The Federal Circuit has affirmed a district court's decision to grant Regeneron Pharmaceuticals a preliminary injunction against Samsung Bioepis, blocking the South Korean company from selling its biosimilar version of the blockbuster eye medication EYLEA in the United States.
In a ruling that provides significant clarity on both personal jurisdiction standards and patent validity challenges, the court rejected Samsung Bioepis's arguments on multiple fronts, delivering a substantial victory for Regeneron in its ongoing effort to protect its aflibercept franchise.
Patent Infringement Case Background
Regeneron initially filed patent infringement suits against Samsung Bioepis and four other defendants over patents related to its EYLEA drug. The cases were consolidated in the Northern District of West Virginia under the Judicial Panel on Multidistrict Litigation.
At issue was Samsung Bioepis's biosimilar product (SB15), which the company had sought approval for through an abbreviated Biologics License Application (aBLA) with the FDA. Under the Hatch-Waxman Act, filing such an application is treated as an admission that the underlying patent claims apply to the biosimilar product.
Samsung Bioepis had entered into an agreement with Biogen—a U.S. company—granting Biogen exclusive rights to commercialize SB15 in the United States, while maintaining involvement through a joint steering committee.
Personal Jurisdiction Ruling Sets Important Precedent
A key aspect of the Federal Circuit's decision addressed whether West Virginia courts had personal jurisdiction over Samsung Bioepis, a company headquartered in South Korea with no direct operations in the state.
Samsung Bioepis argued that its only relevant contact was selling SB15 to Biogen outside of West Virginia, and that Regeneron needed to show evidence that Samsung Bioepis specifically targeted West Virginia as a market.
The Federal Circuit disagreed, stating that "there is simply no good reason for demanding such singling-out evidence as a substitute for persuasive evidence of nationwide targeting without a carve-out." The court held that by filing the aBLA with the FDA, Samsung Bioepis had confirmed its plan to market SB15 throughout the United States, establishing sufficient minimum contacts with West Virginia.
"The directing of sales into [a state] is sufficient for minimum contacts," the court noted, citing precedent from Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc.
This ruling has significant implications for foreign pharmaceutical companies seeking to enter the U.S. market through partnerships with American distributors, as it establishes that plans for nationwide distribution create sufficient contacts for jurisdiction in any state.
Patent Validity Challenges Rejected
Samsung Bioepis also challenged the district court's finding that Regeneron was likely to succeed on the merits of its patent infringement claim, arguing that Regeneron's '865 patent was invalid under an obviousness-type double patenting (ODP) theory.
The company contended that the '865 patent claims were merely obvious variations of Regeneron's earlier '594 patent. Specifically, while the '594 patent disclosed a preferred stability of "at least 90%" for the VEGF trap to be "stable for at least 4 months," the '865 patent claimed a narrower stability value of 98%.
The Federal Circuit provided important clarification on patent domination, stating that the mere fact that one patent has broader claims that encompass a later patent's narrower claims does not automatically render the later patent obvious. Instead, the proper analysis is whether a skilled artisan would have been motivated to arrive at the limitation with a reasonable expectation of success.
"Even if a later claim is necessarily narrower than an earlier claim, claiming it as such may still be non-obvious," the court explained.
Written Description Defense Also Fails
Samsung Bioepis further argued that the '865 patent lacked adequate written description for the claimed glycosylated aflibercept formulations. The Federal Circuit rejected this argument as well, clarifying that the proper inquiry is "whether the patentee has provided an adequate description that 'in a definite way identifies the claimed invention' in sufficient detail."
The court emphasized that "the specification does not need to describe 'every conceivable and possible future embodiment of [the] invention.'"
Implications for Biosimilar Development
This decision represents a significant win for Regeneron in protecting its EYLEA franchise, which generates billions in annual revenue. The ruling will likely delay Samsung Bioepis's entry into the U.S. market with its biosimilar version.
For the broader pharmaceutical industry, the case provides important guidance on both jurisdictional questions for foreign companies seeking to enter the U.S. market and on patent validity challenges in the context of biosimilar development.
The clarification on obviousness-type double patenting is particularly significant, as it establishes that narrower patent claims that fall within the scope of broader earlier patents may still be patentably distinct and valid, potentially strengthening protection for innovator companies with multiple patents covering different aspects of the same product.
