Eli Lilly & Co. v. Mylan Pharms., Inc.

Specific jurisdiction may exist by sending Notice of ANDA filing letter to the branded drug manufacturer.

Spring 2015

GENERICally Speaking

Case Name: Eli Lilly & Co. v. Mylan Pharms., Inc., Civ. No. 14-cv-00389-SEB-TAB, 2015 U.S. Dist. LEXIS 30175 (S.D. Ind. Mar. 12, 2015) (Barker, J.) 

Drug Product and Patents-in-Suit: Effient® (prasugrel hydrochloride); U.S. Patents Nos. 5,288,726 (“the ’726 patent”), 8,404,703 (“the ’703 patent”), and 8,569,325 (“the ’325 patent”)

Nature of the Case and Issue(s) Presented: Defendants were domiciled in West Virginia and India, they did not have any offices or facilities in Indiana, and only four employees resided in Indiana. Mylan argued that general jurisdiction was not proper under the recent Supreme Court decision in Daimler in that Mylan did not have continuous or systematic contacts with Indiana. Moreover, Mylan argued that the Supreme Court in Daimler held that the mere act of conducting business in a forum was not enough to establish general jurisdiction. Lastly, Mylan asserted that its acts did not constitute specific jurisdiction either.

Eli Lily conceded that general jurisdiction was not available under the law in light of the Daimler decision. Instead, it argued that Mylan’s acts of sending the paragraph IV certification notice letter to Eli Lily in Indiana and intending to sell generic drugs in Indiana were sufficient to establish specific jurisdiction. The court agreed.

Why Eli Lily Prevailed: First, the court acknowledged that the Daimler decision altered the general jurisdiction analysis usually conducted in ANDA cases, such as business solicitation and substantial past sales in the jurisdiction. The court agreed that general jurisdiction could not be established. As for specific jurisdiction, the court found that Mylan’s actions were sufficient to establish specific jurisdiction. It reasoned that the Hatch-Waxman framework created an “artificial” act of infringement: filing the PIV ANDA. As such, the jurisdiction analysis was different from that for other cases. The court rejected the idea that the filing of an ANDA was an act not directed at any jurisdiction. Rather, it had to be directed at the jurisdiction of the patent holder.

Moreover, the court found that Mylan knew sending the Notice letter would trigger an infringement suit by Eli Lily. As such, its actions were directed at the forum where Eli Lily was located.

The Court then determined that “traditional notions of fair play and substantial justice” were not offended by maintaining jurisdiction in Indiana over Mylan for several reasons, including the fact that Mylan had litigated cases in Indiana before, it sent employees to Indiana to conduct business, and some of its employees resided in Indiana. Moreover, the court noted it would have been a burden on Eli Lily to have to file suit against every defendant in the defendant’s home forum. Judicial economy favored having one court resolve the disputes related to the Patents-in-Suit.


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