Unit of Drugmaker Shire Blasts FTC’s Lawsuit Over Use of FDA Petitions

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By Dana A. Elfin

Can the repeated filing of citizen petitions asking the FDA to take action on pending generic drug applications be a viable basis for an antitrust action?

A federal court in Delaware is about to consider that question. ShireViroPharma, a unit of Shire plc (ViroPharma), April 10 asked the U.S. Court for the District of Delaware to dismiss an antitrust complaint the FTC filed against it for allegedly abusing the citizen petition process ( FTC v. ShireViroPharma, Inc. , D. Del., No. 1:17-cv-131, brief filed 4/10/17 ).

How the court comes out on that legal point has the potential to open up more avenues of antitrust liability for the pharmaceutical industry.

In February, the Federal Trade Commission sued ViroPharma, alleging the company filed 46 baseless citizen petitions to delay entry of a generic version of its medication Vancocin D. The FTC claimed the company sought to protect monopoly profits by filing “serial, repetitive, and unsupported filings” with the Food and Drug Administration, costing buyers hundreds of millions of dollars.

The FTC’s suit marked the first time the FTC has sued over a citizen petition, but Shire ViroPharma said the FTC doesn’t have a case.

ViroPharma Says FTC Has No Case

Because the FTC failed to show an ongoing or imminent violation of the law on ViroPharma’s part, the commission doesn’t even have the statutory authority to bring the case in federal court, ViroPharma said in its brief in support of its motion to dismiss the complaint.

Even if the FTC were authorized to bring the case, ViroPharma said its citizen petitioning activity was constitutionally protected activity that can’t be prosecuted under the antitrust laws.

The Noerr-Pennington doctrine provides antitrust immunity to petitioning activity unless the petitions are “objectively baseless.” The FTC’s suit, ViroPharma said, doesn’t allege the company’s petitions were “objectively baseless” and its allegations fall far short of what is required to establish sham petitioning to get around Noerr-Pennington.

An `Exaggerated Counting Exercise’

“The FTC’s attempt to establish the application of the sham exception based on the alleged number of ViroPharma’s filings is meritless,” the company asserted. ViroPharma called the FTC’s complaint an “exaggerated counting exercise” using flawed arithmetic.

ViroPharma asked the court to dismiss the FTC’s suit with prejudice—meaning the government wouldn’t be allowed to refile the suit in the future.

The government’s response is due April 24.

The case is before Judge Richard G. Andrews.

Morgan, Lewis & Bockius LLP in Washington, Philadelphia and Wilmington, Del., filed the brief for ViroPharma.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

ShireViroPharma’s opening brief in support of its motion to dismiss is at http://src.bna.com/nPa. The FTC's complaint is at http://src.bna.com/nPv.

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