Copyright 1999 Times Mirror Company
Los Angeles
Times
November 17, 1999, Wednesday, Home Edition
SECTION: Business; Part C; Page 3; Financial Desk
LENGTH: 878 words
HEADLINE:
SCHERING-PLOUGH PUSHES BILL ON PATENT
BYLINE: NICK
ANDERSON, TIMES STAFF WRITER
DATELINE:
WASHINGTON
BODY:
With most of Congress distracted
by the desire to finish the federal budget and leave town, a New Jersey
pharmaceutical company has mounted an all-out drive for legislation aimed at
maintaining the price of an allergy drug hailed by millions of consumers.
Madison, N.J.-based Schering-Plough Corp. is pushing a bill to help it
extend its patent on the immensely popular and profitable drug Claritin.
Extending the patent would forestall competition from generic drug manufacturers
eager to seize a piece of the market for Claritin as early as 2002.
At
stake for consumers are cost savings estimated by one study at $ 7 billion over
five years that would kick in after the patent expires.
As Congress
rushes to adjourn for the year, the behind-the-scenes action on Capitol Hill has
the elements of a classic Washington power play, complete with big-name
lobbyists, a surge in political contributions and the prospect of last-minute
provisions to a must-pass bill.
"They're just trying to retroactively
change the rules of the game for themselves," Maura Kealey, a spokeswoman for
the Washington-based consumer watchdog group Public Citizen, said of
Schering-Plough.
But Schering-Plough officials say its case merits
special attention because unexpected delays in the federal regulatory review of
Claritin ate into the time the company was originally allotted through its
patent to market the drug exclusively in the United States.
The company
is asking Congress to direct the U.S. Patent and Trademark Office to review the
claims of Schering-Plough and a handful of other drug companies seeking patent
extensions for other products.
"It's unfortunate that a proposal to take
the politics out of the patent-extension debate should in itself become
political," said Denise Foy, a Schering-Plough spokeswoman.
Special
patent breaks for drug companies are, in fact, unusual. The last time Congress
granted one was in 1996.
The object of this year's jousting is a
prescription drug, typically given in a once-a-day dosage of 10 milligrams, that
has won acclaim from millions of allergy sufferers. Known generically as
loratadine, Claritin is touted as an antihistamine that won't make its users
drowsy, a common side-effect with other allergy medications.
Sales of
Claritin worldwide in 1998 reached $ 2.3 billion, according to the company. Its
retail price in the United States can vary from $ 1.80 per dose to upward of $
2.50. Generic drug manufacturers are vowing to drive down the price by
two-thirds or more when given the chance to compete.
The question of how
to contain drug prices--at a time when pharmaceutical companies are achieving
unprecedented scientific breakthroughs and political clout--is complex. This
year, for example, proposals to add a prescription drug benefit to Medicare have
stalled in Congress.
But lawmakers on both sides of the Claritin dispute
agree that drug companies like Schering-Plough that pursue expensive yet
innovative research should be rewarded with patents that allow them to exploit
their discoveries. That was one aim of a landmark 1984 patent law authored by
Sen. Orrin G. Hatch (R-Utah) and Rep. Henry A.
Waxman (D-Los Angeles), which granted patent extensions of up
to five years for drug companies whose products got delayed by federal
regulatory review.
The crux of Schering-Plough's argument is that its
drug and a handful of others were caught in the drug approval "pipeline" of the
Food and Drug Administration at the time that law was enacted. As a result,
Schering-Plough and the other companies--each with patented products already
under review--were only granted patent extensions of up to two years.
The upshot: Schering-Plough was able to bring Claritin to market in
1993--after an FDA review lasting about six years--but has exclusive rights to
the drug only until its patent expires in 2002. As a result, the company will
have only nine "effective" years to take full advantage of its patent.
Frequently, drug companies get several more years of effective patent life.
Today, the Senate Judiciary Committee is scheduled to consider the
Schering-Plough request in a bill sponsored by Sen. Robert G. Torricelli
(D-N.J.). Torricelli, who, as chairman of the Democratic Senatorial Campaign
Committee wields considerable clout with his peers, is just one of the heavy
hitters behind the company's effort.
Schering-Plough has spent more than
$ 11 million on lobbying in the last three years, according to a check of public
records by Public Citizen. The records show that the company's lobbyists include
Linda Daschle, wife of Senate Minority Leader Thomas Daschle (D-S.D.); Vic
Fazio, a Sacramento-area senior Democratic congressman who retired last year
after 20 years in office; Richard Ben-Veniste, a former Watergate prosecutor who
has become a well-known Washington lawyer; and former Sen. Howard H. Baker Jr.,
Republican of Tennessee.
The company has also spent liberally on
campaign contributions to help make sure its views get heard. The Campaign Study
Group, a Virginia-based firm that tracks political donations, found that
Schering-Plough has given more than $ 500,000 to Democratic and Republican
campaign committees since 1997, including $ 242,000 this year.
LOAD-DATE: November 17, 1999 
