Human Gene Patenting
1. Introduction / Background
The debate over gene patenting
questions whether genes can be owned and how best to encourage innovation in
this relatively new field. This debate
has grown especially contentious over the last year due to a few high-profile
court cases, most notably against biotech companies Myriad Genetics Inc. and
Monsanto Inc. (1). Since patent scope is determined not by the United States Patent
& Trademark Office (USPTO) but instead by the judicial branch (5), these
cases have been closely watched by the biotechnology industry, researchers, and
the public for who will have access to which resources: private industry, the
public, and/or scientific researchers.
2. Abstract / Business Case
Gene patenting has become the focus
of societal discourse over the developing biotechnology industry. Biotechnology
promises treatments for many common genetic maladies, as well as potential
enhancement of common genetic traits (2). This paper will explore some of the economic
and ethical problems with gene patents and attempt to provide a solution that
will best encourage innovation in the future. Arguments for and against gene
patenting will be explored. Approaches attempted by foreign nations will be
presented, as will a solution for the current debate in the United States.
3. Problem Statement / Introduction
Gene patenting problems center on ethics
and access to resources. Primarily, it is questionable that genes should be
patented in the first place. There has
been much debate in the United States ever since the 1980 Supreme Court
decision, Diamond v. Chakrabarty (3). This landmark case stated that is was legal
to patent “genetically modified organisms” (4). However, this has lead to the
patenting of genes and gene fragments, based on the legal argument that genes
are modified if isolated from the human body. There is no longer a clear
distinction between naturally occurring and scientifically isolated, as
articulated by the recent Myriad case.
Seven patents held by Myriad were invalidated on the basis that they
involved laws of nature (3). To further confuse matters, USPTO uses suspect
language in qualifying gene patents, such as “Step 1: Identify novel genetic
sequence.”(4) If the sequence were truly new then it should be considered
synthetic, and not something found naturally as a part of the human genome.
Private biotechnology industries such as Myriad and Monsanto argue gene
patents retain exclusivity to their genetic product. For example, Myriad owns
gene patents used to predict if women have an increased risk of developing
breast and ovarian cancer. These industries say patents ensure profitability,
and thus, attract initial capitol investment necessary for research and
development (3). However, attracting
initial investment is a risk with any emerging industry, and the large initial
research and development necessary to many biotechnology products and services,
does not make the problem unique. The biotechnology industry claims that consumer
demand may not answer industry investment, and therefore must be protected by
exclusivity. Today, after thirty years of development, there is clearly no
shortage of demand for the services of genetic testing and treatment. The
exclusivity of these industries is being challenged by public interest for
better and cheaper access to the technology, so there is clearly demand for the
product. Private interests argue that
without the guarantee of the protection of such a patent, investors would not
fuel future innovation. “The competition among researchers to find diagnostic
mutations for cystic fibrosis and other common diseases flourishes, even though
no company has exclusivity.” (2) Most scientific research is also funded
publicly in the United States. It is up
to industry to compete in the free market; neither exclusivity, nor economic
success can be guaranteed in a capitalist society.
Public interest organizations, such
as the American Civil Liberties Union (ACLU), are the largest opponent of gene
patents, and also argue against inhibiting innovation. They argue that the ability to patent genes
keeps prices exorbitant and prevents free market competition of obtaining a
second opinion on a person’s genetic test results (1). In addition, patents on genes and patents on
gene fragments impede future scientific discovery. Gene fragments include expressed sequence
tags (ESTs) and single nucleotide polymorphisms (SNPs). “Diagnostic
laboratories are moving away from a dependence on individual gene patenting and
towards multiple-genome analyses, with prominent articles (published as early
as March, 2010) reporting that: ‘when hundreds or thousands of genes are being
tested at once, patents on each individual gene can become a hindrance to innovation
rather than a spur’” (2) Royalties on such “patent stacking” creates multiple
barriers to free access to knowledge and therefore become costs that are likely
passed on to consumers. Advocacy
organizations claim that private biotechnology firms who own certain sets of
patents can effectively monopolize certain gene test markets, which then
stifles innovation.
4. Proposed Solution
4.1
Introduction of Solution
There are many different solutions
to these complex and historically unique problems. Many countries have addressed these issues in
different ways. The United States is
unique in its “Patent first, ask questions later” approach (5). Notably, both the European Union and
Australia have also seen a recent resurgence of this political and ethical
debate (2). Thanks to peer countries
examples of how this problem could be approached, there is a wealth of
solutions.
4.2.a One
solution is to simply maintain the status quo.
4.2.b Especially
in today’s complex and quickly changing economy, many ethical and technological
problems presented by other new technologies have been solved or become moot by
the snowball effect of further development. However, like many arguments by
industry that attempt to maintain the exclusivity of the status quo, there is little
research to support the idea that gene patents actually promote innovation more
than without patents (5). Limiting
patents might even increase competition and innovation. For example, a company
cannot patent bottled water, but this remains a lucrative and competitive
market.
4.3.a Another
option would be to simply ban all gene patents on the basis of being naturally
occurring.
4.3.b However,
this too is inadvisable, since such a change would upset a 30-year precedent, and
thereby set back the development of the biotechnology field (2). With the accelerating pace of technological
development and so much promise on the horizon, it is unlikely that banning all
gene patents would put a complete end to the biotechnology industry.
4.4.a The
third solution recommended is patenting only processes and not genes themselves
to solve both of the ethical and economic problems.
4.4.b There
are two core arguments against gene patenting: one economic and one ethical.
The infringement of innovation (primarily due to cost, but also to
institutional knowledge) is argued on both sides of the patent issue. Gene patenting is also argued against because
of its attempt to patent the natural world. Patenting only the process of gene
isolation and manipulation, as has been proposed in Australia and the European
Union (2), will continue to encourage the development of multiple approaches to
the same gene, and not an exclusive monopoly to that one natural element. Some
care would have to be considered so that this policy does not run rampant,
thereby patenting common scientific practices.
The “non-obviousness” clause of USPTO patenting standards would continue
to protect basic scientific processes from over-patenting as industry “trade
secrets.” This clause states that patents should only be issued to
“non-obvious” inventions that are “not an improvement easily made by someone
trained in the relevant area” (4).
5. Results / Conclusion
Since the sequencing of
the human genome in 2003, genetic testing and treatment has become more widespread
around the world. As with any burgeoning field, innovation is to be encouraged
to promote growth and economic prosperity as well as population health and
freedom from genetic disease. Innovation
requires a complex cooperation of research and industry. Problems of innovation
and ethics have centered on gene patents, and the ability of private industry
to own genes and gene fragments. Private
interests hold that patents spur innovation by encouraging investment in
research and development, while others maintain that the patents inhibit
progress, by creating unnecessary barriers to existing scientific knowledge. At the core of the debate, a new area of
policy consideration has developed: as technological capacity increases, the
lines between natural and synthetic biological processes become blurred.
Patenting of scientific processes such as isolation,
identification, and modification instead of patenting of natural genetic
material would solve these problems.
Patenting processes instead of genes would eliminate the need for
excessive bureaucratic oversight of patent enforcement and royalty extortion
currently propagated by the exclusivity granted by gene patents. Both oversight and royalties have been
charged with inhibiting innovation. If only processes were patented, innovation
could proceed to develop new methods for isolation and identification without
fear of infringement. In addition, patenting
only processes would effectively end the debate of whether or not gene patents
are actually patents on naturally occurring elements.
6. Bibliography
- American Civil Liberties Union. (2011,
December 07). ACLU Asks Supreme Court to Hear Gene Patents Case. Retrieved
from
http://www.aclu.org/blog/free-speech-womens-rights/aclu-asks-supreme-court-hear-gene-patents-case
- Goh, R. (2010, February 24). Gene Patenting:
Information on Gene Patenting. Retrieved from http://genepatents.info/
- Schwartz, J., & Pollack, A. (2010, March
29). Judge invalidates human gene patent. New York Times.
Retrieved from http://www.nytimes.com/2010/03/30/business/30gene.html?scp=1&sq=judge
sweet myriad gene&st=cse
- U.S. Department of Energy. (2010, July 07).
Genetics and Patenting. Retrieved from
http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml
- Yu, P. (2007). Intellectual property
and information wealth: Issues and practices in the digital age. (Vol.
2). Westport, CT: Praeger Publishers. Retrieved from
http://books.google.com/books?id=z_tYraycQRAC&pg=PA239&lpg=PA239&dq=do
patents necessarily lead to
wealth&source=bl&ots=5Pfb_NTAqu&sig=Q7SffqU1ERCHkYgQOReqQTNFDU4&hl=en&sa=X&ei=ung9T5zlOsfq2AWnz9GQCA&ved=0CCIQ6AEwAA
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