(Fwd) Showdown in Court Over Human Growth Hormones

Michele Gale-Sinex/CIAS, UW-Madison (mgs@aae.wisc.edu)
Tue, 4 May 1999 11:25:23 -0500

Howdy all--

Thought this piece from yesterday's /SF Chronicle/ might interest
some of you. I can't say I realized that science wore a "white
frock"--but then again they're talking about scientists in SF. Here
they mostly wear chinos. ;^)

peace
misha

------- Forwarded Message Follows -------

Showdown in Court Over Human Growth Hormones
UCSF, Genentech square off on high-stakes bioengineering rights

Tom Abate
Monday, May 3, 1999

A federal judge will preside over a courtroom drama this morning
involving charges of purloined DNA and patent infringement in the
high-stakes race to develop the first bioengineered human growth
hormone.

The case pits the Bay Area's top biomedical research institute, the
University of California at San Francisco, against the world's
biotech pioneer, Genentech Corp. At issue are conflicting claims about
who discovered what, and when, more than 20 years ago, when biotech
was young.

UCSF lawyer Gerald Dodson actually laid out his case last week when
he painted a smarmy picture of how Genentech allegedly spirited the
DNA for making growth hormone out of a UCSF lab.

Dodson said that in 1978, three UCSF researchers, Howard Goodman,
John Shine and Peter Seeburg, isolated the strand of DNA that makes
growth hormone. That knowledge was the key to mass-producing a growth
hormone drug.

Growth hormone drugs had long been used to help undersize children
grow. But before the DNA was identified, the drugs had to be obtained
from the pituitary glands of cadavers, a messy and expensive process.

Dodson said UCSF's discovery, for using DNA to mass-produce the
hormone, was therefore of great value. So in April 1978, the
university applied for a patent on the process. But that was before
the courts had decided it was OK to patent DNA, so the application
went into legal limbo.

Meanwhile, Dodson said, Genentech, then just 2 years old, tried to
woo the three UCSF scientists to join the startup. Genentech
co-founder Bob Swanson and his venture capital buddy Tom Perkins took
the scientists for sailboat rides on San Francisco Bay, he said.

Finally, said Dodson, Seeburg, a junior member of the UCSF trio, had
a falling out with senior scientist Goodman, and in September 1978
went to work for Genentech.

Then, on New Year's Eve, Dodson said, Seeburg ``returned to his old
laboratory at the University of California, and took the invention,
took the DNA, and he removed it from the university laboratory and
took it to Genentech.''

Dodson sought to prove that, in part by using this DNA, Genentech was
able to quickly develop its own human growth hormone and seek a
patent on it

--despite protests from UCSF. In 1985, Genentech brought the drug,
called Protropin, through the regulatory process and started to sell
the hormone. Since then it has grossed over $1 billion in sales, on
which Dodson argued the university is owed some royalty.

``Genentech got the inventor . . . (and) got the actual DNA itself,''
he said. ``We think when you hear this evidence you will find that
the university's patent has been infringed.''

To bolster his case, Dodson last week put Seeburg himself -- now
director of a scientific institute in Heidelberg, Germany -- on the
stand to admit that he had indeed taken a DNA sample from UCSF to
Genentech 21 years ago, and used it in his research at Genentech.

This week, it will be Genentech attorney John Kidd's turn to make his
case, which he outlined in last week's opening statement.

``The evidence is going to show that we did it independently, we did
our own research,'' said Kidd, who made a two-pronged assault on
Seeburg's credibility.

First, Kidd shrugged off the fact that Seeburg took the DNA from
UCSF, saying it was common for researchers in those days to take
samples of their work. ``But did we use it?'' Kidd asked. ``The
evidence will show that we did not.''

More ominously, Kidd argued that although this patent dispute has
been simmering for two decades, and Seeburg has been questioned
numerous times, it is only in the past two years that he has alleged
that Genentech actually used the DNA he took with him from UCSF.

And, Kidd reminded the 10-person jury, if UCSF prevails and wins back
payment of royalties, Seeburg stands to profit. Under UCSF policy,
its researchers receive 50 percent of all royalties resulting from
their work. Seeburg and the other two would each pocket nearly 17
percent of any settlement and future royalties.

Just how much is at stake in the trial is as contentious as every
other aspect of this messy affair. Genentech has sold about $1.2
billion worth of growth hormone drugs. Should the university win, it
could ask for back royalties of anywhere from 3 percent to 12
percent, and possibly triple damages, a range that goes from $36
million to $432 million.

Officially, Genentech says it doesn't consider the trial a material
risk. But the case certainly grabbed the attention of Genentech chief
executive Art Levinson, who sat in court last week during Seeburg's
testimony.

In addition to attacking Seeburg's credibility, Genentech's lawyers
will spend this week trying to persuade the jury that there are
subtle but essential differences between its growth hormone and the
UCSF variant.

``If differences count, my client does not infringe,'' said Kidd, who
will also point out that Genentech has six patents on growth hormones
to UCSF's one.

Genentech investors seem to have largely ignored the courtroom drama.
Its shares, which hit a 52- week high of $88.94 at the end of March,
slipped 50 cents Friday to close at $84.53.

But no matter which side prevails in court, some damage has already
been done. The trial has lifted the white frock of science, and
revealed beneath it the all-too-familiar outlines of avarice,
ambition and duplicity.

c1999 San Francisco Chronicle Page E1

<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<
Michele Gale-Sinex, communications manager
Center for Integrated Ag Systems
UW-Madison College of Ag and Life Sciences
Voice: (608) 262-8018 FAX: (608) 265-3020
http://www.wisc.edu/cias/
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
There is something fascinating about science.
One gets such wholesale returns of conjecture
out of such trifling investment of fact.
--Mark Twain

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