Zyprexa trial testimony turns to hormone levels

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Zyprexa trial testimony turns to hormone levels

By Jeff Swiatek

jeff.swiatek@...

February 10, 2004

Eli Lilly and Co. on Monday continued building its case in court for the

patent-worthiness of Zyprexa, its best-selling drug.

On day two of its presentation in a patent infringement trial, the drugmaker

put one of its own doctors and two academic scientists on the witness stand.

They testified about the validity of using dogs to study cholesterol in man,

and about the link between Zyprexa and the milk-producing hormone prolactin.

U.S. patent protection for Zyprexa is at stake in the federal trial, which

began Jan. 26.

Much of the trial has focused on a study Lilly did using beagles to show

Zyprexa has fewer side effects than similar drugs, making it deserving of

its separate patent, which runs from 1993 to 2011. Zyprexa also was covered

by a broad patent on a family of like compounds. That patent expired a year

before Zyprexa went on the market in 1996.

The trial has become a replay, in far greater detail, of the issues Lilly

raised to the patent examiner in the early 1990s.

Lilly's attorneys have searched the country to find witnesses to testify

that Zyprexa has a relatively weak tendency to cause production of prolactin

in female lab dogs and doesn't cause a jump in cholesterol levels like a

comparative patented compound does.

Three generic drug manufacturers are behind the effort to break the patent

on the blockbuster schizophrenia drug in the trial in U.S. District Court in

Indianapolis. Their central allegation is that Lilly misled the patent

office with some of its claims.

Lilly medical adviser Dr. Bruce J. Kinon testified that Zyprexa benefits

from being a " prolactin-sparing " drug. Excess prolactin can impair sexual

functioning in humans, he said, and cause mammary glands to grow in males.

Concannon, a retired Cornell University animal physiologist who

still does research at the college in Ithaca, N.Y., said the

prolactin-sparing effect with Zyprexa was even seen in two studies done by

the defendants as part of their legal case. Those tests showed pronounced

levels of prolactin production in most dogs given the comparable compound

and much lesser levels in dogs given Zyprexa, he said.

In cross-examination by defense attorney E. Arthur, Kinon

acknowledged that Zyprexa carries a notice on its drug label that it can

elevate prolactin levels in humans.

Another Lilly witness, Dr. E. Bauer, professor of small animal medicine

at Texas A & M University, said the dog is a good predictive model for

measuring cholesterol in humans. Defense witnesses testified to the opposite

last week.

Call Star reporter Jeff Swiatek at .