Voluntary Compliance Undertaking of Novo Nordisk Canada Inc. to the Patented Medicine Prices Review Board
1.0 Product Summary
1.1 Novolin® ge 30/70; Novolin® ge NPH; Novolin® ge Toronto; Novolin® ge 40/60; Novolin® ge 50/50 (Novolin®) are the brand names of medicine known generically as insulin, human biosynthetic. Novolin® is a patented medicine sold in Canada by Novo Nordisk Canada Inc. (Novo Nordisk Canada).
1.2 Novolin® is sold as vials and cartridges in various formulations as set out below.
1.3 Health Canada issued Notices of Compliance (NOC) for the sale of Novolin® for the treatment of Diabetes Mellitus, where treatment with insulin is indicated, as follows:
| DIN |
Product |
Dosage Strength |
Date of NOC |
Date of First Sale |
| 2024217 |
Novolin® ge 30/70 vial |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024225 |
Novolin® ge NPH vial |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024233 |
Novolin® ge Toronto vial |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024268 |
Novolin® ge NPH cartridge |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024284 |
Novolin® ge Toronto cartridge |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024314 |
Novolin® ge 40/60 cartridge |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2024322 |
Novolin® ge 50/50 cartridge |
100 unit/ml |
1993/3/22 |
1993/10/1 |
| 2025248 |
Novolin® ge 30/70 cartridge |
100 unit/ml |
1993/3/22 |
1993/10/1 |
1.4 Canadian patent 1304022 pertaining to Novolin® which was granted to Novo Nordisk A/S, Denmark (Novo Nordisk Denmark) on June 23, 1992, was due to expire on June 23, 2009, but lapsed in 2004.
1.5 Novo Nordisk Canada has been the patentee for purposes of the Patent Act and the Patented Medicine Prices Review Board (PMPRB).
2.0 Background to Reporting of Pricing Information to the PMPRB
2.1 Novo Nordisk reported pricing information with respect to Novolin® in accordance with the PMPRB Guidelines (Guidelines) from the date of first sale to December 31, 2008. Prices were considered within Guidelines to the end of 2008.
2.2 In 2009, Novo Nordisk Canada ceased reporting pricing information for Novolin® to the PMPRB.
2.3 On October 16, 2012, Novo Nordisk Canada filed Amended Form 1, Medicine Identification Sheets with the PMPRB for all of the Novolin® products, reporting the following patents that pertain to Novolin® for the purposes of the Guidelines.
| Patent Number |
Date Granted |
Expiration Date |
| Numeric only |
Y |
M |
D |
Y |
M |
D |
| 2192942 |
2006 |
3 |
14 |
2015 |
6 |
16 |
| 2241367 |
2007 |
2 |
6 |
2016 |
12 |
18 |
| 2258307 |
2008 |
2 |
12 |
2017 |
7 |
4 |
| 2460206 |
2012 |
1 |
24 |
2022 |
9 |
20 |
| 2521188 |
2012 |
6 |
26 |
2024 |
4 |
2 |
| 2392840 |
2012 |
7 |
17 |
2020 |
12 |
4 |
| 2464616 |
2012 |
7 |
24 |
2022 |
11 |
15 |
3.0 Application of the Excessive Price Guidelines
3.1 Board Staff and Novo Nordisk Canada agree that the maximum non-excessive prices (MNEs)/national non-excessive average prices (N-NEAPs), calculated in accordance with the Guidelines, from 2009 onward, are as follows:
| DIN |
2024217 |
2025248 |
2024314 |
2024322 |
2024225 |
2024268 |
2024233 |
2024284 |
| Product |
Novolin® ge 30/70 vial |
Novolin® ge 30/70 cartridge |
Novolin® ge 40/60 cartridge |
Novolin® ge 50/50 cartridge |
Novolin® ge NPH vial |
Novolin® ge NPH cartridge |
Novolin® ge Toronto vial |
Novolin® ge Toronto cartridge |
| 2009 |
$1.7580 |
$2.4383 |
$2.4535 |
$2.4166 |
$1.7472 |
$2.4039 |
$1.5436 |
$2.3943 |
| 2010 |
$1.7650 |
$2.4713 |
$2.4866 |
$2.4263 |
$1.7542 |
$2.4258 |
$1.5498 |
$2.4058 |
| 2011 |
$1.7938 |
$2.5366 |
$2.5271 |
$2.4659 |
$1.7828 |
$2.4920 |
$1.5750 |
$2.4562 |
| 2012 |
$1.8251 |
$2.5554 |
$2.4599 |
$2.5088 |
$1.8139 |
$2.5193 |
$1.6025 |
$2.4990 |
| 2013 |
$1.8799 |
$2.6321 |
$2.5337 |
$2.5841 |
$1.8683 |
$2.5949 |
$1.6506 |
$2.5740 |
3.2 Based on the above, the prices of Novolin® during the period January 1, 2009 to December 31, 2012, exceeded the MNEs/N-NEAPs, calculated pursuant to the Guidelines, resulting in cumulative excess revenues of $6,503,426.81.
4.0 Position of the Patentee
4.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Novo Nordisk Canada that the prices of Novolin® in Canada are now or were excessive for purposes of the Patent Act.
5.0 Terms of the Voluntary Compliance Undertaking
5.1 In order to comply with the Guidelines, Novo Nordisk Canada agrees to undertake the following:
5.1.1 To reduce the prices of Novolin® to the 2013 N-NEAPs set out in paragraph 3.1 above.
5.1.2 To offset the cumulative excess revenues received from January 1, 2009 to December 31, 2012 by making a payment to Her Majesty in right of Canada in the amount of $6,503,426.81 within 30 days of the acceptance of this VCU.
5.1.3 To offset any additional excess revenues received in 2013, as calculated by Board Staff, within 30 days of the filing of the July to December 2013 price and sales data.
5.1.4 Within 15 days of acceptance of this VCU, to provide notification to customers that the price reduction of Novolin® was for purposes of ensuring adherence to the Guidelines, include a reference to the PMPRB web site for the complete text of this VCU, and provide copies of such notifications to Board Staff.
5.1.5 To file evidence with Board Staff within 30 days of the acceptance of this VCU that the prices of Novolin® have been reduced in a manner consistent with the terms of this VCU.
5.1.6 To ensure that the prices of Novolin® remain within the Guidelines in all future periods in which Novolin® is under the PMPRB's jurisdiction.
Novo Nordisk Canada Inc.
Original signed by:
Name: Vincent Lamanna
Position: President
Date: March 20, 2013