Case Name: Norwich Pharms., Inc. v. Becerra, Civ. No. 23-1611 (RDM), 2023 WL 7174558 (D.D.C. Nov. 1, 2023) (Moss, J.)

Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199 (“the ’199 patent”), 7,902,206 (“the ’206 patents”) (together, the ’199 and ’206 patents are referred to as the “Polymorph Patents”), 8,642,573 (“the ’573 patent”), 9,421,195 (“the ’195 patent”), 10,335,397 (“the ’397 patents”) (together, the ’573, ’195, and ’397 patents are referred to as the “HE Patents”), 8,309,569 (“the ’569 patent”), and 10,765,667 (“the ’667 patent”) (together, the ’569 and ’667 patents are referred to as the “IBS-D Patents”)

Nature of the Case and Issue(s) Presented: Salix markets rifaximin for the treatment of irritable bowel syndrome with diarrhea (“IBS-D”) and the reduction of risk of hepatic encephalopathy (“HE”) recurrence in adults. Norwich wants to market a generic version of the drug, and is awaiting final approval from the FDA. The filing of Norwich’s original ANDA constituted an act of infringement of the Orange Book-listed patents that Salix listed to protect Xifaxan from generic competition. Salix sued Norwich, which lead to a district court decision that invalidated two drug substance patents and the two method-of-use patents covering the IBS-D indication. That court also found that Salix’s three HE method-of-use patents were valid and infringed. Based on that finding, the court entered an order directing “that the effective date of any final approval order of the [FDA] of Norwich’s ANDA ... is to be the date not earlier than the expiration of the” HE method-of-use patents—that is, October 2, 2029.

Given the district court’s decision, Norwich filed an amended ANDA with the FDA, omitting the HE indication from its proposed label. It then filed a motion under FRCP Rule 60(b) in the district court seeking to modify the judgment to permit the FDA to approve the amended ANDA without delay. The district court denied that motion. Norwich appealed that decision and the underlying merits decision. The FDA then tentatively approved Norwich’s ANDA, but it declined to grant final approval before October 2, 2029, in compliance with FDA’s reading of the district court’s final judgment.

Norwich filed this action challenging FDA’s decision to tentatively—not finally—approve Norwich’s amended ANDA. It sought injunctive and declaratory relief directing the FDA immediately to approve Norwich’s amended ANDA. The FDA and Salix opposed, cross-moving for summary judgment. The court denied Norwich’s motion and granted FDA and Salix’s cross motions for summary judgment.

Why FDA and Salix Prevailed: Norwich argued that FDA’s determination that the Delaware District Court’s final judgment precluded it from granting final approval to Norwich’s amended ANDA prior to October 2, 2029, was “arbitrary, capricious, ... or otherwise not in accordance with law” and must therefore be set aside. The FDA’s interpretation of the final judgment was based on two documents: (i) a letter from FDA to Norwich, dated June 2, 2023, explaining that the FDA was “unable to grant final approval to [Norwich’s] ANDA at this time because” the final judgment “ordered that the effective date of any final approval by the FDA of Norwich’s ANDA No. 214369 is to be a date not earlier than the date of expiration of the last to expire of the ’573, ’195, and ’397 Patents (currently October 2, 2029), plus any regulatory exclusivity to which Plaintiffs are or become entitled;” and (ii) a second document from FDA explaining FDA’s decision to tentatively approve Norwich’s ANDA, which states, “Norwich’s ANDA is eligible for only a Tentative Approval based on the 271(e)(4)(A) judgment … we interpret the May 17 order refusing to modify the judgment to say that the prior … still stands and applies to Norwich’s post-amendment ANDA.” Thus, the court found that “in the end, all that matters for present purposes is how that [final judgment] order is best understood.”

The court found that the FDA’s determination tracks the most straightforward reading of the final judgment. Prior to issuing its judgment, the Delaware District Court directed the parties to meet and confer and file a joint proposed final judgment. Salix asked that the final judgment apply to Norwich’s ANDA in its entirety. Norwich, in contrast, argued that such an order would be overly “broad or speculative” and asked, instead, that the Delaware District Court “reject any proposed judgment that presupposes labeling excluding the HE indication would infringe the asserted HE patent claims, or precludes Norwich’s ability to seek a skinny label.” In a memorandum accompanying its final judgment, the District Court notes that the possibility that Norwich may seek to carve out the HE indication was immaterial to its analysis because such a label was not before the court. After amending its ANDA, the District Court denied Norwich’s motion—not because the proposed amendment was unnecessary, but because the court thought it “wrong ... that [Norwich] can litigate a case through trial and final judgment based on a particular ANDA, and then, after final judgment, change the ANDA to what it wishes it had started with, and win in a summary proceeding.” So it is clear what the Delaware District Court intended. The underlying merits of that decision are not before this court, but on appeal at the Federal Circuit.

“All that matters for present purposes is that Norwich has failed to show that the law is so clear that the FDA should have stretched to read the Delaware District Court’s final judgment and Rule 60(b) decision in a manner that ignores their plain terms. That proposition is unsustainable, as is Norwich’s ultimate contention that the FDA erred as a matter of reasoned-decision-making and law in reading those documents to leave the agency free to approve the company’s amended ANDA prior to October 2, 2029.”