UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT ZACHARY SILBERSHER, Relator, No. 20-16176

Plaintiff-Appellant, D.C. No. 3:18-cv- 01496-JD and UNITED STATES OF AMERICA, ex OPINION rel.; STATE OF CALIFORNIA; STATE OF COLORADO; STATE OF CONNECTICUT; STATE OF DELAWARE; STATE OF FLORIDA; STATE OF GEORGIA; STATE OF HAWAII; STATE OF ILLINOIS; STATE OF INDIANA; STATE OF IOWA; STATE OF LOUISIANA; STATE OF MARYLAND; STATE OF MICHIGAN; STATE OF MINNESOTA; STATE OF MONTANA; STATE OF NEVADA; STATE OF NEW HAMPSHIRE; 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 2 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

VERMONT; STATE OF WASHINGTON; COMMONWEALTH OF MASSACHUSETTS; COMMONWEALTH OF VIRGINIA; DISTRICT OF COLUMBIA,

Plaintiffs,

v. VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; VALEANT PHARMACEUTICALS INTERNATIONAL; SALIX PHARMACEUTICALS, LTD.; SALIX PHARMACEUTICALS, INC.; FALK PHARMA GMBH,

Defendants-Appellees.

Appeal from the United States District Court for the Northern District of California James Donato, District Judge, Presiding

Argued and Submitted June 10, 2022 Portland, Oregon

Filed August 3, 2023 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 3

Before: Mary M. Schroeder and Gabriel P. Sanchez, Circuit Judges, and John Antoon II, * District Judge.

Opinion by Judge Sanchez

SUMMARY **

False Claims Act

The panel reversed the district court’s dismissal of relator Zachary Silbersher’s qui tam action under the False Claims Act against Dr. Falk Pharma GmbH and drugmaker Valeant Pharmaceuticals International, Inc., and remanded for further proceedings. Silbersher alleged that Valeant fraudulently obtained two sets of patents related to a drug and asserted these patents to stifle competition from generic drugmakers. Silbersher further alleged that defendants defrauded the federal government by charging an artificially inflated price for the drug while falsely certifying that its price was fair and reasonable. Dismissing Silbersher’s action under the False Claims Act’s public disclosure bar, the district court concluded that his allegations had already

* The Honorable John Antoon II, United States District Judge for the Middle District of Florida, sitting by designation. ** 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 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

been publicly disclosed, including in inter partes patent review (“IPR”) before the Patent and Trademark Office. The False Claims Act’s public disclosure bar, as amended in 2010, applies if (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. Here, it was undisputed that the relevant documents were publicly disclosed. Under the first prong of the public disclosure bar, the Act provides for the following three channels. Channel (i) applies if a disclosure was made “in a Federal criminal, civil, or administrative hearing in which the Government or its agent is a party,” and channel (ii) applies if a disclosure was made “in a congressional, Government Accountability Office, or other Federal Report, hearing, audit, or investigation.” Channel (iii) applies if a disclosure was made in the news media. The panel held that an IPR proceeding in which the Patent and Trademark Office invalidated Valeant’s “‘688” patent was not a channel (i) disclosure because th