Biogen Idec, Inc. v. GlaxoSmithKline LLC
713 F.3d 1090
| Fed. Cir. | 2013Background
- Biogen seeks review of district court’s construction of “anti-CD20 antibody” narrowed by prosecution-history disclaimer.
- District court found a clear and unmistakable disclaimer, and Biogen thus stipulated noninfringement and appealed.
- The ’612 patent covers treatment of CLL with anti-CD20 antibodies and incorporates the ’137 patent; dependent claims list specific antibody types.
- During prosecution, examiner rejected claims for lack of enablement for all anti-CD20 antibodies; Biogen argued enablement for Rituxan-like antibodies.
- The court applied prosecution-history disclaimer, holding that statements during prosecution limit the claim scope; dissent argues no clear disclaimer.
- This opinion affirms the district court’s construction limited by prosecution history.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether there was a clear and unmistakable prosecution disclaimer. | Biogen argues no unambiguous disclaimer. | GSK argues Biogen disclaimed non-Rituxan antibodies. | Yes; the disclaimer is clear and limits scope. |
| Whether Biogen’s statements during prosecution disclaimed broader antibody scope. | Biogen asserts statements were not limited to Rituxan-like antibodies. | District court relied on examiner’s interpretation of statements. | No; statements do not constitute a clear disclaimer. |
| Whether incorporation by reference of the ’137 patent affects the term meaning. | ’137 defines anti-CD20 antibody broadly. | Incorporation by reference does not override prosecution disclaimer. | No; disclaimer controls despite incorporation. |
| Whether the plain meaning should control given the prosecution history. | Plain meaning is broad: any antibody binding CD20. | Prosecution history overrides plain meaning. | Plain meaning is limited by prosecution-history disclaimer. |
Key Cases Cited
- Omega Eng’g., Inc. v. Raytek Corp., 334 F.3d 1314 (Fed. Cir. 2003) (heavy presumption of ordinary meaning unless clear disavowal)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims must be read in light of intrinsic evidence)
- Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111 (Fed. Cir. 2004) (disclaimer requires unambiguous relinquishment of subject matter)
- Sorensen v. Int’l Trade Comm’n, 427 F.3d 1375 (Fed. Cir. 2005) (prosecution history disclaimer requires clear disavowal by patentee)
- TorPharm Inc. v. Ranbaxy Pharm., Inc., 336 F.3d 1322 (Fed. Cir. 2003) (whether applicant challenged examiner’s view affects claim interpretation)