Overview
Insight Economics evaluated claims regarding a motion to preliminarily enjoin the authorization of a private label version of a biologic drug. The dispute centered around the authorization’s alleged irreparable harm, the balance of hardships, and the public interest. Insight’s work informed an order by the district court denying a motion for a preliminary injunction, affirmed by the US Court of Appeals for the Third Circuit.
Challenge
The appeal centered on whether alleged harms in a complex biologics and biosimilars market were sufficiently irreparable to justify the remedy of a preliminary injunction. On a short timetable, Insight evaluated economic literature, utilized research databases, and considered market data from third-party sources to develop and support its opinions.
Results
Insight submitted an expert declaration for Samsung, analyzing biologics market dynamics, expected biosimilar entry, and the potential impact of a private‑label biosimilar. The district judge denied the motion, citing a failure to show Plaintiffs would be irreparably harmed. The Third Circuit, consistent with Insight’s opinions, questioned that calculating the effect of any business disruption would be too difficult to measure

