Voluntary Compliance
Undertaking of Lantheus Medical Imaging to the Patented Medicine Prices Review Board
1. Product Summary
1.1 Technescan MAG3 (technetium TC-99M mertiatide) is a radiopharmaceutical agent used in the diagnosis of diseases.
1.2 Canadian Patents Nos. 1,292,084 and 1,317,066 related to Technescan MAG3 were issued on November 12, 1991 and April 27, 1993, respectively, to the University of Utah Research Foundation (United States). The last patent expired on April 27, 2010. Lantheus Medical Imaging (Lantheus) is the patentee for purposes of the Patented Medicine Prices Review Board (PMPRB).
1.3 Sales of Technescan MAG3 began in Canada on January 1, 2000. Lantheus purchased Technescan MAG3 from Bristol-Myers Squibb Canada Inc. in 2008.
2. Application of the Excessive Price Guidelines
2.1 At introduction, Technescan MAG3 was classified as a category 2 new medicine and the price was within the Board's Excessive Price Guidelines (Guidelines).
2.2 In 2004, the price of Technescan MAG3 exceeded the Guidelines and triggered the investigation criteria.
2.3 During the subsequent reporting periods, the price of Technescan MAG3 exceeded the Guidelines with cumulative excess revenues of $34,800.59 by the end of the expiry of the last patent pertaining to Technescan MAG3 on April 27, 2010.
3. Position of Patentee
3.1 This Voluntary Compliance Undertaking ("VCU") constitutes no admission by Lantheus that the price of Technescan MAG3 is or was excessive for purposes of the Patent Act.
4. Terms of the Voluntary Compliance Undertaking
4.1.1 In order to comply with the Guidelines, Lantheus undertakes as follows:
4.1.2 To offset the cumulative excess revenues received from January 1, 2004 to April 27, 2010 by making a payment of $34,800.59 to Her Majesty in right of Canada, within 30 days of the acceptance of this VCU.
4.1.3 To notify the PMPRB in the event that other patents pertaining to Technescan MAG 3 are issued in any future period.
Signature: _______________________
Name: _______________________
Position: _______________________
Company: Lantheus Medical Imaging
Date: _______________________