Shire Development, LLC v. Watson Pharmaceuticals, Inc.
787 F.3d 1359
Fed. Cir.2015Background
- Shire owns U.S. Patent No. 6,773,720 covering a mesalamine (5-ASA) controlled‑release oral composition with an inner lipophilic matrix and an outer hydrophilic matrix, and 80–95% active ingredient by weight.
- The patent teaches forming discrete lipophilic matrix granules (inner) then mixing/compressing them with hydrophilic excipients (outer) to produce tablets.
- Watson filed an ANDA to market a LIALDA® bioequivalent; Shire sued for infringement of claims 1 and 3 of the ’720 patent.
- The district court construed “inner lipophilic matrix” and “outer hydrophilic matrix” broadly (matrix containing at least one respective excipient and located inside/outside another substance) and found Watson’s product infringed.
- On appeal, this Court reversed two claim‑term constructions and remanded; the Supreme Court vacated and remanded for reconsideration in light of Teva v. Sandoz. On remand, the Federal Circuit again reviews constructions de novo (no underlying factual findings) and reverses the district court.
Issues
| Issue | Plaintiff's Argument (Shire) | Defendant's Argument (Watson) | Held |
|---|---|---|---|
| Proper construction of “inner lipophilic matrix” and “outer hydrophilic matrix” | Terms need not require fully separate/distinct matrices; prosecution language didn’t unambiguously disclaim overlap; district court construction correct | Matrices must be separate volumes whose matrices themselves (not merely an excipient) are lipophilic or hydrophilic; prosecution history and claim structure support separation | Court reversed: matrices must be spatially separate volumes and the matrix itself must exhibit lipophilic/hydrophilic character (not merely include one excipient) |
| Whether district court factual findings based on extrinsic evidence warrant deference | Defer to district court because it heard expert testimony and evidence | No deference because intrinsic record controls and district court made no factual findings underlying construction | Court applied de novo review; no clear‑error deference warranted |
| Role of prosecution history/claim structure in narrowing claim scope | Prosecution statements were not unambiguous disavowals, so shouldn’t narrow claims to require separation | Prosecution arguments distinguishing prior art and amendment to Markush groups inform and compel a requirement of separate matrices | Court: prosecution history, claim phrasing (separate recitations of inner/outer), Markush groups, and specification together require separate matrices |
| Effect of claim construction on infringement finding | District court’s broad construction supported infringement finding | Narrowed construction undermines district court’s infringement conclusion | Court reversed infringement determination and remanded for further proceedings |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (clarifies that factual findings underlying claim construction are reviewed for clear error; legal conclusions reviewed de novo)
- Shire Dev., LLC v. Watson Pharm., Inc., 746 F.3d 1326 (Fed. Cir. 2014) (prior panel decision in this appeal)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim terms given their ordinary and customary meaning; specification guides construction)
- Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) (prosecution disclaimer narrows claim scope when inventor’s disavowal is unequivocal)
- Grober v. Mako Prods., Inc., 686 F.3d 1335 (Fed. Cir. 2012) (doctrine of prosecution disclaimer applies only to unambiguous disavowals)
- In re Papst Licensing Digital Camera Patent Litig., 778 F.3d 1255 (Fed. Cir. 2015) (application of Teva principles to claim construction review)
- Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009) (prosecution disclaimer reviewed de novo)
- Dow Chem. Co. v. Sumitomo Chem. Co., 257 F.3d 1364 (Fed. Cir. 2001) (ordinary meaning standard for claim terms)