Line design
Specific jurisdiction is present in any state where the generic manufacture may sell its ANDA product after FDA approval.
GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.)

Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic emulsion); 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: The issue before the court was whether specific or general jurisdiction existed over the defendants. Mylan argued that there were no facts to support specific jurisdiction because it did not have operations in Texas, had not sold any alleged infringing product in Texas, and Allergan had not offered facts demonstrating an intent by Mylan to sell alleged infringing products in Texas.

Allergan asserted that it had pled facts demonstrating intent by Mylan to sell alleged infringing products in Texas. In particular, Texas was the third-largest market for these types of products, Mylan had sold $460 million worth of products in the Eastern District, and Mylan was licensed to distribute drugs in Texas.

The court agreed with Allergan that specific jurisdiction existed over Mylan.

Why Allergan Prevailed: The district court found that specific jurisdiction was present because Mylan failed to assert that it would not sell the alleged infringing product in Texas or that any of the implicit facts regarding its activities in Texas did not support such a finding. As Texas was the third-largest market, the court found it improbable that Mylan would not seek to sell such products in Texas.  As such, the court found that specific jurisdiction was present and did not address general jurisdiction.

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