In the November 2009 Federal Court decision of Bayer Inc v The Minister of Health and Attorney General of Canada 2009 FC 1171, Justice Russell upheld an earlier decision by the Minister of Health that Canadian patent 2,194979 could not be listed on the Patent Registry in relation to a new drug submission (NDS) filed for a YAZ™ contraceptive formulation.
The applicant had applied to have the patent listed in relation to the NDS, after having been issued a notice of compliance (NOC) for the mixture of compounds in its YAZ contraceptive formulation.
Justice Russell found that, on a plain and ordinary reading, the patent did not meet the requirements of subsection 4(2) of the Patented Medicines (NOC) Regulations because it did not include a claim for the formulation containing the mixture of compounds in the YAZ™ contraceptive. It was held that, when an approved product formulation contains two compounds, the claims of a patent must specifically refer to them both in order to be listed in relation to the corresponding NDS – the applicant had not referred to one of the compounds.
The court drew a distinction between a compound patent (which was considered essentially a medicinal ingredient) and a formulation patent (essentially a mixture of ingredients) and therefore concluded that a different approach was required under the corresponding subsections 4(2)(a) and 4(2)(b) of the Patented Medicines (NOC) Regulations. Here, the previously issued NOC had approved the formulation containing the combination of medicinal ingredients in the YAZ™ contraceptive.