ALTANA PHARMA AG v. TEVA PHARMACEUTICALS USA INC
2:04-cv-02355
D.N.J.May 14, 2013Background
- Altana Pharma AG and Wyeth sue Teva and others in D.N.J. over pantoprazole (Protonix) market effects.
- Teva moves in limine to preclude price erosion joint liability, lost royalties damages, R&D cost evidence, at-risk launches other than pantoprazole, and PPI-drug interactions evidence.
- Court denies Teva’s motion in limine in full after analysis of arguments and evidence.
- Standard framework: motions in limine; Rule 702 expert admissibility; Rule 403 balancing; gatekeeping duties.
- Court notes prior orders allow Nycomed to pursue lost royalties beyond a 5% patent royalty and that lost royalties may be proven with evidence at trial.
- Parties may renew or object at trial depending on context and foundation for specific evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Lost royalties theory admissibility | Nycomed seeks lost royalties beyond 5% patent royalty. | Nycomed mislabeled lost profits as royalties; limit to 5% patent royalty. | Nycomed may present a lost royalties theory; not limited to 5% patent royalty. |
| Joint and several liability for price erosion | Sun and Teva should be jointly and severally liable for price erosion damages. | Liability issue for joint/several not resolved here; to be addressed at oral argument. | Denied pending separate oral argument ruling. |
| Costs of R&D evidence | Non-quantitative background on R&D helps contextualize Hatch-Waxman dynamics. | Average R&D costs are irrelevant or prejudicial without product-specific tying. | Rule 401/403 context pending; no pretrial exclusion; denial of motion. |
| At-risk generic launches evidence | Other at-risk launches bolster reliability of Teva forecasts and market interchangeability. | Irrelevant to Pantoprazole damages; risks inflating damages. | Denied; evidence may be admissible with proper foundation. |
| Drug interactions (clopidogrel with PPIs) in damages trial | Cross-examination on safety and interchangeability of PPIs relevant if Teva asserts all PPIs are interchangeable. | Issue not relevant to damages and lacks expert support. | Denied to preclude; cross-examination allowed if testimony supports interchangeability claim. |
Key Cases Cited
- Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (Sup. Ct. 1993) (gatekeeping for reliability and relevance of expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Sup. Ct. 1999) (broadened Daubert to non-scientific expert testimony)
- Pineda v. Ford Motor Co., 520 F.3d 237 (3d Cir. 2008) (liberal policy of admissibility under Rule 702; reliable methodology)
- Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538 (Fed. Cir. 1995) (damages must be adequate to compensate for infringement)
- King Instruments Corp. v. Perego, 65 F.3d 941 (Fed. Cir. 1995) (Section 284 broad damages scope; no limit to injury types)
- BIC Leisure, L.P. v. Windsurfing Int’l, Inc., 1 F.3d 1215 (Fed. Cir. 1993) (lost royalties concepts and 'but for' causation in damages)
- ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254 (3d Cir. 2012) ( Daubert framework; reliability and fit considerations)
- Oddi v. Ford Motor Co., 234 F.3d 136 (3d Cir. 2000) (liberal admissibility standard for expert testimony)
- United States v. Abel, 469 U.S. 45 (Sup. Ct. 1984) (pretrial evidentiary ruling discretion)