290 F. Supp. 3d 599
N.D. Tex.2017Background
- Plaintiffs (Galderma entities and Nestlé Skin Health) sued under the Hatch‑Waxman Act alleging Teva’s ANDA for generic ivermectin cream infringes five Orange Book‑listed patents covering Soolantra® and sought declaratory and injunctive relief.
- Teva Pharmaceuticals USA (Teva USA) filed ANDA No. 210019; Plaintiffs allege Teva USA sent a Paragraph IV certification to Plaintiffs in the Northern District of Texas.
- Teva USA moved to dismiss under Rule 12(b)(3) for improper venue, arguing it is incorporated in Delaware, prepared/submitted the ANDA outside the Northern District of Texas, and lacks a regular and established place of business there.
- Teva Pharmaceutical Industries Ltd. (Teva Israel) moved under Rule 12(b)(6), arguing the FAC does not plausibly allege Teva Israel actively participated in preparing/submitting the ANDA.
- The Court permitted limited venue discovery after the Federal Circuit’s In re Cray decision, held an evidentiary hearing, and considered competing authority (notably Bristol‑Myers Squibb v. Mylan) about whether intended marketing locations can constitute acts of infringement for venue.
- The Court granted Teva USA’s Rule 12(b)(3) motion (venue improper) and granted Teva Israel’s Rule 12(b)(6) motion (claims dismissed without prejudice), allowing Plaintiffs leave to amend limited allegations if the case is not transferred to Delaware.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether an ANDA filer "has committed acts of infringement" in a district for §1400(b) when it intends to market the product there | ANDA filing + intent to market in district = act of infringement for venue purposes (relying on Bristol‑Myers/Acorda) | Only the ANDA submission itself is the statutory artificial act; intent to market elsewhere does not create venue here | Held: Intent to market outside the district does not, by itself, establish acts of infringement for patent‑venue purposes; venue improper (ANDAs prepared/submitted outside district) |
| Whether the defendant has a "regular and established place of business" in the Northern District of Texas under §1400(b) | Presence of numerous sales reps, distributors, and revenue derived in district establishes a physical, regular place of business | Sales reps mostly employed by a separate entity (TSM); no physical office or defendant control/possession of premises; distributors’ locations are not defendant’s places | Held: Plaintiffs failed to show a physical, regular, and defendant‑controlled place of business; venue improper |
| Whether Teva Israel plausibly can be held liable for submission of the ANDA (Rule 12(b)(6)) | Allegations that Teva Israel controls Teva USA, jointly files ANDAs, will market/distribute post‑approval, and works in active concert suffice to show active involvement/inducement | FAC alleges Teva USA submitted the ANDA; allegations about Teva Israel are conclusory and lack specific factual allegations showing active involvement in ANDA preparation | Held: FAC fails to plausibly allege Teva Israel was "actively involved" in preparing/submitting the ANDA; dismissal without prejudice; leave to amend granted limitedly |
| Remedy for improper venue (transfer v. dismissal) | Plaintiffs prefer transfer (to preserve 30‑month stay and avoid ANDA approval) | Teva USA prefers dismissal | Held: Court inclined to transfer to Delaware (defendant’s state of incorporation) in interest of justice; parties to advise consent to transfer |
Key Cases Cited
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (artificial ANDA filing constitutes an act of infringement under Hatch‑Waxman)
- TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (domestic corporate "resides" for §1400(b) means state of incorporation)
- In re Cray, Inc., 871 F.3d 1355 (Fed. Cir.) (§1400(b) "regular and established place of business" requirements and caution against importing other standards)
- Acorda Therapeutics, Inc. v. Mylan Pharm., Inc., 817 F.3d 755 (Fed. Cir.) (planned future conduct relevant to personal jurisdiction in ANDA context)
- In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511 (Fed. Cir.) (definition of who "submits" an ANDA and active involvement)
- Cephalon, Inc. v. Watson Pharm., Inc., 629 F. Supp. 2d 338 (D. Del.) (related entities "actively involved" in ANDA preparation can be deemed submitters)
- Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (safe‑harbor §271(e)(1) covers preclinical research related to regulatory submissions)
- Schnell v. Peter Eckrich & Sons, Inc., 365 U.S. 260 (statutory venue provisions are not to be liberally construed)