ALTANA PHARMA AG v. TEVA PHARMACEUTICALS USA INC
2:04-cv-02355
D.N.J.Oct 11, 2012Background
- This is a patent infringement action involving United States Patent No. 4,758,579 covering pantoprazole and its sodium salt (Pantoprazole).
- Nycomed GmbH owns the '579 patent; Wyeth markets Protonix in the U.S. as Nycomed’s purported exclusive licensee.
- Defendants Teva, Sun, and KUDCo sought FDA approval for generic pantoprazole; the suit followed earlier Hatch-Waxman actions and a 2010 jury verdict in Plaintiffs’ favor.
- Wyeth’s standing rests on an exclusive license from Nycomed granted in 1996–1997, with subsequent amendments expanding Wyeth’s rights, including exclusive rights to manufacture and sell prescription pantoprazole in the U.S. during patent exclusivity.
- The patent expired July 19, 2010; pediatric exclusivity extended protection to January 19, 2011; litigation proceeded on remaining issues, with Wyeth seeking to maintain standing to pursue infringement.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is Wyeth constitutionally standing as exclusive licensee? | Wyeth held exclusive rights to manufacture/sell prescription pantoprazole in the U.S. during exclusivity. | License lacked exclusive rights due to alleged limitations (trademark/generic carve-outs) and potential non-exclusionary provisions. | Wyeth has standing as exclusive licensee; provides injurious rights to exclude infringers. |
| Does the trademark-based interpretation of the license limit Wyeth’s standing? | Section 2.2.1.3 allows exclusive license to market/sell branded and later generic prescription pantoprazole. | License restricted to branded products; generic rights were not encompassed during exclusivity. | Ambiguity in Section 2.2.1.3; court finds Wyeth’s exclusive license extends to prescription pantoprazole during exclusivity. |
| Does patent exhaustion undermine Wyeth’s standing by allowing Nycomed to license pantoprazole compound? | Wyeth’s rights to exclude extend to the field; exhaustion requires actual licensing to others to impact standing. | Nycomed could license pantoprazole compound to others, potentially eroding Wyeth’s rights. | Exhaustion theory insufficient to defeat standing; Wyeth’s injury shown under the license terms. |
| Does OTC carve-out defeat Wyeth’s exclusive license status? | OTC carve-out does not necessarily eliminate Wyeth’s exclusive rights for prescription pantoprazole. | OTC carve-out limits Wyeth to prescription market, potentially undermining exclusivity. | OTC carve-out acknowledged but does not negate Wyeth’s standing as exclusive licensee for prescription pantoprazole. |
Key Cases Cited
- WiAV Solutions LLC v. Motorola, Inc., 631 F.3d 1257 (Fed. Cir. 2010) (standing requires the injury and the right to exclude under patent law)
- Rite-Hite Corp. v. Kelley Co., Inc., 56 F.3d 1538 (Fed. Cir. 1995) (exclusive licensee must show a promise of exclusion in the territory)
- Spine Solutions, Inc. v. Medtronic Sofamor Danek USA, Inc., 620 F.3d 1305 (Fed. Cir. 2010) (evidence of exclusivity must show intent and scope beyond mere corporate structure)
- Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed. Cir. 2006) (unrelated licensing evidence cannot prove exclusivity without explicit terms)
- Powertech Tech. Inc. v. Tessera, Inc., 660 F.3d 1301 (Fed. Cir. 2011) (exhaustion/contracted rights considerations relate to standing)