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Polsinelli Polsinelli - Hatch-Waxman Litigation and Opinion

March 2015


New Developments in Hatch-Waxman Personal Jurisdiction Cases


For more information about this alert, please contact:


Mark T. Deming



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Tedd Van Buskirk

Practice Area Chair



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Additional Hatch-Waxman Litigation and Opinion Leaders:


Gary E. Hood

Practice Area Chair


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Keith J. Grady

Practice Area Chair


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The United States District Court for the Southern District of Indiana joined the District of Delaware and the Eastern District of Texas in finding specific jurisdiction based on receipt of a Paragraph IV Notice Letter. See Eli Lilly and Co. v. Mylan Pharmaceuticals, Inc., No. 1:14-cv-389 (S.D. Ind. Mar. 12, 2015). For an overview of this developing area of the law, please see our February 2015 update. This latest decision continues the trend of exercising personal jurisdiction over out-of-state Hatch-Waxman filers based in large part on the act of sending a Paragraph IV Notice Letter.

Defendants Mylan Pharmaceuticals, Inc., Mylan, Inc., and Mylan Laboratories, Ltd. challenged the Court's jurisdiction over an infringement suit brought by Eli Lilly and Company based on Mylan's filing of an abbreviated new drug application that seeks approval to sell a generic version of Effient®. Following jurisdictional discovery, the Court found Mylan's sending of a Notice Letter to Indiana constituted a sufficient minimum contact with the forum, and that subjecting Mylan to jurisdiction would not offend traditional notions of fair play and substantial justice.

The Court limited its analysis to specific jurisdiction as Eli Lilly conceded the absence of general jurisdiction. The Court recognized the difficulty in applying specific jurisdiction in Hatch-Waxman cases given the "artificial" act of infringement, but it rejected Mylan's invitation to decide the question based on where the ANDA filer conducts its development or preparation efforts. Mylan argued the Court should look to "where the ANDA was studied, drafted, compiled, and signed," and noted pre-Daimler decisions in which district courts had found specific jurisdiction based on where ANDA filers designed or tested their products or where they prepared their ANDA submissions. Instead, the Court focused on where the "actual consequences [are] felt" and found that Indiana—as home to one of the Notice Letter recipients—was one such place.

Having decided that sending a Notice Letter was a sufficient minimum contact for specific jurisdiction, the Court turned to whether exercising jurisdiction would be fair. The Court noted that "Mylan frequently sends its employees to Indiana for business purposes" and that "[t]wo of its National Account Managers reside in Indiana." The Court also found Indiana has a substantial interest in resolving the suit, and that exercising jurisdiction over all ANDA filers in Indiana—there were more than a dozen NCE-1 filers in this case—would promote judicial efficiency. All things considered, the Court held it would not be an undue burden for Mylan to litigate in Indiana.

There have also been new developments in the pending petitions for interlocutory appeal in AstraZeneca AB v. Mylan Pharmaceuticals, Inc., Case No. 15-117, and Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., Case No. 15-124. Last week, in Case No. 15-117, the Court accepted for filing an amicus brief by the Generic Pharmaceutical Association over AstraZeneca's opposition. The Association urged the Federal Circuit to accept the interlocutory appeal given the potential disruption that could result from uncertainty over where Hatch-Waxman filers are properly subject to personal jurisdiction. Today, the Federal Circuit granted both petitions for leave to appeal.

For More Information

Polsinelli attorneys will continue to monitor the Hatch-Waxman litigation landscape for further developments in this area. If you have questions about how personal jurisdiction can affect a Hatch-Waxman case you are involved in or anticipate being involved in, please contact the authors or your Polsinelli attorney.



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* Law360, March 2014
** The American Lawyer 2013 and 2014 reports


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