Unigene Laboratories, Inc. v. Apotex, Inc.
655 F.3d 1352
| Fed. Cir. | 2011Background
- Unigene owns the reissued '812E patent (reissue dated 2009) covering Fortical®, a salmon calcitonin nasal spray; Fortical® is asserted as a bioequivalent to Miacalcin®.
- Apotex filed ANDA No. 078200 seeking a generic Fortical® with a paragraph IV certification alleging infringement and pursuing noninfringement/inequitable conduct defenses.
- Claim 19 of the '812E patent covers a liquid nasal composition with 2,200 MRC units salmon calcitonin, ~20 mM citric acid, ~0.2% phenylethyl alcohol, ~0.5% benzyl alcohol, ~0.1% polysorbate 80.
- The district court ruled (i) Fortical® not obvious over prior art; (ii) denied Apotex’s crime-fraud privilege challenge; (iii) found Apotex’s added inequitable-conduct counterclaims not colorable; (iv) granted summary judgment in Unigene’s favor on nonobviousness; (v) denied Apotex’s motion for reconsideration and dismissed new claims.
- On appeal, the Federal Circuit reviews the district court’s handling of the crime-fraud exception, the denial of new counterclaims, and the obviousness ruling.
- The court affirmatively holds on all challenged rulings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of claim 19 under 35 U.S.C. §103 | Unigene argues no prior art teaches 20 mM citric acid with the other claim elements; nonobvious overall. | Apotex argues claim 19 would be obvious in view of Miacalcin®, Day, and the '014 patent. | Nonobviousness affirmed. |
| Crime-fraud defendant privilege and intent | Unigene contends no clear intent to defraud; evidence insufficient. | Apotex asserts concealment and misrepresentation support piercing privilege. | District court did not abuse discretion; no clear intent shown. |
| Amendment to add Counts XII–XIV (inequitable conduct/crime-fraud counterclaims) | Counts XII–XIV expand the scope post-reexamination; not colorable. | Counts raise inequitable-conduct/crime-fraud theories. | District court acted within discretion; claims properly denied. |
| Legal standard and review | Court applies Walker Process/Nobelpharma standards; reviews for abuse of discretion and legal conclusions de novo as appropriate. |
Key Cases Cited
- Spalding Sports Worldwide, Inc. v. Ahern, 203 F.3d 800 (Fed.Cir.2000) (crime-fraud standard requires independent and clear evidence of fraudulent intent to pierce attorney-client privilege)
- Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059 (Fed.Cir.1998) (fraud can be by misrepresentation or omission; requires proof of fraud elements)
- KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. 2007) (obviousness requires a motivation to combine prior art and a reasonable expectation of success)
- Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1351 (Fed.Cir.2008) (flexible factors and TSMin determining obviousness; design need/market pressure)
- Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., 471 F.3d 1369 (Fed.Cir.2006) (prima facie for obviousness requires motivation to combine references; lead/reference composition relevance)
- Bayer Schering Pharma. AG v. Barr Labs., Inc., 575 F.3d 1341 (Fed.Cir.2009) (teleology of obviousness; needs guidance from prior art towards the claimed solution)
- In re O'Farrell, 853 F.2d 894 (Fed.Cir.1988) (limits on obviousness when parameters and choices are not directed by prior art)
- E Eisai Co. Ltd. v. Dr. Reddy's Labs., 533 F.3d 1353 (Fed.Cir.2008) (Graham factors for obviousness analysis)