Voluntary compliance undertaking of Novartis Pharmaceuticals Canada Inc. to the Patented Medicine Prices Review Board

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1.0 Product Summary

1.1. Patanol^® (olopatadine hydrochloride) and Pataday^® (olopatadine hydrochloride) are indicated for the treatment of allergic conjunctivitis and the treatment of ocular itching associated with seasonal allergic conjunctivitis, respectively.

1.2. Health Canada first issued a Notice of Compliance to Alcon Canada Inc. (“Alcon”) for Patanol^® 1 mg/milliliter (DIN 02233143) on September 16, 1997, and Pataday^® 2 mg/milliliter (DIN 02362171) on January 21, 2011. Patanol^® and Pataday^® were first sold in Canada on January 26, 1998, and April 14, 2011, respectively.

1.3. The marketing authorization for Patanol^® and Pataday^® was transferred from Alcon to Novartis Pharmaceuticals Canada Inc. (“Novartis”) on February 2, 2017.

1.4. The last reported patent pertaining to Patanol^® and Pataday^®, Canadian Patent No. 2,447,924, expired on June 19, 2022. Novartis is the rights holder for the purposes of the Patent Act and the Patented Medicine Prices Review Board (PMPRB).

2.0 Application of the Guidelines

2.1 Patanol^® was classified by the Human Drug Advisory Panel as a Category 3 new medicine. As a new strength of an existing medicine, Pataday^® was classified as a Slight or No Improvement.

2.2 In 2020, the National Average Transaction Prices (N-ATPs) for Patanol^® and Pataday^® began to exceed the National Non-Excessive Average Prices (N-NEAPs) by an amount which triggered the investigation criteria set out in the Compendium of Policies, Guidelines, and Procedures (“Guidelines”).

3.0 Position of the Rights Holder

3.1 This Voluntary Compliance Undertaking (VCU) constitutes no admission by Novartis that the prices of Patanol^® and Pataday^® are now or were at any time since the date of first sale, excessive for the purposes of the Patent Act, nor is this VCU binding upon any panel of the Board for the purposes of the Patent Act.

4.0 Terms of the Voluntary Compliance Undertaking

4.1 Novartis agrees to undertake the following:

4.1.1 To offset cumulative excess revenues accrued by Novartis in respect to Patanol^® and Pataday^® by making a payment of $393,194.00 to Her Majesty in right of Canada, within 30 days of acceptance of this VCU:

4.1.2 In the event that a new patent is issued, to ensure that the prices of Patanol^® and Pataday^® comply with the PMPRB’s Guidelines in all future periods in which they are under the PMPRB’s jurisdiction.

Name: Pedro Miguel Ferreira
Position: Country Chief Financial Officer
Patentee: Novartis Pharmaceuticals Canada Inc.
Date: 29 August 22