Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117

Background

Vanda (licensee) owns U.S. Patent No. 8,586,610 (the '610 patent), claiming a method of treating schizophrenia with iloperidone where dosage is selected based on CYP2D6 genotype (poor metabolizers receive ≤12 mg/day; others >12 up to 24 mg/day).
West‑Ward filed an ANDA seeking approval to sell generic iloperidone (including strengths up to 12 mg) and amended its ANDA after issuance of the '610 patent to include a Paragraph IV certification asserting invalidity/noninfringement.
Vanda sued alleging infringement under 35 U.S.C. § 271(e)(2); the district court held the asserted claims (claims 1–9, 11–13, 16) valid and infringed (induced infringement based on West‑Ward’s proposed label) and enjoined West‑Ward; West‑Ward appealed.
Key legal questions included: (1) whether the district court had jurisdiction under Hatch‑Waxman when the patent issued after the ANDA filing, (2) whether an ANDA amendment submitting a Paragraph IV to a later‑issued patent can constitute § 271(e)(2) infringement, (3) whether the proposed label induces infringement of the method claims, (4) § 101 eligibility, (5) written description, and (6) availability of § 271(e)(4) remedies (injunction/effective date relief).
The Federal Circuit affirmed: it held jurisdiction proper, amendments to an ANDA (Paragraph IV for a patent issuing after the ANDA) can trigger § 271(e)(2) infringement, the label supports an inducement finding, the claims are § 101‑eligible, written description was adequate for the poor‑metabolizer dosage range, and § 271(e)(4) relief was available to support the injunction.

Issues

Issue	Vanda (Plaintiff) Argument	West‑Ward (Defendant) Argument	Held
Jurisdiction under Hatch‑Waxman for a suit filed before ANDA amendment/certification for a later‑issued patent	Vanda alleged § 271(e)(2) filing created federal question jurisdiction under 28 U.S.C. § 1338(a); an actual controversy existed	West‑Ward said § 271(e)(2) cannot apply to patents issued after ANDA filing and that no Paragraph IV existed at complaint filing	Court: jurisdiction proper under § 1338(a); merits of § 271(e)(2) are separate from jurisdictional inquiry
Does amending an ANDA to add a Paragraph IV for a patent that issued after the ANDA can constitute an act of infringement under 35 U.S.C. § 271(e)(2)(A)?	Yes—amendments/supplements are contemplated by statute and FDA practice; a Paragraph IV submitted after patent issuance may be a qualifying act	No—§ 271(e)(2) should only apply to patents that issued before the initial ANDA filing; “application” excludes later amendments	Court: Amendment submitting a Paragraph IV to a later‑issued patent can be an act of infringement under § 271(e)(2)(A)
Induced infringement based on proposed label (does label recommend/practice claimed steps and show specific intent?)	Label recommends genotyping, obtaining biological samples, and specific dosing tied to genotype; label instructions support inference of specific intent to induce	Label text cannot constitute direct infringement; insufficient proof of physicians directly practicing claims and insufficient specific intent; noninfringing uses predominate	Court: Label recommends genotyping and dosing steps; induced infringement proven (no bar from substantial noninfringing uses for inducement)
Patent eligibility under 35 U.S.C. § 101 (Mayo/Alice framework)	Claims are patent‑eligible: they are treatment methods applying a natural relationship to specific dosage regimens and thus not directed to a law of nature	Claims are directed to natural law (relationship among iloperidone, CYP2D6 metabolism, and QT prolongation) and lack an inventive concept (Mayo/Myriad)	Court: Claims are not directed to a patent‑ineligible concept at step 1; they recite a specific method of treatment and are § 101‑eligible
Written description for claimed dosage ranges (esp. poor metabolizers)	Specification and examples, plus data, support possession of the 12 mg/day or less range for poor metabolizers	Specification lacks explicit experiments at the claimed 12 mg/day or less and data are insufficient	Court: No clear error — specification and examples adequately convey possession for the poor‑metabolizer dosage; non‑poor dosage challenge waived
Availability of injunctive relief / effective FDA approval date adjustment (§ 271(e)(4))	§ 271(e)(4) remedies apply when infringement under § 271(e)(2) is found and support injunction/effective date relief	FDA practice for other ANDAs and the timing of patent issuance limit availability; district court erred in stating § 271(e)(4) unavailable	Court: § 271(e)(4) remedies apply; district court’s injunction is affirmed and may be sustained under § 271(e)(4)

Key Cases Cited

AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir.) (establishes that alleging § 271(e)(2) infringement supplies district court jurisdiction under § 1338(a))
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (U.S.) (explains § 271(e)(2) creates an artificial act of infringement and supports federal jurisdiction)
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (U.S.) (context on Hatch‑Waxman and the artificial infringement concept)
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (U.S.) (framework for laws‑of‑nature analysis under § 101)
Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (U.S.) (distinguishes patentability of natural DNA vs. applications/claims)
Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir.) (method claims applying natural abilities may be § 101‑eligible if directed to a new, useful method)
Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir.) (off‑label use context and caution about inferring intent to induce when noninfringing uses dominate)
Takeda Pharm. U.S.A., Inc. v. West‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir.) (label language can show inducement when it instructs the patented method)
Sanofi v. Watson Labs. Inc., 875 F.3d 636 (Fed. Cir.) (inducement can be found even if product has substantial noninfringing uses when label promotes infringing use)