180 Days Of Exclusive Marketing: A Right, An Incentive, Or A Property Interest?
Under the Hatch-Waxman Act, a drug manufacturer must file a New Drug Application ("NDA") in order to obtain FDA approval of a new drug. Along with the NDA, the drug company must inform the FDA of any patents that cover the drug so the FDA can list the patents in a publication known as the "Orange Book." If such patents are listed in the Orange Book, a generic manufacturer, must make a certification with respect to the listed patents in its Abbreviated New Drug Application ("ANDA"). One certification is that the listed patents are either unenforceable or not infringed by the generic drug ("Paragraph IV certification"). The generic must give notice of the Paragraph IV filing to the NDA company, which has 45 days to file an infringement suit. If no suit is filed, the ANDA may be approved immediately. If suit is filed, that delays approval for 30 months. Either way, any subsequent generic making a similar Paragraph IV certification may not receive approval until 180 days after the earlier of either (1) the first ANDA applicant that submitted a Paragraph IV certification begins commercial marketing, or (2) a court decision holding that the relevant patent is invalid or not infringed.
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