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January 03, 2013
Supreme Court says Viagra patent invalid. Generics get OK

Pfizer Canada Inc.’s patent on the top-selling erectile dysfunction drug Viagra is invalid, the Supreme Court of Canada has ruled.

In a 7-0 decision, the Court said that Pfizer did not disclose sufficient information about the medication when it applied for its Canadian patent.  Specifically, the company did not disclose the exact compound that is effective in treating the dysfunction.  

“Pfizer had the information needed to disclose the useful compound and chose not to release it, even though they knew the effective compound was silenafil at the time it filed the application,” wrote Justice Louis LeBel.  “If there is no quid – proper disclosure – then there can be no quo – exclusive property rights.”

According to media reports, the company listed billions of chemical compounds in its original application without specifying which compound treated the condition.  Based on the ruling, a simple listing of ingredients is no longer sufficient to provide drug patent protection.  As a result, Canada’s drug patent protection laws will likely be subject to review or revision in the near future.

More importantly, the ruling by Canada’s highest court opens the door for generic drug manufacturers to produce and sell their own version of the popular medication.  As a result, plan sponsors with drug plans may see an increase in the number of claims involving generic equivalents to Viagra.

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