Cubist Pharmaceuticals, Inc. v. Hospira, Inc.
805 F.3d 1112
Fed. Cir.2015Background
- Cubist owns five daptomycin patents; Hospira sought a generic; Hatch-Waxman action filed for infringement.
- The five patents include the ’071 reissue (covering daptomycin compounds/formulations), the ’689 and ’967 (dosage regimens), and the ’238 and ’342 (purification).
- District court held four patents invalid for obviousness; the ’071 patent was upheld as valid and infringed if the certificate of correction is proper.
- A certificate of correction changed the Formula 3 diagram from L-Asn to D-Asn; Hospira challenged scope, arguing broadening of claims.
- The court treated the diagram change as a mere correction, not a broadening of claim scope, and upheld validity under 35 U.S.C. § 255 and written description.
- Cross-appeal: Cubist challenged the district court’s obviousness rulings on the dosing and purity patents; those four patents were found invalid for obviousness.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Validity/scope of certificate of correction for ’071 | ’071 is directed to daptomycin; correction aligns diagram with specification. | Correction broadens claim scope to cover daptomycin; invalid under § 255. | Correction did not alter scope; upheld validity. |
| Written description adequacy for ’071 patent | Specification shows possession of daptomycin despite diagram error. | Written description insufficient to support broader corrected structure. | Written description satisfied; not invalid for lack of description. |
| Recapture rule applicability to reissued patent | Reissue claims broaden beyond original; recapture should invalidate. | Reissue narrowed; no recapture violation. | Recapture rule not violated; claims remain valid. |
| Obviousness of dosing patents ’967 and ’689 | Prior art did not suggest once-daily/48-hour regimens with reduced toxicity. | Prior art/disclosures and pharmacokinetics render dosing regimens obvious. | Dosing patents invalid for obviousness. |
| Obviousness of purity patents ’238 and ’342 | Purification steps (micelle filtration + ion exchange) were nonobvious improvements. | Techniques were known; purification levels were obvious with conventional methods. | Purity claims invalid for obviousness. |
Key Cases Cited
- Regents of Univ. of N.M. v. Knight, 321 F.3d 1111 (Fed. Cir. 2003) (structure is not the invention; consider the specification)
- Bayer v. Dow Agrosciences LLC, 728 F.3d 1324 (Fed. Cir. 2013) (broad claim construction risks invalidity; independent of mono/dioxygenase)
- Superior Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358 (Fed. Cir. 2001) (recapture/governs when a correction broadens claim scope)
- Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052 (Fed. Cir. 2005) (written description sufficiency; possession of invention)
- Wallach (In re Wallach), 378 F.3d 1330 (Fed. Cir. 2004) (possession vs. structure in written description context)
- Pannu v. Storz Instruments, Inc., 258 F.3d 1366 (Fed. Cir. 2001) (recapture/subject matter surrendered during prosecution)
- In re Clement, 131 F.3d 1464 (Fed. Cir. 1997) (recapture framework and analysis)
- In re Mostafazadeh, 643 F.3d 1353 (Fed. Cir. 2011) (recapture scope and narrowing considerations)
- In re Youman, 679 F.3d 1335 (Fed. Cir. 2012) (recapture analysis for broader reissues)