“Like the ANDA filing in Acorda, Samsung Bioepis’ aBLA for an Eylea biosimilar ‘reliably confirm[s] a plan to engage in real-world marketing.’” – Federal Circuit
Yesterday, the U.S. Court of Appeals for the Federal Circuit issued a precedential ruling in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. affirming the Northern District of West Virginia’s entry of a preliminary injunction preventing the sale of a biosimilar product approved by the U.S. Food & Drug Administration (FDA) and sold by Korean drug developer Samsung Bioepis. Applying its reasoning from Acorda Therapeutics v. Mylan Pharmaceuticals (2016), the Federal Circuit upheld the district court’s finding that Samsung Bioepis’ application for biosimilar approval filed with the FDA provided sufficient minimum contacts with Northern West Virginia to support personal jurisdiction over the defendant.
In late 2023, Regeneron began infringement proceedings against Samsung Bioepis pursuant to provisions of the Biologics Price Competition and Innovation Act following Samsung Bioepis’ filing of abbreviated Biologics License Applications (aBLAs) with the FDA. Those applications covered biosimilar formulations of Regeneron’s Eylea eye treatment that were also the subject of a development and commercialization agreement between Samsung Bioepis and American biotech company Biogen. In the lawsuit, the district court granted Regeneron’s motion for preliminary injunction, finding that Samsung Bioepis’ aBLA in concert with the national distribution channels established through its agreement with Biogen allowed the Northern West Virginia district court to exercise personal jurisdiction over the Korean defendant.
FDA Filing and Commercialization Activities Satisfy Minimum Contacts Inquiry
Although the Federal Circuit separately affirmed the Northern West Virginia court’s grant of preliminary injunction against German biotech firm Formycon, the Samsung Bioepis ruling was marked precedential presumably due to the closer question of minimum contacts. In the Formycon case, the defendant had also signed a manufacturing and supply agreement as well as a development and licensing agreement related to the accused biosimilar.
On appeal, Samsung Bioepis argued that it lacked sufficient direct contacts with West Virginia to satisfy the constitutional standard required for the court’s exercise of personal jurisdiction. Under its agreement with Biogen, Samsung Bioepis is making a sale of its Eylea biosimilar to a Massachusetts-based company who then has exclusive rights to determine U.S. marketing plans. However, the Federal Circuit agreed with Regeneron that Samsung Bioepis’ aBLA filing, its associated Notice of Commercial Marketing submitted to Regeneron, establish of a robust distribution network and failure to deny allegations that it would commercialize its biosimilar in West Virginia through Biogen all combined to satisfy the minimum contacts requirement.
The Federal Circuit reached this conclusion by applying its reasoning from Acorda, which dealt with similar personal jurisdiction issues in the context of Abbreviated New Drug Applications (ANDA) filed under the Hatch-Waxman Act. The appellate court reasoned in Acorda that enactment of Hatch-Waxman reflected Congress’ recognition of the close relationship between FDA filings and corporate plans to market generic drugs. Although the Federal Circuit noted that the defendant Mylan had engaged in business conduct directed toward Delaware, where it was sued, the court elaborated that Mylan’s networks of independent wholesalers and distributors could market the generic drug in Delaware, establishing minimum contacts.
Like the ANDA filing in Acorda, Samsung Bioepis’ aBLA for an Eylea biosimilar “reliably confirm[s] a plan to engage in real-world marketing,” the Federal Circuit found. The appellate court also found the district court’s finding that Samsung Bioepis intended to distribute its biosimilar nationwide supported by the evidentiary record. Samsung Bioepis’ involvement with commercialization activities under its development agreement with Biogen, and the lack of any carve-out excluding West Virginia from Biogen’s distribution rights, established the defendant’s plans to market in West Virginia. The Federal Circuit dismissed Samsung Bioepis’ arguments against, calling for a bright-line constitutional rule based on which entity distributes and pointing to a lack of affirmative evidence of targeting the West Virginia market, as inconsistent with the holding of Acorda.
No Substantial Invalidity Question Raised by OTDP, Section 112 Arguments
Moving on to the district court’s equitable relief analysis, the Federal Circuit rejected Samsung Bioepis’ various challenges to the preliminary injunction grant. First, the appellate court found no substantial question of invalidity due to obviousness-type double patenting (OTDP), finding a pair of claim limitations from Regeneron’s asserted patent to be patentably distinct from Regeneron’s reference patent submitted by Samsung Biogen. Considering those limitations, the Federal Circuit found that the invention of the asserted patent had better stability of the claimed vascular endothelial growth factor (VEGF) antagonist, which traps VEGF to promote eye health, and exhibited reduced retinal penetration and inflammation risks due to the claimed glycosylated nature of the VEGF trap.
The Federal Circuit similarly nixed Samsung Bioepis’ validity challenge under the written description requirement of 35 U.S.C. § 112. Expert testimony submitted by Regeneron established that a skilled artisan would understand that the claimed VEGF trap should be glycosylated at specific residues, as well as the upper and lower bounds of the claimed stability range.
The appellate court also dismissed Samsung Bioepis’ argument that Regeneron failed to show a causal nexus between infringement and irreparable harm. The lower stability levels for Samsung Bioepis’ Eylea biosimilar claimed in the aBLA did not result in a distinct noninfringing formulation, according to expert testimony. Further, the Federal Circuit noted that the accused product is essentially the claimed invention without significant additional features, simplifying the causal nexus requirement in light of Samsung Bioepis’ contention that Regeneron didn’t establish that the unique limitations of its asserted patent claims drove consumer demand for the invention. The Federal Circuit rejected the rest of Samsung Bioepis’ arguments as unpersuasive and affirmed the district court’s grant of preliminary injunction.
