FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

ZACHARY SILBERSHER, Relator, 

Plaintiff-Appellant, 

and 

UNITED STATES OF AMERICA, ex 

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 

No.20-16176 

D.C. No. 3:18-cv01496-JD 

OPINION
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 the 

government was not a party to that proceeding, and it was 

not a channel (ii) disclosure because its primary function was 

not investigative. The panel held that, under United States 

ex rel. Silbersher v. Allergan, 46 F.4th 991 (9th Cir. 2022), 

the patent prosecution histories of Valeant’s patents were 

qualifying public disclosures under channel (ii). The panel 

assumed without deciding that a Law360 article and two 

published medical studies were channel (iii) disclosures.

The panel held that the “substantially the same” prong of 

the public disclosure bar, as revised by Congress in its 2010 

amendments to the False Claims Act, applies when the 
 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 5 

publicly disclosed facts are substantially similar to the 

relator’s allegations or transactions. None of the qualifying 

public disclosures made a direct claim that Valeant 

committed fraud, nor did they disclose a combination of 

facts sufficient to permit a reasonable inference of 

fraud. Accordingly, the public disclosure bar was not 

triggered. 

The panel resolved a cross-appeal in a separately-issued 

memorandum disposition. 

COUNSEL

Tejinder Singh (argued), Sparacino PLLC, Washington, 

D.C.; Bret D. Hembd, Herrera Kennedy LLP, Burbank, 

California; Nicomedes S. Herrera and Andrew M. Purdy, 

Herrera Kennedy LLP, Oakland, California; Warren T. 

Burns, Burns Charest LLP, Dallas, Texas; Christopher J. 

Cormier, Burns Charest LLP, Washington, D.C.; for 

Plaintiff-Appellant. 

Michelle Lo, Assistant United States Attorney; Office of the 

United States Attorney; San Francisco, California; for 

Plaintiffs United States of America, States of California, 

Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, 

Illinois, Indiana, Iowa, Louisiana, Maryland, Michigan, 

Minnesota, Montana, Nevada, New Hampshire, New Jersey, 

New Mexico, New York, North Carolina, Oklahoma, Rhode 

Island, Tennessee, Texas, Vermont, Washington, the 

Commonwealth of Massachusetts, the Commonwealth of 

Virginia, and District of Columbia. 
6 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

Moez M. Kaba (argued), Padraic W. Foran, Daniel C. 

Sheehan, and Haoxiaohan Cai, Hueston Hennigan LLP, Los 

Angeles, California; for Defendants-Appellees Valeant 

Pharmaceuticals International Inc., Valeant Pharmaceuticals 

International, Salix Pharmaceuticals Ltd., and Salix 

Pharmaceuticals Inc.

Christian E. Mammen (argued), Womble Bond Dickinson 

(US) LLP, San Francisco, California; Mary W. Bourke and 

Kristen Cramer, Womble Bond Dickinson (US) LLP, 

Wilmington, Delaware; for Defendant-Appellee Dr. Falk 

Pharma GmbH. 

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.

Gordon D. Todd, Kimberly A. Leaman, Christopher S. Ross, 

and Katy (Yin Yee) Ho, Sidley Austin LLP, Washington, 

D.C.; Jack E. Pace III and Peter J. Carney, White & Case 

LLP, New York, New York; for Amici Curiae Johnson & 

Johnson and BTG International Ltd.
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 7

OPINION

SANCHEZ, Circuit Judge:

This appeal presents the question whether the public 

disclosure bar to the False Claims Act (“FCA”) applies to 

Zachary Silbersher’s claims against Dr. Falk Pharma GmbH

and drugmaker Valeant Pharmaceuticals International, Inc. 

(collectively, “Valeant”).1 Silbersher alleges that Valeant 

fraudulently obtained two sets of patents related to the antiinflammatory drug Apriso and asserted these patents to stifle 

competition from generic drugmakers. Silbersher further 

alleges that defendants defrauded the government by 

charging an artificially inflated price for Apriso while falsely 

certifying that the drug’s price was fair and reasonable. The 

district court dismissed Silbersher’s qui tam action under the 

public disclosure bar. See 31 U.S.C. § 3730(e)(4)(A). This 

case requires us to examine Congress’s 2010 amendments to 

the FCA’s public disclosure bar and to determine whether 

Silbersher’s claims are “substantially the same” as 

information that was publicly disclosed in one of three 

enumerated channels under the FCA. See id. We have 

jurisdiction pursuant to 28 U.S.C. § 1291, and we reverse.

2

1 In 2015, Valeant Pharmaceuticals International, Inc., acquired Salix 

Pharmaceuticals, Ltd., and its wholly owned subsidiary, Salix 

Pharmaceuticals, Inc. Valeant is now Bausch. We refer to these parties, 

along with Dr. Falk Pharma GmbH, collectively as “Valeant” because 

Silbersher raises the same allegations against them all. 

2 We resolve Dr. Falk Pharma GmbH’s cross-appeal in a separately 

issued memorandum disposition. 
8 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

I. BACKGROUND

A. False Claims Act

The False Claims Act imposes civil liability on anyone 

who “knowingly presents” a “fraudulent claim for payment”

to the federal government. 31 U.S.C. § 3729(a)(1)(A); 

accord United States ex rel. Mateski v. Raytheon Co., 816 

F.3d 565, 569 (9th Cir. 2016). Known as “Lincoln’s Law,” 

Congress passed the Act at President Lincoln’s request to

combat fraud by Civil War defense contractors. See United 

States ex rel. Bennett v. Biotronik, Inc., 876 F.3d 1011, 1013 

n.1 (9th Cir. 2017). The Act allows private citizens, referred 

to as “relators,” to bring fraud claims on the government’s 

behalf against those who have violated the Act’s 

prohibitions. United States ex rel. Silbersher v. Allergan, 46 

F.4th 991, 994 (9th Cir. 2022); see 31 U.S.C. § 3730(b)(1).

3 

If the government declines to proceed, the relator may 

prosecute the action and, if successful, recover up to thirty 

percent of the damages. 31 U.S.C. §§ 3730(b)(4), (d)(2). 

The promise of bounty has sometimes incentivized

relators to bring dubious claims. The Supreme Court’s 

decision in United States ex rel. Marcus v. Hess, 317 U.S. 

537 (1943), provides the paradigmatic example of a

“parasitic” qui tam suit. Hess brought a qui tam action 

alleging that electricians colluded to inflate prices by 

coordinating their bids on government contracts. Id. at 539. 

Before Hess’s qui tam action, the government had already 

indicted the electricians for the same scheme and the 

electricians entered a plea bargain requiring them to pay 

3 Diligent readers of this Court’s opinions may feel a sense of déjà vu: 

we recently wrestled with certain parts of the FCA in another case 

brought by the same relator. See United States ex rel. Silbersher v. 

Allergan, 46 F.4th 991 (9th Cir. 2022).
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 9

$54,000 in fines. Id. at 545. Spotting an opportunity, Hess 

copied the government’s indictment and brought a qui tam

action against the electricians seeking hundreds of thousands 

of dollars in damages. Id. The Court allowed Hess’s suit to 

stand, reasoning that the action advanced “one of the

purposes for which the [FCA] was passed” because it 

promised “a net recovery to the government of $150,000, 

three times as much as the fines imposed in the criminal 

proceedings.” Id. at 545.

“Hess inspired public outcry over the liberality of the qui 

tam provisions that prompted speedy congressional 

response.” United States ex rel. Springfield Terminal Ry. v. 

Quinn, 14 F.3d 645, 650 (D.C. Cir. 1994). In 1943, 

President Roosevelt signed amendments to the FCA that

barred qui tam claims “based upon evidence or information 

in the possession” of the federal government. 31 U.S.C. 

§ 232(C) (1945). Congress later determined, however, that 

this “government knowledge” bar prevented too many 

relators from bringing potentially meritorious claims. See

Mateski, 816 F.3d at 570. In 1986, Congress replaced the 

government knowledge bar with the “public disclosure” bar. 

31 U.S.C. § 3730(e)(4)(A) (1986). The change reflected 

Congress’s effort “to encourage suits by whistle-blowers 

with genuinely valuable information, while discouraging 

litigation by plaintiffs who have no significant information 

of their own to contribute.” Mateski, 816 F.3d at 570. 

The 1986 public disclosure bar prevented qui tam claims 

“based upon” public disclosures “in a criminal, civil, or 

administrative hearing, in a congressional, administrative, or 

Government Accounting Office report, hearing, audit, or 

investigation, or from the news media,” unless the relator 
10 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

was an “original source” of the disclosure.

4 31 U.S.C. 

§ 3730(e)(4)(A) (1986); see Schindler Elevator Corp. v. 

United States ex rel. Kirk, 563 U.S. 401, 412 (2011). The 

public disclosure bar applied when three conditions were

met: “(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 ‘based upon’ the 

allegations or transactions publicly disclosed.” United 

States ex rel. Solis v. Millenium Pharms., Inc., 885 F.3d 623, 

626 (9th Cir. 2018) (quoting Mateski, 816 F.3d at 1570) 

(analyzing the 1986 version of the public disclosure bar). 

Congress made important changes to the public 

disclosure bar in 2010. As amended, the bar precludes qui 

tam actions if:

substantially the same allegations or 

transactions as alleged in the action or claim 

were publicly disclosed—

(i) in a Federal criminal, civil, or 

administrative hearing in which the 

Government or its agent is a party;

(ii) in a congressional, Government 

Accountability Office, or other Federal 

Report, hearing, audit, or investigation; 

or

(iii) from the news media,

4 An “original source” was defined as “an individual who has direct and 

independent knowledge of the information on which the allegations are 

based and has voluntarily provided the information to the Government 

before filing an action under this section which is based on the 

information.” 31 U.S.C. § 3730(e)(4)(B) (1986). 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 11

unless the action is brought by the Attorney 

General or the person bringing the action is 

an original source of the information.5

31 U.S.C. § 3730(e)(4)(A) (2010). We recently concluded 

in Allergan that our three-part test for determining whether 

the public disclosure bar applies to a qui tam action remains 

good law after the 2010 amendments. See Allergan, 46 F.4th 

at 996. 

The 2010 amendments narrowed the requirements for 

triggering the public disclosure bar in several important

respects. Previously, the public disclosure bar was triggered 

if the qui tam action was based upon information publicly 

disclosed in any “criminal, civil, or administrative hearing.” 

See 31 U.S.C. § 3730(e)(4)(A) (1986); see also A-1 

Ambulance Serv., Inc. v. California, 202 F.3d 1238, 1243–

44 (9th Cir. 2000) (applying public disclosure bar to 

information disclosed in county public bidding proceeding). 

Now, only a “Federal criminal, civil, or administrative 

hearing” qualifies as a specified channel (i) disclosure. 31 

U.S.C. § 3730(e)(4)(A)(i) (2010) (emphasis added); see also 

5 An original source is:

an individual who either (i) prior to a public disclosure 

under [the public disclosure bar] has voluntarily 

disclosed to the Government the information on which 

allegations or transactions in a claim are based, or [(ii)]

who has knowledge that is independent of and 

materially adds to the publicly disclosed allegations or 

transactions, and who has voluntarily provided the 

information to the Government before filing an action 

under this section.

31 U.S.C. § 3730(e)(4)(B) (2010). 
12 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

Allergan, 46 F.4th at 998–99. Likewise, for a “report, 

hearing, audit, or investigation” to trigger the public 

disclosure bar under channel (ii), it must now be “Federal.” 

Compare 31 U.S.C. § 3730(e)(4)(A) (1986), with id.

§ 3730(e)(4)(A)(ii) (2010). See also Allergan, 46 F.4th at 

998. Finally, for the public disclosure bar to apply under 

channel (i), the “Government or its agent” must be “a party” 

to the “Federal criminal, civil or administrative hearing.” 

Compare 31 U.S.C. § 3730(e)(4)(A) (1986), with id.

§ 3730(e)(4)(A)(i) (2010). 

B. Patent Prosecution and Inter Partes Review

A patent gives its owner the exclusive right to make, use, 

or sell a patented invention for a limited period. 35 U.S.C. 

§ 271(a). For an invention to be patent-worthy, it must be 

novel and not obvious to a person with ordinary skill in the 

relevant art. 35 U.S.C. §§ 102, 103. The process of 

obtaining a patent is called a patent prosecution. In a patent 

prosecution, an inventor submits a patent application to the 

Patent and Trademark Office (“PTO”), which examines the 

application before accepting or rejecting it. The PTO’s 

examination is an ex parte proceeding. The PTO relies on 

applicants to exercise good faith and candor about the 

originality of their purported inventions. See 37 C.F.R. 

§ 1.56(a). An inventor who applies for a patent must 

disclose to the PTO “all information known to that 

individual to be material to patentability.” Id. Patent 

applications are generally made public eighteen months after 

they are filed. See 35 U.S.C. § 122(b).

After a patent has been granted, anyone can challenge its 

validity by petitioning the PTO to hold inter partes review 

(“IPR”) of the patent. 35 U.S.C. § 311(a). IPR is a trial-like 

proceeding conducted at the Patent Trial and Appeal Board
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 13

(“PTAB”), an adjudicatory branch of the PTO. See id.

§ 6(a). See generally id. §§ 311–19; 37 C.F.R. §§ 42.100–

42.123 (2021). In an IPR proceeding, the person challenging 

the patent argues against the validity of the patent, and the 

patent owner defends it. The PTAB presides as the 

adjudicator. 35 U.S.C. § 316(c). Both the challenger and 

the patent owner may present evidence. See Genzyme 

Therapeutic Prods. Ltd. v. Biomarin Pharm. Inc., 825 F.3d 

1360, 1365–70 (Fed. Cir. 2016). The challenger bears the 

burden of proving the patent is invalid. 35 U.S.C. § 316(e). 

The scope of IPR is limited. Challengers can assert only 

that the patented invention was obvious or not novel and 

introduce as evidence only previously granted patents and 

publications (referred to as “prior art”). See id. § 311(b). An 

IPR does not decide whether an inventor obtained a patent 

wrongfully—by committing fraud, for example. See id.; see 

also Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 

1276, 1288–95 (Fed. Cir. 2011).

C. Factual Background

We now describe the facts as presented in Silbersher’s 

qui tam complaint. Valeant manufactures Apriso, a 

medication prescribed to treat ulcerative colitis. When 

ingested, Apriso travels through the digestive system and

releases its active ingredient, mesalamine. Upon arrival in 

the colon, mesalamine reduces the inflammation and 

discomfort caused by ulcerative colitis. Valeant owns a set 

of patents (“the Otterbeck Patents”) for Apriso’s delayedrelease formula, which maximizes the amount of 

mesalamine that reaches the colon. 

Beginning in 2012, Valeant enforced the Otterbeck 

Patents to prevent competitors from creating cheaper, 

generic versions of Apriso. The absence of generic 
14 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

competition allowed Valeant to charge high prices for the 

drug. A one-month prescription of Apriso retailed for about

$600, earning Valeant over $200 million each year. A 

substantial portion of those proceeds came from the federal 

government, which paid for Apriso through Medicare and 

Medicaid. 

The Otterbeck Patents rested on shaky ground. Several 

patents predating the Otterbeck Patents describe similar 

delayed-release formulas for mesalamine drugs. Viewed 

against those prior inventions, Apriso simply put a new label 

on an old pill. In 2012, Lupin, a generic drug manufacturer, 

submitted an Abbreviated New Drug Application to the FDA 

attesting that the Otterbeck Patents were invalid. If the 

Otterbeck Patents were invalidated, generic competition 

would drive down Apriso’s price. Valeant initiated an 

infringement action against Lupin to prevent that from 

happening. Seeing the writing on the wall, Valeant sought 

to extend its monopoly by applying for a new patent, 

claiming it had recently discovered that Apriso was effective 

when taken without food. The PTO initially rejected the 

application. After several rounds of revisions to the 

application, Valeant finally succeeded, and the PTO granted 

Patent No. 8,865,688 (“the ’688 Patent”) in 2014.6 

Valeant’s gambit paid off. Approval of the ’688 Patent gave 

Valeant leverage: even if Lupin successfully invalidated the 

Otterbeck Patents, it would need to mount a new, separate 

6 The ’688 Patent contained sixteen “claims.” A patent can include 

several claims, each treated as a distinct invention and correspondingly 

a distinct right to exclude others from practicing the invention. See, e.g., 

Leeds & Catlin Co. v. Victor Talking Mach. Co., 213 U.S. 301, 319 

(1909). Only the first and sixteenth claims of the ’688 Patent are relevant

to the present appeal. Our discussion of that patent refers only to those 

two claims. 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 15

challenge to the ’688 Patent before it could manufacture an 

Apriso generic. In September 2014, Valeant dismissed its

infringement claims against Lupin relating to the Otterbeck 

Patents, and Lupin agreed to refrain from introducing a 

generic version of Apriso until 2022, four years after the 

expiration of the Otterbeck Patents. 

In 2015, another generic drug manufacturer, GeneriCo 

LLC, sued to invalidate the ’688 Patent. GeneriCo 

challenged the ’688 Patent through IPR, arguing it was 

obvious that Apriso would be effective without food. As 

evidence, GeneriCo presented two published medical studies 

predating Valeant’s ’688 Patent application (“the Brunner 

and Marakhouski studies”). See GeneriCo, LLC v. Dr. Falk 

Pharma GmbH, No. IPR2016–00297, 2017 WL 2211672 

(P.T.A.B. May 19, 2017), aff’d, 774 F. App’x 665 (Fed. Cir. 

2019). The Brunner and Marakhouski studies established 

that mesalamine drugs were effective when taken without 

food, undermining Valeant’s purported later discovery of the 

same result. Moreover, Valeant’s own head of research coauthored both studies, discrediting Valeant’s claim that 

Apriso’s effectiveness without food had been a new

discovery. Id. at *6. The PTAB agreed with GeneriCo and 

invalidated the ’688 Patent as obvious. Id. at *24.7

A legal news outlet, Law360, published an article 

describing GeneriCo’s successful arguments and the 

PTAB’s decision cancelling the ’688 Patent. See Matthew 

Bultman, Part of Apriso Patent Nixed in IPR with Hedge 

Fund Ties, Law360 (May 19, 2017, 4:58 PM EDT), 

[https://perma.cc/56YR-ET78]. The article stated that

7 The PTAB invalidated “claims 1 and 16 of the ’688 patent.” GeneriCo, 

LLC, 2017 WL 2211672 at *24. The other fourteen claims in the ’688 

Patent were not affected by the PTAB’s decision. Id.
16 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

GeneriCo “had shown the challenged patent claims would 

have been obvious” by pointing to “a collection of references

that included press releases from [Valeant] about clinical 

drug trials and some academic papers.” Id. The article did 

not mention that Valeant’s head of research had co-authored 

the Brunner and Marakhouski studies. Id. 

Silbersher was GeneriCo’s lawyer and led the IPR 

challenge that resulted in the ’688 Patent being invalidated. 

Silbersher’s investigations into Valeant’s Apriso-related 

patents revealed other information that was not disclosed in 

the IPR proceeding. He discovered that three years before 

applying for the ’688 Patent, Valeant had applied for Patent 

No. 8,921,344 (“the ’344 Patent”). In the ’344 Patent

application, Valeant claimed it had made an “unexpected 

finding”: taking mesalamine with food made the drug more 

effective. In other words, the ’344 Patent application 

claimed it was obvious that mesalamine was effective 

without food—the exact opposite of what Valeant would 

claim a few years later in the ’688 Patent application. 

D. Procedural History

Silbersher brought this FCA case seeking damages from 

Valeant for making false claims for payment to the federal 

government. He alleges that Valeant fraudulently obtained

the Otterbeck and ’688 Patents so that it could prolong its 

monopoly and charge an “artificially high price” for Apriso.

According to Silbersher, Valeant “intentionally withheld 

material information demonstrating that Valeant’s claimed 

granulated mesalamine formulation would be effective when 

administered without food.” Silbersher contends that

Valeant knew about the Brunner and Marakhouski studies

and the earlier ’344 Patent application but did not disclose 

that information to the PTO when applying for the ’688 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 17

Patent. Similarly, Silbersher alleges that the Otterbeck 

Patents are invalid because Valeant failed to disclose “at 

least four prior art patents [that] anticipate all or nearly all of 

the alleged inventions claimed in the Otterbeck Patents.” 

Medicare and Medicaid allegedly paid nearly $250 

million for Apriso from 2011 to 2016. Silbersher estimates

that the government would have paid about eighty percent 

less if generic manufacturers of Apriso were allowed to enter 

the market. Silbersher contends that Valeant therefore 

committed fraud when it knowingly overcharged the 

government and certified to Medicare and Medicaid that 

Apriso’s price was fair and reasonable. 

The district court dismissed Silbersher’s qui tam action 

as precluded by the public disclosure bar. Guided by our 

precedent interpreting the pre-2010 FCA, the district court 

reasoned that IPR qualifies as an “other Federal . . . hearing”

under channel (ii) of the bar. The district court determined

that Silbersher’s allegations against Valeant had all been 

disclosed in the IPR that invalidated the ’688 Patent. 

Accordingly, the district court concluded that Silbersher’s 

qui tam action was the “quintessence of the opportunistic 

and ‘parasitic’ lawsuit Congress has always intended to bar.” 

The court gave Silbersher leave to amend his claims, but 

Silbersher instead filed this appeal.

II. DISCUSSION

We review the district court’s ruling on a motion to 

dismiss an FCA action de novo. Allergan, 46 F.4th at 996. 

To determine whether Silbersher’s qui tam action was 

properly dismissed by the district court under the public 

disclosure bar, we must assess whether “(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 
18 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

action is substantially the same as the allegation or 

transaction publicly disclosed.” Id. (internal quotation 

marks omitted) (quoting Solis, 885 F.3d at 626). The parties 

do not dispute that the relevant documents that are the 

subject of this appeal were all publicly disclosed. Therefore, 

our analysis is confined to determining whether the public 

disclosures in question occurred within one of the channels 

specified by the FCA, and if so, whether they disclosed 

“substantially the same allegations or transactions as alleged 

in” Silbersher’s qui tam action. 31 U.S.C. § 3730(e)(4)(A). 

Valeant points us to four sets of disclosures: (1) the 

patent prosecution histories of the ’344, ’688, and Otterbeck 

Patents; (2) the IPR proceeding in which the PTAB 

invalidated the ’688 Patent; (3) the Law360 article 

summarizing the IPR proceeding; and (4) the Brunner and 

Marakhouski studies. We address first whether these 

disclosures occurred within a specified channel. 

A.

The FCA’s public disclosure bar requires federal courts 

to dismiss qui tam suits under certain circumstances where 

the complaint’s allegations closely match information that 

was publicly disclosed in one of three specified channels. 31 

U.S.C. § 3730(e)(4)(A). The full text of the public 

disclosure bar is repeated below:

The court shall dismiss an action or claim 

under this section, unless opposed by the 

Government, if substantially the same 

allegations or transactions as alleged in the 

action or claim were publicly disclosed—
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 19

(i) in a Federal criminal, civil, or 

administrative hearing in which the 

Government or its agent is a party;

(ii) in a congressional, Government 

Accountability Office, or other Federal 

Report, hearing, audit, or investigation; 

or

(iii)from the news media,

unless the action is brought by the Attorney 

General or the person bringing the action is 

an original source of the information.

31 U.S.C. § 3730(e)(4)(A) (2010). 

“[T]he Supreme Court has instructed that to determine 

the meaning of one word in the public disclosure bar, we 

must consider the provision’s entire text, read as an 

integrated whole.” Allergan, 46 F.4th at 997 (internal 

quotation marks omitted) (quoting Schindler, 563 U.S. at 

408). As we explained in Allergan, channels (i) and (ii) 

focus on two distinct types of federal proceedings. Id. at 

999. Channel (i) primarily involves adversarial proceedings 

that are adjudicated on the merits before a neutral tribunal or 

decisionmaker, whereas channel (ii) primarily involves 

federal investigatory proceedings. Id. 

Several textual clues lead us to this conclusion. A 

“Federal criminal, civil, or administrative hearing in which 

the Government . . . is a party” contemplates an adjudicatory 

hearing before a neutral tribunal or decisionmaker. See 

Hearing, Black’s Law Dictionary (11th ed. 2019) (“A 

judicial session, usually open to the public, held for the 

purpose of deciding issues of fact or law, sometimes with 
20 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

witnesses testifying.”); Administrative Hearing, id. (“An 

administrative-agency proceeding in which evidence is 

offered for argument or trial.”). As we observed in Allergan, 

the term “party” describing the government’s role in such a 

hearing contemplates that channel (i) hearings are also 

adversarial. Allergan, 46 F.4th at 999 (noting that channel 

(i) “suggests a focus on adversarial proceedings because 

criminal hearings are always adversarial, and civil and 

administrative hearings are very often adversarial when the 

government is a party” (citing Party, Black’s Law 

Dictionary (11th ed. 2019)). 

Conversely, in Allergan we concluded that prong (ii) “is 

primarily concerned with proceedings to gain information.” 

Id. A “report, hearing, audit, or investigation” all suggest 

the “activity of trying to find out the truth about something,” 

whether by “an authoritative inquiry into certain facts, as by 

a legislative committee, or a systematic examination of some 

intellectual problem or empirical question.” See 

Investigation, Black’s Law Dictionary (11th ed. 2019). 

Invoking the canon of noscitur a sociis, we observed that 

“[a]ll four nouns apply to a fact-finding or investigatory 

process ‘to obtain information,’ and together indicate that 

Congress intended for prong (ii) to cover a wide array of 

investigatory processes.” Allergan, 46 F.4th at 998 

(emphasis removed) (citation omitted) (quoting Schindler, 

563 U.S. at 410). 

We held in Allergan that because a patent prosecution is 

an ex parte proceeding before a federal administrative 

agency—the PTO—such a proceeding qualifies as an “other 

Federal . . . hearing” under channel (ii). Id. at 998–99. We 

rejected the contention that “by adding the government-asa-party language to prong (i) in the 2010 amendment, 

Congress intended to exclude administrative hearings in 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 21

which the government was not a party from the public 

disclosure bar writ large.” Id. at 998. Such a sweeping 

argument would seemingly read “other Federal . . . hearing” 

out of existence from channel (ii), and we noted that the FCA 

“contemplates some redundancy” between the channels. Id.

at 999 (quoting Schindler, 563 U.S. at 410). We explained 

that an ex parte hearing before the PTO in which the 

government is not a party falls within channel (ii), “[b]ut 

when the PTO rejects a patent application and the inventor 

appeals, the appeal could fall under prong (i) but not prong 

(ii)” as an adjudication before the PTAB. Id.

This appeal requires us to address certain public 

disclosures addressed by Allergan as well as other 

disclosures that raise novel questions concerning application 

of the statutory bar. We turn to the four sets of public 

disclosures identified by Valeant. 

The patent prosecutions involving the ’344, ’688, and 

Otterbeck Patents are qualifying public disclosures under 

channel (ii), as “other Federal . . . hearing[s].” See id. at 

997–99. A public disclosure “also ‘encompasses publiclyfiled documents’ submitted as part of the proceeding.” Id. at 

997 (quoting A-1 Ambulance Serv., 202 F.3d at 1244).

Allergan does not, however, resolve whether the IPR that 

invalidated the ’688 Patent was a disclosure occurring within 

a specified channel. See id. at 999 (observing that an appeal 

by an inventor before the PTAB “could fall under prong (i) 

but not prong (ii)” but not reaching the issue). We must 

therefore determine whether the IPR proceeding falls within

channel (i) or channel (ii). 

As previously explained, IPR is a trial-like, adversarial 

hearing conducted before the PTAB between a patent owner 

and patent challenger. See 35 U.S.C. §§ 311–19. Other 
22 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

parties may join in the IPR at the discretion of the PTO. Id. 

§ 315(c). The function of IPR is to adjudicate disputes about 

the patentability of a patented invention under the criteria of 

novelty and obviousness. Id. § 311(b). The parties may file 

motions, take discovery, and present evidence and oral 

testimony at a hearing. Id. § 316(a); see 37 C.F.R. §§ 42.20–

25, 42.51–55, 42.61–42.70. At the conclusion of IPR, the 

PTAB issues “a final written decision with respect to the 

patentability of any patent claim challenged by the 

petitioner.” 35 U.S.C. § 318(a); see 37 C.F.R. §§ 42.20–25. 

The PTAB’s decision may itself be appealed to the Federal 

Circuit. See 35 U.S.C. § 143.

IPR presents many hallmarks of a channel (i) federal 

administrative hearing. It is clearly “Federal”: the PTAB is 

an adjudicatory body of the PTO, an agency within the U.S. 

Department of Commerce. See 35 U.S.C. § 6(a); Allergan, 

46 F.4th at 998. It is an “administrative hearing” in which 

evidence and argument are presented before a neutral 

tribunal that adjudicates the merits of a dispute about the 

patentability of an invention. And it is an adversarial

proceeding between two or more parties to the litigation. See 

35 U.S.C. § 311(a)–(b) (establishing grounds and scope of 

IPR proceeding); id. § 313 (describing patent owner’s right 

to respond); id. § 314 (defining basis for instituting IPR); id.

§ 316(a)(5) (establishing parties’ ability to take “discovery 

of relevant evidence”); id. § 316(a)(8) (establishing parties’ 

ability to present “factual evidence and expert opinions” to 

support their arguments); id. § 318 (“[T]he [PTAB] shall 

issue a final written decision with respect to the patentability 

of any patent claim challenged by the petitioner . . . .”). 

But because the government was not a “party” to the IPR

proceeding concerning the ’688 Patent, the proceeding here

was not a channel (i) disclosure. See 31 U.S.C. 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 23

§ 3730(e)(4)(A)(i). Valeant contends that the government 

was a party to the IPR because the Director of the PTO is 

charged with determining whether an IPR should proceed 

and is permitted to participate in an appeal of a PTAB 

decision—procedural features that suggest the PTO is acting 

on behalf of the United States. We disagree. That the 

Director of the PTO decides whether an IPR should be 

instituted, see 35 U.S.C. § 314(a), and may adjudicate claims 

raised in the IPR as a member of the PTAB, see id. § 6(a), 

does not transform the PTO into a “party” to the IPR 

proceeding. A “party” is “[o]ne by or against whom a 

lawsuit is brought; . . . [a] Litigant.” Party, Black’s Law 

Dictionary (11th ed. 2019); see Allergan, 46 F.4th at 999. 

The government did not participate as a litigant in the IPR 

challenging the ’688 Patent. See GeneriCo, 2017 WL 

2211672, at *1, 3–6, 21 (referring to the “parties” as the 

petitioner and patent owner). 

Valeant also contends that the IPR qualifies under 

channel (ii) as an “other Federal . . . hearing.” Again, we 

disagree. The IPR’s primary function was not investigative

in the sense of conducting a “fact-finding or investigatory 

process ‘to obtain information.’” Allergan, 46 F.4th at 998

(emphasis removed) (quoting Schindler, 563 U.S. at 410). It

was adjudicatory—its purpose was to render a decision 

between Valeant and GeneriCo as to the obviousness or 

novelty of the ’688 Patent through a trial-like federal 

administrative hearing. Moreover, as we emphasized in 

Allergan, an important demarcation between channel (i) and 

channel (ii) disclosures is whether the proceeding is ex parte

or adversarial. Id. at 999. Here, the IPR was without 

question adversarial. To conclude that an adversarial, 

adjudicatory, federal administrative hearing before the 

PTAB in which the government was not a party nevertheless 
24 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

qualifies under channel (ii) as an “other Federal . . . hearing”

would render the government-as-a-party requirement in

channel (i) a nullity. As Allergan noted, “[i]t is our duty to 

give effect, if possible, to every clause and word of a 

statute.” Allergan, 46 F.4th at 999 (alteration in original) 

(internal quotation marks omitted) (quoting Duncan v. 

Walker, 533 U.S. 167, 174 (2001)). Accordingly, we 

conclude that the IPR proceeding invalidating the ’688 

Patent was not a disclosure occurring in a specified channel.

Finally, Valeant contends that the Law360 article and 

Brunner and Marakhouski studies are qualifying “news 

media” disclosures under channel (iii). See 31 U.S.C. 

§ 3730(e)(4)(A)(iii). Silbersher does not meaningfully 

challenge this argument. We need not resolve Valeant’s 

contention because, as we explain below, the Law360 article 

and the Brunner and Marakhouski studies do not disclose 

“substantially the same . . . allegations or transactions” as 

Silbersher’s claims. 

In sum, we hold that the disclosures in the IPR 

proceeding at issue here did not constitute a disclosure 

occurring within a specified channel. The prosecution 

histories of the ’344, ’688, and Otterbeck Patents were 

disclosures in the second channel. See Allergan, 46 F.4th at 

997–99. And we assume without deciding that the Law360

article and the Brunner and Marakhouski studies were 

disclosures occurring within the third channel. 

B.

We next consider whether the qualifying disclosures 

reveal “substantially the same . . . allegations or 

transactions” as Silbersher’s qui tam action. We have not 

yet interpreted the “substantially the same” prong of the 

public disclosure bar as revised by Congress in its 2010 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 25

amendments to the FCA. Compare 31 U.S.C. 

§ 3730(e)(4)(A) (2010), with id. (1986). In the previous 

version of the Act, the public disclosure bar applied when a 

relator’s allegations were “based upon” a prior public 

disclosure. See id. (1986). 

Ordinarily, Congress’s decision to change “based upon” 

to “substantially the same as” would indicate the two phrases 

have different meanings. See Rumsfeld v. F. for Acad. & 

Institutional Rts., Inc., 547 U.S. 47, 57–58 (2006); Stone v. 

INS, 514 U.S. 386, 397 (1995). Here, however, the change 

aligns with our caselaw interpreting the previous version of 

the Act. Under the pre-2010 version of the FCA, our circuit 

interpreted “based upon” to mean “substantially similar to.” 

See generally Mateski, 816 F.3d at 573 (“Under our case

law, for a relator’s allegations to be ‘based upon’ a prior 

public disclosure, ‘the publicly disclosed facts need not be 

identical with, but only substantially similar to, the relator’s 

allegations.’” (emphasis added) (quoting United States ex 

rel. Meyer v. Horizon Health Corp., 565 F.3d 1195, 1199 

(9th Cir. 2009)); see also United States ex rel. Lujan v. 

Hughes Aircraft Co., 243 F.3d 1181, 1189 (9th Cir. 2001). 

Thus, as we suggested in Allergan, we conclude that 

Congress re-enacted its prior law in clearer terms by 

replacing “based upon” with “substantially the same as,” 

leaving our precedent interpreting that phrase undisturbed. 

See Allergan, 46 F.4th at 996 n.5; Mateski, 816 F.3d at 569 

n.7, 573 n.14.

Guided by our precedent interpreting “based upon,” we 

next ask whether “substantially the same allegations or 

transactions . . . alleged in [Silbersher’s] action or claim 

were publicly disclosed.” 31 U.S.C. § 3730(4)(A). We have 

recognized a distinction between an “allegation” and a 

“transaction” for purposes of the public disclosure bar. An 
26 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

allegation refers to a prior “direct claim of fraud,” while a 

“transaction” refers to the disclosure of “facts from which 

fraud can be inferred.” Mateski, 816 F.3d at 571 (endorsing 

the definition adopted in Springfield Terminal, 14 F.3d at

653–54). 

As the parties acknowledge, none of the public 

disclosures makes a direct claim that Valeant committed 

fraud. We instead turn to the broader question: whether the 

qualifying disclosures reveal “facts from which fraud can be 

inferred.” The Mateski court explained that “[I]f X + Y = Z, 

Z represents the allegation of fraud and X and Y represent 

its essential elements. In order to disclose [a] fraudulent 

transaction publicly, the combination of X and Y must be 

revealed, from which readers or listeners may infer Z, i.e., 

the conclusion that fraud has been committed.” Mateski, 816

F.3d at 571 (first alteration in original) (quoting United 

States ex rel. Found. Aiding the Elderly v. Horizon W., Inc., 

265 F.3d 1011, 1015 (9th Cir.), amended on denial of reh’g, 

275 F.3d 1189 (9th Cir. 2001)). In the Mateski formula, the 

variables X and Y stand for the fundamental elements of 

fraud: “a misrepresented state of facts and a true state of 

facts.” Id. (quoting Horizon, 265 F.3d at 1015); see also 

Amphastar Pharms. Inc. v. Aventis Pharma SA, 856 F.3d 

696, 704 (9th Cir. 2017) (“If enough of the underlying facts 

making up the elements of fraud are disclosed, the [public 

disclosure] bar applies.”).

Applying this framework, we conclude that the 

qualifying public disclosures here do not disclose a 

combination of facts sufficient to permit a reasonable 

inference of fraud. To refresh, Silbersher’s qui tam

complaint alleges that (1) Valeant “intentionally withheld 

material information” demonstrating that Apriso’s 

effectiveness without food was obvious from prior art (the 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 27

Brunner and Marakhouski studies) when Valeant filed the 

’688 Patent application; (2) Valeant’s claims in the ’688 

Patent prosecution directly contradicted its claims in the 

earlier ’344 Patent prosecution that taking mesalamine with 

food made the drug more effective; (3) the ’688 Patent was 

invalidly obtained because Valeant was aware that the 

Otterbeck Patents were themselves invalid based on prior art 

and vulnerable to challenge; and (4) by fraudulently 

obtaining the ’688 Patent, Valeant prolonged its monopoly 

of Apriso and charged the government an “artificially high 

price for the drug,” all while falsely certifying that the drug 

price was “fair and reasonable.”

Translating Silbersher’s allegations into the formula, X 

stands for the misrepresented facts—Valeant’s claim that it 

was not obvious that Apriso would be effective without food

and that the Otterbeck Patents for Apriso’s delayed-release 

formula were original discoveries. And Y stands for the 

alleged truth—it was obvious that Apriso can be effectively 

administered without food and that the Otterbeck Patents 

were invalidly obtained. The scattered disclosures possibly

reveal both X and Y, but never the combination of the two. 

See Mateski, F.3d at 571. Valeant claimed in the ’688 Patent 

that Apriso’s effectiveness without food was not obvious. 

Nothing in the prosecution history of that patent, however, 

reveals the alleged truth—that it was obvious. In 

mathematic terms, the ’688 Patent discloses X but not Y. 

The ’344 Patent, meanwhile, has the opposite problem. In 

that patent prosecution, Valeant claimed it was obvious that 

Apriso would be effective without food. But the ’344 Patent 

application contains no misrepresentation, thus disclosing Y 

without X. To prove fraud under the FCA, the relator must 

demonstrate that a person “knowingly present[ed]” a 

“fraudulent claim for payment” to the federal government. 
28 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

31 U.S.C. § 3729(a)(1)(A). Silbersher’s qui tam allegations 

provide a critical fact necessary for scienter: Falk and 

Valeant took conflicting positions in their patent 

prosecutions of the ’344 and ’688 Patents. Neither of these 

patent prosecutions, or any other disclosure, revealsthat fact.

The Law360 article states that “two claims in the [’688 

Patent] were obvious based on a collection of references that 

included press releases from [Valeant] about clinical drug 

trials and some academic papers.” But the Law360 article 

does not disclose—nor even imply—that Valeant knowingly 

withheld information when applying for the ’688 Patent. 

Similarly, the Brunner and Marakhouski studies (and 

Valeant’s involvement in those studies) reinforce that 

Valeant understood the obviousness of Apriso’s food-free 

effectiveness. The studies do not, however, say anything 

about Valeant’s application for the ’688 Patent. The Law360

article and the medical studies thus reveal Y and not X. 

Finally, none of the qualifying disclosures—the ’688 and 

’344 Patents, the Law360 article, or the scientific studies—

makes any mention of the Otterbeck Patents, much less 

disclose anything about the validity of these patents. Valeant 

allegedly misrepresented to the PTO that Apriso’s delayedrelease formula underlying the Otterbeck Patents was an 

original discovery. The patent prosecutions, however, do

not reveal the alleged truth: the patents were invalidly 

obtained. Once again, the Otterbeck Patents disclose X but 

not Y. 

In sum, the scattered qualifying public disclosures each 

contain a piece of the puzzle, but none shows the full picture. 

In his qui tam action, Silbersher filled the gaps by putting 

together the material elements of the allegedly fraudulent 

scheme. See Mateski, 816 F.3d at 571. 
SILBERSHER V. VALEANT PHARMACEUTICALS INT’L 29

Valeant contends that our decision in Amphastar should 

guide us to a different conclusion. In Amphastar, we 

affirmed the dismissal of FCA claims asserted against a drug 

manufacturer under the 1986 version of the public disclosure 

bar. Amphastar, 856 F.3d at 711. Amphastar, a generic drug 

manufacturer, filed an application seeking the Food and 

Drug Administration’s approval to market a generic blood

thinner. Id. at 701. The patent holder, Aventis, sued in 

federal district court for patent infringement. Id. at 701–02. 

In its amended answer and counterclaim, Amphastar 

asserted that Aventis had obtained an invalid patent through 

“misrepresentations,” alleged that Aventis “attempted to 

maintain or obtain a monopoly” over others, and claimed 

that Aventis “wrongfully derive[d] income” from this 

conduct. Id. at 704. After Amphastar succeeded in 

invalidating the patent, it filed a qui tam action against 

Aventis alleging the patentee had “obtained an illegal 

monopoly” over the drug “and then knowingly overcharged 

the United States.” Id. at 702. 

In upholding the dismissal of the qui tam suit, we 

grounded our decision on several factors that distinguish it 

from the present case. There, dismissal was based on the 

1986 public disclosure bar, which prevented qui tam claims 

based upon public disclosures “in a criminal, civil, or 

administrative hearing” and did not require, as now, that the 

government be a party to the hearing. 31 U.S.C. 

§ 3730(e)(4)(A) (1986); see Amphastar, 702 856 F.3d at 702 

n.7. The Amphastar court also held that the prior public 

disclosure—the amended answer and counterclaim—“made 

nearly identical allegations” of fraud as the qui tam 

complaint. Id. at 704 (emphasis added). Here, no party 

contends that any public disclosure has made a direct claim 

of fraud. Finally, we concluded that Amphastar’s prior 
30 SILBERSHER V. VALEANT PHARMACEUTICALS INT’L

amended answer and counterclaim also revealed sufficient

facts from which fraud could be inferred, noting all the 

material facts had been disclosed in that filing except the 

claim of overcharging the government. Id. at 704–05. 

Unlike in Amphastar, no public disclosure here, individually 

or in combination, establishes facts from which fraud could 

be inferred. It is the combination of disclosures and conduct 

alleged in Silbersher’s complaint that bring together the 

constituent elements of fraud. 

We therefore determine that the public disclosure bar is 

not triggered here. In concluding that prior public 

disclosures did not reveal “substantially the same” 

allegations or transactions as described in Silbersher’s qui 

tam complaint, we make no statement about the sufficiency 

of the pleadings. The Federal Rules require fraud to be 

pleaded with particularity, see Fed. R. Civ. P. 9(b), and the 

district court did not address whether Silbersher’s 

allegations meet that requirement. We remand this case for 

the district court to consider whether Silbersher’s qui tam

action may proceed. 

III.CONCLUSION

We reverse the district court’s order dismissing 

Silbersher’s action and remand the case for further 

proceedings consistent with this opinion.