For over 25 years, Canadian practice concerning medical “kits” and “packages” has been considered to be a well-settled area of law, so it was very surprising when the Canadian Patent Office (CIPO) recently proposed to disturb this practice in the “Consultation Document: 17.03.04 – Kits and Packages” posted online on April 24, 2017.

Existing practice follows the guidance provided in the Supreme Court of Canada’s decision Shell Oil v. Commissioner of Patents (1982) 67 C.P.R. (2nd) 1 (SCC), which is the leading decision on inventions relating to new uses of known compounds, and the Commissioner’s Decision Re Application for Patent of Wayne State (1988) 22 C.P.R. (3rd) 407, in which the Patent Appeal Board at the Canadian Patent Office applied the reasoning of Shell Oil to a scenario involving a new medical use for a known compound.

Notably, in Wayne State, the Patent Appeal Board upheld the following package claim, which has been used as a model for Canadian patent agents ever since:

4. A commercial package containing as an active pharmaceutical ingredient 3-methyl-1-[2-(2-napthyloxy)-ethyl]-2-pyrazolin-5-one or a pharmaceutically acceptable salt thereof, together with instructions for the use thereof for reducing metastasis and neoplastic growth in a mammal. Thus, conventionally, medical kit and package claims in Canada generally have the following structure: “A kit/commercial package containing compound X and instructions for the use thereof to treat Y”, where the “instructions for use” are considered to be an essential part of the kit or package that can be relied upon for the purposes of novelty and inventive step. These kinds of claims offer important protection for inventions relating to second medical uses, given the prohibition on patenting methods of medical treatment in Canada.

Under CIPO’s proposed changes, the “instructions for use” would no longer carry patentable weight. There have been no Court decisions in Canada that would directly support such a drastic change to our practice, so it is a bit of a mystery as to why CIPO has had a change of heart in this respect.

But at this point, the story takes a very interesting twist. CIPO had invited feedback from Canadian patent agents on the Consultation Document, and in the process of developing such feedback, an unpublished Decision of the Federal Court of Appeal came to light that establishes that the conventional kit/package claim structure has been expressly considered and sanctioned by our Courts.

This situation came about because simple (without reasons) Judgments and Orders are not published in Canada unless specifically requested by the Judge, and no such request was made in this case. The unpublished Decision at issue here was part of the same proceedings that gave rise to a series of well-known decisions (the AZT decisions), which stand for the proposition that a new use of an old compound for the treatment of a disease is not a method of medical treatment and is good subject matter for a patent (Apotex Inc. v. Wellcome Foundation Ltd. [2002] SCR 153; affg [2001] 1 FCR 495; affg in part [1998] 145 FTR 161). And while the published AZT decisions (with reasons) were widely read, the related but unpublished Decision may well have languished forever in the archives of the Courts and the personal files of the litigators of the case, had it not suddenly become vital for responding to CIPO’s attack on kit and package claims.

In the unpublished Decision, the Federal Court of Appeal upheld the following claim to a containerized pharmaceutical product because it also recited instructions a new and inventive use for the formulation contained therein:

24. A containerized pharmaceutical product comprising a container containing a formulation comprising 3'-azido-3'-deoxythymidine and a pharmaceutically acceptable carrier thereof, and instructions associated with said container directing use of the formulation in the treatment or prophylaxis of AIDS.

The judgment of the Federal Court of Appeal in this regard was affirmed by the Supreme Court of Canada ([2002] 4 SCR 153), which is the highest court in Canada.

Thus, CIPO’s Consultation Document has had the unexpected result of making the case for pharmaceutical kit and commercial packages claims in Canada even more compelling.