Court Battle Over For Apotex And Merck

3 April 1997

A Canadian Federal Court judge has thrown out the final delaying actionsby Merck Frosst, Merck & Co's Canadian subsidiary, aimed at keeping generic lovastatin off the market, Canadian firm Apotex has told local press.

The delay came about as a result of the "linkage regulations," appended to Bill C-91 (Marketletters passim), which state that if a brand-name pharmaceutical company alleges a generic competitor is about to infringe on its patent, the government must withhold the "notice of compliance" the generic company needs to market its product, until a hearing its held, commented Canada's Financial Post.

Jack Kay, president of Apotex, said that his firm's product has been held up for 43 months after Merck Frosst won two extensions. The latest request for an extension by the firm was refused, and Apotex then received its notice of compliance. Apotex has begun shipping its product, while Merck says it intends to sue for patent infringement.

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