880 F.3d 1315
Fed. Cir.2018Background
- Janssen filed application No. 08/192,093 (’093), designated as a continuation‑in‑part (CIP) of application No. 08/013,413 (’413) and No. 08/010,406 (’406); U.S. Patent No. 6,284,471 (’471) issued from the ’093 application.
- The ’413 parent had a restriction requirement separating several groups (including antibodies and treatment methods); Janssen elected certain groups but the ’093 CIP still contained matter from both the ’413 and the ’406 applications.
- Other related applications (including ’102 and ’799) issued as reference patents (notably U.S. Pat. Nos. 5,656,272 and 5,698,195) that the PTO later used in a double‑patenting rejection against claims 1–7 of the ’471 patent.
- Janssen, during a 2013 ex parte reexamination, amended the ’471 patent to delete the benefit claim to the ’406 application and sought to conform the specification and designate the ’093 as a divisional for § 121 safe‑harbor protection; the PTO entered the amendments for reexamination purposes but did not confirm divisional status.
- The examiner and the Patent Trial and Appeal Board rejected Janssen’s § 121 defense, applied the one‑way obviousness‑type double patenting test, and affirmed rejection of claims 1–7; Janssen appealed.
Issues
| Issue | Plaintiff's Argument (Janssen) | Defendant's Argument (PTO/Board) | Held |
|---|---|---|---|
| Whether § 121 safe‑harbor protects the ’471 patent | Janssen: reexamination amendments redesignating the CIP as a divisional (and deleting ’406 matter) bring the patent within § 121 | PTO: CIP issued patent cannot be retroactively made a divisional by amendment in reexamination; § 121 protects only patents issued on divisional apps | Held: § 121 does not apply; a patent that issued on a CIP cannot be retroactively covered by § 121 via reexamination amendment |
| Whether Janssen’s post‑issuance amendment deprived the public or improperly extended term | Janssen: no issued claims relied on the deleted CIP new matter, so no benefit was obtained | PTO: multiple intervening patents claimed priority through the CIP; redesignation could affect other patents and cannot be retroactive | Held: Janssen cannot retroactively disclaim CIP status; safe harbor denied |
| Whether two‑way double‑patenting test applies | Janssen: PTO’s timing warrants two‑way test because decisions produced an unfair issuance order | PTO: two‑way applies only in narrow ‘‘PTO solely responsible’’ circumstances and basic/improvement ordering; Janssen caused delays | Held: Two‑way test does not apply because (1) filing/issuance facts don’t present the basic/improvement reverse‑order problem and (2) Janssen’s actions contributed to delay; one‑way test applies |
| Whether claims 1–7 are unpatentable for obviousness‑type double patenting | Janssen: protected by § 121 and/or two‑way test would avoid invalidation | PTO: reference patents available; one‑way test shows unpatentability | Held: Claims 1–7 are unpatentable under obviousness‑type double patenting; Board affirmed |
Key Cases Cited
- G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349 (Fed. Cir.) (a patent that issued on a CIP cannot be retroactively brought within § 121 by post‑issuance reissue/redesignation)
- Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir.) (§ 121 protects only patents issued on divisional applications, not CIPs)
- Amgen Inc. v. F. Hoffmann‑La Roche Ltd., 580 F.3d 1340 (Fed. Cir.) (strict application of § 121; continuation patents are not divisional for § 121)
- In re Berg, 140 F.3d 1428 (Fed. Cir.) (two‑way double‑patenting test is narrow and applies when PTO solely caused reverse order of allowance)
- Basell Poliolefine Italia S.P.A. v. ExxonMobil Chem. Co., 547 F.3d 1371 (Fed. Cir.) (distinguishing one‑way and two‑way obviousness‑type double patenting tests)