On
The
Background: The PMPRB's challenge of Alexion's pricing for SOLIRIS
Alexion markets the patented medicine SOLIRIS, a breakthrough treatment for two rare and life-threatening blood-related disorders. The PMPRB initiated proceedings considering whether Alexion priced SOLIRIS excessively contrary to the Patent Act. The PMPRB found that it did, and ordered Alexion to forfeit what it deemed as excess revenues earned between 2009 and 2017. The Board relied on the fact that the Canadian list price of SOLIRIS was higher than the price in one of seven comparator countries. According to the PMPRB, the price of SOLIRIS had to be lower than that of all seven comparator countries to avoid being excessive, departing from the provisions of the PMPRB Guidelines.
Alexion applied for judicial review. The Federal Court dismissed Alexion's application, finding that the PMPRB's decision was reasonable because it was entitled to significant deference. Alexion appealed, and the
Alexion
1. General price control is not part of the balance struck by the Patent Act:
2. The PMPRB's mandate is to prevent patent abuse & excessive pricing; not consumer protection:
3. The Patent Act sets out the test for excessive pricing: The PMPRB's analysis of excessive pricing must be grounded in the law.4 The Court held that the test for excessive pricing is that codified in section 85 of the Patent Act, and it must be applied by the PMPRB before any other factors are considered.5 The PMPRB must interpret section 85 purposively and in context; not in a non-tendentious, non-expedient way.6
If in its decision the Board departs from the PMPRB Guidelines, which are non-binding, it must provide a reasoned explanation for any such departure.7 The PMPRB did not do so. The Court found the PMPRB obfuscated its decision making it impossible for a reviewing court to know whether the Board has helped itself to a power it does not lawfully have, effectively putting itself beyond review. The Court cautioned that administrative boards like the PMPRB "cannot put themselves in a position where they are not accountable"8
What does this mean for the pharmaceutical industry in
Canadian appeal courts have sent a strong signal that general price control and consumer protection is not within the PMPRB's jurisdiction, and are not part of balance struck in the Patent Act between incentivizing research and development of patented medicines in
Consistent with the
Footnotes
1. ¶ 49-50.
2. ¶ 49.
3. ¶ 11.
4. ¶ 34.
5. ¶ 36, 40.
6. ¶ 36-37.
7. ¶ 38-39, 58-60.
8. ¶ 44.
9.
To view the original article click here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
TechLex Blog
McCarthy Tétrault LLP
Suite 5300,
ON M5K 1E6
Tel: 416362 1812
Fax: 416868 0673
E-mail: info@mccarthy.ca
URL: www.mccarthy.ca
© Mondaq Ltd, 2022 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source