JACKSON, Miss. (AP) - A federal lawsuit filed this week in Mississippi claims a major pharmaceutical company made millions of dollars by misrepresenting clinical data and using sham litigation to maintain a monopoly over a drug used to treat depression and anxiety.
Uniondale Chemists Inc., a retail pharmacy in Uniondale, N.Y., filed the lawsuit Tuesday in U.S. District Court in Mississippi against Wyeth LLC, which is now part of Pfizer Inc. The lawsuit claims the patent on Wyeth's Effexor expired in June 2008 and the drug maker fraudulently obtained three patents on extended-release versions.
Pfizer officials denied the allegations.
"We are aware of a complaint filed in the Southern District of Mississippi. We have not been served with the complaint. We categorically deny the claims asserted in the complaint relating to the Effexor XR patents," Pfizer said in a statement. "The company stands behind its Effexor XR portfolio, which represents an important innovation in the treatment of depression and anxiety and has benefited millions of patients across the country. We intend to defend ourselves vigorously against the plaintiff's claims."
The retail pharmacy claims Wyeth used the fraudulent patents and bruising legal tactics to corner the market on the drug, also known as venlafaxine hydrochloride, after the original patent lapsed.
"As a result of Wyeth's fraud and other exclusionary conduct, generic versions of Effexor XR were illegally blocked from the marketplace from June 2008 through at least June 2010," according to the lawsuit. "During this period of foreclosure, U.S. retail sales of Effexor XR topped $4.5 billion."
The lawsuit seeks class-action status for companies such as Uniondale Chemists that allegedly paid "artificially inflated prices for their extended release venlafaxine hydrochloride requirements."
As part of the alleged scheme, Uniondale Chemists claims, Wyeth misrepresented studies by "fraudulently claiming clinical data showed that Wyeth's extended release version of venlafaxine hydrochloride, Effexor XR, reduced the incidence of nausea and vomiting associated with instant release Effexor."
The lawsuit also alleges Wyeth lied when it claimed to unexpectedly discover the extended-release formula of the drug, relying on this claim to secure additional patents.
"The (U.S. Food and Drug Administration) relies completely on the brand name manufacturer's truthfulness about patents' validity and applicability; the FDA has neither the authority nor the resources to check the manufacturer's representations for accuracy or trustworthiness," the lawsuit says.
An FDA spokeswoman did not immediately respond to questions.