Therasense, Inc. v. Becton, Dickinson & Co.
864 F. Supp. 2d 856
N.D. Cal.2012Background
- En banc court remanded to reassess inequitable conduct under Therasense's new intent and materiality standards.
- District court previously found the patent unenforceable due to inequitable conduct by Sanghera and Pope, after a bench trial.
- Abbott withheld European EPO briefs and related submissions from the PTO during U.S. prosecution of Abbott’s '551 patent.
- Abbott’s in-house counsel Pope and Abbott’s director Sanghera testified (or submitted declarations) about the membrane requirement in the '382 patent to support patentability.
- EPO briefs argued that the membrane was optional, not mandatory; Abbott argued to the EPO that a membrane was optional or preferred.
- Remand instructed to determine if the EPO briefs were material but-for the examiner’s decision to allow the patent and whether withholding them was to deceive the PTO, leading to unenforceability.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Materiality under but-for standard | Abbott argues EPO briefs were but-for material to patent grant. | Therasense changed materiality; withholding may be non-material if it would not have caused rejection. | EPO briefs are but-for material under new standard. |
| Knowledge of materiality | Sanghera and Pope knew EPO briefs were material. | Unknown whether they understood materiality or its impact. | Clear and convincing evidence they knew materiality. |
| Specific intent to deceive | Three-element threshold shows intent to deceive can be inferred from conduct. | Absence of explicit intent explanations could negate inference. | Single most reasonable inference is intent to deceive; unenforceability warranted. |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (establishes new but-for materiality and specific-intent standard for inequitable conduct)
- American Calcar, Inc. v. American Honda Motor Co., Inc., 651 F.3d 1318 (Fed. Cir. 2011) (affirms three-element threshold for intent inference)
- Bruno Independent Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348 (Fed. Cir. 2005) (materiality and duty of candor framework for Rule 56 disclosures)
- Kingsdoum Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (standard for inferring deceitful intent from circumstantial evidence)
- Scanner Techs., Corp. v. ICOS Vision Sys. Corp., 528 F.3d 1365 (Fed. Cir. 2008) (requires single most reasonable inference for intent in circumstantial cases)
- Star Scientific Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (discusses circumstantial evidence and inference standards for deceit)