Advanced ruling certificate - Photofrin
Pursuant to subsection 98(4) of the Patent Act
Re: Quadra Logic Technologies Inc. And Photofrin 75 mg vial (DIN 02019876) and Photofrin 15 mg vial (DIN 02020033)
I hereby certify, pursuant to subsection 98(4)of the Patent Act, that the Board is satisfied on the basis of the undertaking provided by Quadro Logic Technologies Inc. (QLT)dated 2 March 1995 that there would not ne sufficient grounds to make an order under section 83 of the Patent Act in respect of QLT concerning the above-noted matter.
In accordance with the statutory provision, this certificate is not binding on the Board. It is based on the material facts disclosed, and may be revoked or altered, in whole or in part, at any time. Should the circumstances warrant, the Board would not be precluded from taking enforcement action on this drug product, irrespective of the issuance of this certificate.
M. C. Eastman
Chairman
Date: March 3, 1995
Undertaking
1. Introduction
1.1 Quadra Logic Technologies Inc. ("QLT") makes this undertaking to the Patented Medicine Prices Review Board (the "Board") as a condition for the issuance by the Board of an advanced Ruling Certificate under subsection 98(4) of the Patent Act.
2.0 Proposed Price
2.1 QLT intends to introduce PHOTOFRIN® in Canada in 1995 at a proposed price of $2,650.00 for the 75 mg vial and $530.00 for the 15 mg vial or $35.333 per mg.
3.0 Description of Photofrin
3.1 PHOTOFRIN® porfimer sodium is an injectable antineoplastic photosensitizing agent, a mixture of porphyrin ethers and esters that, when exposed to light in the presence of oxygen becomes an efficient photosensitizer producing toxic effects. The requirement for oxygen, together with light, in the presence of a photosensitizer which has cytotoxic activity is termed the "photodynamic effect".
3.2 Photodynamic Therapy (“PDT") is a photochemical process requiring specific lasers and fibre optics. PDT with PHOTOFRIN® is indicated following transurethral resection in patients with recurring superficial papillary bladder cancer as a second-line treatment for those who have failed a standard intravesical therapy. Its ATC classification is L01XX.
3.3 Health and Welfare Canada Issued a Notice of Compliance to QLT for PHOTOFRINI® on 19 April 1993. The product is approved for the treatment of superficial bladder cancer.
3.4 4 PHOTOFRIN® is a patented medicine. Canadian Patent No. 1265460 pertaining to PHOTOFRIN® was issued on 6 February 1990 and expires on 6 February 2007. The patent holder is Health Research Inc. USA.
3.5 QLT has licensed the rights to the patent from Health Research Inc. USA.
4.0 Application of the Guidelines
4.1 QLT has been advised by Board staff by letter dated 10 February 1995 of its review of the proposed price for PHOTOFRIN®.
4.2 Specifically, Board staff advised that:
- the Human Drug Advisory Panel has classified PHOTOFRIN® as a category 3 drug product but has been unable to recommend a comparable drug product for purposes of a Therapeutic Class Comparison;
- consequently, the relevant introductory price test is the median International Price Comparison:
- as PHOTOFRIN® is not being sold in any of the seven countries listed in the Patented Medicines Regulations (the ”foreign countries"), it is not possible to conduct an International Price Comparison;
5.0 Prices in the Foreign Countries
5.1 Of the foreign countries, QLT or its affiliated companies have applied for approval to sell PHOTOFRIN® in Germany, the United States, France, and Italy.
5.2 Once approved for sale, QLT intends to introduce Photofrin® for sale in those countries at prices equivalent to $2,700.00 Cdn. per 75 mg vial.
6.0 Terms of Undertaking
6.1 QLT hereby undertakes not to sell PHOTOFRIN® at a price that exceeds the maximum non-excessive price established by the Board's Guidelines.
6.2 Without limiting the generality of the foregoing, and subject to paragraph 6.3, QLT undertakes that the price of PHOTOFRIN® will not exceed:
- at the time of introduction for sale in Canada, the median international price; and
- in future years, the maximum non-excessive price calculated in accordance with the Guidelines.
6.3 For a period of three years from the date of first sale in Canada, or until PHOTOFRIN® is sold in at least five of the foreign countries, whichever comes first, QLT undertakes to do the following within 30 days of the fast sale of PHOTOFRIN® in a foreign country:
- notify the Board of the price of PHOTOFRIN® in that country; and
- reduce the price of PHOTOFRIN® in Canada, if the median international price is lowered as the result of the introduction of PHOTOFRIN® in the country, so that it does not exceed the median international price.
A price established under paragraph (b) will become the new benchmark price for purposes of the Guidelines.
6.4 If QLT is required to reduce the price of PHOTOFRIN®, in accordance with paragraph 6.3(b), it will, at the request of the staff of the Board, file separate reports of the price and sales information required under the Regulations for the periods in which it sold PHOTOFRIN® at different prices.
6.5 If QLT should receive any excess revenues from a price higher than that determined by· paragraphs 6. 1 to 6.3 inclusive, it shall offset such excess revenues by lowering the price of PHOTOFRIN® over the subsequent 12 month period or by making a payment to Her Majesty in the right of Canada within 30 days of being notified by Board staff of the amount of excess revenues.
7.0 Additional
7.1 QLT agrees that non-compliance with the terms of this undertaking or any terms and conditions attached to the Advanced Ruling Certificate will constitute a significant change in the material facts upon which the certificate was issued and will render OLT susceptible to proceedings under section 83 of the Act.
7.2 If the Board issues the Advanced Ruling Certificate, QLT agrees that the Board may make public this undertaking, the certificate and any reasons therefore.
Signature:
Company Officer: Julia Levy
Position: Sr. Vice President, Scientific Affairs & CSO
Date: March 2, 1995