72 F. Supp. 3d 539
D. Del.2014Background
- Takeda sues Hikma for induced infringement under 35 U.S.C. § 271(b) seeking a preliminary injunction.
- Patents cover methods of colchicine administration for acute gout flares and prophylaxis, with Hikma’s Mitigare™ labeled for prophylaxis only.
- Hikma pursued NDA pathway under § 505(b)(2) with a label omitting patented indications; FDA ANDA route not used.
- Court granted TRO, then denied Takeda’s preliminary injunction after expanded record.
- Key issues include whether Hikma induced infringement, and whether Takeda proved irreparable harm and patent validity.
- Court analyzes AstraZeneca v. Apotex and related 271 theories to assess intent and label impact.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Likelihood of infringement | Takeda contends Hikma induces infringement via label directing off-label use. | Hikma argues its label does not instruct or encourage infringement; risks are not clearly directed to patented methods. | No likelihood of inducement proven at this stage. |
| Active steps to encourage infringement | Label and marketing evidence demonstrate affirmative steps to promote infringing uses. | Label warns and avoids explicit instructions; not enough to show active encouragement. | Insufficient evidence of affirmative steps to induce infringement. |
| Irreparable harm | Market shift to infringing product would irreparably harm Takeda. | Noninfringing uses exist; market reality weakens irreparable harm showing. | Takeda failed to prove irreparable harm. |
| Validity of patents | Prior art does not disclose the claimed low-dose regimens; patents likely valid. | Prior art shows some relevance but not enabling disclosures; but challenges lack substantial question. | No substantial question as to validity. |
| DDI patents and labeling | Label recommending avoidance or dose adjustments implies infringement potential. | Label is a warning, not an instruction; no direct or induced infringement proven. | Induced infringement not established for DDI patents. |
Key Cases Cited
- eBay, Inc. v. MercExchange, LLC, 547 U.S. 388 (U.S. 2006) (injunctions are extraordinary and granted on equitable grounds)
- Kos Pharma., Inc. v. Andrx Corp., 369 F.3d 700 (3d Cir. 2004) (preliminary injunctions require likelihood of success and irreparable harm)
- DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (inducement requires affirmative steps to promote infringement)
- Grokster, Ltd. v. MGM, 545 U.S. 913 (U.S. 2005) (intent to induce infringement requires statements or actions directed to promoting infringement)
- Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003) (substantial noninfringing uses cannot prove inducement from mere knowledge)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) (label language and downward titration considerations in inducement analysis)
- AstraZeneca Pharmaceuticals LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) (271(e)(2) scope aligns with ANDA indication and labeling context)
- Barzingus v. Wilheim, 306 F.3d 17 (10th Cir. 2010) (arbitrary examples; (not central to this opinion but cited in some analyses))
- Apple Inc. v. Samsung Electronics Co., 678 F.3d 1314 (Fed. Cir. 2012) (market realities and consumer choice affecting irreparable harm analysis)