CIPO Releases Revised Examination Practice Respecting Medical Uses: Claims for Fixed Dosage Regimen or Range May Be Patentable Subject Matter

On March 18, 2015, the Canadian Intellectual Property Office (CIPO) released its revised Examination Practice Respecting Medical Uses(Practice Notice PN 2015-01), revising PN 2013-04 (as reported in the E-TIPS® newsletter). The revised guidance follows the recent Federal Court decision in AbbVie Biotechnology Ltd v The Attorney General of Canada,2014 FC 1251 (AbbVie, previously reported in the E-TIPS® newsletter).

The Federal Court in AbbVie held that “a claim which does not restrict, or interfere with, or otherwise engage professional skill or judgment – including a claim for a fixed dosage and or a fixed dosage schedule or interval” may be patentable subject matter unless there is evidence to the contrary.

The revised Practice Notice still maintains that inventions that prevent physicians from exercising their skill and judgment in using a known compound for an established purpose cover a method of medical treatment and therefore are non-statutory subject matter. However, CIPO now indicates that essential claim 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.

More information on the revised Practice Notice is available here.