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.
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 on all claims at trial, with Judge Stark holding that none of the claims were infringed do to the lack of the required citric acid/sodium citrate buffer element.
Following this victory, Bionpharma moved for fees under 285, on a variety of theories related to the relative strength of Silvergate's case and especially the weakness of their DOE theory. All fairly run of the mill stuff which Judge Goldberg (inheriting the case following Judge Stark's elevation to the Federal Circuit) denied. Nothing worthy of a post on so preeminent a blog as this.
The one interesting twist was that Silvergate had refused Bionpharma's offer of confidential access, and had thus filed suit without ever viewing the complete ANDA. Bionpharma called this failure unreasonable and argued that it rendered the case exceptional.
Judge Goldberg, however, found that the refusal was not unreasonable due to the onerous restrictions placed on the OCA:
Bionpharma originally offered terms that would have prevented Azurity’s outside counsel from engaging in “any patent prosecution or any … work before or involving the FDA”—the area in which Azurity’s lawyers have expertise. Those terms would have barred not just FDA regulatory work but prevented Azurity’s attorneys from engaging in “any FDA counseling, litigation or other work before or involving the FDA.” In contrast, under the terms Azurity later agreed to, its lawyers could continue to engage in patent prosecutions unrelated to the patents at issue in this lawsuit. Bionpharma has not sufficiently established that Azurity could not view the earlier terms as “unacceptable” given that they would have “barr[ed] … [an] entire outside law firm from engaging in any prosecution or FDA regulatory work … regardless of subject matter.”
Id. at 12-13 (internal citations omitted).
I've been watching for a cleaner version of this fact pattern for a while now -- i.e., one where the NDA holder refuses a plainly reasonable OCA and ultimately loses at trial -- but this is the closest I've seen. Thinking about it more, I'm dubious we'll see a better version of this fact pattern, as it's generally in the NDA holders interest to review the whole ANDA as soon as possible, both (as here) to avoid any charge that they brought the suit without a proper investigation, and just to get a head start on the complaint and contentions.
I keep hoping though, and I'll keep you in the loop if a better exemplar comes along.
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