Enzo Biochem Inc. v. Applera Corp.
780 F.3d 1149
| Fed. Cir. | 2015Background
- Enzo sued Applera for infringement of U.S. Patent No. 5,449,767, claiming nucleotide probes that carry a moiety “A” attached to a base “B” to produce a detectable signal in DNA sequencing and detection methods.
- Claim 1 recites that A “comprises at least three carbon atoms and represents at least one component of a signaling moiety capable of producing a detectable signal,” and that A is attached so as not to substantially interfere with formation of the signaling moiety.
- The district court construed “A” and “signalling moiety” to allow A to be the whole signalling moiety (i.e., permit direct detection) and the case proceeded to a jury verdict for Enzo on infringement and against Applera’s invalidity defenses.
- Applera appealed the claim construction (and alternatively challenged enablement/written description). The Federal Circuit reviewed claim construction, applying Phillips and Teva for intrinsic/extrinsic evidence weight.
- The Federal Circuit majority held the claim language and specification indicate A is a component of a multi-part signalling moiety (supporting only indirect detection), reversed the district court’s claim construction, vacated the infringement finding, and remanded for further proceedings under the new construction.
- Judge Newman dissented, arguing the district court’s factual findings (including expert testimony and dependent-claim evidence) supported the broader construction permitting direct detection and deserved deference under Teva.
Issues
| Issue | Plaintiff's Argument (Enzo) | Defendant's Argument (Applera) | Held |
|---|---|---|---|
| Whether claim 1 covers direct detection (A can be entire signalling moiety) or only indirect detection (A is a component of a multi-part signalling moiety) | Claim language “at least one component” and examples allow A to be the whole signalling moiety; dependent claims and expert testimony support direct detection | Plain claim text and specification show A is a component that forms a signalling moiety only in combination with other parts; "component" implies multipart system | Reversed: claim 1 limited to indirect detection (A is a component), district court construction allowing direct detection was erroneous; infringement vacated and case remanded |
| Whether district court may rely on dependent claims or claim differentiation to broaden independent claim 1 to include direct detection | Dependent claims (e.g., claims 67–70) teach indicator molecules/direct detection, so claim 1 should not be limited to indirect detection | Dependent claims cannot broaden the independent claim; claim 1’s plain meaning controls | Held for Applera: cannot use claim differentiation to import limitations that broaden independent claim; claim 1 is limited by its own language |
| Standard of review for claim construction where extrinsic evidence was considered | Enzo: district court’s factual findings (expert evidence, example 9) supporting broader construction should get deference under Teva | Applera: where intrinsic evidence resolves meaning, construction is legal and reviewed de novo; specification and claim language support narrow construction | Court applied Phillips/Teva principles: intrinsic evidence controls and where extrinsic evidence was not persuasive to overcome intrinsic record, de novo construction led to reversal; dissent argued district court factual findings deserved deference |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (factual findings underlying claim construction receive clear-error review; ultimate construction is legal and reviewed de novo)
- Phillips v. AWH Corp., 415 F.3d 1303 (2005) (en banc) (claim terms given ordinary meaning as understood by a person of skill; specification and prosecution history guide interpretation)
- Howmedica Osteonics Corp. v. Wright Med. Tech., Inc., 540 F.3d 1337 (2008) (phrase “at least one” means one or more; used by parties to argue scope)
- Bicon, Inc. v. Straumann Co., 441 F.3d 945 (2006) (claims interpreted to give effect to all terms; avoid reading out claim language)
- Curtiss-Wright Flow Control Corp. v. Velan, Inc., 438 F.3d 1374 (2006) (doctrine of claim differentiation presumption: dependent claims do not broaden independent claims)