The Federal Circuit affirmed a preliminary injunction against Samsung Bioepis concerning its biosimilar product for Regeneron’s Eylea treatment. The court used the precedent set in Acorda Therapeutics v. Mylan to justify the jurisdictional ruling, stating that Samsung's abbreviated Biologics License Application (aBLA) created sufficient connections with Northern West Virginia. The case highlights the significant role that FDA filings and commercialization agreements play in legal jurisdiction regarding biopharmaceuticals, reinforcing the authority of district courts in such matters.
In a significant legal decision, the Federal Circuit upheld a preliminary injunction against Samsung Bioepis, emphasizing the importance of jurisdiction based on FDA biosimilar applications.
The court determined that Samsung Bioepis’ aBLA filing and marketing plans were sufficient to establish personal jurisdiction in Northern West Virginia.
Collection
[
|
...
]