VCU accepted on October 21, 2003
1.0 Product Summary
1.1 Dostinex, a patented medicine until November 8, 2000, is marketed in Canada by Pfizer Canada (Pfizer). Dostinex was initially marketed by Pharmacia Canada (Pharmacia) which was acquired by Pfizer in August 2003.
1.2 Dostinex (cabergoline) is a synthetic ergoline derivative dopamine agonist indicated for the treatment of hyperprolactinaemia, inhibition of physiological lactation and suppression of established lactation.
1.3 Health Canada issued a Notice of Compliance to Pharmacia for Dostinex 0.5 mg/tablet (DIN 02242471) on June 30, 2000. Pharmacia began selling Dostinex in Canada on that date.
1.4 Canadian Patent No. 1,156,648 pertaining to Dostinex was granted to Farmitalia Carlo Erbas S.p.A on November 8, 1983 and expired on November 8, 2000. Pharmacia was the licensee of the Canadian patent.
1.5 In compliance with the Patented Medicines Regulations, Pharmacia filed price and sales information with respect to Dostinex for the period of June 30 to November 8, 2000.
1.6 Pharmacia was the Canadian patentee for Dostinex until November 8, 2000, and became a former patentee with respect to Dostinex thereafter.
2.0 Terms of the VCU
2.1 Within 30 days of notice to Pfizer of the acceptance of the Voluntary Compliance Undertaking (VCU) by the Chairman of the PMPRB, Pfizer undertakes to pay Her Majesty in right of Canada the amount of $42,116.31.
2.2 Should any new patents issue for Dostinex, Pfizer will notify PMPRB in accordance with the Patent Act and the Patented Medicines Regulations.
2.3 This VCU constitutes no admission by Pfizer that the price of Dostinex is or was excessive for purposes of the Patent Act. Pfizer reserves all rights to assert any position relating to the pricing of Dostinex, or challenge the Board staff's position relating to the pricing of Dostinex, at any time in the future if it be asserted that the price of Dostinex is within the jurisdiction of the PMPRB.
Signature: Original signed by Catherine Fitzsimon
Company Officer: Catherine Fitzsimon
Position: Director, Patient Access
Date: October 21, 2003