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Hawaii Attorney General Urges Hawaii Residents to Submit Claims for Provigil Settlement

Attorney General Doug Chin urges eligible Hawaii residents to file claims or make their views known on a $125 million multistate settlement that provides $35 million to consumers who purchased the brand-name drug Provigil or generic Modafinil from June 24, 2006 to March 31, 2012.

The deadline to file claims is June 25, 2017.

Eligible consumers include residents of Hawaii and all other states except California or Louisiana, who paid for the drug from June 24, 2006 to March 31, 2012.

Provigil is approved by the Food and Drug Administration (FDA) to improve wakefulness in adult patients with excessive sleepiness. In August 2016, Hawaii and 47 other state attorneys general announced the settlement with biopharmaceutical company Cephalon and its affiliated companies. The settlement resolved allegations that the companies engaged in unlawful “pay-for-delay” anticompetitive conduct involving patent exclusivity for Provigil. “Pay for delay” occurs when a branded drug company unlawfully maintains its exclusive rights by paying a would-be generic competitor to delay entry into the market, keeping prices at artificially high levels.

As the patent for Provigil neared expiration in 2001, the states alleged that Cephalon intentionally misled the U.S. 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.

For additional information or to obtain a claim form, visit www.StateAGProvigilSettlement.com or call 1-877-236-1413.

Companies to Pay More Than $1 Million to Hawaii for Hindering Release of Generic Versions to Consumers

Attorney General Doug Chin today announced a $125 million multistate settlement with Cephalon and affiliated companies (Cephalon). The settlement ends a multistate investigation into anticompetitive conduct by Cephalon to protect the monopoly profits it earned from its wakefulness drug, Provigil. That conduct delayed generic versions of Provigil from entering the market for several years.

Cephalon

The settlement includes $35 million for distribution to consumers in 48 states plus the District of Columbia who bought Provigil. Based on pharmaceutical retail sales data, Hawaii consumers’ share of the $35 million is estimated to be $160,000, depending on the number and quality of claims submitted. In addition, Hawaii is expected to receive about $1,020,543.05. This amount consists of $400,994.62 to compensate for Provigil purchases by certain state entities or authorized purchases from state contracts and $619,548.43 for Hawaii’s share of disgorgement and costs.

As patent and regulatory barriers that prevented generic competition to Provigil neared expiration, Cephalon intentionally defrauded the Patent and Trademark Office to secure an additional patent, which a court subsequently deemed invalid and unenforceable. Before that court finding, Cephalon was able to delay generic competition for nearly six years by filing patent infringement lawsuits against all potential generic competitors. Cephalon settled those lawsuits in 2005 and early 2006 by paying the generic competitors to delay sale of their generic versions of Provigil until at least April 2012. Because of that delayed entry, consumers, states, and others paid hundreds of millions more for Provigil than they would have if generic versions of the drug had launched by early 2006, as expected.

This multistate settlement was facilitated by litigation brought against Cephalon by the Federal Trade Commission. In May 2015, the FTC settled its suit against Cephalon for injunctive relief and $1.2 billion, which was paid into an escrow account. The FTC settlement allowed for those escrow funds to be distributed for settlement of certain related cases and government investigations, such as those of the 48 states.

The settlement is subject to court review, including providing consumers with notice and an opportunity to participate in, object to, or opt out of settlement. The states expect court review will be provided by Judge Mitchell Goldberg of the Eastern District of Pennsylvania, who is currently overseeing other litigation concerning Provigil against Cephalon and others.