Otsuka Pharmaceutical Co. v. Mylan Inc.
106 F. Supp. 3d 456
D.N.J.2015Background
- Otsuka sued Mylan Inc., Mylan Pharmaceuticals Inc. (Mylan Pharma), and Mylan Laboratories Ltd. (Mylan Labs) for patent infringement after Mylan Pharma filed an ANDA seeking to market generic aripiprazole (Ability®).
- Mylan Inc. (Pennsylvania) and Mylan Pharma (West Virginia) are registered to do business in New Jersey, maintain in‑state registered agents, hold NJ wholesale distribution licenses, and derive substantial NJ revenue; neither has physical offices in NJ.
- Mylan Labs (an Indian subsidiary) has not registered as a foreign corporation in New Jersey, but holds a NJ wholesale distribution license and has limited NJ-related sales and litigation history.
- The motion: Mylan moved to dismiss for lack of personal jurisdiction; Otsuka argued general jurisdiction, consent-by-registration, and specific jurisdiction based on Mylan’s forum contacts and ANDA activity.
- The court considered Federal Circuit law applicable to personal jurisdiction in Hatch‑Waxman/ANDA patent cases and reviewed jurisdictional rules post‑Daimler.
- Ruling: Court denied dismissal as to Mylan Inc. and Mylan Pharma (found consent by registration), but granted dismissal as to Mylan Labs for lack of specific jurisdiction.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Choice of law: which precedent governs personal jurisdiction in ANDA suit | Federal Circuit law does not alter Third Circuit long‑arm application; local law controls | Federal Circuit law governs due‑process analysis in patent/ANDA cases | Federal Circuit law governs jurisdictional due‑process analysis in Hatch‑Waxman patent suits (applies here) |
| General jurisdiction after Daimler: are Mylan entities "at home" in NJ? | Mylan’s continuous revenue, licensing, litigation, and subsidiaries make them essentially at home | Daimler limits general jurisdiction largely to place of incorporation and principal place of business; Mylan’s contacts insufficient | Court need not decide “at home” question for Mylan Inc./Pharma because consent resolved jurisdiction; Daimler narrows general‑jurisdiction scope and Mylan’s contacts likely insufficient absent consent |
| Consent by registration: does NJ registration and appointment of agent constitute consent to suit? | Registration, appointment of an in‑state agent, NJ business activity and state precedent show consent to suit | Post‑International Shoe and post‑Daimler jurisprudence limit consent‑by‑registration theory; registration shouldn’t automatically confer general jurisdiction | Court held Mylan Inc. and Mylan Pharma consented to NJ jurisdiction by registering and appointing agents under NJ statute and NJ precedent; consent-by‑registration remains valid |
| Specific jurisdiction over Mylan Labs: did Mylan Labs purposefully direct activities to NJ related to the claims? | Mylan Labs’ integrated corporate structure and affiliation with US entities support imputing contacts | Mylan Labs had no ANDA involvement or claim‑related NJ contacts; lacked registration/agent | Court found no specific jurisdiction over Mylan Labs; dismissed Mylan Labs for lack of jurisdiction |
Key Cases Cited
- Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (limits general jurisdiction; corporation generally "at home" only in state of incorporation or principal place of business, except in exceptional cases)
- Int'l Shoe Co. v. Washington, 326 U.S. 310 (1945) (due‑process minimum contacts framework)
- Pa. Fire Ins. Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93 (1917) (appointment of agent under state statute can constitute consent to suit)
- Nuance Commc'ns, Inc. v. Abbyy Software House, 626 F.3d 1222 (Fed. Cir. 2010) (Federal Circuit law governs personal jurisdiction analysis in patent cases)
- Autogenomics, Inc. v. Oxford Gene Tech. Ltd., 566 F.3d 1012 (Fed. Cir. 2009) (two‑step test: state long‑arm and due‑process analysis; where state long‑arm reaches to due‑process limits, inquiry collapses)
- Bane v. Netlink, Inc., 925 F.2d 637 (3d Cir. 1991) (registration to do business can constitute consent to be sued under certain state statutes)