Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals USA, Inc.
743 F.3d 1359
Fed. Cir.2014Background
- Takeda owns the ’994 patent directed to an orally disintegrable lansoprazole tablet with fine granules to avoid mouth roughness.
- Zydus filed ANDA seeking to market a generic Prevacid SoluTab; Takeda sued alleging infringement of claim 1 of the ’994 patent.
- Claim 1 requires fine granules with average particle diameter of 400 µm or less, an enteric coating with a sustained-release component, and at least 10% acid-labile lansoprazole, plus a hardness range and disintegration requirement.
- District court adopted a claim construction allowing ±10% in the 400 µm limit; infringement turned on measurement of particle size and whether deagglomeration was required.
- District court held literal infringement and that claim 1 was not invalid; Zydus appealed on both construction and validity grounds.
- This court held that the term should be construed as precisely 400 µm or less, reversed the infringement finding, but affirmed the validity ruling and remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper construction of 400 µm term | Takeda argued for ±10%; Zydus argued for exactly 400 µm. | Zydus contends no deviation; Takeda seeks broader interpretation based on measurement variability. | Term construed precisely at 400 µm or less. |
| Infringement under the corrected construction | Takeda asserted infringement under prior construction using dissection of agglomerates. | Zydus argued the ANDA product would infringe if measurements include deagglomerates; otherwise non-infringing. | No literal infringement; measurement shows 412.28 µm, outside the revised 400 µm limit. |
| Validity: indefiniteness | Zydus argued ambiguity in measurement method could render claim indefinite. | Takeda contended multiple measurement methods each yield valid results. | Not indefinite; multiple methods can report average particle diameter and are sufficiently definite. |
| Validity: enablement and written description | Zydus contended post-formulation particle size and deagglomeration were not described, risking lack of enablement/written description. | Patent discloses laser diffraction and the skilled artisan can measure particle size; enablement satisfied. | Enablement satisfied; no lack of written description; potential need for deagglomeration discussed but not required by claim. |
Key Cases Cited
- Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (claim construction reviewed without deference)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims interpreted in light of specification and prosecution history)
- Renishaw PLC v. Marposs Società per Azioni, 158 F.3d 1243 (Fed. Cir. 1998) (preferred narrow construction aligned with specification)
- Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573 (Fed. Cir. 1996) (narrower meaning appropriate when enabling disclosure supports it)
- Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) (invalidity for indefiniteness where claim targets a moving target)
- Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464 (Fed. Cir. 1993) (definiteness and claim clarity guiding analysis)
- Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc., 619 F.3d 1329 (Fed. Cir. 2010) (post-formulation measurement considerations for enablement/validity)
- PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558 (Fed. Cir. 1996) (definiteness and measurement equivalents)
- Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340 (Fed. Cir. 2012) (enablement analysis standard)