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SOLIRIS PMPRB redetermination proceeding resolved on consent

Authored byKatie Lee

In September 2017, the Patented Medicine Prices Review Board (PMPRB) decided that Alexion’s SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines, in finding the appropriate benchmark was the lowest international price. The Federal Court dismissed Alexion’s application for judicial review. On July 29, 2021, the Federal Court of Appeal (FCA) set aside the Federal Court’s decision and remitted the matter to the Board for redetermination.

On August 2, 2022, the PMPRB Hearing Panel announced that it had issued an order, based on a joint request by the parties. The Order sets out three terms:

  1. Alexion’s previous payment of $4,245,329.60 for the period of July 2009 to September 2017, on or about July 19, 2018, will be retained by the PMPRB;
  2. Alexion will make an additional payment of $7,371,763.07 within 30 days of issuance of the Order for the period of September 2017 to December 31, 2021;
  3. From January 1, 2022 to the expiry of the last patent pertaining to SOLIRIS, the Canadian ex-factory list price for SOLIRIS will be set by Alexion at $222.51 per mg and fixed until patent expiry.

As a result, the redetermination proceeding was discontinued.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.

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