Lawmakers, Drug Makers Spar Over Pharma Patent Settlements
June 03 2009 - 4:20PM
Dow Jones News
Executives for Mylan Inc. (MYL) and Endo Pharmaceuticals Inc.
(ENDP) faced a grilling on Capitol Hill Wednesday from lawmakers
who support legislation to bar pharmaceutical patent settlements
that delay the introduction of generic drugs.
Critics in Congress and at the U.S. Federal Trade Commission say
the deals are anticompetitive because branded drug makers pay their
generic counterparts to abandon patent challenges that could lead
to early market entry of competing generic medicines.
"Generic companies are getting paid handsomely to sit on the
sidelines," said Richard Feinstein, head of the FTC's Bureau of
Competition.
Feinstein, speaking before a House subcommittee that examines
antitrust issues, said the settlements are a "win-win for the drug
companies" but "impose enormous costs on the health care
system."
Guy Donatiello, Endo's vice president for intellectual property,
took a very different view, saying the settlements often were good
for consumers.
Donatiello, whose company makes branded and generic drugs, said
the settlements often allow generic drugs on the market before a
branded drug-maker's patent ends, while also removing the
uncertainty of litigation.
"While it's a delicate balance, the current system works," he
said.
Mylan's chief operating officer, Heather Bresch, said her
company and other generic makers were sometimes forced into
settlements by branded companies that exploit a loophole in the
federal law Congress passed to encourage generic companies to
challenge questionable drug patents.
That loophole, Bresch said, essentially allows a brand-name drug
maker to re-label one of its medicines and market the very same
product as an "authorized generic" version.
Branded drug makers threaten this preemptive move when a
competing generic company mounts a legal challenge to one of their
patented medicines, she said.
"It definitely serves as a huge detriment to the generic
industry," Bresch said.
In written testimony, Bresch singled out Eli Lilly & Co.
(LLY) and GlaxoSmithKline PLC (GSK) as advocates of this
practice.
The FTC's Feinstein said the agency was studying the issue of
authorized generics and planned on issuing preliminary findings
soon.
Lawmakers voiced competing views on whether patent settlements
that delay generic drugs should be banned.
"Look folks, drugs are too expensive," said House Judiciary
Committee Chairman John Conyers, D-Mich. "Generics are cheaper.
Settlements make drugs more expensive."
Rep. Bob Goodlatte, R-Va., said most courts to consider the
issue have ruled that the settlements are not anticompetitive.
Modern antitrust law, he said, has moved away from rules to make
certain business practices automatically illegal.
The FTC has challenged some drug agreements in court but has had
limited success.
Most recently, the agency sued three drug makers in February,
alleging that Brussels-based Solvay Pharmaceuticals Inc. (SVYSY),
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.
-By Brent Kendall, Dow Jones Newswires; 202-862-9222;
brent.kendall@dowjones.com