Voluntary Compliance Undertaking of Graceway Pharmaceuticals to the Patented Medicine Prices Review Board
1. Product Summary
1.1 Airomir (salbutamol sulfate) was indicated for the treatment of asthma, chronic bronchitis, and other breathing disorders. Airomir was available in a CFC-Free 200 Metered Dose Inhaler.
1.2 Health Canada issued a Notice of Compliance (NOC) to 3M Pharmaceuticals for Airomir 0.1 mg/dose (DIN 02232570) on August 20, 1997. Airomir was sold from June 29, 1999 until December 29, 2006 by 3M Canada Company. The marketing rights for Airomir were acquired by Graceway Pharmaceuticals (Graceway) and sales by Graceway commenced on January 1, 2007. Health Canada reissued a NOC to Graceway on April 16, 2007.
1.3 The last Canadian Patent No. 2,161,632 pertaining to Airomir was issued to Minnesota Mining and Manufacturing Company (United States of America) on August 10, 1999 and expires on April 15, 2014.
1.4 Pursuant to a Court Order dated October 4, 2011, RSM Richter Inc. was appointed as the receiver of Graceway. Effective December 2, 2011, Graceway ceased to operate in Canada.
1.5 For purposes of the Patented Medicine Prices Review Board (PMPRB), Graceway was a patentee from January 1, 2007 until December 1, 2011 (the “Relevant Period”).
2. Application of the Excessive Price Guidelines
2.1 Following the Board´s 2010 Guidelines, Board Staff conducted a Reasonable Relationship Test and an International Price Comparison Test. During the introductory period, the price of Airomir exceeded the Guidelines. In particular, the introductory price in 2007 of $0.0387 was 29.4% above the maximum non-excessive (MNE) price of $0.0299.
2.2 The PMPRB has determined that the MNE prices from 2008 to 2011 were $0.0306, $0.0307, $0.0312 and $0.0322. A review of the subsequent reporting periods indicated that the price of Airomir continued to exceed the Guidelines, with cumulative excess revenues of $206,583.48 at the end of December 2011.
3. Position of the Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Graceway that the price of Airomir was, at any time since the date of first sale, excessive for purposes of the Patent Act. Graceway provides this VCU to resolve Board Staff´s concerns about the pricing of Airomir during the Relevant Period.
4. Terms of the Voluntary Compliance Undertaking
4.1 Graceway undertakes within 30 days of the acceptance of this VCU, to offset cumulative excess revenues as alleged by Board Staff to have been received from between January 1, 2007 to the end of December 2011 by making a payment in the amount of $206,583.48 to Her Majesty in right of Canada.
Signature: Original signed by David Sieradzki
Name: David Sieradzki
Position: Managing Director
Patentee: Duff & Phelps Canada Restructuring Inc., in its capacity as court appointed Receiver of Graceway Canada Company
Date: April 11, 2013