Are Genes Intellectual Property?

AuthorDavid Koepsell
ProfessionAuthor, philosopher, attorney, and educator whose recent research focuses on the nexus of science, technology, ethics, and public policy
Who Owns You?: Science, Innovation, and the Gene Patent Wars, Second Edition. David Koepsell.
© 2015 John Wiley & Sons, Ltd. Published 2015 by John Wiley & Sons, Ltd.
Are Genes Intellectual Property?
US law has until recently treated unmodified and merely “isolated” genes
as a form of intellectual property. Specifically, genes have been treated as
patentable, and both modified and cDNA genes remain so. The Patent Act,
as it has been interpreted in the United States enables the first inventor to
successfully file a patent to exclude others from making or selling his or
her new, useful, and nonobvious invention or improvement upon an exist-
ing invention. Because of various treaty organizations and agreements,
US patents and patent systems mimicking that of the United States in many
respects recognize or grant similar patents around the world, including
patents over genes. Patents protect processes, methods, manufactures, and
compositions of matter. Patents do not protect ideas but rather exclude the
use of those ideas by others. Patent protection was long extended to
unmodified, isolated genes and gene segments, as well as to the products
and processes associated with both. Patents on many cDNA claims remain
valid in the United States and abroad. Patent applications typically state
numerous claims, some or all of which might be granted, or separately
struck down by the Patent and Trademark Office (PTO) as falling outside
the scope of patent protection. By now, many thousands of gene patents
have been granted, and included among the claims of most of these are
the representations of the gene sequences themselves, meaning molecules
created from the string of bases depicted by the letters A, C, T and G. Are
genes in any form properly protected under patent or under any other
existing intellectual property scheme?
We slipped into the practice of gene patenting without much in the way
of reasoned introspection, and the courts and PTO have at times reasoned
102 Are Genes Intellectual Property?
along similar, or at times divergent, paths. The legislature has more or less
sat out the debate, with only modest attempts at various times to weigh in
on the patentability of genes. So it has been up to the courts and the PTO,
each supposedly guided by the Constitutional grant of Congresss authority
to create the patent system for the purposes of encouraging the creative and
useful arts. Clearly, gene patents are perceived as very useful. They have
certainly been valuable parts of the patent portfolios of many universities
and pharmaceutical companies. There were many entrenched interested
parties ready to lobby for the status quo, but there were also those who came
out vocally opposed to gene patents, often on ethical, moral, or religious
grounds. Legal theorists and intellectual property scholars have similarly
weighed in on the patentability of genes, often uncritical of the strained
lines of reasoning that made first “isolated and purified” products of nature
patentable, or simply weighing the costs vs. benefits.1 We should consider
this question, separate and apart from the moral and ethical considerations
of gene patents, and ask for now whether under any theory of intellectual
property genes may properly be considered capable ofprotection.
First, let us consider the question of what qualifies as intellectual prop-
erty, and under what conditions? This question requires a bit of review,
including both the philosophical justifications of intellectual property and
the historical antecedents to this rather new form of property protection.
Once we look at the nature of intellectual property in its various forms,
wecan ask whether genes have the necessary and sufficient features for
belonging to the category of objects capable of receiving intellectual prop-
erty protection, which particular intellectual property categories they
might belong to, and whether they are capable or worthy of other forms of
The Historical Development of Intellectual Property
Ideas are unbounded and uncontainable. The only way to protect them
from use by others is by secret‐keeping. In fact, secret‐keeping was the first
form of intellectual property protection, and still accounts for an economi-
cally significant amount of protection for various “trade secrets,” such as the
formula for Coca‐ColaTM or Kentucky Fried ChickenTM, as well as thou-
sands of industrial and commercial products and processes. But trade
secrets do not prevent independent discovery and use, and offer no recourse

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