Valeant Pharmaceuticals v. Mylan Pharmaceuticals, 978 F.3d 1374

After TC Heartland narrowed patent venue, Valeant (brand/NDA holder) sued Mylan entities under the Hatch‑Waxman Act after MPI filed an ANDA (Paragraph IV) for a generic of Jublia; the ANDA was sent from MPI’s West Virginia office to the FDA in Maryland.
Valeant filed in D.N.J., alleging that New Jersey was a likely distribution destination; Mylan moved to dismiss for improper venue (Fed. R. Civ. P. 12(b)(3)) and moved under 12(b)(6) against the foreign affiliate MLL.
The district court held the relevant infringing act was the ANDA submission (occurring in West Virginia/Maryland), dismissed the case for improper venue as to all defendants, and did not resolve the 12(b)(6) challenge to MLL.
The Federal Circuit addressed whether §1400(b)’s “acts of infringement” in §271(e)(2) cases include contemplated future distribution (nationwide) or are limited to past acts tied to the ANDA submission.
The court held that for §271(e)(2)(A) claims the infringing act is the ANDA submission (and related acts tied to submission), so venue is proper only in districts where actions related to the ANDA submission occurred—not in every district where future distribution is contemplated.
Result: affirmed dismissal for improper venue as to MPI and Mylan Inc.; vacated and remanded the dismissal of foreign defendant MLL so the district court can consider the 12(b)(6) arguments (venue for foreign defendants is proper in any district).

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether §1400(b) "acts of infringement" in §271(e)(2) ANDA cases includes planned future distribution (nationwide)	"Acts" include planned future marketing/distribution; venue proper where product likely to be sold	"Acts" are past acts; the ANDA submission (and related submission activities) is the infringing act that determines venue	Acts are past; venue is limited to districts tied to ANDA submission (not all contemplated distribution)
Whether dismissal of foreign defendant MLL was proper without addressing 12(b)(6) plausibility of being a "submitter"	Complaint sufficiently alleges Mylan (collectively) submitted the ANDA or that MLL participated in preparation and benefits (Rosuvastatin)	Complaint alleges MPI alone submitted the ANDA; MLL not a proper §271(e) defendant	District court erred to dismiss MLL on venue grounds without ruling on 12(b)(6); remand for district court to decide if MLL plausibly is a submitter; venue for foreign defendants is proper in any district

TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017) (holds §1400(b) "resides" means state of incorporation and limits patent‑case venue)
Fourco Glass Co. v. Transmirra Prods. Corp., 353 U.S. 222 (1957) (historic interpretation of patent venue statute)
Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016) (planned future acts can support personal jurisdiction in ANDA cases)
In re Cray Inc., 871 F.3d 1355 (Fed. Cir. 2017) (narrow construction of §1400(b) "regular and established place of business")
In re Google LLC, 949 F.3d 1338 (Fed. Cir. 2020) (agents' activities do not substitute for defendant's own place of business under §1400(b))
In re Rosuvastatin Calcium Patent Litig., 703 F.3d 511 (Fed. Cir. 2012) (who counts as an ANDA "submitter" for Hatch‑Waxman liability)
Schnell v. Peter Eckrich & Sons, Inc., 365 U.S. 260 (1961) (venue statutes are not to be liberally construed for policy reasons)
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) (characterizing ANDA submission as a "highly artificial act of infringement")