Billups-Rothenberg, Inc. v. Associated Regional & University Pathologists, Inc.
642 F.3d 1031
Fed. Cir.2011Background
- Billups-Rothenberg sued ARUP and Bio-Rad for infringement of the '681 and '425 patents on a genetic test for Type I hereditary hemochromatosis.
- The district court granted summary judgment: the '681 claims invalid for lack of written description and the '425 claims invalid for anticipation by the '130 patent.
- The '681 patent claims test methods for mutations in a gene encoding a nonclassical MHC class I heavy chain on chromosome six, but discloses no specific gene sequence or mutations at filing.
- The '130 patent discloses the S65C, C282Y, and H63D mutations and describes HH diagnostic testing and test kits; Bio-Rad owns the '130 patent and licenses it to ARUP.
- ARUP’s 1998 publication showed that H63D probes also identified S65C, and ARUP developed the current assay infringing the asserted patents.
- The '425 patent claims diagnosing an iron disorder by detecting S65C in exon 2 of HFE; the district court held it anticipated by the '130 patent.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Written description for '681 patent | Billups argues a genus with regional mutation location suffices. | ARUP/Bio-Rad contend no specific species or structural disclosure. | Invalid for lack of written description. |
| Enablement as separate ground for '681 | Enablement should be considered due to broad functional language. | Enablement not necessary given lack of description. | District court properly declined enablement ruling after finding lack of written description. |
| Anticipation of '425 patent by '130 patent | Dispute whether '130 discloses the S65C-based diagnosis as claimed. | ‘130 discloses diagnostic testing including S65C; anticipates '425. | Anticipated by the '130 patent. |
Key Cases Cited
- Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written description requires sufficient disclosure to show possession of claimed invention)
- Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (DNA description must recite structural features for genus claims)
- Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993) (description must enable identification of the DNA itself, not just functional result)
- Regents v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (DNA sequence specificity required for valid cDNA claims)
- Celeritas Techs., Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354 (Fed. Cir. 1998) (anticipation not defeated by an invention being disparaged)
- Kalman v. Kimberly-Clark Corp., 713 F.2d 760 (Fed. Cir. 1983) (anticipation requires reading the claims on something disclosed in the reference)
- Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) (summary judgment standards and burden related to factual inferences)
- SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107 (Fed. Cir. 1985) (en banc; context for anticipatory contexts in later decisions)