Irreparable Harm

Cornerstone Research has worked with Professor Henry Grabowski of Duke University on a number of cases to evaluate whether the incumbent branded drug company would suffer irreparable harm if the generic company launched its product “at-risk,” i.e., prior to resolution of the patent litigation.

Cornerstone Research has worked with Professor Henry Grabowski of Duke University on a number of cases to evaluate whether the incumbent branded drug company would suffer irreparable harm if the generic company launched its product “at-risk,” i.e., prior to resolution of the patent litigation.

In several of these cases, courts have agreed with our analyses of irreparable harm and granted motions for preliminary injunctions filed by the branded drug companies.

The rapid and severe loss of revenues of a branded drug following generic entry is well documented. There are a number of effects, however, beyond the direct revenue loss associated with “at-risk” generic entry that may lead to irreparable harm for the branded drug company. These include the curtailment or postponement of specific research projects and other research budget cuts, reduction of promotions and other patient and physician education efforts, share loss to therapeutic substitutes, displacement from prescription drug plan formularies, loss of goodwill with patients and physicians, reduction in employment, and adverse impact on manufacturing facilities. In several of these cases, courts have agreed with our analyses of irreparable harm and granted motions for preliminary injunctions filed by the branded drug companies.