Last week's ANDA win by a generic-drug manufacturer in the District of Delaware is notable for many reasons, chief among them the Court's double patenting analysis. See IP Law360 (subscription). But Judge Farnan's opinion is also notable for its discussion of an obscure term-extension device, the Section 253 terminal disclaimer.
After recounting the underlying family of applications, and the concomitant risk of double patenting, the Court addressed -- and rejected -- the patentee's assertion that its partial disclaimer of the patent-in-suit's remaining term mooted an invalidity finding. By doing so, the Court highlighted the importance of timing when filing a terminal disclaimer.
The Court began by noting the "dual problem" in the litigation: that the disclaimer was filed near the conclusion of trial and after the expiration of the earlier patent. Looking to the limited Federal Circuit precedent, the Court concluded that a "terminal disclaimer may overcome a nonstatutory double patenting rejection only if the earlier patent has not yet expired."
Beyond the statutory arguments, the Court also expressed concern about the patentee's delay in seeking the disclaimer:
[E]xtensive delay in filing a document which may ultimately moot a double patenting issue can have harsh effects on the judicial system as a whole resulting in gamesmanship during trial, and/or a waste of the Court's and the parties' resources. (Op. at 22-23 n.8)
Having filed the disclaimer after the earlier patent's expiration, the Court concluded that the patentee could not invoke Section 253's safe harbor provisions in its efforts to escape a finding of invalidity.
Boehringer Ingelheim Int'l GMBH v. Barr Labs. Inc., C.A. No. 05-700-JJF (D. Del. June 26, 2008) (Farnan, J.).