As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year.
- The Aflibercept BPCIA Litigations Continue Into 2025
As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year. To start 2024, Regeneron, Mylan, and Biocon appealed the District Court for the Northern District of West Virginia’s judgment from December 2023, finding certain claims of one Regeneron patent to be valid and infringed while other claims invalid. In April 2024, the Federal Circuit dismissed the appeals for lack of jurisdiction on procedural grounds.
Regeneron filed a motion in January 2024 seeking to establish a multi-district litigation (“MDL”) encompassing the various aflibercept BPCIA cases it filed in the District Court for the Northern District of West Virginia and to transfer its case against Amgen, which had been before the District Court for the Central District of California. The various biosimilar defendants opposed the request for an MDL. The request for MDL was granted and all of the cases have now been consolidated in the Northern District of West Virginia for pre-trial proceedings.
In June 2024, Regeneron obtained a permanent injunction against Mylan and Biocon in the pending aflibercept litigation. Regeneron obtained preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion that same month. Each of those defendants has appealed the grant of a preliminary injunction. Those appeals are currently pending.
In August 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz related to Sandoz’s ENVEEZU (aflibercept-abzv). In the complaint, Regeneron asserted 46 patents against Sandoz. The case against Sandoz was subsequently consolidated in the MDL and transferred to the District Court for the Northern District of West Virginia for pre-trial proceedings.
In September 2024, Judge Kleeh of the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen, finding that Amgen did not infringe the asserted patent, U.S. Patent No. 11,084,865. Regeneron immediately appealed, seeking an emergency injunction as the appeal proceeded. The Federal Circuit denied Regeneron’s request for an emergency injunction pending appeal. Oral argument in Regeneron’s appeal occurred earlier today, January 14, 2025. Amgen became the first aflibercept biosimilar to launch in October 2024.
- The Denosumab BPCIA Litigations Expanded in 2024
In March 2024, the FDA approved Sandoz’s denosumab biosimilars, WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz), as interchangeable with Amgen’s XGEVA and PROLIA products. Amgen, however, filed a BPCIA complaint against Sandoz back in May 2023 in the District of New Jersey. After over a year of litigation, the District Court for the District of New Jersey signed off on the parties’ stipulation to dismiss the litigation in April 2024 as a result of a confidential settlement agreement. As part of the stipulation, Sandoz agreed to be enjoined from “making, using, offering to sell, or selling Jubbonti or Wyost in [the United States], or importing Jubbonti or Wyost into” the United States until February 19, 2025.
Separately, Amgen filed BPCIA complaints against four other biosimilar companies in relation to their proposed denosumab biosimilars: Celltrion in May 2024, in the District Court for the District of New Jersey; Samsung Bioepis and Samsung Biologics in August 2024, also in the District Court for the District of New Jersey; Fresenius Kabi in October 2024, in the District Court for the Northern District of Illinois; and Accord Biopharma in November 2024, in the District Court for the Eastern District of North Carolina.
Amgen’s BPCIA case against Celltrion has been set for trial on April 7, 2025.
On November 15, 2024, Amgen filed a motion with the U.S. Judicial Panel on Multidistrict Litigation, to establish a multidistrict litigation for the various denosumab BPCIA cases, and to transfer the cases against Fresenius and Accord Biopharma to the District Court for the District of New Jersey for consolidation pre-trial proceedings. Accord Biopharma, Celltrion, and Fresenius Kabi have opposed Amgen’s motion. A panel hearing is scheduled for January 30, 2025.
- Alexion and Samsung Settle Eculizumab BPCIA Litigation
In January 2024, Alexion sued Samsung Bioepis in the District Court for the District of Delaware, asserting six patents under the BPCIA based on Samsung Bioepis’s submission of its BLA for EPYSQLI. The FDA approved EPYSQLI in July 2024. Prior to its approval, Alexion had sought a preliminary injunction, but the Court denied the motion in May 2024, finding that Alexion had failed to demonstrate a likelihood of success on the merits due to doubts about the validity of the asserted patent claims. This decision came on the heels of the PTAB instituting IPR for five of the six asserted patents in the district court litigation in December 2023. Alexion appealed the denial of the preliminary injunction.
In August 2024, Alexion and Samsung settled the BPCIA dispute, also dismissing Alexion’s Federal Circuit appeal and the pending IPRs.
- Litigation challenging the Inflation Reduction Act
As we reported at the end of 2023, several legal challenges were initiated against the Inflation Reduction Act’s Drug Price Negotiation Program after the first ten drugs were selected for the program. In 2024, district courts ruled in favor of the government in several cases, granting the government’s motion to dismiss in the Chambers of Commerce case, and granting the government’s motions for summary judgment in challenges separately brought by BMS, Janssen, Boehringer Ingelheim, AstraZeneca, Novartis, and Novo Nordisk. Appeals of those rulings are currently pending before the Sixth Circuit Court of Appeals (Chambers of Commerce), the Third Circuit Court of Appeals (BMS, Janssen, AstraZeneca, Novartis, Novo Nordisk), and the Second Circuit Court of Appeals (Boehringer Ingelheim).
The government also prevailed on a motion to dismiss in a challenge brought by PhRMA, the Global Colon Cancer Association, and the National Infusion Center Association in the District Court for the Western District of Texas. The Court of Appeals for the Fifth Circuit reversed that ruling in September and remanded the case to the district court for further proceedings.
Merck’s challenge to the Program—the first, filed in June 2023—remains pending in the District Court for the District of D.C.
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As we look ahead to 2025, we will continue to follow key legal developments in the biologics and biosimilars market, including the aflibercept and denosumab BPCIA litigation, and the various challenges to the Inflation Reduction Act’s Drug Price Negotiation Program. Stay tuned for the latest updates.
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