechnology Ltd v Canada (Attorney General) [“AbbVie”] the Federal Court allowed AbbVie’s appeal of a decision by the Commissioner of Patents refusing to grant a patent on Canadian Patent Application No. 2,385,7451. The Court directed the Commissioner to allow the claims at issue. This decision provides some welcome guidance on the patent-eligibility of medical use claims in Canada and confirms that certain claims containing specific dosages and/or dosing schedules are patentable.
Recent jurisprudence in Canada has held that certain medical use claims containing dosage ranges and/or regimens constitute methods of medical treatment and are therefore not patentable. In clarifying its position concerning medical use claims, the Canadian Intellectual Property Office (CIPO) released a document entitled Examination Practice Respecting Medical Uses dated June 10, 2013 [“the Guidelines”]. The Guidelines provided guidance as to CIPO’s policy on how patent applications directed to medical uses should be examined (click here for more details). In particular, the Guidelines state that inventions which prevent physicians from exercising their skill and judgment in using a known compound for an established purpose effectively cover a method of medical treatment.
The claims at issue in Abbvie contain the following essential elements: a preloaded syringe of 40 mg of the drug Humira® for the treatment of arthritic disease or an inflammatory bowel disease; administered subcutaneously; for use on a bi-weekly dosing interval of 14 days. Before the Patent Appeal Board, the Applicant argued that the claims exclude the exercise of medical professional skill or judgment and are patentable subject matter as they feature a fixed dose and fixed dosing interval. However, the Commissioner found that such a claim would interfere with the ability of physicians to exercise their judgment in the administration of Humira® when generic versions become available. Accordingly, the claims at issue were held to cover an unpatentable method of medical treatment. AbbVie appealed to the Federal Court.
Federal Court Decision
The Federal Court overturned the Commissioner’s decision and found that the claims at issue were not methods of medical treatment. The Court ruled that the question to be answered is whether a claim is directed to the exercise of professional skill or judgment. Further, the Court ruled that this determination will likely require expert evidence about the invention and not just a reliance on the language used in the claim.
In other words, a claim which includes a fixed dosage and/or a fixed dosing schedule will constitute patent-eligible subject-matter (i.e. is not a method of medical treatment) so long as there is no evidence to suggest that professional skill and judgment is engaged. To this end, the Federal Court distinguished between cases where professional skill and judgment is exercised within the claim (e.g. where adjustments would be required) and those where it is not (e.g. a physician determining whether a claimed use is appropriate for a patient). Once a physician decides to prescribe a medicine according to a claimed use, the evidence must demonstrate that the specific dosage and/or interval cannot, or should not, be altered by the physician.
This decision indicates that a medical use claim (including those with fixed dosages and/or dosing schedules) constitutes patent-eligible subject-matter so long as there is no evidence to suggest that professional skill and judgment is engaged. The reasons also indicate that the patent-eligibility of a claim will not be impacted if a physician exercises skill and judgment in determining whether a claimed dosage/schedule is appropriate for a patient. However, once prescribed, there should be no restriction on the exercise of skill or judgment; for example, the claimed dosage/schedule should be appropriate for all those to whom it is administered.
Looking forward, further guidance on the patent-eligibility of medical use claims containing dosage ranges may be received once the Federal Court of Appeal releases its decision on the appeal from the decision of the Federal Court in Bayer Inc v Cobalt Pharmaceuticals Company.