On August 20, 2014, Judge Leonard P. Stark issued what appears to be the first order requiring a branded pharmaceutical company to delist a patent from the Food & Drug Administration’s (FDA) Orange Book. See Avanir Pharm., Inc., et al. v. Actavis S. Atl. LLC, et al., No. 11-0704 (D. Del.). Judge Stark ordered removal of the patent because it did not claim “the drug for which the application was approved.” Id., ECF No. 518. Thus, this marks the first successful use of 21 U.S.C. § 355(j)(5)(C)(ii)(I) (also known as the “counterclaim provision”) to remove a listed patent.
As a brief background, the “Orange Book” is an FDA publication where branded companies list patents covering new drugs. If a generic pharmaceutical company wants to enter the market before Orange Book-listed patents expire, it may challenge the patents by showing they are invalid, unenforceable, or not infringed (the so-called “Paragraph IV certification”).
In 2003, Congress armed generic challengers with the ability to dispute Orange Book listings. This new ability, codified in 21 U.S.C. § 355(j)(5)(C)(ii)(I), was famously the topic of the Supreme Court’s decision in Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670 (2012). Prior to 2003, generic challengers had no way to challenge improperly listed Orange Book patents.
In the order, Judge Stark noted that Plaintiff Avanir had previously tried to remove the same patent from the Orange Book. Not satisfied with the failed attempt, the Court ordered Avanir to “try again.” The second time, Judge Stark issued a mandatory injunction to correct the Orange Book entry for Nuedexta®.
As a result of this ruling, there is now at least one decision generic companies may rely on in challenging Orange Book-listed patents.