On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with Regeneron Pharmaceuticals, Inc. (“Regeneron”).[1] The Federal Circuit affirmed the district court’s exercise of personal jurisdiction over both defendants as well as the entries of preliminary injunctions against both companies’ aflibercept biosimilar products. With respect to personal jurisdiction, the Federal Circuit has taken a broad view of Acorda,[2] signaling that foreign companies that file an ANDA or aBLA in the U.S. can expect to be subject to personal jurisdiction in any given forum state unless they specifically carve out the forum state from their distribution networks for their drug products.
Formycon and SB are both foreign companies that filed aBLAs seeking FDA approval of aflibercept biosimilars in the United States. Both companies served on Regeneron a Notice of Commercial Marketing pursuant to 42 U.S.C. 262(l)(8)(A), which the Federal Circuit found “expressly communicated an intent to begin marketing of [the biosimilars] upon FDA approval.”[3] Both companies stated that they would not engage in any sales of their aflibercept biosimilar products, but instead have contracted (or will contract) with distributors who will make sales in the United States.[4]
In Acorda, the Federal Circuit addressed the question of whether a Hatch-Waxman defendant’s conduct satisfied the minimum contacts requirement for specific personal jurisdiction in the context of an infringement suit brought under 35 U.S.C. § 271(e)(2). The Court concluded that Mylan’s ANDA filings and its distribution channels were sufficient to establish personal jurisdiction in the forum state of Delaware. In particular, the Court found the ANDA filing “realistically establish[es] a plan to market.”[5] They also stated that, while Mylan’s conduct indicated that it planned to make direct sales of its generic product into the forum state, “even if Mylan does not sell its drugs directly into Delaware, it has a network of independent wholesalers and distributors with which it contracts to market the drugs in Delaware. Such directing of sales into Delaware is sufficient for minimum contacts.”[6] However, the facts in Acorda included additional evidence showing Mylan’s intent to market a generic drug product in the forum state, including Mylan having registered to do business in Delaware, appointed an agent to accept service of process there, and registered with the Delaware Board of Pharmacy as a licensed “Pharmacy-Wholesale” and a “Distributor/Manufacturer CSR.”[7] Thus, SB and Formycon argued that Acorda did not hold that filing an ANDA or aBLA seeking approval to market a product throughout the United States, or contracting with distributors to sell throughout the United States, necessarily evidenced the intent to market the generic or biosimilar drug product in each individual state sufficient to establish personal jurisdiction in any given state.
In the Samsung Bioepis opinion, the Court explained that, like in Acorda, each foreign defendant had engaged in conduct indicating an intent to distribute its drug product nationwide in the U.S. (including in the forum state of West Virginia) by filing an aBLA with the FDA, serving a Notice of Commercial Marketing expressing an intent to begin marketing upon FDA approval, and engaging with partner companies to commercialize and distribute its drug product without excluding any individual U.S. states from the distribution agreement. Although both defendants asserted that they would not be responsible for any decision-making regarding U.S. commercialization because the distribution, marketing, or sales of their respective drug products would be handled solely by non-party partner companies, the Court rejected that argument, pointing out that it had already rejected a similar argument in Acorda “[c]onsistent with the practical focus of the constitutional standard.”[8]
Additionally, the Court was unpersuaded that, as the defendants contended, Regeneron needed to show affirmative evidence that they were expressly targeting West Virginia as a market. Instead, the Court determined that there was “simply no good reason, under the constitutional standard, for demanding such singling-out evidence as a substitute for persuasive evidence of nationwide targeting without a carveout.”[9] In this regard, the Court suggested that, while each defendant’s aBLA does not identify any parts of the U.S. as places where it does not intend to market and distribute the approved product, it could have excluded the forum state as a target for commercialization by, for example, selecting distributors that only reached a limited region of the U.S. (and not the forum state).
As a final note, during oral argument, Judge Moore had alluded to a possible application of Fed. R. Civ. P. 4(k)(2), which provides that a court may exercise personal jurisdiction over a defendant who is not subject to jurisdiction in any state’s courts. In response, Formycon’s counsel asserted that Rule 4(k)(2) did not apply based on Formycon’s voluntary waiver of personal jurisdiction in the state of Washington. Ultimately, having found SB’s and Formycon’s conduct sufficient to meet the minimum-contacts requirement, the Court declined in its opinion to further address whether any alternative means of establishing specific personal jurisdiction, such as Rule 4(k)(2), would have applied here.
[1] Regeneron Pharms, Inc. v. Mylan Pharms Inc., No. 24-2009 et al.; Regeneron Pharms, Inc. v. Mylan Pharms Inc., No. 24-1965 et al. The Court issued a precedential opinion in the SB case, authored by Judge Taranto, and a per curiam opinion addressing additional arguments specific to Formycon’s case.
[2] Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016).
[3] No. 24-1965 at 13; see also No. 24-2009 at 7-8.
[4] No. 24-1965 at 7, 15; see also No. 24-2009 at 7-8.
[5] Acorda, 817 F.3d. at 761.
[6] Id. at 763.
[7] Id.
[8] No. 24-1965 at 15.
[9] Id.