Copyright 1999 The New York Times Company
The New
York Times
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May 10, 1999, Monday, Late Edition - Final
SECTION: Section C; Page 13; Column
4; Business/Financial Desk
LENGTH: 934 words
HEADLINE: Patents;
Claritin and six other drugs
hope to get a little Congressional help on further patent protection.
BYLINE: By Teresa Riordan
BODY:
WITH this season's bumper crop of pollen,
many allergy sufferers are turning to Claritin, a powerful antihistamine that
subdues the sneezing and coughing and general misery of allergies without
inducing drowsiness. Indeed, Claritin is one of the most popular prescription
allergy treatments on the market, with $1.9 billion in national sales for its
maker, Schering-Plough, last year.
Because of patent protection,
Schering-Plough enjoys a monopoly on crucial chemical compounds in Claritin.
Thus, no cheaper generic equivalents are available.
Given the drug's
best-seller status, though, a number of drug makers are poised to bring generic
knock-offs to market when the original Claritin patent -- granted in 1981 --
expires in 2002. That is, unless Schering-Plough succeeds with its mighty
lobbying effort to persuade Congress to give it three more years of patent
protection, until 2005.
At stake for Schering-Plough -- and for
consumers, collectively -- are many millions of dollars. Generic drugs are
usually priced 30 percent to 60 percent less than brand-name counterparts, and
the generic market is likely to divert a large chunk of business from
Schering-Plough.
Last month Representative Ed Bryant, a Tennessee
Republican, and Representative Jim McDermott, a Washington Democrat, introduced
a bill in the House that would, in effect, extend patent protection for seven
drugs, including Claritin.
The bill's backers contend that the drug
companies deserve extensions because of lengthy delays they encountered after
receiving their patents, as they awaited Food and Drug Administration approval
to sell the drugs to the public.
But the measure, which has been
proposed in the past, has its critics, too. "This is the same smelly piece of
garbage that it has always been," said Maura Kealey, a representative of Public
Citizen, a health consumer interest group founded by Ralph Nader. "It's a greedy
special-interest grab at the expense of consumers and the health industry."
This is the first time that a formal bill on the matter has been
introduced. Previously the drugs' backers preferred the stealth approach. Last
year, for example, Senator Frank Lautenberg, Democrat of New Jersey, slipped the
measure into a huge Federal spending bill. But it was dropped after the
generic-drug industry and some consumer groups cried foul.
The bill's
introduction, however, does not preclude its being tied to a faster-moving piece
of legislation. H. W. Menn 3d, a spokesman for the Generic Pharmaceutical
Industry Association, said his group feared the measure would be attached
surreptitiously to the Kosovo relief bill now pending on Capitol Hill.
The last successful attempt to extend a patent was in 1996, when a
measure covering Daypro, an anti-inflammatory drug made by the Monsanto
Company's G. D. Searle unit, was attached to emergency legislation to avert a
Government shutdown.
Claritin is perhaps the most recognizable drug in
the current patent-extension bill, but the bill would also cover Eulexin, a
Schering-Plough treatment for prostate cancer.
The remaining drugs
seeking extra patent life also have powerful parents. They are Dermatop (Hoechst
Marion Roussel); Penetrex (Rhone-Poulenc-Rorer); Cardiogen-82 (Bristol-Myers
Squibb); Nimotap (Bayer A.G.), and Relafen (SmithKline Beecham).
So far
no equivalent bill is pending in the Senate. But Schering-Plough and its
compatriots should not be wanting for friends. By one estimate, nine law and
lobbying operations have been making their case on Capitol Hill. According to
numbers compiled by Congress Watch and the Center for Responsive Politics,
Schering-Plough spent nearly $4.3 million on lobbying in 1997-98.
During
the first six months of 1998, $200,000 of that went to Baker, Donelson, Bearman
& Caldwell, a law firm that includes Howard H. Baker Jr., the former Senate
majority leader, and Linda Hall Daschle, the wife of the Senate's minority
leader, Thomas A. Daschle.
Schering-Plough alone made about $170,000 in
direct contributions to House and Senate campaigns in 1997-98. And the company
contributed another $50,000 to the Democratic Senate Campaign Committee, which
is headed by Senator Robert Torricelli, a Democrat who, like Frank Lautenberg is
from Schering-Plough's home state of New Jersey. A spokesman for Mr. Torricelli
said the Senator had no plans to introduce the patent-extension legislation.
Schering-Plough says it and the other companies represented in the bill
simply want to be treated fairly.
Claritin and the other drugs have
already received a patent extension under the Hatch-Waxman Act,
which was passed in 1984 to give pharmaceutical companies extra years of patent
protection to compensate for the often lengthy Food and Drug Administration
approval process. Since they were in the regulatory "pipeline" at the time the
legislation was passed, though, they were given only two years of extra
protection, rather than the typical five.
"These drugs spent an
inordinate amount of time in regulatory review" at the F.D.A., said William
O'Donnell, a spokesman for Schering-Plough. He also noted that the legislation
does not call for an outright extension but for an impartial review process to
determine whether the patents should be extended.
Critics disagree.
"They've structured it with very tight timelines," Ms. Kealey said. "There's
really no way to object to the extensions."
Patents may be viewed on the
World Wide Web at www.uspto.gov or may be ordered through the mail, by patent
number, for $3 from the Patent and Trademark Office, Washington, D.C. 20231.
http://www.nytimes.com
LOAD-DATE: May
10, 1999 
