Celgene Corporation v. Mylan Pharmaceuticals Inc.
17 F.4th 1111
Fed. Cir.2021Background
- Celgene markets pomalidomide (Pomalyst) and sued Mylan entities after Mylan Pharmaceuticals, Inc. (MPI) submitted an ANDA with paragraph IV certifications seeking approval to market a generic during patent term.
- Celgene filed suit in the District of New Jersey; MPI is based in West Virginia, Mylan Inc. in Pennsylvania, and Mylan N.V. (a foreign parent) in Pennsylvania/the Netherlands.
- The district court, after venue-focused discovery, dismissed MPI and Mylan Inc. for improper venue under 28 U.S.C. § 1400(b) and dismissed Mylan N.V. for failure to state a claim; Celgene’s request for leave to amend was denied.
- Key factual findings: the ANDA was signed and submitted by MPI (not by Mylan N.V.); employees of MPI/Mylan Inc. lived in NJ (homes and a few employee-rented storage lockers), and a now-dissolved affiliate (MLI) formerly maintained an NJ office.
- Celgene argued venue based on (a) nationwide effect of the ANDA and paragraph IV notice to Celgene’s NJ HQ, (b) imputing employee home/locker/MLI office locations to MPI and Mylan Inc., and (c) asserting Mylan N.V. participated in or controlled the ANDA submission. The court rejected each theory.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether defendants "committed acts of infringement" in NJ for §1400(b) venue | ANDA submission has nationwide effect; paragraph IV notice sent to Celgene in NJ makes NJ an infringing locus | Venue hinges on where the ANDA was submitted; only the ANDA submission (not subsequent notice) constitutes the past infringing act | Submission of an ANDA is the infringing act; venue depends on where the ANDA was submitted — paragraph IV notice receipt in NJ is not the infringing act; Celgene failed to show infringement in NJ |
| Whether MPI and Mylan Inc. had a "regular and established place of business" in NJ (employee homes/lockers) | Employee homes, business cards, LinkedIn, job postings, and storage lockers show regular places of business in NJ | Homes/lockers were employee-chosen, not owned/leased/controlled by defendants; no evidence defendants ratified those locations | Employee homes and lockers did not qualify as defendants' regular and established places of business under Cray; venue improper for MPI and Mylan Inc. |
| Whether MLI's (defunct subsidiary) NJ office should be imputed to MPI/Mylan Inc. | MLI’s NJ office, shared personnel/branding, and corporate interrelations mean venue should be imputed to related Mylan entities | Corporate separateness was maintained; Celgene failed to prove alter-ego/veil-piercing or ratification of MLI office by MPI/Mylan Inc. | Venue not imputed from MLI absent a showing of disregard for corporate form or ratification; Celgene failed to pierce the veil or show ratification |
| Whether Celgene adequately pleaded that Mylan N.V. submitted or was liable for the ANDA | Allegations that defendants act in concert, that MPI is controlled by/alter ego of Mylan N.V., and that the Mylan family filed the ANDA suffice to state a claim | The ANDA was signed by MPI; allegations against Mylan N.V. are conclusory, lacking nonconclusory facts showing active involvement, agency, or alter-ego | Dismissal of Mylan N.V. for failure to state a claim affirmed; pleadings were conclusory and did not plausibly allege Mylan N.V. submitted the ANDA or was alter ego; denial of leave to amend not an abuse of discretion |
Key Cases Cited
- Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., 978 F.3d 1374 (Fed. Cir.) (ANDA submission is the infringing act for Hatch-Waxman venue purposes)
- In re Cray Inc., 871 F.3d 1355 (Fed. Cir.) (three-part test for a defendant's "regular and established place of business")
- In re Rosuvastatin Calcium Pat. Litig., 703 F.3d 511 (Fed. Cir.) (entity actively involved in preparation/submission and benefit from ANDA can be a "submitter")
- Andra Grp., LP v. Victoria's Secret Stores, L.L.C., 6 F.4th 1283 (Fed. Cir.) (plaintiff bears burden to establish proper venue in patent cases)
- TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (Sup. Ct.) (§1400(b) is the exclusive venue statute for patent cases)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (Sup. Ct.) (overview of Hatch-Waxman ANDA framework)
- FTC v. Actavis, Inc., 570 U.S. 136 (Sup. Ct.) (paragraph IV notice and Hatch-Waxman framework context)
- Ashcroft v. Iqbal, 556 U.S. 662 (Sup. Ct.) (plausibility pleading standard)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (Sup. Ct.) (plausibility standard and pleading requirements)
- Pearson v. Component Tech. Corp., 247 F.3d 471 (3d Cir.) (Third Circuit alter-ego/veil-piercing factors)