Apotex Inc. v. Ucb, Inc.
763 F.3d 1354
| Fed. Cir. | 2014Background
- Apotex appeals a district court ruling that the ’556 patent is unenforceable due to inequitable conduct by Dr. Sherman during PTO prosecution.
- The district court found Sherman aware Univasc was made according to his process, concealed this, and misrepresented the nature of Univasc and prior art through counsel and an expert declaration.
- Prior art included the 450 patent and Gu article; the examiner allowed after claims were limited to >80% conversion to moexipril magnesium.
- The district court held Sherman liable for misrepresentations, withholding prior art (including the 560 PCT), and fabricating experiment results in the patent spec.
- Findings included Sherman’s intent to deceive the PTO, credibility issues, and a pattern of lack of candor, leading to unenforceability and related defenses (judicial estoppel, laches, indefiniteness) being moot.
- On appeal, the court affirmed inequitable conduct, concluding the misrepresentations were but-for material and Sherman acted with deceptive intent.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Materiality of misrepresentations | Apotex asserts material misrepresentations and omitted art affected the PTO's decision. | UCB contends the misrepresentations were not material or that materiality cannot be shown. | Materiality found; but-for materiality established. |
| Dr. Sherman’s intent to deceive the PTO | Apotex argues Sherman acted with deceptive intent evidenced by pattern and credibility issues. | UCB contends intent cannot be inferred from alleged misstatements alone. | Clear and convincing evidence of intent to deceive. |
Key Cases Cited
- TheraSense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc standard for inequitable conduct and materiality)
- Rothman v. Target Corp., 556 F.3d 1310 (Fed. Cir. 2009) (deceptive intent and materiality considerations)
- Mentor H/S, Inc. v. Med. Device Alliance, Inc., 244 F.3d 1365 (Fed. Cir. 2001) (witness credibility and re-litigation concerns in inequitable conduct)
- Star Scientific Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (evidence of intent and materiality in inequitable conduct)
- LNP Eng’g Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347 (Fed. Cir. 2001) (credibility and motive assessments on review)
- Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012) (context for inequitable conduct and materiality standards)