The Canadian Intellectual Property Office (CIPO) released in 2013 examination guidelines titled “Examination Practice Respecting Medical Uses” (PN2013-04). The guidelines affirmed CIPO’s long-standing position that methods of medical treatment are unpatentable. The guidelines went on to explain that “medical use” claims are generally permitted, as long as they do not equate to a medical or surgical method (e.g. do not include an active treatment or surgical step) that would prevent physicians from exercising their skill and judgment. However, guidelines took the position that claims that include a dosage regimen, or restrictions on “how and when” to administer a drug, cover an unpatentable method of medical treatment. In a recent case, the Federal Court has criticized those guidelines.
In AbbVie Biotechnology Ltd. v. Canada (A.G.) (2014 FC 1251), the Federal Court considered an appeal of a refusal of the Commissioner of Patents to grant a patent on claims to a fixed dosage and schedule. In refusing the claims at issue (syringe claims, Swiss claims, and use claims), the Commissioner cited the examination guidelines as setting out the Office’s interpretation of case law pertaining to “medical use” claims.
The Commissioner argued that the claims were unpatentable in view of case law, on the basis that they would place restrictions on “how and when” to administer a drug. The Federal Court rejected the argument, and instead held that claims for a fixed dosage and schedule do not automatically constitute unpatentable subject matter. The Court held that claims to a fixed dosage, and/or a fixed dosage schedule or interval, are not unpatentable subject matter where there is no evidence to contradict that claimed dosage, i.e. no evidence that adjustments requiring skill and judgment are needed. The Court held that the issue remains whether the claims cover a method of medical treatment that prevents physicians from exercising skill and judgement. The Court considered that the Commissioner’s focus on “how and when” to administer a drug was misplaced. To the extent that the Commissioner sought to advance new policy as set out in the examination guidelines for rejecting subject matter, the Court considered that he went too far.
Applying the foregoing to the claims at issue, and distinguishing from the case law, the Federal Court found there was no evidence to suggest that the dosage would not be fixed as claimed, and that adjustments requiring skill and judgment would be needed as a result. Accordingly, the Commissioner was not justified in finding that the claims sought to patent the exercise of skill and judgment, and thus constitute an unpatentable method of medical treatment. In the result, the Federal Court directed the Commissioner to allow the claims. The Commissioner has 30 days to appeal the Federal Court decision.
In view of the decision, it appears that applicants are free to pursue “medical use” claims that include a (fixed) dosage regimen or restrictions on “how and when” to administer a drug, absent evidence that such claims would prevent physicians from exercising skill and judgment.