IP Law Daily, PATENT—Fed. Cir.: Preliminary injunction barring Samsung Bioepis’ biosimilar of Regeneron’s EYLEA® affirmed on appeal, (Jan 29, 2025)

By Saurabh Kashyap, B.A., LL.B., LL.M.

District court correctly applied the four-part test for injunctive relief based on infringement likelihood, irreparable harm, balance of hardships, and public interest.

In a precedential decision, the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction issued by a federal district court barring Samsung Bioepis Co., Ltd. (Samsung) from launching SB15, a biosimilar version of Regeneron Pharmaceuticals, Inc.’s aflibercept product, EYLEA®. The Federal Circuit held that the district court correctly exercised personal jurisdiction over Samsung and properly granted injunctive relief, finding that Regeneron demonstrated a likelihood of success on the merits and that it would suffer irreparable harm absent an injunction, Samsung failed to raise a substantial question of patent validity, and the balance of hardships and public interest weighed in favor of Regeneron (Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 24-1965 (Fed. Cir. Jan. 29, 2025)).

Background. The plaintiff, Regeneron Pharmaceuticals, Inc., is a biotechnology company specializing in ophthalmic and anti-inflammatory biologics. It holds the Biologics License Application (BLA) for EYLEA®, a VEGF inhibitor used to treat conditions such as age-related macular degeneration (AMD) and diabetic macular edema (DME).

The defendant, Samsung Bioepis Co., Ltd. (Samsung), is a South Korean biopharmaceutical company focused on biosimilar development. Samsung partnered with Biogen MA Inc. to commercialize SB15, its aflibercept biosimilar, in the U.S.

Regeneron’s asserted U.S. Patent No. 11,084,865 (the ’865 patent) is titled “Stable Formulations of VEGF Antagonists.” It claims compositions of aflibercept (EYLEA®’s active ingredient) with specific stability and formulation requirements. The key limitations of the ’865 patent include a stability requirement of “at least 98% of the VEGF antagonist [remaining] in native conformation following storage at 5°C for two months,” a glycosylation requirement for the VEGF antagonist, and a formulation comprising a vial containing 40 mg/mL of aflibercept, polysorbate 20, and stabilizing agents.

The dispute arose after Samsung filed an Abbreviated Biologics License Application (aBLA) with the U.S. Food and Drug Administration (FDA), seeking approval to market SB15 as an interchangeable biosimilar of EYLEA®. As required under the Biologics Price Competition and Innovation Act (BPCIA), a framework analogous to the Hatch-Waxman Act for biologics, Samsung provided Regeneron with a Notice of Commercial Marketing, signaling its intent to launch SB15 upon FDA approval.

Regeneron initiated litigation in August 2022 under the BPCIA, alleging that Samsung and four other biosimilar applicants’ aBLAs infringed EYLEA®’s constituent patents. After the Judicial Panel on Multidistrict Litigation consolidated cases in the Northern District of West Virginia, Regeneron narrowed its focus to the ’865 patent and moved for a preliminary injunction, arguing that Samsung’s launch would cause irreparable harm by triggering price erosion, loss of market share, and reputational damage. The district court granted the injunction, holding that Regeneron had met all four factors required for injunctive relief under Winter v. Natural Resources Defense Council, Inc., 555 U.S. 7 (2008). Samsung appealed, challenging both the district court’s personal jurisdiction over it and the injunction’s legal basis.

Personal jurisdiction. Samsung argued that the district court lacked personal jurisdiction, claiming it had no direct presence or business operations in West Virginia and had delegated all commercialization efforts to Biogen. The Federal Circuit rejected this argument, finding that Samsung’s aBLA filing and Notice of Commercial Marketing demonstrated a clear intent to market SB15 in all 50 states, including West Virginia.

Citing Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016), the court emphasized that BPCIA applicants subject themselves to personal jurisdiction in every state where their biosimilar product will be sold. Since Samsung had not restricted any geographic sales, its claim that it lacked jurisdictional ties to West Virginia was meritless. The court further found that Biogen’s involvement did not absolve Samsung of jurisdiction, as Samsung remained the primary applicant and manufacturer of SB15.

Preliminary injunction analysis. To secure a preliminary injunction, Regeneron had to satisfy the four-part test established in Winter, which requires a showing of: (1)Likelihood of success on the merits; (2) Likelihood of irreparable harm absent an injunction; (3) Balance of hardships favoring the movant; and (4) Public interest in granting the injunction.

Likelihood of success on merits. The Federal Circuit upheld the district court’s conclusion that Regeneron demonstrated a likelihood of success on the merits. SB15 met all limitations of the asserted claims of the ’865 patent, including the VEGF antagonist concentration and stability-enhancing modifications covered by the patent. Samsung did not dispute infringement but challenged the patent’s validity on obviousness-type double patenting (ODP) grounds.

Samsung raised an obviousness-type double patenting (ODP) defense, arguing that the ’865 patent was not patentably distinct from an earlier Regeneron-owned patent, U.S. Patent No. 9,340,594 (the ’594 patent), which expired in 2021. The ’594 patent also covered aflibercept formulations, and Samsung contended that the stability and glycosylation modifications in the ’865 patent were routine optimizations rather than novel improvements. The Federal Circuit rejected this argument, concluding that Regeneron’s formulations provided novel benefits and that Samsung failed to establish a motivation to combine prior art elements to achieve the claimed invention. The court further ruled that Regeneron’s patent term extension (PTE) under 35 U.S.C. § 156 was lawfully granted, citing Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018) and rejecting Samsung’s attempt to use ODP to challenge PTE.

Irreparable harm. The Federal Circuit affirmed that Regeneron would suffer irreparable harm if SB15 entered the market and rejected Samsung’s argument that Regeneron’s claimed harm was speculative. It reasoned that biosimilar entry would cause immediate price erosion, and once pricing pressure was introduced, Regeneron could not restore prior pricing levels, even if it later prevailed in litigation. The court also recognized that physicians and insurers could permanently switch to SB15, making it difficult for Regeneron to recover lost market share.

Further, the appellate court emphasized that biosimilar competition could lead to unquantifiable losses in goodwill and market position. The court also dismissed Samsung’s assertion that it could launch a non-infringing alternative, as there was no evidence that Samsung had sought FDA approval for a different formulation.

Balance of hardships. The court found that the balance of hardships weighed heavily in Regeneron’s favor. Since SB15 had not yet launched, Samsung faced no immediate financial loss, whereas Regeneron risked substantial and lasting harm. The court emphasized that temporary delays in biosimilar entry are a foreseeable consequence of patent litigation, and Samsung took on this risk when it filed for FDA approval despite Regeneron’s existing patent protections.

The court also recognized that Regeneron had invested significant resources in developing and marketing EYLEA®, and an early biosimilar launch could damage its competitive position, disrupt insurer contracts, and erode goodwill. In contrast, Samsung’s only hardship was a delay in potential revenue, which the court deemed insufficient to outweigh the harm Regeneron would suffer.

Public interest. The Federal Circuit ruled that the public interest weighed in favor of granting the injunction, as enforcing valid patent rights promotes innovation in the pharmaceutical industry. It emphasized that strong patent protections are necessary to incentivize biologics research and development, and premature biosimilar entry could undermine investment in breakthrough treatments. The court also noted that Regeneron’s patent exclusivity was legally granted, and allowing SB15 to enter the market prematurely would contradict congressional intent behind the BPCIA and the Hatch-Waxman framework.

Thus, the appellate court affirmed the district court’s exercise of personal jurisdiction over Samsung and upheld the preliminary injunction, preventing Samsung from launching its aflibercept biosimilar.

The Case is Nos. 24-1965, 24-1966, 24-2082, 24-2083.

Judge: Taranto, R.

Attorneys: David I. Berl (Williams & Connolly LLP) for Regeneron Pharmaceuticals, Inc. William Adams (Quinn Emanuel Urquhart & Sullivan, LLP) for Samsung Bioepis Co., Ltd.

Companies: Regeneron Pharmaceuticals, Inc.; Samsung Bioepis Co., Ltd.

Cases: Patent FedCirNews WestVirginiaNews GCNNews