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SOLIRIS PMPRB Redetermination Proceeding Resolved On Consent – Patent



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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.

The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
directly.

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