In July 2008, the Patented Medicine Prices Review Board (PMPRB) announced that it has issued two Notices of Hearing with respect to the prices of generic drugs sold in Canada by Apotex Inc. and ratiopharm Inc. These are the first Notices of Hearing issued by the Board with respect to the price of generic drugs. In March, the Board had also commenced proceedings against Apotex to determine if Apotex is required to file price and sales information with the PMPRB with respect to drugs to which a patent may pertain.
Under the Patent Act, the PMPRB is mandated to ensure that the prices charged by patentees for patented medicines are not excessive. These cases involve generic versions of salbutamol sulphate, a bronchodilator medicine. The Statements of Allegations filed by Board Staff claim that they are patented medicines sold as "authorized generics" under licensing agreements with the patentees. It is alleged that both Apotex and ratiopharm began selling Apo-Salvent and ratio-Salbutamol in 2002 but failed to report them to the PMPRB until the fall of 2006. It is also alleged, based on publicly-available information, that the prices of both drugs increased in 2005 from $4.64 per inhaler to $7.73, contrary to the PMPRB's Guidelines.
The PMPRB has set down December 8, 2008 for the hearing with respect to Apo-Salvent and January 12, 2009 for the ratio-Salbutamol matter. The hearing into Apotex's filing obligations is scheduled for October 6, 2008.
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