White & Case Files Supreme Court Amicus Brief on Behalf of BIO and PhRMA Addressing Important False Claims Act Issues

Press Release
2 min read

Global law firm White & Case LLP has filed an amicus brief with the Supreme Court of the United States on behalf of Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA), two of the largest pharmaceutical and biotechnology trade organizations, in the closely watched case, Valeant Pharms. Intl., Inc., et al. v. United States ex rel. Silbersher, which will have significant implications for False Claims Act (FCA) and antitrust litigation moving forward, particularly in the pharmaceutical and biotechnology industries.

In the amicus brief, BIO and PhRMA ask the Supreme Court to grant a writ of certiorari and, ultimately, reverse the Ninth Circuit's novel holding regarding the scope of the FCA's public disclosure bar, which generally prohibits a qui tam relator from bringing an FCA claim based on information previously disclosed through public channels, in the context of inter partes review (IPR) proceedings. Diverging from Supreme Court precedent, and creating a split with its sister circuits, the Ninth Circuit wrongly held that information in an IPR proceeding is not "publicly disclosed" for purposes of the public disclosure bar and a qui tam relator can avoid the public disclosure bar by merely "stitching together" publicly available information.

"Unless remedied by the Court, the Ninth Circuit's ruling will have significant consequences for US-based innovators in all patent-intensive industries,” said White & Case partner Kevin Adam. "IPRs and opportunistic FCA cases will skyrocket. The threat of costly FCA damages will discourage critical investments in research and development, as well as alter the incentives for parties to resolve IPR proceedings through settlement or other alternatives. And the decision will foster an environment where legal counsel in IPR proceedings may seek to prioritize personal gain over client interests, positioning themselves to benefit from potential follow-on FCA cases.”

The full amicus brief is available here.

The White & Case team includes partners Jack Pace (New York), Peter Carney (Washington, DC) and Kevin Adam (Boston), along with associates Cansu Gunel (Washington, DC) and Daniel Medici (Boston).

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