Can citizen petitions, which ask the FDA to take action on pending generic drug applications, be viable bases for antitrust actions?
We may soon have an answer from at least one federal court.
In February, the Federal Trade Commission sued Shire ViroPharma, a unit of Shire plc, for allegedly abusing the citizen petition process, marking the first time the FTC has sued over a citizen petition.
Shire ViroPharma April 10 asked U.S. Court for the District of Delaware to dismiss the FTC’s suit with prejudice—meaning the government wouldn’t be allowed to refile the suit in the future.
The FTC’s suit alleges the company filed 46 baseless citizen petitions to delay entry of a generic version of its medication Vancocin D (FTC v. Shire ViroPharma, Inc., D. Del., No. 17-131, filed 2/7/17). 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.
But Shire ViroPharma blasted the FTC’s complaint is an “exaggerated counting exercise” using flawed arithmetic. Its citizen petitioning activity was constitutionally protected activity that can’t be prosecuted under the antitrust laws, Shire ViroPharma said in a brief filed in support of its dismissal motion.
The Noerr-Pennington doctrine provides antitrust immunity to petitioning activity unless the petitions are “objectively baseless.”
The FTC’s suit, it said, doesn’t allege the company’s petitions were “objectively baseless” and its allegations fall far short of what’s required to establish sham petitioning to get around Noerr-Pennington. “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.
The government’s response is due April 24.
A copy of Shire ViroPharma’s opening brief in support of its motion to dismiss is available here.
Read my interview with Michael A. Carrier, distinguished professor at Rutgers Law School in Camden, N.J., on the intersection of citizen petitions and antitrust law, and the next frontiers of antitrust actions in the pharmaceutical arena here.
Read my full story on Shire ViroPharma here.
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