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chapter 6
Use of Reissue Proceedings
in Hatch-Waxman Litigation
I. Introduction
What happens when a patent owner discovers that its issued patent con-
tains an error? If the error is simple or ministerial, a certificate of correc-
tion may be requested. But what about when a patent owner finds more
substantive errors, which cannot be remedied with a certificate of correc-
tion? When that type of error is discovered, the patent owner first surren-
ders the issued patent and files a reissue application. The issued patent
must be considered to have been, through some kind of error, to be “wholly
or partly inoperative or invalid.”1
What if the substantive error was the basis for an eventual finding of
invalidity in a district court or Federal Circuit proceeding? This chapter
explores how reissue proceedings can and have been used to undo such a
finding of invalidity. We examine several cases as well as look at how this
affects strategy for both branded and generic drug companies.
II. The Reissue Application
The reissue procedure has long been recognized by courts and was later
codified in 35 U.S.C. § 251:
Whenever any patent is, through error, deemed wholly or partly
inoperative or invalid, by reason of a defective specification or
Andrew M. Alul, Joseph M. Bennett-Paris, Ph.D., and Richard T. Ruzich, Taft Stettinius &
Hollister LLP.
dor54588_06_ch06_115-128.indd 115 5/5/16 5:31 PM
