Decision: PMPRB-06-D1-RISPERDAL CONSTA

IN THE MATTER OF the Patent Act R.S.C. 1985, c. P-4, as amended AND IN THE MATTER OF Janssen-Ortho Inc. (the “Respondent”) and the medicine “Risperdal Consta”

ORDER

Pursuant to subsection 83(6) of the Patent Act, the Patented Medicine Prices Review Board (the “Board”) issued a Notice of Hearing on January 30, 2006, pertaining to allegations of Board Staff that the medicine Risperdal Consta had been, and was being, sold by Janssen-Ortho Inc. (“Janssen-Ortho”) in Canada at prices that exceeded the prices calculated in accordance with the Board's Excessive Price Guidelines. Janssen-Ortho responded to the allegations of Board Staff set out in its Statement of Allegations, attached to the Notice of Hearing, and Board Staff replied to that response. The Board heard the matter.

On June 1, 2007, Janssen-Ortho filed a Voluntary Compliance Undertaking (“VCU”) by which Janssen-Ortho proposed to resolve all issues raised by the Statement of Allegations. A copy of the VCU is attached hereto.

The Board has decided to accept Janssen-Ortho's VCU. Accordingly, by Order of this Board, the proceeding that was commenced by the issuance of the Notice of Hearing is hereby concluded.

Board Members:
Dr. Brien G. Benoit
Anthony Boardman
Thomas (Tim) Armstrong

Board Counsel:
Peter Annis

Sylvie Dupont
Secretary of the Board

June 4, 2007