Pregnant with Ambiguity: Credibility and the PTO Utility Guidelines in Light of Brenner
![handle is hein.journals/indana73 and id is 1007 raw text is: Pregnant with Ambiguity: Credibility and
the PTO Utility Guidelines in Light of
Brenner
ANDREW T. KIGHT*
'The abuse of frivolous patents is likely to cause more inconvenience than is
countervailed by those really useful.
-Thomas Jefferson
INTRODUCTION
A simple, everyday word can be[come] pregnant with ambiguity when applied
to the facts of life.2 Although Justice Fortas wrote this more than thirty years
ago in response to conflict over the proper application of the United States Patent
Act's utility standard, it still rings true today. No longer a standard of meaningful
application, the current utility requirement has been shaped and sculpted into a
distant cousin of its predecessor, with consequences that threaten not only the
integrity of the patent system, but the scientific research community as well.
With the advent of faster and cheaper gene-sequencing methods,3
bioprospectors are flooding the Patent and Trademark Office (PTO) with
applications at a frenzied rate. Often the applications represent only gene-
sequence fragments of undetermined function (often referred to as expressed
sequence tags, or ESTs), yet they attempt to lay claim not just to the fragment
but to the entire gene and any protein it may encode as well. This may have far-
reaching effects, as the protein a gene produces can be purified, mass produced,
and sold as a pharmaceutical drug or other useful compound,4 or the gene itself
may be used for gene therapy The ultimate result is that the companies which
conduct[] the more meaningful and costly scientific work-that of incorporating
* J.D., December 1997, Indiana University School of Law-Bloomington; B.A., 1993,
Hamilton College. Special thanks to my family for their unending love and support, and
especially my wife for her guidance and value as a veritable thesaurus. Thank you also to
Professors John A. Scanlan and Daniel J. Lueders for their assistance.
1. SILVIO A. BEDINI, THOMAS JEFFERSON 209 (1990) (quoting Thomas Jefferson).
2. Brenner v. Manson, 383 U.S. 519, 529 (1966).
3. See infra notes 47-60 and accompanying text for a discussion on gene sequencing.
4. For instance, Amgen, Inc. eams more than $500 million a year from sales of Epogen,
a treatment for anemia based on a patented gene. See Joan 0. Hamilton, Get a Life, CAL. LAW.,
Feb. 1996, at 39, 39.
5. On September 14, 1990, four-year-old Ashanti DeSilva, who was born without a
working immune system resulting from a rare disorder known as severe combined immune
deficiency (SCID), was given new genes to correct the defect. SCID renders cells unable to
produce an essential immune-system enzyme and usually results in early death. In order to
battle the disease, doctors at the National Institutes of Health (NIH) injected about a billion
genetically altered cells into Ashanti's body by simple intravenous infusion. This was the first
time gene therapy had been administered to a human in an attempt to cure disease, and today
Ashanti is attending school and leading a normal childhood. See Ralph Oman, Biotech
Patenting Issues Raise Ethical Concerns, NAT'L L.J., May 8, 1995, at C42, C42.](ViewImageLocal?handle=hein.journals/indana73&div=42&collection=&method=preview&ext=.png&size=3)
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Pregnant with Ambiguity: Credibility and the PTO Utility Guidelines in Light of Brenner
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