copy-cat competitors, their key
weapon is a federal statute that com-
mands the FDA to delay for up to 30
months the approval of any generic if
there is a dispute over a patent.

The 1984 law was intended to protect
branded drugs during what were

Typically, generics take away about half
of the U.S. sales of a branded drug dur-
ing the first six months of competition.
If Schering-Plough's metabolite defense
can postpone generics for half a year,
the company could gain as much as
$650 million in U.S. Claritin sales-
most of which is profit.

The brand-name companies say that
all they are doing is legitimately pro-
tecting their intellectual property and
patients. But their maneuvering is one
reason why the FDA typically takes
longer to approve generic-drug applica-
tions than it does to certify more-compli-
cated brand-name applications. Agency
records show that last year, the median
time for reviewing a generic drug was
18.2 months, or 63% longer than the 11.2
months it took for a brand-name to
gain approval.

Brand-name companies file thick citizen
petitions under 1977 federal regulations
designed to allow anyone to raise con-
cerns about the safety of a drug or other
items the FDA is reviewing. A petition
doesn't prevent the FDA from approving
a new drug. But in practice, the agency
tends to delay generic approvals, some-
times for six months or more, to scruti-
nize objections raised by brand-name
companies. "We don't want to put a
product out with some cloud hanging
over it," says Mr. Buehler.

When brand-name companies go to
court to impede the introduction of

An hour later, Bristol-Myers hand-
delivered its new patent to the FDA,
according to records later filed with
the federal district court in
Washington. The company informed
the agency that it intended to use the
metabolite patent to try to block the
generics and requested that the FDA

delay approval of generic compeitors
for up to 30 months. The FDA agreed.

A Contradiction

Bristol-Myers executives deny the
company made any contradictory
statements to the government or exag-
gerated the scope of any of its patents.
"I really don't want to leave you with
the thought that we told the patent
office we wouldn't do something and
then we went to the FDA with the
opposite, because that did not happen,"
says Dr. Bodnar, the Bristol-Myers
Vice President. He stresses that
Bristol-Myers sent a letter to the patent
office, stating that in the company's
view, the metabolite patent application
still covered swallowing BuSpar, even if
those words didn't appear in the patent
that was approved.