Biotech Values

[DewDiligence]

Any later filed patents will not trigger a new thirty-month stay, unless the ANDA is amended to assert that it does not infringe a new patent that has been listed in the Orange Book.

That’s not quite right. Since enactment of the 2003 Medicare Modernization Act, a patent added to the Orange Book after an ANDA is submitted cannot cause a new 30-month stay under any circumstances.