FOR IMMEDIATE RELEASE
NEWS RELEASE
April 18, 2017
For More Information, contact:
Mike Lewis (334) 353-2199
Steven T. Marshall
Joy Patterson (334) 242-7491
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Alabama Attorney General
AG MARSHALL URGES ELIGIBLE CONSUMERS
TO SUBMIT CLAIMS FOR PROVIGIL SETTLEMENT
Claims Must be Filed by Wednesday, June 25
(MONTGOMERY)–Attorney General Steven T. Marshall urges Alabama
consumers to file claims or make their views known on a settlement involving the drug
Provigil by the new deadline, which is June 25, 2017.
The $125 million multistate settlement provides $35 million for distribution to
consumers who paid for the brand-name drug Provigil or generic modafinil from June
24, 2006, to March 31, 2012. A previous deadline had been set for consumers to respond
by April 13, but the court has granted the states’ request and extended the time to file
claims or express views on the settlement until June 25, 2017.
Provigil, which includes the active ingredient modafinil, is approved by the
federal Food and Drug Administration (FDA) to improve wakefulness in adult patients
with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift
work disorder.
In August 2016, Alabama and 47 other state attorneys general announced the
settlement with biopharmaceutical company Cephalon and its affiliated companies,
including Teva Pharmaceutical Industries, Teva Pharmaceuticals USA and Barr
Laboratories. The settlement resolved allegations that the companies engaged in
unlawful “pay-for-delay” anticompetitive conduct involving the patent exclusivity for
Provigil.
“I am pleased that this settlement will help to compensate consumers for many
millions of dollars that they should not have had to pay for Provigil,” said Attorney
General Marshall. “These overcharges resulted from misrepresentations and
inappropriate manipulations of federal patent regulations by Cephalon to delay the
availability of generic versions of the drug.”
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501 Washington Avenue * Montgomery, AL 36104 * (334) 242-7300
www.ago.state.al.us Page 2 of 2
The settlement included $35 million to compensate eligible consumers who may
have been harmed by the alleged conduct. While the claims period has been advertised
for several months, many consumers may not realize that the claims period will close
and that the deadline is nearing.
Eligible consumers are those who reside in the District of Columbia or any state
other than California or Louisiana, and who paid for brand-name Provigil or generic
modafinil from June 24, 2006, to March 31, 2012. It is not yet known how much
Alabama consumers are eligible to receive in restitution payments through this
settlement.
For more information or to obtain a claim form, consumers may visit
www.StateAGProvigilSettlement.com or call 1-877-236-1413.
“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.
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. 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.
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