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").
