It's uncommon to see the Court dismiss an ANDA case before trial. The patents are usually grounded enough to avoid easy 101 issues, infringement is as likely to be conceded as disputed, and any other serious invalidity contentions are normally simply reserved for trial (none of our Delaware judges allow for SJ motions in ANDA cases without leave).
That being the case, Judge Stark's dismissal of the complaint in Almirall, LLC v. Torrent Pharmaceuticals Ltd., C.A No. 20-1373-LPS, D.I. 50 (D. Del. July 13, 2021) ("Almirall II"), via a 12(c) motion is worthy of comment merely because it dismissed an ANDA complaint on the pleadings before Markman. What makes it prime blog material, is that it might have gone differently if the plaintiff had briefed the issue differently.
This is more than just Monday morning quarterbacking. The opinion itself notes that Judge Fallon had gone the other way in a related case regarding the same patent in Almirall LLC v. Taro Pharm. Indus. Ltd , C.A. No. 17-663-JFB-SRF D.I. 39 (D . Del. Nov. 28, 2017) ("Almirall I"), denying a motion for early summary judgment based on similar arguments on the grounds that the issues were "more properly resolved following the completion of discovery and claim construction." Id. at 2.
Unfortunately for the plaintiff, they failed to raise the particular argument that Judge Fallon found warranted further discovery in Almirall I in its briefing. Instead, the issue was raised for the first time in oral argument and then again in a request for further briefing. Judge Stark found this failure amounted to a waiver of the argument, noting that:
[p]articularly given that this is evidently Almirall' s sixth or seventh infringement case involving the same NDA and same patent (see id. at 12-13), there is no excuse for Almirall omitting from its brief what it now, belatedly, seeks to feature as its key theory of DOE infringement.
Almirall II at 12.
Judge Stark justified this preclusion by noting that, since the Court "was not obligated to hear oral argument on Torrent' s motion . . . [i]t would have been entirely proper for the Court to have decided the motion based solely on the briefing, in which case the Court would have had no way to consider arguments Almirall only raised for the first time after briefing." Id.
It is, of course, possible that the case might have gone differently if the defendant's motion had not been so strong—the Court noted that "[i]t is difficult to imagine a clearer disclaimer" than the one it found dispositive here. Id. at 8. But its a good lesson in the importance of raising every relevant argument in the briefing, rather than assuming the Court will accept them at oral argument.
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