Senju Pharmaceutical Co. v. Apotex Inc.
746 F.3d 1344
Fed. Cir.2014Background
- Senju filed suit in Delaware district court alleging infringement of claims 6 and 12-16 of Senju’s reexamined U.S. Patent No. 6,333,045 (the '045 patent) by Apotex’s Gatifloxacin ophthalmic solution under ANDA No. 79-084.
- Apotex moved to dismiss, arguing claim preclusion barred the second action because Senju previously sued over the same patent before reexamination.
- In the first action, the district court found original claims 1-3, 6-9 invalid as obvious, and final judgment followed in 2011; Senju’s claim 7 was specifically upheld invalid on that basis.
- Senju requested reexamination; the PTO granted it, and in 2011 issued a reexamination certificate cancelling claims 1-3 and 8-11 and patenting amended claim 6, new claim 12, and new dependent claims 13-16.
- Senju’s second suit filed November 28, 2011, during the post-remand period but before final judgment in the first action, asserted infringement of the reexamined claims 6 and 12-16.
- The district court dismissed the second action as barred by claim preclusion, holding reexamined claims did not create a new cause of action because they were not broader than the original claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether reexamined claims create a new cause of action | Senju: reexamined claims may grant new rights not in original action. | Apotex: reexamined claims are within the same patent rights; no new action. | Reexamined claims do not create a new action; barred. |
| Whether products in both actions were essentially the same | Senju: differences in claims matter; may avoid preclusion. | Apotex: identical product described in ANDA No. 79-084; overlap supports preclusion. | Yes, the product overlap supports claim preclusion. |
| Whether the same patent rights were involved in both suits | Senju: reexamined claims can create rights not asserted earlier. | Apotex: reexamined claims cannot broaden beyond original and thus do not create new rights. | Reexamined claims do not create a new action; same patent rights for purposes of preclusion. |
| Impact of Aspex Eyewear on this case | Senju: Aspex requires detailed comparison of reexamined vs original claims to determine overlap. | Apotex: Aspex supports treating reexamined claims as non-new if not broader. | Aspex supports no new grounds to assert infringement; reexamined claims here are not a new action. |
| Whether reexamination can ever yield a material difference creating a new action | Senju: possible, requiring remand to compare material differences. | Apotex: reexamination cannot broaden claims; no new action. | Not necessary to opine; no material difference shown here; preclusion applies. |
Key Cases Cited
- Acumed LLC v. Stryker Corp., 525 F.3d 1319 (Fed. Cir. 2008) (define overlap-based preclusion analysis in patent cases)
- CoreStates Bank, N.A. v. Huls Am., Inc., 176 F.3d 187 (3d Cir. 1999) (three-factor test for claim preclusion in Third Circuit)
- Lawlor v. Nat'l Screen Serv. Corp., 349 U.S. 322 (Supreme Court 1955) (final judgment bars claims that could have been raised)
- Kearns v. Gen. Motors Corp., 94 F.3d 1553 (Fed. Cir. 1996) (each patent asserted generally constitutes a separate cause of action)
- Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335 (Fed. Cir. 2012) (reexamined claims not broader than original do not create new rights)
- Superior Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358 (Fed. Cir. 2001) (presumption of validity applies to reexamined claims)
- Superior Fireplace Co. v. Majestic Prods. Co., 540 F.3d 1358 (Fed. Cir. 2001) (reexamination claims are limited by original patent)
- C.I.R. v. Sunnen, 333 U.S. 591 (Supreme Court 1948) (final judgments bind as to all matters raised or that could have been raised)
- Cromwell v. Sac Co., 94 U.S. 351 (Supreme Court 1876) (operational framework for res judicata)
- Transclean Corp. v. Jiffy Lube Int'l, Inc., 474 F.3d 1298 (Fed. Cir. 2007) (same patent and same accused device support preclusion)
