![handle is hein.journals/infctel13 and id is 1 raw text is: Information & Communications Technology Law, Carfax Publishing
Vol. 13, No. 1, 2004 P
Rethinking the Product of Nature Doctrine as a Barrier
to Biotechnology Patents in the United States-And
Perhaps Europe as Well'
JOHN M. CONLEY
University of North Carolina, USA
ROBERTE MAKOWSKI
Villanova University, USA
ABSTRACT For more than a decade, gene patents have been the driving force behind the
burgeoning American biotechnology industry. Many people-even otherwise sophisti-
cated lawyers-assume that such patents cover only methods and therapeutic applica-
tions. They are shocked to learn that patents on genes themselves, as long as they are
isolated from the body, are routinely allowed by the United States Patent and Trademark
Office and acquiesced in by the courts. The practical consequences of this development
are equally startling to the non-patent community: gene patent holders can control not
only commercial applications, but virtually all research involving the subject genes.
Since genes are valuable as transmitters of information, the ultimate effect can be a
monopoly on the use of that information. This, we believe, takes intellectual property
protection to an unprecedented level.
All challenges to gene patents in the United States have thus far been dismissed
almost out of hand. One possible avenue of attack that has gotten little attention involves
the 'product of nature' doctrine, whose roots in American patent law go back to the
nineteenth century. In its strongest form, it holds that compounds and compositions of
matter that are not materially different from naturally occurring products are not
patentable subject matter. In this article, we explore the history and current status of this
doctrine. After reviewing some of the critical scientific elements of gene patents, we ask
whether the product of nature doctrine, properly argued, might be reinvigorated as a
brake on the rush to patenting the human genome. We believe that it would be
particularly useful for lawyers and regulators in Europe to examine the American
experience, since the European position on gene patents seems still to be more open to
debate.
1. Introduction
United States Patent 5,397,696, issued on 14 March 1995, claims '[a] cell line,
designated Papua New Guinea-1(pNG-1) ATCC CRL 10528'.2 In simplest terms,
a cell line is the perpetuation, in an artificial medium, of an original sample of
cells from a host. This patent claimed a cell line derived from the white blood
cells of a single resident of Papua New Guinea. His tribe, the Hagahai, is an
ISSN 1360-0834 print/ISSN 1469-8404 online/ 04 /010003-38 @ 2004 Taylor & Francis Ltd
DOI: 10.1080/1360083042000190625](ViewImageLocal?handle=hein.journals/infctel13&div=1&collection=&method=preview&ext=.png&size=3)
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