Shire Development, LLC v. Watson Pharmaceuticals, Inc.
746 F.3d 1326
Fed. Cir.2014Background
- Shire owns U.S. Patent No. 6,773,720 on mesalamine controlled-release compositions for inflammatory bowel disease sold as LIALDA®.
- Watson sought FDA approval to market a bioequivalent product and Shire sued for infringement.
- The district court construed two claim terms: inner lipophilic matrix and outer hydrophilic matrix, and found infringement.
- The district court held that Watson’s product met the limitations because mesalamine was dispersed in both matrices.
- On appeal, the Federal Circuit reverses the district court’s constructions as impermissibly broad and remands for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Correct construction of inner lipophilic matrix | Matrices must be lipophilic and separate from the outer matrix. | Two-matrix concept is not required to be separate by claim language alone. | Two separate matrices required; inner and outer must be distinct. |
| Correct construction of outer hydrophilic matrix | Outer matrix is a hydrophilic matrix surrounding the inner lipophilic matrix. | Not necessarily require spatial separation or distinct matrices. | Same as above; outer must be separate from inner. |
| Prosecution history and disclaimer | No unambiguous disclaimer limiting the scope to two separate matrices. | Prosecution history informs claim scope, even if not unambiguous disavowal. | Prosecution history informs construction; does not require abandonment of dual-matrix requirement. |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims are construed to stay true to the claim language and description)
- Grober v. Mako Prods., Inc., 686 F.3d 1335 (Fed. Cir. 2012) (prosecution disclaimer requires unambiguous disavowal)
- Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) (prosecution disclaimer governs claim scope)
- Ekchian v. Home Depot, Inc., 104 F.3d 1299 (Fed. Cir. 1997) (prosecution history informs, but not invariably limits)
- Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009) (de novo review of prosecution disclaimer)