Economics Of Irreparable Harm In Pharma Patent Litigation

Law360, New York (November 18, 2013, 2:13 PM EST) -- The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, allows generic products to be launched while the patent(s) on the equivalent branded drug are in litigation. Such a launch is called at-risk because of the possibility that, at trial, the court finds the generic drug infringed on the branded drug's patents. Branded companies often seek a preliminary injunction to prevent the generic from launching at-risk. For such an injunction to be granted, the branded company must establish that it would suffer irreparable harm from the at-risk entry (i.e., it would not be fully compensated by a monetary damages reward if the brand ultimately prevails at trial). This article discusses the economic rationale for the different sources of irreparable harm that courts have considered, such as reductions in research and development (R&D), loss of share to therapeutic competitors, loss of goodwill and negative impacts on employment and manufacturing facilities.[1]...

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