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High court reviews how much a patent can restrict new drug
By HOPE YEN
Associated Press Writer
e
WASHINGTON (AP) -
Pharmaceutical ~ companies
must have flexibility to conduct
rescarch into potentially
ground-breaking new medi
anes, the Supreme Court was
told Wednesday, as it heard
arguments on how far a patent
can go to thwart a rival firm’s
efforts to develop new drugs.
The court considered the
case of Integra Life Sciences
Holdings Corp., which accuses
Germanys Merck KGaA of
infringing a patent it holds on
certain molecules Merck s
using for research. Merck,
which isnt related to the U.S.
company, says a federal law
gives it leeway to experiment.
“You dont spend millions on
toxicity studies unless you have
a safe drug candidate,” said
MCG commencement scheduled May 13
The Medical College of
Georgia will confer diplo
mas to 0662 health sci
ences students during
commencement Friday,
May 13 at 2 p.m. in the
Augusta-Richmond
County Civic Center. Dr.
Thomas Meredith, chan
cellor of the University
System of Georgia, will
deliver the commence
ment address.
Dr. Meredith was
appointed chancellor in
2002, having previously
served as chancellor of the
University of Alabama
System. He holds a bach
clor of arts degree in
social studies from Ken
tucky Wesleyan College, a
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Joshua Rosenkranz, an attorney
for Merck, arguing that com
panies need room for trial and
error without overly burden-
SOMe restrictions.
But Mauricio Flores, Integras
attorney, argued that a jury
properly found that Merck
researchers had overstepped
their bounds since Integra held
a patent. *Chicken embryos
have nothing to do with safety,”
he said, suggesting that most of
the company’s work was a fish
ing expedition.
Most justices appeared ready
to ask the lower court to ke a
second look at its ruling,
expressing concern that patent
protections that are too strong
will stifle valid research. All nine
justices participated in the argu
ment, suggesting the full court
would nllfi%on the case.
In January, Justices Sandra
Day O'Connor and Stephen
master of arts degree in
education administration
and supervision from
Western Kentucky Uni
versity and a doctorate of
education in administra
tion and supervision from
the University of Missis
sippi. He completed the
Institute tor Educational
Management at Harvard
University and participat
ed in the Higher Educa
tion Roundtable at
Oxtord University.
The chancellor and his
wife, Susan, have two
sons. Mark is a third-year
resident in pediatrics at
the University of Alabama
at Birmingham, and
Matthew is a recent grad
Breyer had removed themselves
in"tz: vote to hear the case. The
two own shares in the U.S
based Merck & Co., which was
affiliated with Merck KGaA in
the 1800 s, but the companies
are now te.
The m pits hfifl;;g
companies such as Indi
lis-based Eli Lilly and Co.,
Wyeth and Pfizer Inc., which
seck greater flexibility to pro
duce innovative new medi
cines, against smaller biotech
firms who say they are entitled
to strong legal protection in the
highly compeutive industry.
A ruling for Integra would
“restrict significandy the devel
opment of new drugs,” argues
the Bush administration,
which filed a brief backing
Merck. “A rescarcher aware of a
promising new cure involving a
patented inventon could not
undertake the research neces
uate of Southern
Methodist University
Dedman School of Law.
Coinciding with com
mencement will be year
end ceremonies for each
of MCG's five schools.
The School of Allied
Health Sciences will hold
an honors ceremony May
13 at 10:30 a.m. at Grace
United Methodist
Church, 639 Georgia Ave.
in North Augusta, S.C.
The School of Dentistry
will hold a hooding cere
mony May 13 at 10:30
a.m. at Augusta’s First
Baptist Church, 3500
Walton Way. A luncheon
will follow in the church’s
Actuvities Center.
AUGUSTA FOCUS
sary to develop the drug,”
The case centers on a patent
held by Integra, which is based
in Plainsboro, N.J., that was set
to expire by 2006. Integra sued
forc’g)atcm mfi'mgcn:if::ll after
Merck set up animal trials for a
romising cancer therapy as a
Em stel;?n a decade-long plan
toward possible approval.
The peptides, or biological
molccu{:,p contain a specific
amino acid sequence that
researchers hope could inhibit
tumors.
At issue is whether Integras
tent prohibits Merck’s from
Eginning rescarch into a
potential new anticancer drug,
even if the drug could not feasi
bly be marketed until after the
patent expired.
Merck contends it was enti
tled to the “head-start” research
under a Food and Drug
Administration exemption for
The School of Graduate
Studies will hold a hood
ing ceremony May 13 at 8
a.m. at Augusta’s Warren
Baptist Church, 3203
Washington Rd.
The School of Medicine
will hold a hooding cere
mony May 12 at 2 p.m. at
Augusta’s Bell Auditori
um, 712 Telfair St A
reception will follow at
Sacred Heart Cultural
Center, 1301 Greene St.
The School of Nursing
will hold an honors con
vocation May 13 at 10:30
a.m. at Bell Auditorium.
The Medical College of
Georgia is the state’s
health sciences university
and includes the Schools
studies “reasonably related” to a
future drug application, saying
it won;ld promote the innova
tion of cu treatments
while msfi)ecumn'gng-cd%ic rights of
patent holders.
The Washington-based U.S.
Court of Aflp&k for the Feder
al Circuit, however, ruled that
the FDA exemption did not
extend to exploratory research
_only latc:;)fiasc, human trials
ically involving generic
Z‘fig&. It reasoned that Con
gress intended only to promote
the growth of generics when it
passed the exemption in 1984.
AARP, the ad:ri(xmy group
for people 50 and over, argues
in gfi(l)lgs that the warguhas
important implications for
olg Americans amid skyrock
eting prescription Costs.
rflgdus duisiondnstjagnds, the
inevitable effect will be thar the
costs of drug development will
of Allied Health Sciences,
Denustry, Graduate Studies,
Medicine and Nursing. MCG
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be driven up even further and it
will serve to delay the develop
ment of new medicines,” the
group states.
But smaller firms such as
Invitrogen Corp., which devel
ops scientific tools for use in
drug research, counter that
their $26 billion industry
would go bankrupt if larger
companies are given freedom
to poke around their patented
work without paying a licens
ing fee first.
“The patent system, as it
presently operates, provides the
incentive necessary to fuel the
development of innovative and
beneficial research tools by
granting an inventor the exdu
sive right to control the use of
his invention for a limited
tume,” Invitrogen, based in
Carlsbad, Ca.l.lfg,t writes in its
friend-of-the-court filing,
is a unit of the University Sys
tem of Georgia and an equal
opportunity institution.
15A