Serono Labs Inc v. Ferring Pharm. Inc.

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• holding that differing staff interpretations did not affect court’s deference to the views of “the decisionmaker authorized to speak on behalf of the agency”
• recognizing that “the NDA process,” which is “costly and time- consuming,” impedes the “availab[ility] of low cost generic drugs”
• holding that an RLD manufacturer was unlikely to succeed on its challenge to the FDA’s reliance on animal studies to establish the bioequivalency of a proposed generic because courts “are bound to show deference to the agency’s fact-finding in this area of its technical expertise”
• assuming that the plaintiff would be irreparably injured if the FDA was not enjoined from approving an ANDA where the plaintiff would suffer an unrecoverable loss of sales to the generic manufacturer
• holding that an RLD manufacturer was unlikely to succeed on its challenge to the FDA’s reliance on animal studies to establish the bioequivalency of a proposed generic because courts “are bound to show deference to the agency’s fact-finding in this area of its technical expertise”
• explaining that “if . . . [the movant] is not likely to establish that [the generic drug applications were] wrongly approved, then the public interest considerations weigh against an injunction”

Source: CourtListener parenthetical corpus (CC0).