Belbuca® (buprenorphine)
Case Name: BioDelivery Sciences Int’l, Inc. v. Alvogen PB Research & Development LLC, Civ. No. 18-1395-CFC, 2026 WL 84392 (D. Del. Jan. 12, 2026) (Connolly, J.)
Drug Product and Patent(s)-in-Suit: Belbuca® (buprenorphine); U.S. Patent Nos. 8,147,866 (“the ’866 patent”) and 9,655,843 (“the ’843 patent”)
Nature of the Case and Issue(s) Presented: This case was filed in 2018 when Alvogen submitted to the FDA an ANDA for approval to market generic Belbuca, a buprenorphine buccal film used to administer the drug transmucosally. On January 22, 2022, the court entered a final judgment in favor of BDSI and the case was closed. Four weeks earlier, the court issued its opinion, which included the findings of facts and conclusions of law that the court made resulting from a three-day bench trial. The court ordered the parties to “submit no later than January 18, 2022, a proposed order by which the Court may enter final judgment consistent with the Opinion.” Paragraph 7 of the judgment was drafted by Alvogen and agreed to by BDSI, but on the eve of filing the proposed judgment, Alvogen took the position that it should not be included in the judgment. Given that the parties at one point agreed to the language, the court included it in the judgment. Paragraph 7 read:
Pursuant to 35 U.S.C. § 271(e)(4)(B), Defendants and its officers, agents, servants, employees, successors, and attorneys, and those persons in active concert or participation with them, are enjoined, until the expiration of each of the ’866 patent, and the ’539 patent, from commercially manufacturing, using, selling or offering for sale in the United States, or importing into the United States Defendants’ ANDA Products.
Both parties appealed and the Federal Circuit affirmed the judgment insofar as it declared that claims 9 and 20 of the ’539 patent and claims 4 and 5 of the ’866 patent are not invalid. The court vacated the judgment insofar as it declared that claims 8, 9, and 20 of the ’843 patent and claims 3 and 10 of the ’866 patent are invalid. The Federal Circuit remanded the case “for the sole purpose of reconsidering the evidence already presented at trial regarding long-felt need and unexpected results under the correct evidentiary standard.” Given the injunction set forth in paragraph 7 of the district court judgment, the district court took no action “unless and until I heard from the parties.”
In the meantime, Alvogen filed with the FDA new ANDA No. 220582. As it did with its earlier ANDA, Alvogen’s new ANDA sought FDA approval to market a buprenorphine buccal film. In response, and more than two years after the Federal Circuit remand, on July 22, 2025, BDSI filed a motion to enforce the final judgment. The court denied BDSI’s motion.
Why Alvogen Prevailed: BDSI says the drug product covered by ANDA No. 220582 is “substantially identical” to the product covered by ANDA No. 211594 and that ANDA No. 220582 “appears to be an attempt by Alvogen to circumvent the Final Judgment” entered in the earlier case. BDSI’s motion seeks an order: (i) confirming that Alvogen’s new ANDA product is within the scope of the original final judgment; (ii) that the sale of the new ANDA product would infringe the patents-in-suit; and (iii) preventing Alvogen from marketing any generic buprenorphine film until the expiration of the later-expiring patent-in-suit.
Alvogen argued that its new ANDA product is a reformulation of the old ANDA product. The new ANDA product “has a more basic backing layer pH than the ANDA No. 211594 product” and that “this change of the pH constitutes a legitimate design-around that removes the ANDA No. 220582 product from the scope of the ’539 patent’s claims and thus the scope of the injunction in paragraph 7 of the judgment.” Alvogen also argued that BDSI’s motion was procedurally barred because “permanent injunctions are only ‘enforced’ via a contempt motion.
Although the court found that the term “ANDA Products” in Paragraph 7 of the judgment was not defined, “[b]ut I think it is beyond debate that ANDA Products refers to products covered by Alvogen’s ANDA No. 211594,” it resolved the motion by adopting Alvogen’s second argument regarding the impropriety of BDSI’s motion.
An injunction is an equitable decree compelling obedience under the threat of contempt. Therefore, injunctions are enforced through the district court’s civil contempt power. None of the cases relied on by BDSI stand for the proposition that a motion to enforce judgment is appropriate for addressing post-judgment developments. “The adoption of such a rule would subject courts to never-ending motion practice to address the infinite “developments” that might arise following entry of a judgment.”
