Apotex' Enalapril Taken Off Market In Canada

The Federal Court of Canada has issued an injunction which has effectively taken Apotex' generic version of Merck's Vasotec (enalapril) off the market. The court ruled that Apotex infringed a patent held by Merck Frosst Canada.

A Merck spokesman said that the company saw revenues down about C$90 million ($65 million) last year in lost enalapril sales, adding that the generic was 20% cheaper than Vasotec. Enalapril's patents have not been successfully challenged anywhere in the world, he said, noting that the Canadian patent runs until 2007. Apotex says it plans to appeal the verdict, and ask for a stay of the injunction pending the appeal. The firm began selling the product after it received a notice of compliance from the Canadian federal government's health department in 1993. Merck challenged the notice, saying that it only confirmed that the drug met safety and efficacy standards but did not give marketing rights to the product.

The Canadian Supreme Court has already upheld the decision to issue a notice of compliance to Apotex, but the Merck spokesman said that the Federal Court decision was the key ruling.