196 F. Supp. 3d 871
N.D. Ill.2016Background
- Daiichi Sankyo Co., Ltd. (DS Japan) owns U.S. Patent No. 6,878,703 (the ’703 patent); its U.S. subsidiary Daiichi Sankyo, Inc. (DS USA) holds the NDA and markets Benicar (olmesartan). The ’703 patent was formally disclaimed in 2006 but remains listed in the Orange Book.
- Three generic manufacturers (Torrent, Alembic, Aurobindo) filed ANDAs with Paragraph IV certifications that their generics do not infringe the ’703 patent; Mylan was the first ANDA filer and claims presumptive 180-day generic exclusivity beginning after October 25, 2016.
- Plaintiffs sued in the Northern District of Illinois, seeking declaratory judgments of non-infringement to trigger potential forfeiture of Mylan’s exclusivity; they moved for summary judgment based on Daiichi’s disclaimer of the ’703 patent.
- Defendants moved to dismiss for lack of personal jurisdiction; Mylan moved on ripeness/jurisdiction grounds as well. Plaintiffs argued defendants had waived jurisdictional objections by not contesting jurisdiction in related Apotex litigation and that defendants have sufficient U.S. contacts.
- The court applied Federal Circuit law for patent-related jurisdiction issues, rejected a waiver theory, and held that in declaratory-judgment suits against patentees the court must focus on the patentee’s enforcement-related activities in the forum (not merely patent ownership, Orange Book listing, or filing for a U.S. patent).
- Because Plaintiffs alleged no enforcement or enforcement-related licensing activity by DS USA in Illinois or by DS Japan in the United States, and DS Japan denies enforcement/licensing contacts, the court concluded it lacked specific personal jurisdiction and dismissed the actions without prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether defendants waived personal jurisdiction by not objecting in Apotex | Daiichi consented to this district by failing to contest jurisdiction in Apotex | No waiver: consent in one case does not bind defendants in separate suits; Daimler changed the law since Apotex | No waiver; failure to object in Apotex does not concede jurisdiction here |
| Whether DS USA is subject to specific jurisdiction in Illinois | DS USA’s U.S. presence, Orange Book listing, and patent prosecution suffice to confer jurisdiction in Illinois | Plaintiffs point to no enforcement activity by DS USA in Illinois; such commercialization/activity is not the relevant contact in declaratory suits against patentees | No specific jurisdiction over DS USA in Illinois; plaintiffs did not show enforcement-related contacts |
| Whether DS Japan is subject to specific jurisdiction in the U.S. under Rule 4(k)(2) | Obtaining a U.S. patent, licensing, and Orange Book listing constitute U.S.-wide contacts justifying jurisdiction | Mere patent procurement, listing, or non-enforcement licensing is insufficient absent enforcement obligations or forum-related enforcement conduct | No specific jurisdiction over DS Japan under Rule 4(k)(2); plaintiffs failed to allege enforcement-related contacts in the U.S. |
| Whether Avocent/Acorda standards control jurisdiction in Hatch-Waxman declaratory suits | Acorda’s reasoning (ANDA filings support jurisdiction) should mirror and permit jurisdiction here | Avocent controls declaratory-judgment patentee-defendant suits; Acorda applies to suits where alleged infringer is defendant; mirror logic fails because patentee must have enforcement contacts | Avocent (not Acorda mirror) governs; Acorda does not relax the requirement that patentee show enforcement-related forum contacts |
Key Cases Cited
- Daimler AG v. Bauman, 571 U.S. 117 (2014) (limits general jurisdiction; a corporation is "at home" primarily where incorporated or principal place of business)
- Walden v. Fiore, 571 U.S. 277 (2014) (specific jurisdiction requires defendant’s contacts with the forum state itself, not just effects felt there)
- Avocent Huntsville Corp. v. Aten Int’l Co., 552 F.3d 1324 (Fed. Cir. 2008) (in declaratory-judgment suits against patentees, relevant contacts are enforcement-related activities)
- Acorda Therapeutics, Inc. v. Mylan Pharm., Inc., 817 F.3d 755 (Fed. Cir. 2016) (in Hatch-Waxman infringement suits, an ANDA filing can constitute suit-related contacts for jurisdiction over an alleged infringer)
- Silent Drive, Inc. v. Strong Indus., Inc., 326 F.3d 1194 (Fed. Cir. 2003) (sending a cease-and-desist into a forum is insufficient alone to establish personal jurisdiction in declaratory-judgment context)
- Synthes (U.S.A.) v. G.M. Dos Reis Jr., 563 F.3d 1285 (Fed. Cir. 2009) (plaintiff bears prima facie burden of personal jurisdiction in absence of evidentiary hearing)
- Apotex, Inc. v. Daiichi Sankyo, Inc., 781 F.3d 1356 (Fed. Cir. 2015) (Federal Circuit found Article III controversy in similar dispute and remanded to district court)
- Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010) (Orange Book listing rules and consequences explained)
- Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540 F.3d 1353 (Fed. Cir. 2008) (describes the 180-day exclusivity incentive for first ANDA filers)
- Red Wing Shoe Co. v. Hockerson-Halberstadt, Inc., 148 F.3d 1355 (Fed. Cir. 1998) (rejects mirror-image jurisdictional reasoning in declaratory judgment context)