1Overview
Dr. DeForest McDuff, Ryan Penkowski, and their team 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. The team’s work informed an order by the district court denying a motion for a preliminary injunction, affirmed by the U.S. Court of Appeals for the Third Circuit.
2The Challenge
Was the harm truly irreparable in a biosimilars market?
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, Dr. McDuff, Mr. Penkowski, and their team evaluated economic literature, utilized research databases, and considered market data from third-party sources to develop and support its opinions.
3The Outcome
Injunction denied, and affirmed by the Third Circuit
Dr. McDuff, Mr. Penkowski, and their team 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 Dr. McDuff’s opinions, questioned that calculating the effect of any business disruption would be too difficult to measure.
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