FTC Sues Three Drugmakers Over Generic-Drug Settlement
03 February 2009 - 6:13AM
Dow Jones News
In its latest attack on pharmaceutical settlements that delay
the entry of generic drugs, the U.S. Federal Trade Commission has
filed a lawsuit charging three drug makers with conspiring to
postpone generic competition for a leading testosterone-replacement
drug.
The FTC alleges that Brussels-based Solvay Pharmaceuticals Inc.,
the maker of the testosterone drug AndroGel, entered into an
illegal agreement with generic drug companies Watson
Pharmaceuticals Inc. (WPI) and Par Pharmaceutical Cos. (PRX) to
delay the introduction of a generic competitor.
The generic companies had sought U.S. Food and Drug
Administration approval to market generic versions of AndroGel.
They said in FDA filings that their generics wouldn't infringe
Solvay's patent for the drug, and they argued that Solvay's patent
was invalid.
The FTC said that Solvay, faced with the prospect of plummeting
sales if the generics entered the market, paid Watson and Par a
share of its AndroGel profits in exchange for a promise that the
generics would not introduce a competing drug until 2015. The
generic companies also agreed to drop their patent challenge.
"The evidence in this case will show that Watson and Par agreed
to defer their generic entry for nine years, not out of respect for
Solvay's patent, but due to the size of Solvay's payments to them,"
said David Wales, the chief competition enforcer at the FTC.
Promising a vigorous defense against the charges, Watson Chief
Executive Paul Bisaro said, "We believe the agreement fully
complies with both the spirit and letter of the antitrust and
consumer protection laws."
The agreement, Bisaro said, promoted competition because it
provided for a generic version of AndroGel five years before
Solvay's patent expires in 2020.
Solvay promotes AndroGel as the top-selling
testosterone-replacement therapy on the market. The FTC said the
drug accounts for $400 million in annual sales.
The commission filed the lawsuit jointly with the California
attorney general's office in a Riverside, Calif., federal
court.
With the lawsuit, the FTC is now litigating two so-called
"pay-for-delay" cases.
Last year, it sued Cephalon Inc. (CEPH), alleging that the
company paid generic drug makers to delay competing versions of its
best-selling narcolepsy drug Provigil.
The FTC has continued to attack such settlements even though
some judicial circuits have ruled that the agreements are legal.
The Supreme Court hasn't ruled on the issue.
In 2006, the high court refused to consider the FTC's challenge
to an agreement between Schering-Plough (SGP) and generic companies
that delayed competing versions of K-Dur 20, a potassium
supplement.
In a widely noticed schism, the Bush administration refused to
support the FTC's Supreme Court appeal in the Schering case.
The FTC likely will find more support from the Obama White
House.
As a senator, Obama co-sponsored legislation that would have
barred pharmaceutical agreements that delay competing generic
drugs.
-By Brent Kendall, Dow Jones Newswires; 202-862-9222;
brent.kendall@dowjones.com
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