Application granted in Donepezil

Yesterday, the Federal Court released a decision in Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC, 2011 FC 547 (Donepezil) (Court File No. T-1118-09).

In the decision, Justice Hughes allowed Pfizer’s application and prohibited the Minister of Health from issuing an NOC to Mylan until expiry of the patent. The key issue addressed by the court was whether the patent was invalid on the basis of an unsound prediction of utility.

The decision begins with:

This is an application for prohibition brought under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133, as amended (NOC Regulations). The medicine at issue is a new compound known as donepezil, which is said to be useful in treating senile dementia. The Applicant Pfizer Canada Inc. has approval from the Respondent Minister of Health to sell in Canada a drug incorporating donepezil hydrochloride in tablet form for oral administration in 5 mg and 10 mg doses. This drug is approved for a use described as symptomatic treatment of patients with mild, moderate and severe dementia of the Alzheimer’s type.