It is not uncommon for a plaintiff who has commenced a patent litigation under the Hatch-Waxman Act to eventually move for a preliminary injunction to prevent a defendant from launching its generic drug product during the course of the litigation.
Under the Hatch-Waxman Act, disputes over patents covering a drug can be resolved before the launch of a generic product. If a generic wishes to challenge the validity, infringement or enforceability of a listed patent and to market its generic product before the listed patent expires, the brand name holder typically commences an infringement action which triggers an automatic stay of final FDA approval of the generic that lasts 30 months or until a court decision is issued in the generic's favor, whichever occurs first.
If the 30-month stay expires before resolution of the lawsuit, the first generic can launch its product "at-risk". Typically, the branded company seeks to prevent the generic's at-risk launch.
To obtain a preliminary injunction, the branded company must establish that:
- it is likely to succeed on the merits;
- it is likely to suffer irreparable harm in the absence of preliminary relief;
- the balance of equities tips in the branded company's favour; and
- an injunction is in the public interest.
Winter v NRDC, 129 SCt 365, 374-376 (2008). Irreparable harm can no longer be presumed in patent cases based on a strong showing of a likelihood of success. eBay, Inc v MerchExchange, LLC, 547 U.S. 388, 392-394 (2006); Automated Merch Systems, Inc v Crane, 2009 US App Lexis 27667 at *8-9 (FedCir 2009) (unpub).
Among the factors that courts consider in determining whether and to what extent to issue injunctive relief include the plaintiff's plans to launch an authorised generic, and the generic's ability to pay damages should infringement ultimately be found. See King Pharmaceuticals, Inc v Corepharma, 10 Civ 1878 (DNJ) (GEB) (May 7 2010).
Thus, to preliminarily enjoin a generic at-risk launch, a branded company will need to establish not only a likelihood of success, but also that it will likely suffer irreparable harm, the balance of harm tips in its favour, and injunctive relief would be in the public interest. An inability of the generic to pay possible infringement damages will factor into the grant of an injunction.
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| Martin B Pavane, Julia S Kim and Michael C Stuart |
Cohen Pontani Lieberman & Pavane LLP
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