Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp.
785 F.3d 625
| Fed. Cir. | 2015Background
- Takeda owns patents on specific colchicine dosing regimens for (1) treatment of acute gout flares and (2) prophylaxis when co‑administered with certain CYP3A4/P‑gp inhibitors; colchicine itself is unpatented.
- Hikma obtained FDA approval via a 505(b)(2) paper NDA for Mitigare for prophylaxis of gout (not for acute-flare treatment) and launched Mitigare and planned an authorized generic.
- Takeda sued for induced infringement based on Hikma’s Mitigare labeling and sought a preliminary injunction to stop sales; the district court denied the injunction.
- The district court found Takeda failed to show a likelihood of proving induced infringement and failed to show irreparable harm; an initial TRO (with a 10‑day notice provision) was later vacated on appeal.
- Central factual disputes: whether Hikma’s label (which warns that Mitigare wasn’t studied for acute treatment and tells patients to “tell your healthcare provider” if a flare occurs) constitutes active encouragement that would induce physicians to practice Takeda’s patented methods; whether Mitigare dosing/formulation would realistically be used in the patented DDI dose regimens.
Issues
| Issue | Plaintiff's Argument (Takeda) | Defendant's Argument (Hikma) | Held |
|---|---|---|---|
| Whether Hikma’s Mitigare label induces infringement of Takeda’s acute‑gout method patents | The label’s instruction to patients to tell their providers will inevitably lead physicians to prescribe Mitigare per Takeda’s patented acute‑treatment regimen | The label does not recommend, encourage, or instruct an infringing use; mere knowledge that some physicians may use it off‑label is insufficient | No — plaintiff failed to show likelihood of proving induced infringement; vague label + speculation about physician behavior is insufficient |
| Whether Hikma’s label induces infringement of Takeda’s DDI patents (reduced dosing with certain inhibitors) | The label’s warnings and suggestion to reduce dose or frequency will lead physicians to use Takeda’s patented reduced regimens | Label does not recommend the patented specific regimens; practical barriers (capsule strength, dosing frequency, clinician practices) make direct infringement unlikely | No — insufficient evidence of likely direct infringement and no adequate evidence of inducement |
| Whether substantial non‑infringing uses preclude inferring intent to induce | Takeda: physician practices and availability will lead to infringement despite non‑infringing uses | Hikma: numerous non‑infringing alternatives and labeling disclaimers show lack of intent to promote infringement | Court: presence of substantial non‑infringing uses and lack of label encouragement weigh against inducement finding |
| Whether the district court abused its discretion in denying a preliminary injunction | Takeda: met standards for likelihood of success and irreparable harm | Hikma: Takeda failed to show likelihood of success or causal nexus for irreparable harm | No abuse of discretion; denial of preliminary injunction affirmed |
Key Cases Cited
- Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (knowledge of possible off‑label infringement insufficient for inducement; specific intent required)
- Caraco Pharm. Labs. v. Novo Nordisk A/S, 132 S. Ct. 1670 (U.S. 2012) (Hatch‑Waxman permits approval for some indications without certifying patents for other indications)
- Metro‑Goldwyn‑Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913 (U.S. 2005) (inducement requires active steps to encourage infringing use; mere sale of lawful product is not enough)
- Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed. Cir. 2008) (standard of review for preliminary injunction denial)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) (label instructions that necessarily lead to infringement can support inducement)
- Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263 (Fed. Cir. 2004) (sale of a lawful product with knowledge of infringing uses alone does not constitute inducement)
- Ricoh Co. v. Quanta Computer Inc., 550 F.3d 1325 (Fed. Cir. 2008) (discussion of inducement requiring evidence of promotion or encouragement)