Assessment of irreparable harm for an osteoporosis treatment

Following a district court finding of invalidity and/or non-infringement and plaintiff’s stated intention to appeal, CRA was asked to assess whether branded manufacturer would suffer irreparable harm should the generic manufacturer launch at risk. CRA discussed the formulary process and how manufacturers have regained formulary position following generic entry and exit; the branded manufacturer’s use of copay coupons, resulting in copayments that would not be expected to fall following generic entry; and the generic manufacturer’s ability to pay. CRA submitted declarations. The district court and the Court of Appeals for the Federal Circuit agreed there would be no irreparable harm and rejected motions for a temporary injunction.