NIH Holds Public Meeting
on "March-In" Petition
June 4, 2004 - The National Institutes of Health (NIH)
May 25 held a public meeting to hear comments on whether the
agency should take action for compulsory licensing of a patented
AIDS drug currently made by a private pharmaceutical firm.
In December 2003, Abbott Laboratories raised the retail price
of its protease inhibitor, ritonavir, from around $2.00 per
100-milligram dose to approximately $10.00. The drug, under
the brand name Norvirtm, is widely used in combination with
other protease inhibitors to make them more effective, and
the price hike thus affects many HIV/AIDS patients relying
on such combination therapies.
James Love, president of the public interest firm Essential
Inventions, Inc., argued in favor of his firm's petition for
NIH to exercise so-called "march-in" rights to take
title to the drug. Ritonavir was invented in part with research
funding from the NIH in the late 1980s. The Bayh-Dole Act,
which permits universities and other organizations to own
inventions produced with federal research grants, does allow
the federal government to take back an invention if certain
conditions warrant. Love argues that by raising Norvir's price
400 percent "in a single day," Abbott Laboratories
has failed to make the invention available to the public on
"reasonable terms" (a condition of the Bayh-Dole
Act) and that NIH should license other firms to manufacture
the drug at more competitive prices. Benjamin Young, M.D.,
Ph.D., a physician at the University of Colorado Health Sciences
Center and an advocate for HIV/AIDS patients, endorsed the
petition, and described the implications of the price hike
for many patients.
However, several of the meeting's other invited speakers,
including former Senator Birch Bayh (D-Ind.), a co-author
of Bayh-Dole Act, argued that the Act's march-in provisions
were decidedly not intended to regulate the market price of
a resulting invention. Rather, the "reasonable terms"
was intended as the government's guarantee that a new technology
would not be locked away. Ted Poehler, Ph.D., vice provost
for research at Johns Hopkins University, and Andrew Neighbour,
associate vice chancellor for research at UCLA, representing
the Association
of American Universities (AAU) and the Council on Governmental
Relations (COGR), strongly opposed the exercise of march-in
rights, which would make it far less likely for industry to
license technology from universities, and could lead to fewer
drugs being developed in the future. Jeff Leiden, M.D., Ph.D.
president and chief operating officer for Abbott Laboratories,
defended the company's "repricing" of Norvir. He
noted that, given the importance of Norvir in making other
treatments more effective, its original price was not commensurate
with its value. Even at the higher retail price, the drug
remains the least expensive drug in its class. He also noted
that the price was not raised for Medicaid, various state
drug programs, or for research, and outlined steps the company
has taken to make Norvir available to other patients. No date
was promised for a decision by NIH on the petition.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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