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DewDiligence

10/14/10 9:40 PM

#106363 RE: DewDiligence #106082

Hatch-Waxman Quiz

In #msg-55372870, I said:

…since enactment of the Medicare Modernization Act of 2003, a branded-drug company can obtain only one 30-month stay against a given challenger for a given drug, regardless of how many patents protect the drug in question.

The above is almost always true, but there is one exception—what is it?

Hint 1: The MMA change to Hatch-Waxman grants no 30-month stay for any patent added to the Orange Book after a given Paragraph-IV challenge is filed.

Hint 2: The exception in the quiz hardly ever comes into play in practice.