GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.
313 F. Supp. 3d 582
D. Del.2018Background
- GSK owns U.S. Reissue Patent RE40,000 (the '000 patent) claiming a method of decreasing mortality caused by congestive heart failure (CHF) using carvedilol for a maintenance period > six months; Coreg® was marketed for CHF.
- Teva obtained FDA approval to sell generic carvedilol. From Jan 2008–Apr 2011 Teva used a "skinny" (carve‑out) label excluding the CHF indication; from May 2011–June 2015 Teva used a full/amended label that included the CHF indication.
- GSK sued for induced infringement; a jury found willful induced infringement during the skinny label for some claims and willful inducement during the full label for all asserted claims, no invalidity, and awarded lost profits and a reasonable royalty.
- Teva moved for JMOL (or new trial) arguing lack of causation/inducement, lack of willfulness, and invalidity; GSK moved for enhanced damages and fees.
- The court reviewed the trial record, focused on whether Teva’s conduct actually caused physicians to prescribe carvedilol for the patented CHF use, and evaluated whether substantial evidence supported the jury’s inducement verdict.
Issues
| Issue | Plaintiff's Argument (GSK) | Defendant's Argument (Teva) | Held |
|---|---|---|---|
| Inducement during skinny‑label period | Teva’s AB‑rating, product literature, and market presence caused physicians (as a class or at least one) to prescribe generics for CHF despite carve‑out | Teva’s skinny label expressly omitted CHF; physicians relied on prior clinical literature, guidelines, GSK promotion, and their own knowledge — not Teva’s label | JMOL granted for Teva — no substantial evidence that Teva caused (as a class or any physician) direct infringement during skinny period |
| Inducement during full‑label period | Teva’s amended full label and marketing materials caused physicians to prescribe generics for the patented CHF use | Even after label change physicians were already prescribing for CHF for non‑Teva reasons; no evidence Teva caused a change in prescribing | JMOL granted for Teva — no substantial evidence of causation for full period either |
| Damages, willfulness, enhanced fees | GSK asserted willfulness and sought lost profits/enhancement based on jury finding | Teva argued no liability if inducement fails; jury award excessive absent causation | Because inducement reversed, willfulness and damages/enhancement claims moot; GSK’s motion denied as moot |
| Invalidity (anticipation/obviousness) | Teva argued Kelly ± Garg anticipate or render claims obvious | GSK argued factual disputes (duration, population, enablement) and secondary considerations rebut obviousness | JMOL denied for Teva — jury reasonably found no anticipation or obviousness; substantial evidence supported patent validity |
Key Cases Cited
- Warner‑Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir.) (a skinny label that omits the patented use does not itself induce infringement)
- Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334 (Fed. Cir.) (reviewing court must consider uncontradicted evidence favoring moving party when assessing JMOL)
- Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263 (Fed. Cir.) (distinguishes class‑wide inducement theories from proofs identifying individual acts of direct infringement)
- Sanofi‑Aventis v. Watson Labs., 875 F.3d 636 (Fed. Cir.) (posture where inducement before launch focuses on intent; different analysis when actual post‑launch conduct exists)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (U.S.) (section viii carve‑out mechanism for generics)
- Takeda Pharms. U.S.A., Inc. v. West‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir.) (a proposed label avoiding a patented use can avoid infringement)