Ibsa Institut Biochimique v. Teva Pharmaceuticals USA
966 F.3d 1374
Fed. Cir.2020Background
- IBSA owns U.S. Patent No. 7,723,390 covering soft gel/soft elastic capsule formulations of levothyroxine (Tirosint®); Teva filed an ANDA with a Paragraph IV certification and litigation followed.
- Independent claim 1 recites a soft elastic capsule containing a “liquid or half-liquid inner phase” with thyroid hormones; dependent claims 2, 4, and 7–9 depend from claim 1.
- Central dispute: meaning of the term “half-liquid.” IBSA urged it means “semi-liquid” (a semifluid between solid and liquid); Teva argued the term is indefinite (or at least not a well-defined term of art).
- The prosecution history includes an Italian priority application using “semiliquido” and a U.S. filing that used “half-liquid”; a dependent claim once used “semi-liquid” but was deleted during prosecution.
- The district court concluded intrinsic and extrinsic evidence failed to define “half-liquid” with reasonable certainty and held claims 1, 2, 4, and 7–9 invalid under 35 U.S.C. § 112; the Federal Circuit affirmed.
Issues
| Issue | Plaintiff's Argument (IBSA) | Defendant's Argument (Teva) | Held |
|---|---|---|---|
| Whether the term “half-liquid” satisfies § 112 definiteness | “Half-liquid” means “semi-liquid” (a semifluid with thick consistency between solid and liquid) and is sufficiently definite | Term is not a well-known term of art and is indefinite; POSA cannot ascertain boundaries with reasonable certainty | Court held the term indefinite and claims invalid under § 112 |
| Whether the Italian priority application (“semiliquido”) establishes that “half-liquid” = “semi-liquid” | The Italian application uses “semiliquido” in the same contexts, and a certified translation shows “semi-liquid,” so a POSA would treat them as synonyms | Discrepancies between the Italian application and the U.S. filing indicate intentional different word choice; the U.S. filing is more probative | Court gave little weight to the foreign translation and treated differences as indicating distinct meanings |
| Whether extrinsic evidence (dictionaries, other patents, expert testimony) can supply a definite meaning | Dictionaries, exemplar patents, and expert testimony support IBSA’s construction | Extrinsic sources are weak or inapplicable; expert could not define clear boundaries; cited patents use the term in different contexts only | Court found extrinsic evidence unpersuasive and not corrective of intrinsic ambiguity |
| Whether prosecution statements and specification narrow or define the term’s boundaries | IBSA relied on specification passages and prior-art distinctions to show meaning | Teva pointed to prosecution statements distinguishing gels/slurries and to specification language listing half-liquid as distinct from gels/pastes | Court found specification lists and prosecution history indicated alternatives (half-liquid distinct from gels/pastes), but overall ambiguity remained so § 112 not satisfied |
Key Cases Cited
- Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) (indefiniteness standard: claims must inform skilled artisans of scope with reasonable certainty)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (claim construction and public notice rationale)
- HZNP Meds. LLC v. Actavis Labs. UT, Inc., 940 F.3d 680 (Fed. Cir. 2019) (review standards for indefiniteness)
- BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360 (Fed. Cir. 2017) (review of intrinsic vs extrinsic evidence; standards of review)
- Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) (consider claim language first when assessing definiteness)
- SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187 (Fed. Cir. 2013) (disjunctive lists in specifications indicate alternatives)
- Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009) (discrepancies between foreign priority and U.S. filing may be treated as intentional)