Government Briefs: White House Moves On Patent Reform, DOJ Settles Endo Off-Label Complaints

Endo admits to marketing its post-herpetic neuralgia pain drug Lidoderm for unapproved uses in a $192.7 million settlement; National Economic Council Director says there is “a sweet spot for bipartisan compromise” on patent troll bills introduced in the House and Senate.

Endo Resolves Lidoderm Off-Label Marketing Charges

Endo International PLC and its subsidiary Endo Pharmaceuticals Inc. have agreed to pay $192.7 million to the federal government and states for off-label marketing of Lidoderm (lidocaine patch). In a deferred prosecution agreement, “Endo admitted that it intended that Lidoderm be used for unapproved indications and that it promoted Lidoderm to health care providers for those unapproved indications,” the Department of Justice said in a release.

A criminal information filed by the DOJ on Feb. 21 in the Northern District of New York charges that Endo marketed Lidoderm from 2002 to 2006 for uses other than its approved indication for relief of pain associated with post-herpetic neuralgia. As part of the settlement, Endo also entered into a corporate integrity agreement with the HHS Office of Inspector General. The settlement resolves three qui tam, or whistleblower, suits brought by two former Lidoderm sales representatives and a physician.

White House Pushes For Passage Of Patent Troll Bill

At a Feb. 20 White House briefing on patent reform, administration officials encouraged Congress to pass legislation intended to curb abusive patent litigation by patent assertion entities, known as patent trolls. The House passed the Innovation Act, H.R. 3309, in December (Also see "Patent Troll Bill Clears House; Provisions Problematic For PhRMA Remain" - Pink Sheet, 5 Dec, 2013.). The Senate Judiciary Committee held a hearing on the chamber’s companion bill, the Patent Transparency and Improvements Act, S. 1720, two weeks later (Also see "Drug Firms Ask Senate For Narrow Patent Troll Bill" - Pink Sheet, 23 Dec, 2013.).

There is “a sweet spot for bipartisan compromise,” said Gene Sperling, assistant to the president for economic policy and director of the National Economic Council. He cited a provision on fee shifting, whereby a judge could require the losing party in litigation to pay the attorneys’ fees of the winner. Commerce Secretary Penny Pritzker announced three White House executive actions on patent reform: “crowdsourcing” prior art, whereby the Patent and Trademark Office will partner with the innovation community to identify prior art to determine if an invention is worthy of a new patent; plans for the PTO to create a public-private partnership to provide pro bono support for inventors and small businesses; and expansion of PTO’s existing training program. PTO Deputy Director Michelle Lee noted that the agency will hold public events March 13 in Alexandria, Va., and March 26 in San Francisco on its proposed rule to require that the owner of a patent be identified while the patent application is pending.