In United States ex rel. Silbersher v. Allergan, Inc., 2022 WL 3652967 (9th Cir. Aug. 26, 2022), the Ninth Circuit ruled that the FCA public disclosure bar, as amended in 2010, encompasses information provided to the U.S. Patent & Trademark Office (“PTO”) during a patent prosecution. Accordingly, a qui tam action premised entirely on materials obtained from PTO records is barred.

The Relator filed a series of FCA suits relating to pharmaceutical products whose underlying patents were invalidated in PTO or judicial proceedings. For each suit, Relator reviewed the records of the PTO proceedings and identified information Relator asserted was omitted or incorrectly presented, to support allegations of fraud on the PTO. This fraud, Relator asserted, led to improper issuance of patents, which in turn excluded generic competition, which in turn led to high drug prices, which in turn elevated government reimbursement costs.

As the Supreme Court explained in Schindler Elevator Corp. v. United States ex rel. Kirk, 563 U.S. 401, 412–13 (2011), the public disclosure bar stops relators from bringing “parasitic” or “opportunistic” cases. To achieve that goal, the bar prevents relators from bringing FCA cases based on publicly available information. Otherwise, as the Allergan court explained, a relator could “merely repackage[e] information … for personal profit by asserting an FCA claim.”

But not all public information comes within the bar. Instead, the FCA’s text specifically...

Read Full Story: https://fcablog.sidley.com/ninth-circuit-construes-post-2010-public-disclosur...