In a first-of-its-kind public decision, Frommer Lawrence & Haug LLP obtained a stay and administrative closure of a Hatch-Waxman patent case on behalf of its client Shire Pharmaceuticals, because of the generic drug maker Mylan Pharmaceuticals’ problems with their application in the FDA. Judge Charlene Honeywell, of the U.S. Middle District of Florida stated that the uncertainty surrounding the status of Mylan’s proposed generic product warranted her action. 

As set forth in the decision, Mylan’s failure to respond to a deficiency letter received from FDA in May 2014 “raise[d] serious questions in the Court’s mind as to the viability of Mylan’s ANDA product as currently formulated.” And Mylan’s June 2015 request for a year-long extension to respond to FDA – made three months prior to trial – “further reinforce[d] that there is a significant possibility that Mylan’s product will have to be reformulated and/or its ANDA materially amended.”

Under the terms of the August 11, 2015 Order, the case will remain administratively closed, with all case deadlines tolled and stayed, until May 31, 2016 or until Mylan provides its ANDA resubmission, whichever occurs first. Notwithstanding the administrative closure, the Order further requires Mylan to timely produce all correspondence with FDA regarding its ANDA to Shire in the meantime.

Attorneys from Frommer Lawrence & Haug LLP involved in the case on behalf of Shire Pharmaceuticals include: Ed Haug, Jason Lief, Andrew Wasson and Elizabeth Murphy.

The case name and number are Shire Development LLC, et al. v. Mylan Pharmaceuticals, Inc., et al., No. 8:12-cv-01190-CEH-AEP (M.D. Fla.).