Voluntary Compliance Undertaking of Janssen-Ortho Inc. to the Patented Medicine Prices Review Board
1. Product Summary
1.1. Ortho 7/7/7 is a patented medicine being sold in Canada by Janssen Ortho Inc. (Janssen-Ortho).
1.2. Ortho 7/7/7, (norethindrone-ethinyl, estradiol) is an oral contraceptive. It is classified in the WHO ATC index 2004 as Hormonal Contraceptives for Systemic Use. Its Anatomical Therapeutic Chemical (ATC) Classification System is G03AB02. Ortho 7/7/7 is available in 16.485 mg/21 tablets and 16.485 mg/28 tablets.
1.3. Canadian Patent No. 1,226,221 pertains to Ortho 7/7/7. This patent was granted to Ortho Pharmaceutical Corp., USA on September 1, 1987 and expired on September 1, 2004. Janssen-Ortho is the Canadian patentee for all purposes relating to the Patent Act (“the Act”) and the Patented Medicines Regulations (“the Regulations”) in respect of the jurisdiction of the PMPRB.
1.4. Health Canada issued a Notice of Compliance (“NOC”) for Ortho 7/7/7 on August 17, 1983. It was introduced to the Canadian market in September 1983.
2. Application of the Excessive Price Guidelines
2.1 The prices of both Ortho 7/7/7 products were reviewed in accordance with the PMPRB=s Excessive Price Guidelines (the “Guidelines”) and were found to be within the Guidelines from the time they were introduced to the Canadian market through December 31, 1992.
2.2 For the period from January 1, 1993 through June 30, 1994, the prices of both Ortho 7/7/7 products exceeded the CPI adjusted MNE prices by a range of 0.6% to 3.0% with resulting excess revenues of $487,090.70. As a result, the PMPRB accepted a Voluntary Compliance Undertaking (VCU) from Ortho-McNeil Inc. dated October 28, 1994 to reduce the price of both Ortho 7/7/7 products and offset excess revenues through a payment to Her Majesty the Queen in Right of Canada.
2.3 Following the acceptance of the VCU in 1994 the prices of both Ortho 7/7/7 products were within the Guidelines until the end of December 2000.
2.4 For the periods from January 1, 2001 through September 1, 2004, the prices of both Ortho 7/7/7 products exceeded the CPI adjusted MNE prices by a range of 0.0008% to 0.0121% with resulting cumulative excess revenues of $99,892.72.
3. Position of Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Janssen-Ortho that the prices of both Ortho 7/7/7 products are or were excessive for purposes of the Patent Act.
4. Terms of the Voluntary Compliance Undertaking
4.1 In order to comply with the Guidelines, Janssen-Ortho undertakes as follows:
4.1.1 To agree that the 2004 MNE prices of Ortho 7/7/7 16.485 mg/21 tablets and 16.485 mg/28 tablets were respectively, $11.4301 and $11.0616.
4.1.2 To offset excess revenues received by Janssen-Ortho during the periods January 1, 2001 to September 1, 2004 by making a payment to Her Majesty the Queen in Right of Canada, within 30 days of acceptance of this VCU, in the amount of $99,892.72.
Signature: Original signed by
Company Officer: Gary Pruden
Date: July 27, 2005