Astrazeneca AB v. Mylan Pharmaceuticals, Inc.
72 F. Supp. 3d 549
D. Del.2014Background
- AstraZeneca (Swedish parent; U.S. subsidiary in Delaware) sued Mylan (WV corp.) for patent infringement under 35 U.S.C. § 271(e)(2) after Mylan filed two ANDAs for generic saxagliptin products. The suit was filed in the District of Delaware.
- Mylan filed a Rule 12(b)(2) motion to dismiss for lack of personal jurisdiction. Mylan has no offices or direct sales force in Delaware but is registered to do business there and has a Delaware registered agent.
- AstraZeneca asserted (1) consent to general jurisdiction via Delaware registration, (2) general jurisdiction based on Mylan’s contacts and litigation history in Delaware, and (3) specific jurisdiction based on Mylan’s paragraph IV notice to AstraZeneca U.S. in Delaware.
- The court applied constitutional due-process analysis (Daimler-era standard for general jurisdiction) and considered whether ANDA filings and paragraph IV notices supply sufficient minimum contacts for specific jurisdiction.
- The court denied Mylan’s motion: it rejected general-jurisdiction and consent theories but found specific jurisdiction proper because Mylan’s paragraph IV certification to the Delaware patent holder constituted purposeful contacts giving rise to AstraZeneca’s § 271(e)(2) claim, and the exercise of jurisdiction was reasonable.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mylan is subject to general (all-purpose) jurisdiction in Delaware | Mylan’s Delaware registration, alleged substantial Delaware sales through third parties, and repeated litigation here render it "at home" in Delaware | Mylan’s incorporation and principal place of business are in West Virginia; its Delaware contacts are not comparable to being "at home" | Court: No — Daimler controls; registration and sales network insufficient to show Mylan is "essentially at home" in Delaware |
| Whether Mylan consented to general jurisdiction by registering and appointing a registered agent in Delaware | Delaware registration and appointed agent constitute express consent to be sued in Delaware | Registration is procedural and does not waive due-process limits on jurisdiction | Court: No — Daimler undermines treating mere statutory registration as consent to nationwide jurisdiction; such a rule would offend due process |
| Whether Mylan is subject to specific (case-linked) jurisdiction for AstraZeneca’s § 271(e)(2) claim | Paragraph IV notice sent to AstraZeneca U.S. in Delaware constitutes purposeful direction to Delaware and gives rise to the claim | ANDA filings are filed with the FDA in Maryland and prepared in West Virginia; contacts are with the federal government or outside Delaware, not directed to Delaware | Court: Yes — filing the ANDA and sending paragraph IV notice to AstraZeneca U.S. in Delaware are purposeful contacts giving rise to the claim; jurisdiction is reasonable |
| Whether exercising jurisdiction would be fair and reasonable | Asserting jurisdiction in Delaware furthers Hatch-Waxman balance, judicial efficiency, and plaintiff’s ability to obtain relief; burden on Mylan is not substantial | Subjecting Mylan to suit in Delaware would be unfair absent stronger contacts | Court: Held fair — considerations (forum interest, plaintiff’s interest, efficiency) favor exercising specific jurisdiction |
Key Cases Cited
- International Shoe Co. v. State of Wash., 326 U.S. 310 (minimum contacts due process standard)
- Burger King Corp. v. Rudzewicz, 471 U.S. 462 (specific jurisdiction — purposeful direction and relatedness)
- Daimler AG v. Bauman, 134 S. Ct. 746 (general jurisdiction limited to forums where corporation is "at home")
- Goodyear Dunlop Tires Operations, S.A. v. Brown, 131 S. Ct. 2846 (general jurisdiction discussion)
- Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (ANDA-specific-jurisdiction analysis)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (treatment of § 271(e)(2) as a statutory, "artificial" act of infringement)
- World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (reasonableness factors for jurisdiction)
- Shaffer v. Heitner, 433 U.S. 186 (due-process foundations for state-court jurisdiction)
- Sternberg v. O’Neil, 550 A.2d 1105 (Del. 1988) (Delaware precedent on registration-based consent; discussed and distinguished)