PMNOC – A Patent Listed Under Section 4(2)(b) Must Claim All Medicinal Ingredients in the Formulation Approved in the NOC
Bayer Inc. v. The Minister of Health (AG Canada)  2009 FC 1171 (Russell J.)

November 17, 2009

Frederick B. Woyiwada for the Commissioner
Gunars A. Gaikis and Nancy P. Pei for Bayer Inc. (Bayer)

This was an application brought by Bayer for judicial review of a March 11, 2009 decision of the Minister of Health holding Bayer’s Canadian Patent No. 2,194,979 (the ‘979 Patent) ineligible for listing on the Patent Registry in relation to NDS 119387.

The Minister’s decision was based upon the finding that while NDS 119387 was directed towards a combination oral contraceptive containing a low dose of the progestin drospirenone and a low dose of the estrogen ethinyl estradiol, the ‘979 Patent only claimed a combination of β-cyclodextrin and 17α-ethinylestradiol in solid form to reduce oxidative degradation of the 17α-ethinylestradiol.

Bayer argued that the ‘979 Patent is eligible for listing if it covers one of the medicinal ingredients, and explicit reference to all of the medicinal ingredients making up the formulation in the NDS is not required. Bayer relied upon a statutory interpretation of Section 4(2)(b) of the PMNOC Regulations that it submitted should be interpreted to be consistent with s. 4(2)(a). This interpretation, according to Bayer, is consistent with the prevention of patent infringement since a patent covering a product using the formulation of the NDS need not claim the second medicinal ingredient.

Justice Russell found that on a plain and ordinary reading of Section 4(2)(b), the ‘979 Patent failed to claim the formulation that has been approved. The approved formulation contains two medicinal ingredients, while the ‘979 Patent only claims a formulation containing one of the approved medicinal ingredients. An interpretation that the term “the medicinal ingredient” actually meant “one of the medicinal ingredients” would be a distortion of the plain and ordinary meaning of the term.

The Court found that this interpretation was consistent with the meaning of Section 4(2)(a) which allows for the listing of a compound patent containing a claim that refers to only one medicinal ingredient against a combination product. A compound patent is fundamentally different from a formulation patent since the compound patent contains a claim for the approved medicinal ingredient which is the key active part of the drug formulation. A formulation patent does not contain a claim for the medicinal ingredient itself, only the approved mixture of medicinal and non-medicinal ingredients actually administered to the patient.

Justice Russell held that the Minister was correct in his interpretation of the Regulations and dismissed the application with costs.

By: Etienne de Villiers, Dimock Stratton LLP