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May 15, 2017

Miller Urges Eligible Iowans to Submit Provigil Settlement Claims

Judge extended claims deadline to June 25 for prescription drugs used to treat sleep disorders

DES MOINES – Iowans who paid for the brand-name sleep disorder brand-name drug Provigil or generic drug modafinil during a six-year period have until June 25 to file a payment claim through a multistate settlement reached last year with 48-state attorneys general, including Attorney General Tom Miller, who alleged the manufacturer engaged in anticompetitive conduct.

Last month, a federal judge extended the previous April 13 consumer claims deadline as part of the $125 million settlement with drugmaker Cephalon and its affiliated companies, including Teva Pharmaceutical Industries, Teva Pharmaceuticals USA and Barr Laboratories. The agreement provides $35 million to consumers who purchased the drugs from June 24, 2006, to March 31, 2012.

The 2016 settlement resolved allegations that the companies engaged in unlawful "pay-for-delay" anticompetitive conduct involving the patent exclusivity for Provigil. "Pay for delay" conduct occurs when a branded drug company seeks to unlawfully maintain its exclusive rights by paying a would-be generic competitor to delay entry into the market and thus keep prices at artificially high levels.

Provigil, which includes the active ingredient modafinil, is approved by the Food and Drug Administration to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.

States Alleged Company Improperly Extended Patent, Fought Competition
As the patent for Provigil neared expiration in 2001, the states alleged that Cephalon intentionally misled the United States Patent & Trademark Office (PTO) in order to secure an additional patent for the purpose of preventing competition.

By misleading the PTO, Cephalon was able to obtain FDA exclusivity for modafinil until June 2006, and extend patent exclusivity until April 2012. A court subsequently deemed the additional patent invalid and unenforceable, but prior to that ruling, Cephalon was able to delay generic competition for over a decade by filing patent infringement lawsuits against all potential generic competitors.

Cephalon later settled lawsuits with its generic competitors in 2005 and early 2006 by paying them to delay the sale of their generic versions of Provigil until at least April 2012 – six years after expiration of FDA exclusivity but three years before patent expiration. The delayed entry cost consumers, states and others hundreds of millions more for Provigil than if generic versions of the drug had launched by early 2006, as expected.

Consumers can obtain a claim form or seek more information about the settlement at www.StateAGProvigilSettlement.com or 877-236-1413. Consumers are urged to contact their pharmacy if they need assistance determining whether they purchased the qualifying drugs during the required time frame and, if so, the amount paid.

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