Apotex, Inc. v. UCB, Inc.
970 F. Supp. 2d 1297
S.D. Fla.2013Background
- Apotex (via inventor Dr. Bernard Sherman) obtained U.S. Patent No. 6,767,556 claiming a wet-granulation process converting moexipril (or its salt) to moexipril magnesium (>80% conversion) and later sued UCB for infringement by Univasc/Uniretic.
- Univasc/Uniretic were marketed since the 1990s; their ingredients and labeling were publicly disclosed and skilled formulators could deduce wet granulation processing.
- During prosecution Sherman represented to the PTO that Univasc was made by prior-art processes and that components were “unreacted but combined,” submitted expert declaration (Lipp), and included past-tense Examples that were never actually performed.
- Internal Apotex testing (2001 study) and other documents indicated Univasc likely contained moexipril magnesium (i.e., conversion had occurred); Sherman failed to disclose those tests and did not cite a relevant prior PCT reference (the '560 PCT) during prosecution.
- At bench trial the court found Sherman knowingly misled the PTO, committed other misconduct, and that claims were also indefinite and disclaimed Univasc/Uniretic; Apotex was further barred by laches from pre-suit damages. Final judgment for UCB.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Inequitable conduct (failure to disclose/misrepresentations to PTO) | Sherman did not deceive; prosecution statements were proper distinctions from prior art | UCB: Sherman withheld material prior art/tests and submitted false/misleading statements/expert affidavit with intent to deceive | Court: Held unenforceable for inequitable conduct — specific intent and but‑for/materiality met; also found egregious misconduct |
| Judicial estoppel (inconsistent positions re: Univasc) | Apotex: prosecution statements characterized prior art, not factual assertions about Univasc | UCB: Sherman’s sworn PTO statements contradict current infringement claim | Court: Applied judicial estoppel — barred Apotex from arguing Univasc/Uniretic infringe |
| Indefiniteness (35 U.S.C. §112) | Apotex: disputed terms are understood by skilled artisan and tied to >80% conversion | UCB: Claim terms ("sufficient amount of solvent", "predetermined amount of time", "controlled manner") and >80% conversion lack objective bounds/tests | Court: Claims invalid as indefinite — no guidance or measurable test to determine >80% conversion |
| Prosecution disclaimer | Apotex: statements reflected public descriptions of prior art, not an intent to disclaim Univasc | UCB: repeated PTO representations disavowed processes like Univasc/Uniretic | Court: Found clear disavowal — Univasc/Uniretic processes excluded from claim scope |
| Laches (pre-suit damages) | Apotex: lacked definitive proof of >80% conversion until later testing | UCB: Apotex knew or should have known earlier; delay prejudiced UCB economically and evidentially | Court: Presumption of laches applied; Apotex failed to rebut — barred from pre‑filing damages |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir.) (sets heightened standards for intent and but‑for materiality in inequitable conduct)
- A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir.) (framework for laches in patent cases)
- Biosig Instruments, Inc. v. Nautilus, Inc., 715 F.3d 891 (Fed. Cir.) (definiteness standard; words of degree require objective standard)
- Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir.) (equitable clean‑hands principle in patent unenforceability)
- Apotex USA, Inc. v. Merck & Co., Inc., 254 F.3d 1031 (Fed. Cir.) (prior litigation showing that adding water to prior art produced claimed process)
- Precision Instrument Mfg. Co. v. Automotive Maintenance Mach. Co., 324 U.S. 806 (U.S.) (historical Supreme Court authority on equitable unclean hands/inequitable conduct)