One of the hallmarks of the Hatch-Waxman Act is the "offer of confidential access," wherein the generic manufacturer must offer the NDA holder, you guessed it, confidential access to the ANDA before the deadline to file suit.
AI-Generated, displayed with permission
One of the lesser explored implications of the OCA is the effect of a patentee declining the offer and bringing suit without reviewing the actual ANDA. In particular, how does that decision effect the attorney's fees inquiry if the NDA holder is ultimately unsuccessful at trial?
This was the question Judge Goldberg addressed on Friday in Silvergate Pharms., Inc. v. Bionpharma Inc., C.A. No. 18-1962-MSG (D. Del. Oct. 4, 2024) (Mem. Op.). Bionpharma had prevailed …
A motion for attorneys' fees is a tough row to hoe. The shoddiest AI lawyer could pull together 8 paragraphs of quotes from the Supreme Court, the Federal Circuit, Blackstone, and Hammurabi's code, warning that fees are an extreme sanction to be used only sparingly, lest their mysterious power be depleted.
And he works for peanuts!AI-Generated, displayed with permission
As Judge Williams' opinion in BearBox LLC v. Lancium LLC, C.A. No. 21-534-GBW (D. Del. Jan 9, 2024) shows, you can even lose a motion for fees if the Court previously held the other party acted in bad faith.
The opinion in Bearbox, contains a healthy recitation of losses by the plaintiff at various stages of the case, culminating in an unsuccessful trial on the merits. Its' not worth rehashing the whole thing for our purposes—
(Eds. note - what is our purpose? sound off in the comments, but know in advance that I will not read anything by a philosopher or anyone else with a fuller beard than I possess)
—but the big takeaway is that the defendant's failure to win the case at summary judgment effectively scuttled any argument that the plaintiffs' claims were objectively baseless and unreasonable:
Moreover, while the Court adopted Defendants' proposed claim constructions, the Court denied Defendants' motion for summary judgement because the Court found that there existed genuine issues of material fact regarding who conceived of the '433 patent's subject matter. Thus, Plaintiffs' decision to continue litigating the sole inventorship claim after receiving the Court's claim constructions was not sufficiently unreasonable to warrant a finding that this case is exceptional . . .
The Court, in denying Defendants' motion for summary judgement, rejected Defendants' argument that no reasonable juror could find that Mr. Storms was the sole inventor of the '433 patent. Thus, even considering the '632 patent application, Plaintiffs' position that Mr. Storms was the sole inventor of the '433 patent was not meritless.
Id. at 4, 6-7 (internal citations omitted).
The one issue where they seemed to get some traction was in a successful motion to strike filed earlier in the case. The plaintiff had apparently served a new expert report, without leave, in order to conform their expert's opinion to a the Court's claim construction. Defendants successfully moved to strike the report. In its decision, the Court applied the Pennypack factors and actually found that the plaintiffs' actions indicated bad faith.
Nevertheless, in ruling on the § 285 motion, Judge Williams found that this act of bad faith was not enough to make the case exceptional:
Accordingly, even though the Court found Plaintiffs' timing indicative of bad faith, the Court finds that, in this instance, Plaintiffs' desire to supplement Dr. McClellan's expert report to ensure consistency with the Court's claim construction order did not render this an exceptional case.
Id. at 5.
So take heart, those have shown bad faith. You may yet find yourselves sufficiently redeemed to avoid fees.
This blog is for general informational purposes. It is not an offer to perform legal services, and should not be considered a substitute for legal advice. Nothing in this blog should be construed as forming an attorney-client relationship. If you have legal questions, please consult counsel in your jurisdiction.
