837 F.3d 1256
Fed. Cir.2016Background
- Yeda obtained U.S. Patent No. 6,090,923 claiming a "monoclonal antibody" that binds a defined human cytotoxin; the specification describes mouse (murine) monoclonal antibodies and examples using mouse hybridomas.
- During prosecution, Yeda initially limited claims to murine antibodies, later sought broader claims omitting the species limitation and expressly proposed claims covering chimeric and humanized antibodies.
- The Examiner rejected the species-specific chimeric/human claims as new matter not supported by the specification; Yeda withdrew those proposed claims and ultimately prosecuted to allowance without explicit chimeric/humanized language in claim 1.
- Yeda argued to the Examiner that "monoclonal antibody" should encompass chimeric and humanized derivatives and submitted an expert declaration and pre‑filing references describing chimeric antibodies; the Examiner nevertheless refused the specific chimeric claims.
- UCB sued for declaratory judgment of non‑infringement and invalidity; Yeda counterclaimed for infringement by UCB’s Cimzia® (a chimeric/humanized antibody). The district court granted summary judgment of non‑infringement, construing "monoclonal antibody" to exclude chimeric and humanized antibodies based on the prosecution history.
- The Federal Circuit affirmed, holding Yeda is estopped by its prosecution positions and the Examiner’s new‑matter rejection from reading chimeric/humanized antibodies into claim 1.
Issues
| Issue | Plaintiff's Argument (UCB) | Defendant's Argument (Yeda) | Held |
|---|---|---|---|
| Whether "monoclonal antibody" in claim 1 covers chimeric or humanized antibodies | Claims should be limited by prosecution history; Yeda’s attempts to claim chimeras were rejected, so chimeric/humanized antibodies are excluded | The generic term "monoclonal antibody" is broad and should include chimeric/humanized antibodies known in 1984; prosecution statements about other claims do not narrow claim 1 | Held: Excluded — prosecution history and Examiner’s new‑matter rejection estop Yeda from reading chimeric/humanized antibodies into claim 1 |
| Whether summary judgment was appropriate on claim construction/non‑infringement | Construction excluding chimeric/humanized antibodies resolves non‑infringement as a matter of law | Claim construction should be objective and not driven by accused product; claim 1 lacks explicit species limitation | Held: Summary judgment appropriate because claim construction was a legal question informed by unambiguous prosecution history |
Key Cases Cited
- Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (claim construction is a legal determination based on underlying facts)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986) (summary judgment standard)
- Advance Transformer Co. v. Levinson, 837 F.2d 1081 (Fed. Cir. 1988) (prosecution positions inform claim interpretation and may create estoppel)
- Builders Concrete, Inc. v. Bremerton Concrete Products Co., 757 F.2d 255 (Fed. Cir. 1985) (file‑wrapper estoppel can arise without an amendment)
- Wang Laboratories, Inc. v. Mitsubishi Electronics America, Inc., 103 F.3d 1571 (Fed. Cir. 1997) (statements and actions during prosecution are examined to determine what scope was surrendered)