Zyprexa trial testimony turns to hormone levels

[Guest guest]

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 (317) 444-6483.

[Guest guest]

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 (317) 444-6483.