False Claims Act/FCA Archives

Scattered Disclosures May Not Lead to Inference of Fraud in FCA Claim

by Cecilia Choy, Ph.D. | Feb 1, 2024 | Patents

The US Court of Appeals for the Ninth Circuit denied a petition for panel rehearing and rehearing en banc and issued an amended opinion that reversed a district court’s decision regarding the False Claims Act’s (FCA) public disclosure bar. Silbersher v. Valeant Pharm. Int’l, Inc., Case No. 20-16176 (9th Cir. Aug. 3, 2023; amended Jan. 5, 2024) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on those who knowingly present a fraudulent claim for payment to the federal government and allows “relators” to bring fraud claims on behalf of the government.

Valeant owns a set of patents that cover a delayed-release formula for a medication prescribed to treat ulcerative colitis. In 2015, a generic drug manufacturer, GeneriCo, challenged one of Valeant’s patents in an inter partes review (IPR) proceeding. Ultimately, the Patent Trial & Appeal Board found Valeant’s patent unpatentable based on two articles co-authored by Valeant’s head of research.

Silbersher was GeneriCo’s lawyer in the IPR proceeding. He discovered that three years before applying for the challenged patent, Valeant had applied for another patent that disclosed the exact opposite of what Valeant would claim in the challenged patent. Silbersher brought an FCA action alleging that Valeant failed to disclose this information in the IPR proceeding. In response, Valeant argued that the public disclosure bar applied. The district court decided that an IPR qualified as an “other Federal hearing” under channel (ii) of the public disclosure bar and dismissed Silbersher’s action. Silbersher appealed.

On appeal, the Ninth Circuit reversed the district court. Valeant filed a petition for panel rehearing and rehearing en banc. The Court issued an amended decision that refocused on its analysis under its 2016 decision in Mateski v. Raytheon. Under Mateski, the public disclosure bar applies when “the disclosure at issue occurred through one of the channels specified in the statute; the disclosure was ‘public;’ and the relator’s actions are ‘based upon’ the allegations or transactions publicly disclosed.”

The Ninth Circuit discussed whether Valeant’s disclosures revealed “substantially the same allegations or transactions” as Silbersher’s qui tam action. As discussed in the original decision, this was a first for this court, which had not yet “interpreted substantially the same prong of the public disclosure bar” under the 2010 Congress amendments. Mateski explained that to disclose a public fraudulent transaction according to the formulation X+Y=Z (where Z is the fraud allegation and X and Y are the essential elements), “the combination of X and Y must be revealed from which readers or listeners may infer Z, the conclusion that fraud has been committed.”

The Ninth Circuit then applied the Mateski framework to conclude that the qualifying public disclosures here did not collectively disclose a combination of facts sufficient to permit a reasonable inference of fraud. It explained that although “scattered disclosures when viewed together possibly reveal some of these true and misrepresented facts,” fraud could not reasonably be inferred from the combinations. Neither Valeant’s patent prosecutions nor disclosures revealed the critical information necessary to support [...]

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Tune to the Right Channel: Disclosure Lacking Fraud Information Isn’t an FCA Qui Tam Bar

by Cecilia Choy, Ph.D. | Aug 17, 2023 | Patents

The US Court of Appeals for the Ninth Circuit reversed a district court’s decision to dismiss a qui tam action brought under the False Claims Act (FCA) after analyzing the public disclosure bar channels. The case required the Ninth Circuit to examine Congress’s 2010 amendments to the FCA public disclosure bar to determine whether the claims were substantially the same as information publicly disclosed in any one of three enumerated channels. Silbersher v. Valeant Pharm. Int’l, Inc., No. 20-16176 (9th Cir. Aug. 3, 2023) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on anyone who knowingly presents a fraudulent claim for payment to the federal government. The FCA includes a qui tam provision that allows private citizens (or “relators”) to bring fraud claims on behalf of the government. In 2010, Congress’s public disclosure bar precluded qui tam actions if substantially the same allegations or transactions were publicly disclosed in one of three channels:

In a federal criminal, civil or administrative hearing in which the government or its agent is a party
In a congressional, Government Accountability Office (GAO) or other Federal Report hearing, audit or investigation
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.

Valeant owns the “Otterbeck patents” for its drug Apriso’s delayed-release formula. Valeant initiated an infringement action against Lupin, a generic drug manufacturer that attested in an abbreviated new drug application (ANDA) that the Otterbeck patents were invalid because of prior art that described a similar delayed-release formula. Thereafter, Valeant extended its monopoly by applying for and being granted a new patent that claimed a recent discovery that Apriso was effective when taken without food. GeneriCo then challenged the new patent in an inter partes review (IPR) proceeding, arguing that it was obvious that Apriso would be effective without food. GeneriCo presented two medical studies as support. The Patent Trial & Appeal Board agreed and invalidated the claims in the new patent.

Zachary Silbersher, GeneriCo’s IPR lawyer and a relator in another FCA suit in the same court, discovered that Valeant failed to disclose certain information to the US Patent &Trademark Office (PTO) during the IPR proceeding. Specifically, he discovered that three years before applying for the new patent, Valeant applied for another patent where it claimed it made an unexpected finding that taking Apriso’s active ingredient with food made the drug more effective. This claim was the opposite of the claim made in the new application that had been invalidated in the IPR proceeding.

Silbersher brought an FCA case seeking damages from Valeant, alleging that Valeant fraudulently obtained the Otterbeck and new patent to prolong its monopoly and charge an artificially high price for Apriso. The district court dismissed Silbersher’s qui tam action as precluded by the public disclosure bar because the IPR qualified as an “other Federal hearing” under channel two of the bar, as described above. Silbersher appealed.

The Ninth Circuit analyzed whether [...]

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Nothing Private about Relator’s Qui Tam Action Info

by Paul Devinsky | Sep 22, 2022 | Patents

The US Court of Appeals for the Ninth Circuit reversed a district court’s order denying the defendants’ motion to dismiss a qui tam action under the False Claims Act (FCA) and remanded for further proceedings. U.S. ex rel Silbersher v. Allergan, Inc., Case No. 21-15420 (9th Cir. Aug. 25, 2022) (Gould, Bennett, Nelson, JJ)

Relator Silbersher, a patent lawyer, brought his action against the defendants under the FCA. (31 U.S.C. § 3730(b)). Silbersher alleged that the defendants unlawfully obtained several patents related to two drugs used to treat Alzheimer’s disease. He asserted that by fraudulently obtaining these patents, the defendants prevented generic drug competitors from entering the market. As a result, Medicare paid inflated prices for the two drugs in violation of the FCA.

The US Department of Justice, all of the states that have analogues to the federal qui tam provision and the District of Columbia declined to intervene in Silbersher’s action. Additionally, the key factual information in Silbersher’s complaint was all disclosed publicly and much of it could be found on the US Patent & Trademark Office’s (PTO) website as well as on other government websites. The district court denied the defendants’ motion to dismiss, holding that the public disclosure bar did not apply to Silbersher’s claims. The defendants appealed.

The Ninth Circuit reversed and remanded, noting that 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).” The FCA limits who can bring a qui tam action and the sources of information upon which they can base their suit. The public disclosure bar seeks to strike a balance between encouraging suits by whistleblowers with genuinely valuable information and discouraging plaintiffs who have no significant information of their own to contribute. The Court, citing its 2018 case United States ex rel. Solis v. Millennium Pharms., 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.”

The Ninth Circuit determined that only the first element was at issue in this case and that “[i]t is salient and potentially controlling that the key factual information underlying Silbersher’s complaint was all publicly disclosed, and much could be found in websites maintained by the PTO and other government agencies.” Under the public disclosure bar, a court shall dismiss an action or claim if substantially the same allegations or transactions as alleged were publicly disclosed (1) in a federal criminal, civil or administrative hearing in which the government was a party; (2) in a congressional, Government Accountability Office, or other federal report, hearing, audit or investigation or (3) from the news [...]

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