BI Must Submit Settlement Papers to FTC After Supreme Court Rejection

January 26, 2016

Boehringer Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications.

In a list of orders issued last week, the justices denied the company’s petition to review a lower court decision requiring Boehringer to turn over financial analyses from two recent settlement cases to the FTC for review. As with most Supreme Court refusals, no explanation is provided for the decision.

The petition stems from an FTC subpoena demanding access to documents produced as part of two patent settlements the company negotiated with Barr Pharmaceuticals in 2008: one for the Parkinson’s disease drug Mirapex and one for the blood thinner medication Aggrenox. The commission wanted the documents as part of a pay-for-delay investigation into the deal, which called for Barr to hold off on marketing generic Mirapex until January 2010 — 16 months after the settlement — in exchange for Boehringer paying “certain specified fees and royalties” to a Barr subsidiary as part of a co-promotion deal for the two drugs.

While Boehringer produced most of the documents the FTC demanded, it refused to part with financial analyses of the deals that were drafted at the request of the company’s in-house counsel. According to Boehringer, those documents constitute a “protected work product” because they were requested by a company attorney, meaning they cannot be subpoenaed.

A district court supported that assessment, but a panel of judges for the U.S. Court of Appeals for the D.C. Circuit disagreed, saying that because the documents did not actually reflect the attorney’s legal opinions, they amounted to fact work products that are not protected from subpoena.

Boehringer unsuccessfully argued in its petition that the D.C. panel’s ruling conflicts with those from other appellate courts and that the high court should take up the case to resolve the issues.

Boehringer representatives did not respond to a request for comment last week.

Read the petition here: www.fdanews.com/01-20-16-Petition.pdf.