Zachary Silbersher v. Allergan, Inc.

46 F.4th 991
CourtCourt of Appeals for the Ninth Circuit
DecidedAugust 25, 2022
Docket21-15420
StatusPublished
Cited by18 cases

This text of 46 F.4th 991 (Zachary Silbersher v. Allergan, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zachary Silbersher v. Allergan, Inc., 46 F.4th 991 (9th Cir. 2022).

Opinion

FOR PUBLICATION

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

UNITED STATES OF AMERICA; STATE No. 21-15420 OF CALIFORNIA; STATE OF COLORADO; STATE OF D.C. No. CONNECTICUT; STATE OF 3:18-cv-03018- DELAWARE; STATE OF FLORIDA; JCS STATE OF GEORGIA; STATE OF HAWAII; STATE OF ILLINOIS; STATE OF INDIANA; STATE OF IOWA; STATE OPINION OF LOUISIANA; STATE OF MARYLAND; STATE OF MICHIGAN; STATE OF MINNESOTA; STATE OF MONTANA; STATE OF NEVADA; STATE OF NEW JERSEY; STATE OF NEW MEXICO; STATE OF NEW YORK; STATE OF NORTH CAROLINA; STATE OF OKLAHOMA; STATE OF RHODE ISLAND; STATE OF TENNESSEE; STATE OF TEXAS; STATE OF VERMONT; STATE OF WASHINGTON; COMMONWEALTH OF MASSACHUSETTS; COMMONWEALTH OF VIRGINIA; DISTRICT OF COLUMBIA, ex rel ZACHARY SILBERSHER, Relator, Plaintiffs-Appellees,

v. 2 UNITED STATES EX REL. SILBERSHER V. ALLERGAN

ALLERGAN, INC.; ALLERGAN USA, INC.; ALLERGAN SALES, LLC; FOREST LABORATORIES HOLDINGS, LTD.; ADAMAS PHARMA LLC; ADAMAS PHARMACEUTICALS, INC., Defendants-Appellants.

Appeal from the United States District Court for the Northern District of California Joseph C. Spero, Magistrate Judge, Presiding

Argued and Submitted January 10, 2022 San Francisco, California

Filed August 25, 2022

Before: Ronald M. Gould, Mark J. Bennett, and Ryan D. Nelson, Circuit Judges.

Opinion by Judge Gould UNITED STATES EX REL. SILBERSHER V. ALLERGAN 3

SUMMARY *

False Claims Act

The panel reversed the district court’s order denying defendants’ motion to dismiss a qui tam action under the False Claims Act and remanded for further proceedings.

Relator alleged that, by virtue of fraudulently-obtained patents on two Alzheimer’s disease drugs, defendants prevented generic drug competitors from entering the market. Relator alleged that this permitted defendants to charge Medicare inflated prices for the two drugs, in violation of the False Claims Act. The district court denied defendants’ motion to dismiss based on the False Claims Act’s public disclosure bar, which prevents a relator from merely repackaging publicly disclosed information for personal profit by asserting a claim under the Act.

Addressing the public disclosure bar, as revised in 2010, the panel reaffirmed the elements of the test for triggering the bar: (1) the disclosure at issue occurred through one of the channels specified in the statute; (2) the disclosure was public; and (3) the relator’s action is substantially the same as the allegation or transaction publicly disclosed. Only the first element was at issue. The statute states that the public disclosure bar applies if “substantially the same allegations or transactions as alleged in the action or claim were publicly disclosed . . . in . . . [an] other Federal . . . hearing.” The panel held that an ex parte patent prosecution is an “other

* This summary constitutes no part of the opinion of the court. It has been prepared by court staff for the convenience of the reader. 4 UNITED STATES EX REL. SILBERSHER V. ALLERGAN

Federal . . . hearing” under 31 U.S.C. § 3730(e)(4)(A)(ii); accordingly, the public disclosure bar was triggered.

The panel expressed no view on whether relator still could bring his qui tam action because he was an “original source” of the information in his complaint. The panel remanded to the district court for further proceedings.

COUNSEL

Erin E. Murphy (argued), M. Sean Royall, Olivia Adendorff, Kasdin M. Mitchell, and James Y. Xi, Kirkland & Ellis LLP, Washington, D.C., for Defendants-Appellants Allergan, Inc.; Allergan USA, Inc.; Allergan Sales, LLC; and Forest Laboratories Holdings, Ltd.

Andrew Hoffman II (argued), Matthew Holian, Courtney Saleski, and Lianna Bash, DLA Piper LLP (U.S.), Los Angeles, California, for Defendants-Appellants Adamas Pharma LLC, and Adamas Pharmaceuticals, Inc.

Tejinder Singh (argued), Goldstein & Russell P.C., Bethesda, Maryland; Nicomedes Sy Herrera and Bret D. Hembd, Herrera Kennedy LLP, Oakland, California; Warren T. Burns and Christopher J. Cormier, Burns Charest LLP, Dallas, Texas; for Plaintiffs-Appellees.

Jeffrey S. Bucholtz and Jeremy M. Bylund, King & Spalding LLP, Washington, D.C.; Andrew R. Varcoe and Paul V. Lettow, U.S. Chamber Litigation Center, Washington, D.C.; James C. Stansel and Melissa B. Kimmel, Pharmaceutical Research and Manufacturers of America; for Amici Curiae Chamber of Commerce of the United States of America and Pharmaceutical Research and Manufacturers of America. UNITED STATES EX REL. SILBERSHER V. ALLERGAN 5

Gordon D. Todd, Kimberly A. Leaman, Christopher S. Ross, Alaric R. Smith, and Katy (Yin Yee) Ho, Sidley Austin LLP, Washington, D.C.; Jack E. Pace III, Peter J. Carney, and Kevin M. Bolan, White & Case LLP, New York, New York; for Amici Curiae Johnson & Johnson and BTG International Ltd.

Justin T. Berger, Cotchett Pitre & McCarthy LLP, Burlingame, California; Jacklyn DeMar, Taxpayers Against Fraud Education Fund, Washington, D.C.; for Amicus Curiae Taxpayers Against Fraud Education Fund.

Alexandra H. Moss, Public Interest Patent Law Institute, La Quinta, California, for Amicus Curiae Public Interest Patent Law Institute. 6 UNITED STATES EX REL. SILBERSHER V. ALLERGAN

OPINION

GOULD, Circuit Judge:

Defendant-Appellants (“Appellants”) challenge the district court’s denial of their motion to dismiss relator Zachary Silbersher’s qui tam action. In his qui tam action, Silbersher alleged that Appellants violated the False Claims Act (FCA). Silbersher contended that Appellants fraudulently obtained patents on two drugs to combat Alzheimer’s disease and, by virtue of these fraudulent patents, prevented generic drug competitors from entering the market. According to Silbersher, preventing generic drug competitors from entering the market permitted Appellants to charge Medicare inflated prices for the two drugs. We have jurisdiction pursuant to 28 U.S.C. § 1292(b), and we reverse the district court’s denial of Appellants’ motion to dismiss and remand.

I. BACKGROUND

A. The FCA

The FCA creates civil liability for “any person who (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.” 31 U.S.C. § 3729(a)(1). A private person, known as a qui tam relator, may bring a civil action under the FCA in the name of the U.S. government. 31 U.S.C. § 3730(b). The government may proceed with the action or decline to take over the action; if the government declines, then the relator UNITED STATES EX REL. SILBERSHER V. ALLERGAN 7

can still pursue the action. 1 Id. § 3730(b)(4). The FCA incentivizes whistleblowers to come forward by offering successful relators up to thirty percent of the recovery. Id. § 3730(d).

“The FCA was enacted in 1863 with the principal goal of stopping the massive frauds perpetrated by large private contractors during the Civil War.” Vt. Agency of Nat. Res. v. United States ex rel. Stevens, 529 U.S. 765, 781 (2000) (cleaned up). When it was originally enacted, “the FCA placed no restriction on the sources from which a qui tam relator could acquire information on which to base a lawsuit.” Schindler Elevator Corp.

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