Amphastar Pharmaceuticals Inc. v. Aventis Pharma SA
856 F.3d 696
| 9th Cir. | 2017Background
- Aventis obtained U.S. Patent No. 5,389,618 (the “618 Patent”) for a version of enoxaparin after submitting expert declarations that relied on Example 6, which purported a longer half-life for the 618 Product; the declaration omitted a material dosing difference.
- Amphastar developed a generic enoxaparin, filed an ANDA in 2003, and was sued by Aventis for patent infringement; Amphastar later amended to assert inequitable conduct based on the Example 6 misstatement.
- Courts found the 618 Patent unenforceable for inequitable conduct after multiple proceedings; Amphastar thereafter filed a qui tam suit under the False Claims Act alleging Aventis’s fraud enabled an unlawful monopoly and caused the government to overpay.
- The district court dismissed the qui tam suit for lack of subject-matter jurisdiction under the FCA public-disclosure bar because Amphastar’s claims were based on publicly disclosed allegations and Amphastar was not an "original source" with direct and independent knowledge.
- The Ninth Circuit affirmed dismissal on the public-disclosure/original-source grounds but held the district court erred in concluding it lacked power to award attorney’s fees to Aventis; the case was remanded for the fee determination.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Did the FCA public-disclosure bar preclude jurisdiction? | Amphastar: prior public pleadings did not disclose claims that the government paid false claims; its qui tam alleges new government-payment facts. | Aventis: prior public filings (Aventis I pleadings and filings) disclosed the essential facts and transactions enabling the qui tam allegations. | Held: Public-disclosure bar applies—prior public filings disclosed substantially similar allegations/facts. |
| Was Amphastar an "original source" with direct and independent knowledge? | Amphastar: its pre-litigation experiments showed Example 6 was false and gave independent, direct knowledge. | Aventis: Amphastar had no credible pre-disclosure evidence; experiments relied on 618 Patent and produced inconsistent records; testimony not credible. | Held: Amphastar failed to prove direct and independent knowledge; not an original source; jurisdiction lacking. |
| Did district court err in evidentiary rulings (late theory / Rule 37)? | Amphastar: Aventis raised a copying theory at the evidentiary hearing not timely disclosed; evidence should’ve been excluded. | Aventis: Amphastar waived Rule 37 objection by not raising it below; any error was harmless. | Held: Argument waived; even if error, harmless given strength of other findings. |
| Can a district court award attorneys’ fees under 31 U.S.C. § 3730(d)(4) after dismissal for lack of jurisdiction? | Amphastar: Branson precedent precludes fee awards when action dismissed for lack of subject-matter jurisdiction. | Aventis: CRST and statutory purpose allow fee awards to deter frivolous FCA suits; § 3730(d)(4) grants jurisdiction to decide fees. | Held: § 3730(d)(4) provides an independent grant to decide fee claims; a defendant may be a "prevailing party" even where underlying suit is dismissed for lack of jurisdiction; remand for fee determination. |
Key Cases Cited
- United States ex rel. Mateski v. Raytheon Co., 816 F.3d 565 (9th Cir. 2016) (explains when public disclosures of facts/ allegations trigger FCA jurisdictional bar).
- United States v. Alcan Elec. & Eng’g, Inc., 197 F.3d 1014 (9th Cir. 1999) (defines "direct" knowledge and explains public-disclosure bar scope).
- Hagood v. Sonoma County Water Agency, 81 F.3d 1465 (9th Cir. 1996) (discusses treatment of public-disclosure as a threshold/"quick-trigger").
- Foundation Aiding the Elderly v. Horizon W., Inc., 265 F.3d 1011 (9th Cir. 2001) (framework for combining disclosed elements to infer fraud for public-disclosure analysis).
- CRST Van Expedited, Inc. v. E.E.O.C., 136 S. Ct. 1642 (2016) (explains that a defendant can be a prevailing party even without a merits victory).
- Branson v. Nott, 62 F.3d 287 (9th Cir. 1995) (pre-CRST precedent limiting fee awards when suit dismissed for lack of jurisdiction; court explains its treatment in light of CRST).
- A-1 Ambulance Serv., Inc. v. California, 202 F.3d 1238 (9th Cir. 2000) (publicly disclosed information may contain material facts underlying FCA allegations).
- United States ex rel. Springfield Terminal Ry. Co. v. Quinn, 14 F.3d 645 (D.C. Cir. 1994) (adopted approach for "critical mass" of disclosed facts triggering public-disclosure bar).