87 F.4th 1361
Fed. Cir.2023Background
- Trintellix (vortioxetine) is FDA-approved to treat major depressive disorder (MDD); plaintiffs Lundbeck and Takeda own compound and method-of-use patents listed in the Orange Book.
- Plaintiffs obtained two later method-of-use patents: the ’096 patent (treating MDD in patients who previously received certain antidepressants and ceased/reduced them due to sexually related adverse events) and the ’910 patent (treating cognitive impairment associated with depression).
- Multiple generics filed ANDAs seeking approval to market vortioxetine for MDD only; defendants used section viii carve-outs to omit the patented indications/data from their proposed labels.
- Plaintiffs sued for induced and contributory infringement of the ’096 and ’910 patents; district court found no induced or contributory infringement and plaintiffs appealed.
- Separate suit: Lupin’s ANDA-supplied manufacturing process was accused of infringing the ’626 process patent; district court construed “reacting” to mean conversion of reactants to products and found Lupin infringed claim 12; Lupin cross-appealed.
- Federal Circuit affirmed noninfringement of the ’096 and ’910 patents, affirmed Lupin’s infringement of the ’626 patent, and did not address the asserted invalidity of the ’096 and ’910 patents.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether §271(e)(2)(A) creates infringement liability when an ANDA seeks approval for a non‑patented use but the drug could be prescribed for a patented use | §271(e)(2)(A) forbids any ANDA submission for a drug when some uses of that drug are patented, regardless of the ANDA’s claimed indication | §271(e)(2)(A) applies only when the ANDA seeks approval for the patented use — ‘‘the use . . . claimed in a patent’’ must be the use for which approval is sought | Affirmed: §271(e)(2)(A) limited to the use for which the ANDA seeks approval (Warner‑Lambert line controls) |
| Induced infringement of claim 7 of the ’096 patent based on ANDA labels | Defendants’ labels (and clinicians’ likely prescribing) will cause doctors to prescribe for the patented patient class, so the labels induce infringement | Labels are FDA‑required/correspond to the branded MDD indication; defendants carved out the inducing material; no affirmative instructions to infringe or new safety info that would create intent to encourage infringement | Affirmed: no inducement — labels do not demonstrate the specific intent and affirmative steps required for inducement |
| Contributory infringement under §271(c) for selling the ANDA products | Selling the product knowing physicians will use it for the patented methods makes defendants contributorily liable | There are substantial noninfringing uses (MDD generally, patients not in claimed subgroups), and §271(c) only looks to the asserted patent’s scope | Affirmed: no contributory infringement because substantial noninfringing uses exist and scienter element applies |
| Claim construction of “reacting” in the ’626 process patent and infringement | Plaintiffs: “reacting” = ordinary meaning — changing reactant(s) to product(s) (broad) | Lupin: “reacting” requires that named compounds be added as starting materials at the beginning of the process (narrow) | Affirmed: “reacting” construed broadly as conversion of reactants to products; district court did not err and Lupin infringed under that construction |
Key Cases Cited
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (Hatch‑Waxman framework, Orange Book, and section viii carve‑out mechanism)
- Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (§271(e)(2) liability limited to uses for which ANDA seeks approval)
- AstraZeneca Pharms. LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) (Warner‑Lambert principles apply even when patented use overlaps approved NDA indication)
- Takeda Pharms. U.S.A., Inc. v. West‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. 2015) (inducement requires specific intent to encourage infringement)
- Metro‑Goldwyn‑Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (2005) (examples of active steps that can support inducement liability)
- Global‑Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011) (§271(c) contains a scienter requirement for contributory infringement)
- Vanda Pharm. Inc. v. West‑Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) (labels that impose necessary safety steps can support inducement)
- Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 845 F.3d 1357 (Fed. Cir. 2017) (label instructions to take a co‑administered product may support inducement)