Undertaking of Merck Canada Inc. to the Patented Medicine Prices Review Board
Approved by the Chairperson, October 14, 2011
1.0 Product Summary
1.1 Orgalutran (ganirelix acetate) is a gonadotropin-releasing hormone (GnRH) antagonist that is indicated for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH). It is supplied in 250 mcg prefilled syringes for subcutaneous injection.
1.2 Health Canada issued a Notice of Compliance for Orgalutran on May 1, 2002. Orgalutran has been sold in Canada since August 23, 2002.
1.3 Canadian Patent No. 1,339,043 pertaining to Orgalutran was granted to Syntex (U.S.A.) Inc. on April 1, 1997 and will expire on April 1, 2014. Organon Canada Ltd. was the patentee for purposes of the PMPRB until the company merged with Schering-Plough Canada Inc. in 2008. Schering-Plough Canada Inc. and Merck Frosst Canada Inc. have since merged to form Merck Canada Inc., which is the patentee for purposes of the PMPRB.
2.0 Application of the Excessive Price Guidelines
2.1 The August to December 2002 introductory price of Orgalutran was reviewed in accordance with the Board's Excessive Price Guidelines and was found by Board Staff to be within the Guidelines.
2.2 The average transaction price (ATP) of Orgalutran remained within the Guidelines until December 2004, after which the Canadian price became the highest of the comparator countries in which it was sold. An investigation was opened and during the course of the investigation Merck Canada Inc. re-filed Form 2, Block 5 data for the United States going back to the date of first sale.
2.3 The re-filed data resulted in the introductory price of Orgalutran exceeding the highest international price of the comparator countries in which it was sold and triggering the investigation criteria.
2.4 The ATP of Orgalutran remained above the maximum non-excessive (MNE) price in subsequent reporting periods.
2.5 There were cumulative excess revenues of $393,558.85 as of December 31, 2010.
3.0 Position of the Patentee
3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Merck Canada Inc. that the price in Canada of Orgalutran was excessive for purposes of the Patent Act.
4.0 Terms of the Voluntary Compliance Undertaking
4.1 Merck Canada Inc. agrees to undertake the following:
4.1.1 To agree that the MNE prices of Orgalutran for 2002 to 2009 and the 2010 and 2011 national non-excessive average prices (N-NEAPs) are as follows:
4.1.2 To offset the cumulative excess revenues received from August 2002 to December 31, 2010 by making a payment to Her Majesty in right of Canada in the amount of $393,558.85 within 30 days of the acceptance of the VCU;
4.1.3 To offset any excess revenues received during the period January 1, 2011 to December 31, 2011 by making a payment within 30 days of the filing of semi-annual price and sales data as required by the Patented Medicines Regulations in the amount of the excess revenues, as calculated by Board Staff, received as a result of selling Orgalutran at a price in excess of the 2011 N-NEAP set out in sub-paragraph 4.1.1 above;
4.1.4 To ensure that the price of Orgalutran remains within the Guidelines in all future periods in which Orgalutran is under the PMPRB's jurisdiction.
Merck Canada Inc.
Signature: Original singed by
Company Officer: Kirk Duguid
Position: VP, Finance
Date: October 5, 2011