Order regarding scheduling

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In the matter of the patent act, r.s.c. 1985, c. p-4, as amended and in the matter of Horizon Pharma (the “respondent”) and the medicine cysteamine bitartrate sold by the respondent under the trade name procysbi

1. The panel of the Patented Medicine Prices Review Board seized with this proceeding (the “Panel”) has carefully reviewed and considered the Draft Revised Scheduling Order jointly filed by Board Staff and the Respondent on August 7, 2020 (the “Draft Schedule”), as well as the Parties’ written submissions dated August 21, 2020 (the “Written Submissions”).

2. The Draft Schedule was jointly filed by the Parties in accordance with a Direction of the Panel dated July 21, 2020.

3. The Written Submissions were filed by each of the Parties in accordance with a Direction of the Panel dated August 17, 2020. In this Direction, the Panel granted the Respondent’s request for a brief extension to complete its document production, and accordingly, directed the Parties to provide the Panel with any proposed Amendments to the Draft Schedule resulting from this brief extension.

4. In its Written Submissions, Board Staff requested that the deadline in the Draft Schedule for serving Board Staff’s responding expert reports be extended by four days (from October 2, 2020 to October 6, 2020). Board Staff submitted that the balance of the deadlines contained in the Draft Schedule should remain in place, including the Respondent’s deadline to serve its responding expert reports.

5. In its Written Submissions, the Respondent consented to Board Staff’s request to extend the deadline for serving responding expert reports from October 2, 2020 to October 6, 2020, provided that the extension applies to the deadline for service of both Parties’ responding expert reports. Moreover, the Respondent requested that the deadline in the Draft Schedule for serving the reply expert reports also be extended by four days (from October 30, 2020 to November 3, 2020).

6. After fully considering the materials filed by Board Staff and the Respondent, the Panel orders that the schedule for the remainder of this proceeding shall be as follows (subject to change at the discretion of the Panel):

7. As demonstrated in paragraph 6 above, the Panel has denied Board Staff’s request to only extend the deadline for serving Board Staff’s responding expert reports. The Draft Schedule filed by the Parties provides for the simultaneous exchange of responding expert reports. The Panel agrees that simultaneous exchange is fair and appropriate in the circumstances – the brief extension granted to the Respondent to complete its document production does not change this.

8. The Panel has granted the Respondent’s requests to: (i) extend the deadline for both Parties to serve their responding expert reports to October 6, 2020; and (ii) extend the deadline for both Parties to serve their reply expert reports to November 3, 2020. Granting these brief extensions will not delay the hearing of this matter or prejudice either party. To the contrary, these extensions will permit both Parties and their experts to have sufficient and equal time to prepare the reports at issue.

9. The March dates proposed by the Parties in the Draft Schedule for oral closing submissions are not available. The Panel directs the Parties to consult and to provide their available dates for oral closing submissions during the period March 8 to April 30, 2021, by September 18, 2020. The Panel will confirm the dates for oral closing submissions, as well as the due date for written closing submissions, shortly thereafter

Dated at Ottawa, this 8^th day of September, 2020.

Signed on behalf of the Panel by Carolyn Kobernick

Panel Members

Carolyn Kobernick
Mitchell Levine

Counsel for Board Staff

David Migicovsky
Christopher Morris
Courtney March

Counsel for the Respondent:

Sheila Block
Andrew Shaughnessy
Rachael Saab
Stacey Reisman

Counsel for the Panel:

Sandra Forbes
Megan Percy