12 Intell. Prop. L. Bull. 159 (2007-2008)
Running Cases through a Merck Siveve: Biopharmaceutical Research in the WAke of Merck v. Integra

handle is hein.journals/iprop12 and id is 163 raw text is: Running Cases Through a Merck Sieve:
Biopharmaceutical Research in the
Wake of Merck v. Integra
In Whittemore v. Cutter, Justice Joseph Story created the experi-
mental use exception with the oft-cited declaration that it could
never have been the intention of the legislature to punish a man who
constructed such a machine merely for philosophical experiments, or
for the purpose of ascertaining the sufficiency of the machine to pro-
duce its described effects.' One hundred ninety-two years later, Jus-
tice Antonin Scalia expressed the view of the Supreme Court in Merck
v. Integra that as an initial matter, we think it apparent from the stat-
utory text that 271(e)(1)'s exemption from infringement extends to all
uses of patented inventions that are reasonably related to the develop-
ment and submission of any information under the FDCA [Food,
Drug and Cosmetic Act].'2 Although the patent community has come
to recognize the common law experimental use exception described
by Justice Story, it has yet to be determined what effect Scalia's decla-
ration will have on the Court of Appeals' application of the newly
expanded 271(e)(1) statutory safe harbor.'3 The Court of Appeals'
response will indicate whether the broadened scope of protection, cre-
ated by the Supreme Court, will be preserved.
These two justices' declarations forced universities, small phar-
maceutical companies, and any entity wishing to patent a generic drug
to run their processes through a sieve of sorts. The application of
the safe harbor rules by the Court of Appeals, and more specifi-
cally, by the Federal Circuit, will determine what will or will not pass
through the sieve created by Merck v. Integra.4 This article tracks
the reaction of the Court of Appeals to Merck v. Integra, analyzing the
handful of decisions since Merck that address the bounds of the
271(e)(1) safe harbor.
*  Ms. Gagnier is a 2008 Juris Doctor candidate of University of San Francisco School of Law.
1. Whittemore v. Cutter, 29 F.Cas. 1120, 1121 (C.C.D. Mass. 1813).
2. Merck KGaA v. Integra Lifesciences I. Ltd., 545 U.S. 193, 202 (2005). The FDCA is the
Federal Food, Drug, and Cosmetic Act, the federal legislation that provides the regulatory framework
of the Food and Drug Administration.
3. See 35 U.S.C. § 271(1994).
4. See Merck, 545 U.S. 193.

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