Allergan, Inc. v. Teva Pharms. USA, Inc.

Generic company’s original ANDA, though amended, provided subject-matter jurisdiction for patent litigation, and its recertification under PIV did nothing to change that, particularly when the reformulated product was not significantly different from the original product.

October 20, 2017

GENERICally Speaking

Case Name:  Allergan, Inc. v. Teva Pharms. USA, Inc., No. 2:15-CV-1455-WCB, 2017 U.S. Dist. LEXIS 136445 (E.D. Tex. Aug. 25, 2017) (Bryson, C.J.) 

Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine); U.S. Patents Nos. 8,629,111 (“the ’111 patent”), 8,633,162 (“the ’162 patent”), 8,642,556 (“the ’556 patent”), 8,648,048 (“the ’048 patent”), 8,685,930 (“the ’930 patent”), and 9,248,191 (“the ’191 patent”)

Nature of the Case and Issue(s) Presented:  Allergan sought a court order to have defendants provide seven days’ notice before they launched a generic product.  Allergan argued it would suffer irreparable harm if defendants were to release a generic product before the end of the trial. Defendants argued that no such order was necessary because they had agreed to not launch a generic product until the conclusion of the trial. 

The district court agreed with defendants and denied Allergan’s request.

Why Defendants Prevailed:  The district court held that Allergan had failed to show that irreparable harm would occur. First, the court noted that defendants had agreed not to release a generic product until after trial. Second, Allergan had not established a likelihood of success on the merits, as the court had only a high-level view of the case. Accordingly, the district court denied Allergan’s request.

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