[Pharm-policy] Columbia University amendment on patent extensio

[James Love]

CongressDaily
May 12, 2000

Controversy Dogs Labor-HHS Bill
A unanimous Senate Appropriations Committee Thursday approved the
FY2001

....Meanwhile, the Agriculture appropriations bill approved by Senate
appropriators Wednesday would open a new front in the war over drug
patent extensions.

Buried with the bill's supplemental spending for FY2000 is a provision,
inserted by Sen. Judd Gregg, R-N.H., that would extend a Columbia
University patent on a process that uses gene-splicing to produce
proteins used to make drugs. Drugs produced using the
"cotransformation" patent are eligible to apply for patent extensions
under
the 1984 Hatch-Waxman Act to make up for delays in the approval
process at the FDA.

But Columbia itself is not eligible to apply for an extension for the
process that makes the drugs possible "because its patent describes a
process that is not itself subject to direct FDA review," according to a
justification of the amendment written by Columbia's counsels, the firm
of Wiley, Rein and Fielding.

Columbia argues that it has nevertheless suffered because of delays in
approving the drugs that generate the royalties on the patent. "Without
legislative relief, Columbia, which reinvests its royalty income in
fundamental research and education, will not capture the full benefit of
its patent. From a public policy perspective, patents like the
Cotransformation patent should be eligible for extension," wrote the
attorneys.

- By Julie Rovner
-- 
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James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
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