Celgene Corporation v. Peter
931 F.3d 1342
Fed. Cir.2019Background
- Celgene owned two pre-AIA patents directed to computer-mediated systems (Original and Enhanced S.T.E.P.S.) for distributing teratogenic drugs (thalidomide) while preventing fetal exposure: U.S. Pat. No. 6,045,501 (’501) and U.S. Pat. No. 6,315,720 (’720).
- CFAD filed inter partes review (IPR) petitions challenging all claims of the ’501 patent and all claims of the ’720 patent; the PTAB found claims 1–10 of the ’501 patent and claims 1–9 and 11–32 of the ’720 patent obvious and unpatentable (with one claim of the ’720 later preserved on rehearing).
- Celgene appealed the obviousness rulings and separately argued that retroactive application of IPRs to pre-AIA patents is an unconstitutional taking under the Fifth Amendment.
- The PTAB’s obviousness findings rested on combinations of prior art (Powell, Mitchell, Dishman, Thalomid package insert, Cunningham, Zeldis, Mann, etc.), claim construction (broadest reasonable interpretation), and credibility of expert testimony regarding counseling males and risk assessment features.
- The Federal Circuit reviewed legal conclusions de novo and fact findings for substantial evidence, affirmed the PTAB on obviousness for the challenged claims, and addressed Celgene’s takings challenge on the merits.
Issues
| Issue | Celgene's Argument | PTO/CFAD's Argument | Held |
|---|---|---|---|
| Whether PTAB erred in construing "computer readable storage medium" to allow non-centralized media | Claim requires a centralized database; "said medium" means a single medium | "A/an" may mean one or more; specification and prosecution history do not limit to centralized database | Court affirmed PTAB: broadest reasonable interpretation does not require centralization; Dishman meets limitation under that construction |
| Whether counseling male patients (capable of impregnating females) was obvious | Counseling males about fetal-risk from drug would not have been obvious; Powell disclaims male-sperm effects | Expert testimony and Mann study show male sperm effects and would motivate counseling; Powell’s statement read in context does not foreclose | Substantial evidence supports PTAB that counseling males would have been obvious |
| Whether claimed improvements in the ’720 patent (risk groups, affirmative risk assessment, approval code) were obvious | No specific motivation to overhaul an already effective Original S.T.E.P.S.; prior art did not teach affirmative prospective assessment and approval-code scheme | Safety concerns create motivation to improve; prior art taught risk-grouping and approval-code concepts (e.g., Cunningham); combination yields predictable result | Court affirmed PTAB: motivation to improve safety and prior art teachings make claims obvious |
| Whether retroactive application of IPRs to pre-AIA patents is an unconstitutional taking | Retroactive exposure of pre-AIA patents to IPRs destroys investment-backed expectations and effects a regulatory taking without compensation | Patents long subject to PTO reexamination; IPRs are a new form of longstanding reconsideration (same substantive grounds, standard of proof, Director discretion); differences are procedural and not a taking | Court held no Fifth Amendment taking: IPRs sufficiently similar to preexisting reexamination mechanisms and district-court challenges, so retroactivity is not a taking |
Key Cases Cited
- Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016) (IPR is a ‘‘second look’’ reexamination and PTAB claim-construction approach discussed)
- Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, 138 S. Ct. 1365 (2018) (IPR constitutionality re Article III and patents as public rights; left retroactivity question open)
- Patlex Corp. v. Mossinghoff, 758 F.2d 594 (Fed. Cir. 1985) (retroactive application of PTO reexamination did not violate due process or effect a taking)
- Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064 (Fed. Cir. 2015) (obviousness standard: legal conclusion based on underlying facts)
- In re NTP, Inc., 654 F.3d 1279 (Fed. Cir. 2011) (appellate review limits—do not reweigh PTAB fact findings)
- Return Mail, Inc. v. United States Postal Serv., 139 S. Ct. 1853 (2019) (post-AIA: patents can be reexamined in court, ex parte reexamination, or PTAB proceedings)