5 Colum. Sci. & Tech. L. Rev. 1 (2003-2004)

handle is hein.journals/cstlr5 and id is 1 raw text is: The Columbia
SCIENCE AND TECHNOLOGY LAW REVIEW
www.stlr.org
IT'S THE ANTIGEN STUPID': A RISK/REWARD APPROACH TO THE PROBLEM
OF ORPHAN DRUG ACT EXCLUSIVITY FOR MONOCLONAL ANTIBODY
THERAPEUTICS
By Robert A. Bohrer*
The Orphan Drug Act of 1983 is an attempt at solving an important
problem: how to induce a market-driven pharmaceutical industry to
develop new therapeutics for diseases affecting relatively small numbers
of persons. In the case of protein therapeutics produced by biotechnology,
the FDA's administration of the Act has repeatedly led to litigation and
controversy. The principal and recurrent problem has been determining
when a second applicant for the approval of a drug to treat an orphan
disease (or indication) is seeking approval for the same drug as a
previously approved orphan drug.   The problem  is how to provide
sufficient protection for pioneering orphan drugs to stimulate the
development of new drugs for smaller patient populations, while not so
broadly protecting orphan drugs as to preclude additional therapeutics that
make new contributions to the treatment of those diseases. In the context
of antibody therapeutics, that problem is somewhat different than for other
protein therapeutics. For antibodies, it is the antigen that will primarily
determine the antibody's efficacy, and it is the proof that an antigen is
clinically useful in the treatment of a disease that provides the biggest risk
in antibody development.   The approach to orphan drug exclusivity
recommended here is that the FDA presume antibodies to the same
antigen, of the same immunoglobin class and with the same mechanism of
action to be the same drug unless the second antibody is shown to be
clinically superior to the first.
1 It's the Economy Stupid was the central theme of Bill Clinton's 1992 run for the presidency. It is used
here as a reminder that a successful approach to important problems requires keeping a clear focus on the
central issue. See David S. Broder and Dan Balz, Gore Fails to Cash In on Prosperity; Swing Voters Give
Vice President Little Economic Credit, Wash. Post, July 23, 2000, at Section A, page AO1 for a reference to
the Clinton theme.

* Professor of Law at California Western School of Law.

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