If a generic manufacturer wants to begin selling a pharmaceutical drug before the innovator company’s patent is expired, the generic can file an Abbreviated New Drug Application (ANDA) with the FDA along with a certification that asserts that either (i) the patents listed in the Orange Book are invalid or (ii) the listed patents do not cover the generic’s product. This certification is known as a “paragraph IV certification.”
Once an ANDA is filed, the patent holder has a strong incentive to act quickly to charge the generic with infringement. If charges are filed within 45 days, an automatic statutory stay is triggered that delays approval of the generic’s ANDA for thirty-months.
Senators Stabenow (D, MI) and Lott (R, MS) have recently submitted a bill (S.2300) to the Senate that would allow courts to shorten the thirty-month stay based on a “totality of the circumstances, including whether the plaintiff sought to extend the discovery schedule, delayed producing discovery, or otherwise acted in a dilatory manner, and the public interest. According to the Bill, this is necessary to “prevent abuse of the thirty-month stay-of-effectiveness period.” The Bill would actually require that approval take place at least by the end of thirty-month months, thus preventing any further delay.
The proposal also limits the extent that patent exclusivity can be extended in return for ensuring pediatric safety and effectiveness.