Copyright 2000 Globe Newspaper Company
The Boston
Globe
July 13, 2000, Thursday ,THIRD EDITION
SECTION: METRO/REGION; Pg. A1
LENGTH: 1359 words
HEADLINE:
GREGG DRAWS IRE OVER COLUMBIA PATENT MOVE
BYLINE: By
Ronald Rosenberg, Globe Staff
BODY:
A last-minute
effort by US Senator Judd Gregg of New Hampshire to extend a lucrative
biotechnology patent held by Columbia University, his alma mater, is running
into a storm of criticism from drug manufacturers, consumer groups, and members
of Congress, including Senator Edward M. Kennedy.
The
manufacturing-process patent, which expires in August, is licensed by 33
companies who collectively have provided the Ivy League school with
$280 million over the past 12 years. Last year Columbia
received nearly $100 million, by far its largest amount ever,
from this single patent. All the money goes to basic research at the school's
New York City campus.
To prevent the funding from
drying up next month, Columbia has turned to Gregg, who graduated in 1969. He
has 2 1/2 weeks left to persuade Congress to approve an extension before the
summer recess and the national political conventions.
So far, the
Republican legislator has tried unsuccessfully to insert a 350-word amendment
into an unrelated federal spending bill that would enable Columbia to seek a
patent extension that would bring in about $150 million over
the next 15 months.
Opponents say Gregg's precedent-setting approach,
which has Columbia's blessing, is a misuse of power. Requiring drug makers to
continue to pay royalties after a patent has expired, they say, will raise the
price of drugs.
The extension is "simply a giveaway by Congress to
patent holders who don't deserve it," said Kennedy, a Massachusetts Democrat,
and will "impose unacceptable increases in the price of prescription drugs."
Gregg, who tried to include the amendment in an agricultural spending
bill in May, told colleagues his measure would enable Columbia to ask the US
Patent and Trademark Office to extend its major university biotech patent beyond
its August expiration.
Last month, he withdrew a similar amendment from
a military-construction bill, but congressional sources say they expect he will
try again before the end of July.
Columbia officials say they are
seeking a 15-month extension on the patent, which was granted in 1983 and covers
a key manufacturing process for using animal cells to produce proteins used as
drugs. But companies that have been paying Columbia to use the patent say the
extension is unfair because it circumvents patent law and would set a bad
precedent.
"What Senator Gregg is doing is simply outrageous," said Lisa
Raines, vice president of government affairs at Genzyme Corp., which relies on
the patent to make Cerezyme, a major treatment for Gaucher's disease, a rare
disorder of the spleen and bone joints.
"There has never been any
discussion in Congress about Columbia's proposal, and we, like other biotech
companies, have a contract that says we stop paying when the patent expires,"
she said. "Now Columbia wants to change the terms by slipping it through a
government budget appropriations bill with no discussion. It's simply wrong."
In March, Columbia turned to Gregg, who as a subcommittee chairman on
the powerful Senate Appropriations Committee is in a good position to insert
such a provision. Gregg argued that the Hatch-Waxman Act of
1984 allows extensions of patents when drug development is delayed by government
action, such as Food and Drug Administration approval. The provision has been
applied to drugs in the past, but never to manufacturing processes.
"Columbia is finally reaping the reward of its research, and drug
manufacturers are using this patent more and more," wrote Gregg in a recent
letter cosigned by Democratic Senator Daniel Patrick Moynihan of New York. "The
fact is that the drug and biologic campaign against this language is based on
money. These companies want to continue to take advantage of this gap that
exists in the law to avoid paying royalties."
But US Representative
Henry A. Waxman, the California Democrat who coauthored the
1984 law, insists that Columbia and Gregg are misinterpreting the law. He says
it was designed to compensate not universities, but drug makers who experienced
FDA delays.
The Gregg proposal "has nothing to do with the original
intent of the act," he said. "On the contrary, it runs counter to what we
accomplished with the law."
Despite mounting opposition, Gregg is
reportedly looking to insert the patent-extension amendment into what are called
"must pass" conference committee bills required for the federal 2001 budget.
This "must pass" legislation involves measures that have been approved by the
House and Senate but had to be sent to a conference committee so differences can
be ironed out before another vote.
Congresssional leaders, such as
subcommittee chairmen like Gregg, have the power to insert measures that were
not in either chamber's version of the bill.
When Gregg attempted to
insert the extension into the agricultural funding bill, several consumer
watchdog groups raised an uproar.
"This is a classic example of backroom
dealing, and it should be pulled form the bill immediately," said Frank
Clemente, director of Public Citizen's Congress Watch. "This secretly added
provision would be a windfall to Columbia University at the expense of
consumers."
Despite Gregg's apparent determination to get the
patent-extension measure approved, the senator has not spoken to the media
recently about the provision. He was unavailable for comment this week despite
several attempts to reach him through his Washington office.
Although
Columbia was granted its biotechnology processing patent in 1983, it did not
collect royalties until 1988. Since then it has received $280
million in license fees and royalties from 33 companies including Biogen Corp
and Genzyme Corp., both based in Cambridge, Amgen Inc. of Thousand Oaks, Calif.,
which is the nation's largest biotech company, and Genentech Inc. of San
Francisco. These four companies and about six others have created 14
government-approved biotech drugs that use the patent, according to Columbia
officials.
Last year, license fees from the patent reached an all-time
high as Columbia collected nearly $100 million. All the funds
are used for unrestricted basic research by Columbia. Losing about 25 percent of
the $400 million the university spends annually on research
would eliminate the opportunity to expand into new research arenas.
Columbia officials insist the school is seeking only a 15-month
extension to compensate it for the five years between 1983 and 1988. That's when
the FDA had regulatory issues and procedural delays with some biotech companies
that prevented the university from obtaining royalties. "We are the only
university that has come forth and raised our hand about remedying the patent
policy situation and we are getting whacked pretty hard," said Michael Crow,
Columbia's executive vice provost.
Crow acknowledged that there were no
congressional discussions about the patent extension and that inserting it into
an appropriations bill as Congress prepares to adjourn is a shortcut.
"Sure, drug companies don't like the fact that we have taken this tack,
and perhaps it is unusual for a university to act this way, but we are not
asking Congress to give us the extension, just the chance the present our case
to the US Patent and Trademark Office," said Crow.
Columbia has little
bipartisan support beyond Gregg and Moynihan. New York's other senator, Democrat
Charles E. Schumer, did not support Columbia's request.
Other
universities have seen lucrative patents expire without seeking extensions.
Stanford University's patent that helped Genentech create its first drug expired
in 1997.
Last month Kennedy, along with Democratic Senator Richard J.
Durbin of Illinois and Republican Senator John McCain of Arizona, asked
colleagues to vote against the Columbia amendment, which they called "the
greening of the ivory tower."
"At the end of the day, this provision's
main effect will be to increase drug prices," wrote the three senators. "Breast
cancer patients, heart and stroke patients, people with multiple sclerosis or
other debilitating diseases are the ones who will pay for Columbia's new
royalties."
LOAD-DATE: July 13, 2000
