790 F.3d 1349
Fed. Cir.2015Background
- Pfizer sought reissue of the ’068 patent as RE ’048 after prior restriction-driven prosecution across multiple continuations/divisionals.
- The 1994 restriction on the ’594 application led to the ’165 patent; Pfizer later pursued the 1997 restriction on the ’113 application leading to the ’068 patent.
- RE ’048 issued from the reissue of the ’068 patent, which itself issued from the ’113 application (a continuation-in-part with new matter).
- The district court held the RE ’048 patent not properly reissued under 35 U.S.C. § 251 and not protected by § 121 safe harbor, and that it is invalid for obviousness-type double patenting over the ’165 patent.
- This appeal asks (a) whether § 251 authorized reissue under the circumstances, and (b) whether § 121 applies to shield RE ’048 from the ’165 patent in the double-patenting analysis.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether § 251 allowed Pfizer to reissue the ’068 patent | Pfizer argues the alleged error (continuation-in-part) is correctable by reissue under § 251. | The district court rejected the reissue as improper under § 251. | Yes, reissue authorized under § 251. |
| Whether § 121 safe harbor applies to RE ’048 against the ’165 patent | Pfizer reliance on § 121 to shield RE ’048 from § 165 double-patenting. | The safe harbor does not apply because RE ’048 did not issue from a divisional of the original restricted application. | § 121 does not apply to RE ’048. |
Key Cases Cited
- Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368 (Fed. Cir. 2012) (double patenting prevention; general framework for § 121)
- Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) (strict application of § 121 to avoid windfall)
- Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) (requires strict plain-language application of § 121)
- Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) (safe harbor inapplicable to certain continuations/divisionals)
- Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343 (Fed. Cir. 2004) (common-lineage requirement for § 121)
- Boehringer Ingelheim Int’l GmbH v. Barr Labs., Inc., 592 F.3d 1340 (Fed. Cir. 2010) (two restriction requirements must share common lineage)
- In re Serenkin, 479 F.3d 1359 (Fed. Cir. 2007) (reissue/equity considerations under § 251)
- In re Harita, 847 F.2d 809 (Fed. Cir. 1988) (equity considerations in § 251)