802 F.3d 1301
Fed. Cir.2015Background
- Consolidated Hatch-Waxman litigation over LDX mesylate patents ('486, '630, '253, '787) between Shire and ANDA defendants plus Johnson Matthey; claims cover mesylate salts of LDX and its use.
- Shire markets Vyvanse(s) with LDX dimesylate; FDA-approved capsules listed in Orange Book.
- ANDAs filed with Paragraph IV certifications alleging invalidity or noninfringement; Shire sued under 35 U.S.C. §271(e).
- District court granted summary judgment on nonobviousness and certain infringement issues; Johnson Matthey induced infringement finding upheld unclear after appeal; on-sale-bar amendment denied.
- Court reviews de novo; local patent rules applied; district court denied motion to amend on on-sale bar; case remanded for Johnson Matthey issue and related proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of the asserted claims | Shire argues AU'168 discloses LDX and renders salts obvious | Defendants contend AU'168 and Miller render LDX obvious | Obviousness nonproved; claims not invalid as obvious |
| Denial of amendment to include on-sale bar defense | Shire argues timely amendment; good cause shown | Defendants claim untimely; prejudice to Shire | District court did not abuse discretion; amendment denied |
| Induced infringement of compound claims by Johnson Matthey | Shire argues JM induced infringement via supplying API | JM protected by 271(e)(1) safe harbor; no direct/induced liability yet | Reverse judgment on induced infringement; JM not liable currently; remanded for further proceedings |
Key Cases Cited
- Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 1263 (Fed. Cir. 2007) (Can be liable under 271(e)(2) for future infringement via 271(b) (context for inducement))
- Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363 (Fed. Cir. 2008) (Motivation required for combining references; obviousness requires reasoned pathway)
- Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008) (Hindsight cannot form the basis for obviousness)
- Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352 (Fed. Cir. 2011) (AU'168 did not render mesylate salts obvious)
- Microsoft Corp. v. i4i Ltd., 131 S. Ct. 2238 (2011) (Patent validity presumption; clear and convincing standard)
- O2 Micro Int’l Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355 (Fed. Cir. 2006) (Standards for reviewing summary judgments in patent cases)