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Federal judge allows discovery to proceed in REMS duty to deal dispute

Robert F. Leibenluft

Robert F. Leibenluft,

Washington, D.C.

Lauren E. Battaglia

Lauren E. Battaglia,

Washington, D.C.

21 October 2013
Last week a U.S. district court judge in New Jersey heard oral arguments on a motion for judgment on the pleadings in a dispute between Actelion and three generic drug manufacturers regarding whether or not Actelion has an antitrust duty to supply the generics with samples of drugs marketed under a restricted distribution program. The generic firms contend that these samples are needed in order to conduct the bioequivalence testing often required for FDA approval under an Abbreviated New Drug Application. Ruling immediately after the close of arguments, Judge Noel Hillman held that he did not have sufficient information to rule on the substantive issues and therefore the case should proceed to discovery.
Federal judge allows discovery to proceed in REMS duty to deal dispute

It is worth noting that despite the FTC's recent efforts to become involved in private antitrust suits involving the pharmaceutical industry (see here and here), it was unable to participate in the proceedings due to the recent government shutdown.

For additional background on the case and the issues, please refer to this article.

Robert F. Leibenluft

Robert F. Leibenluft,

Washington, D.C.

Lauren E. Battaglia

Lauren E. Battaglia,

Washington, D.C.

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