17 Effective Protection of DNA Sequences and Gene Innovations
Invited Reseacher: Dae Hwan Koo(*)
This Article examines whether patenting DNA sequences and gene innovations is desirable froman economic perspective to encourage innovations. In order to evaluate this, the characteristics of
DNA sequences and gene innovations are discussed. DNA sequences have a dual character as achemical and as an information carrier. Gene innovations are incremental, sequential and cumulative.
Because of these characters, DNA sequences and gene innovation should not automatically be
regarded as patentable.
The main problem in the patent system is that it is based on an exclusive right that tends to
impede innovations in sequential innovations. Many disadvantages of patent protection are revealed
through the examination of the patent system in the context of the characteristics of gene innovation.
Therefore, it is necessary to find a way to provide the first comer with incentives, and second comers
with freedom to utilize the first comer’s innovation if they are willing to pay.
In order to accomplish this goal, first, I suggest that clearly defined ‘research exemptions,’
enhanced patentability standards, and Purpose-bound Protection should be employed. Second, aclearinghouse, Genetic Sequence Right, and automatic licensing system should be introduced. Third,
the patent system should integrate useful standards included in the Direct Protection of Innovation.

Iestablished a patent thicket. Any particulargene therapy requires the concurrent use ofmany of these patents. It requires theaggregation of multiple patents to create asingle product. This results in anticommons
problems. Thus, some oppose patenting
human genes. Others argue that DNA
sequences should not be subject-matter ofpatent because they are discoveries of nature,
which are the common heritage of all, rather
than man-made inventions. Nonetheless,many jurisdictions including the US, the EU,
Korea and Japan, allow patents on DNA
fragments and human genes.

Introduction

Patents have been used to protect DNA
sequences and gene products. Copyright andtrade secret also might be used to protect
them. Many commentators have suggested
the possibilities of copyright protection of
biotechnology innovation. However, becauseof (1) the significant discrepancy between
characteristics of DNA sequences and thoseof copyright and trade secret, and (2) the
great incentives given to patent rights, DNA
sequences and gene innovations are mainly
protected by patents.
The patent system can be regarded as ameans to induce the disclosure of secrets inreturn for the grant of exclusive rights.
According to classical economic theory,
patenting stimulates innovation. Patenting,however, tends to weaken competition,
increase consumer prices, make market lessflexible, and entail significant management
costs. The patent system may also constrain
innovation if the protection it gives is too
broad.
PatentingDNA
sequences
has

II

PatentProtection
Sequences

1

DNA

Arguments
forPatentingDNA
Sequences
DNA sequences are vulnerable to easyacquisition of equivalence. If the cost of
copying compared with the cost of innovationis small enough, it can destroy thelead-time.
Recently, especially in the US, patent(*) Professor of Law and Technology, College of Law, Seoul National University, Seoul, Korea.

1
IIP Bulletin 2007ofprotection has been extended to protect DNA
related inventions. However, there have been
many debates between those for and against
extending the patentability of these creations.
Advocates assert that expanded protection
will provide stronger incentives to develop
new technologies, and that expanded
protection will make it possible for newcompanies to secure finance.
Patentdocuments
stimulatedevelopment, because the public can build on
published gene patents. Without patents, theinventor would have no incentive to disclose
his invention. He will keep the invention
secret to maintain competitiveness over hiscompetitors. Expanded protection may
providestrongerincentives
forthegeneration and diffusion of new technologies.
Patents can also be used to bargain withcompanies for use of their patents. Thus,
gene patentability makes it worthwhile forinvestors to invest large resources to R&D.
Genes neither operates independently
nor performs a single function.(*1) Genomes
are not just collections of separately
functioning elements that can be combined
and recombined precisely without any
unintended consequences. Thus, proponents
argue that there are sound legal andscientific grounds that genes could berecognized as a patentable subject-matter
when their functions are disclosed, such ascoding for a particular protein, or association
with a disease.
The most important reason for applying
for patent protection is to protect own
technology from imitation and prevent
competitors’ patenting and application
activities.(*2) In many cases the patent
protection is essential to corporations ingeneral, small and medium sized enterprises(SMEs)
inparticular,
engaging
inbiotechnology R&D.(*3) If SMEs were unable

to patent their discoveries, they have no
choice but to join large companies which
could commercialize and benefit from theresearch results by SMEs. This is because
SMEs cannot commercialize their research
result due to their limited resources. This
trend would diminish research in the end
because SMEs are a very important source ofinnovation. The biotechnology industry is
still in its infancy. It is extremely expensive
to discover new medicines and obtainapproval for a new therapeutics and the useof technical information included in a specific
DNA sequence could result in these
medicines and therapeutic. Therefore, if thepatent protection could be granted to genefragments, the industry would benefit fromthe increased investment and improved
security that such patents would provide.
Proponents for extended patentability forgenes and gene fragments argue thatinventors of research tools also require areturn on their investment, and that allowing
patents on end products only will further
industry concentration.(*4) They argue thatwhile genes are an essential element of life, if
we consider the intellectual effort required tolocate, characterize, and determine the rolethat genes play in disease, genes should be
regarded as patentable inventions rather
than mere discoveries. Most businesses andpatent practitioners regard a disclosed DNA
as a newly characterized chemical.(*5) Isolated
and purified chemicals produced in livingorganisms including humans have been
patented in Europe and the US for more than
100 years. For example, adrenaline waspatented in 1903, and insulin in 1923. If DNA
compounds are regarded only as a chemical,
it is not surprising to patent them.
The possibilities to cure different typesof cancer, heart disease or other sufferings
support the view that the patent laws should(*1) Graham Dutfield, DNA Patenting: Implications for Public Health Research, Bulletin of the World
Health Organization, May 2006,
vol.84, no.5 [cited 21 August 2006] at 388-392, [hereinafter Dutfield, DNA Patenting].
(*2) Nikolaus Thumm (and edited by Swiss Federal Institute of Intellectual Property), Research and Patenting in Biotechnology – A Survey
in Switzerland , Publication No 1 (12.03) at 22-25, available at www.ige.ch/E/jurinfo/documents/j10005e.pdf, accessed on August 20, 2006.
(*3) Byron V. Olsen, The Biotechnology Balancing Act: Patents for Gene Fragments, and Licensing the "Useful Arts", 7 Alb. L.J. Sci. & Tech.
295 (1997) at 321-322, [hereinafter Olsen, Patents for Gene Fragments ].
(*4) John R., An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies, CRS
Report for Congress (Order Code RL30648) August, 2000.
(*5) Dutfield, DNA Patenting, supra note 1 at 388-389.

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than in the US. European patent system
includes a “morality” or “ordre public”
provision. Objections based on morality arethose who think DNA patents are morally
inappropriate because such patents create aproperty right on the material that composes
lives including human beings.(*8) They would
argue that all lives have equal rights. Genepatents could also result in a strong threat tohumanbeings,suchasgeneticallyengineered crops destroying local biodiversity,
increased bacterial resistance throughoveruse of antibiotics, and biological warfare
through genetically created diseases. The
following arguments against gene patenting
are (1) that DNA sequences are product ofnature, and (2) that gene patenting impedes
follow-on innovations.
(1) Product of Nature and Laws of NatureFirst, patents should not be granted onsomething that is not an invention but a
product of nature. According to Demaine &Fellmeth, DNA sequences and proteins,
discovered or undiscovered, purified or
unpurified, isolated or insolated, whosefunctions are identified or unidentified,should be regarded as laws of nature or
natural phenomena.(*9) Opponents argue thatany of these technical processes cannot turna product of nature into a human invention,and thus DNA sequences are explicitly aproduct of nature.(*10) As far as DNA
sequences and proteins are laws of nature or
natural phenomena, patenting these cannot
be justified.
(2) Economics of Gene Innovations
Second, in economic perspective of gene
innovation, patenting DNA sequences isinappropriate, because DNA patents could
restrict research in genetic engineering areasand slow down medical progress in disease
management. They result in prohibitively
high cost of basic or applied research toacademics
andcorporations.(*11)
Thereflect
thesocietal
need
for
gene
(*6)
technology.
This view holds that society
should provide every incentive to thecorporations that can make life saving
therapeutics through genetic engineering.
Thus, patents might actually promote R&D
because patents facilitate the allocation ofresearch
efforts
andavert
wasteful
duplication. Companies will not spend
resources reinventing an already patented
product. Patents enable all interested parties
to access the disclosed invention, because
patents are granted only when the applicant
discloses all details of the invention.
The public can access the new
information and may practice freely when thepatent expires. Even during the lifetime of apatent, other parties can practice patented
inventions through licensing and royalty
agreements.

2

Arguments against Patenting DNA
Sequences
Patenting DNA sequences confers
monopoly not only on the sequence but also
on any uses that can be made of the sequence.
A gene patent grants a monopoly over thegene for 20 years. Its owner can prevent
others from conducting research, performing
tests, or developing therapies for that genewithout obtaining a license and paying
royalties.(*7)
Objections to DNA patents are expressedin various ways. The Council of Europe and
UNESCO argue that genes are part of our“common human heritage” and thus, are notappropriate
patentablesubject-matter.
Others maintain that human genes are
inalienable, and that patenting human genes
is treating human beings as a market
commodity. Others based on theology object
gene patents on the ground that genes belong
to God. Objections to gene patents are
generally more favorably received in Europe(*6) Olsen, Patents for Gene Fragments, supra note 3 at 321.
(*7) Michael J. Malinowski and Radhika Rao, Legal History and Legal Theory: Legal Limitations on Genetic Research and theCommercialization of its Results, 54 Am. J. Comp. L. 45 (2006) at 49-50.
(*8) Courtney J. Miller, Patent Law and Human Genomics, 26 Cap. U.L. Rev. 893 (1997) at 918.
(*9) Linda J. Demaine & Aaron Xavier Fellmeth, Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the
Biotechnology Patent, 55 Stan. L. Rev. 303 (2002) at 309, [hereinafter Demaine et al., Reinventing the Double Helix ].
(*10) Dutfield, DNA Patenting, supra note 1 at 388-389.
(*11) Olsen, Patents for Gene Fragments, supra note 3 at 323-324.

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IIP Bulletin 2007

possibility of private ownership of segmentsof the human genome and the potential valueof it can freeze the scientific researchcommunity. This prevents the free flow anddisclosure of information, resulting inincreased secrecy and scarce collaboration.

sequences would encourage a company toprohibit using those sequences in developing
a diagnostic test or therapy altogether. Whilemost diseases are caused by both genetic andenvironmental
components,
privateownership of any contributing factor could bea cause to extract charges from those who
develop a diagnostic test, therapy, or
pharmaceutical. This results in higher
medical costs and decreased availability tothose in need.

Incremental,
sequential,
cumulative
innovations
Identifying DNA sequences is now aroutine process. Most genetic discoveries are
now incremental.(*12) Patent protection ofincremental improvements is inadequate
because to be patentable an invention shouldhave an inventive step. Typical biomedical
treatments comprise many components andinnovations developed by earlier innovators.
Due to this sequential and cumulative
characteristic of gene innovations, almost all
developers of any life saving treatments will
involuntarily infringe a gene patent during
the processes of their developments. It isdifficult to check to ensure that none of theseprocesses infringes one of the DNA patents
already granted, and to license all of thosepatents.
According to the concept of ‘sequential
innovation’systems,(*13)
which
was
generalized by Bessen and Maskin, patenting
gene innovations is not economicallyadequate. They argue that when innovationis sequential and complementary, imitation
becomes a spur to innovation and strong
patents become an impediment.
In addition, because patent rights are
exclusive, they hinder follow-on innovation insequential innovation process. Criticalproblems in sequential innovation process
exist in the relationship between the firstinnovator and follow-on innovators. Patentrights to a single gene or a single brief DNA
sequence could result in a near monopoly on
diagnostic
tests
and
treatments
for
(*14)
diseases.
Private ownership of DNA

Tragedy of the anticommons
Huge number of patents and patentapplications for genes and DNA fragments
has created a problem, the "tragedy of the
anticommons" that is named by Michael
Heller and Rebecca Eisenberg.(*15) The
tragedy of the anticommons means thecomplex obstacles that arise when a userneeds access to multiple patents to create asingle useful product. Each upstream patentadds to the cost and slows the pace ofdownstream innovation. Because many
companies attempting to produce a productwell recognize the complications whichblocking or complementary patents create,
they search for ways to by-pass these
problems. Describing a patenting problem
with gene patents as “tragedy of the
anticommons,” Heller and Eisenberg assertthat a proliferation of IPRs upstream may
stifle life-saving downstream innovations.
Costs of blocking or complementary patents
The most common deterrent to gene
innovation is the prohibitively high costs inusing a patented DNA molecule, protein,etc.(*16) The costs impede research that relieson access to the patented biochemicals, andhinder the development of downstream
products such as pharmaceuticals, medical
therapies, and diagnostic tests.
Most biotechnological research involves(*12) Demaine et al .,, Reinventing the Double Helix, supra note 9 at 410.
(*13) James Bessen and Eric Maskin, Sequential Innovation, Patents, and Imitation, Working Paper Department of Economics,
Massachusetts Institute of Technology, No. 00-01, January 2000.
(*14) Demaine et al ., Reinventing the Double Helix, supra note 9 at 308-309.
(*15) Bradley J. Levang, Evaluating the Use of Patent Pools For Biotechnology: A Refutation to the USPTO White Paper Concerning
Biotechnology Patent Pools, 19 Santa Clara Computer & High Tech. L.J. 229 (2002) at 234-235; Michael S. Mireles, An Examination ofPatents, Licensing, Research Tools, and the Tragedy of the Anticommons in Biotechnology innovation, 38 U. Mich. J.L. Reform 141 (2004) at
171-172, [hereinafter Mireles, Patents and Anticommons in Biotechnology innovation ].
(*16) Demaine et al ., Reinventing the Double Helix, supra note 9 at 415.

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anticommons, patent thicket, and blocking
patents. These problems result from (1)intrinsic nature of DNA sequences carrying
genetic code that could be regarded as laws ofnature, and (2) the disharmony between
characteristics of gene innovation and patentrights.
Patent protection of a DNA sequence
impedes follow-on innovations because
patents are based on proprietary rules.(*21)
Under the current situations that a numberof patents have already been granted to DNA
sequences, it might not be realistic to suggestthat further patents should not be granted
anymore. If we have no choice but to patent,
protection of gene innovation should not be
too strong to hinder follow-on innovation.
Any second comers should be allowed toaccess research tools freely as far as they are
ready to pay for their use of the first comers’
information.

complicated interactions among many genes
andproteins
discovered
by
prior
(*17)
researchers.
Thus, the transaction costs toobtain licenses can multiply quickly in a
regime that private parties can own many
basic natural products. These impediments
would include “blocking patents” resulted
from the cumulative and sequential nature ofinnovation, or “complementary patents”
granted to different inventors who haveinvented components of a large invention.(*18)
Inventing around
Patenting DNA sequences prevents
inventing around, e.g. developing a new drug,
diagnostic tests, or tests using protein
products based on a patented DNA sequence,
because these developing activities arecovered by the patent on a DNA sequence.
DNA is special in the sense that downstream
DNA patents are always substantiallydependent on upstream DNA patents. For
example, when a subsequent downstream
inventor has developed a new medical
application for a specific disease caused by aflawed gene that is the subject of an
upstream patent, he is obliged to use the
DNA patent because he has no alternative.
This is not always in classical chemistry. In
chemistry there might be different ways tocure a specific disease. Thus, gene patents
are special in that inventing around a genepatent is impossible.(*19) For this reason, apatent provides a real monopoly.(*20)

III Copyright Protection
Copyright attaches to expressions of ascientific or technical nature. Copyright was
originally devised to protect literary andartistic works. Copyright law forbids
protection of “any idea, procedure, process,system, method of operation, concept,
principle, or discovery, regardless of the form
in which it is described…”(*22)
Copyright might be maintained over the
written representation of the genetic
sequence of modified genetic material, or
genetic products such as proteins.(*23) N.
Boorstyn asserts that DNA sequences can beprotected by copyright.(*24) Sue Coke argues

3

Conclusion of Patent Protection
A number of patents have been granted
to DNA sequences. These patents resulted indifficult problems such as the tragedy of(*17) Ibid.
(*18) Mireles, Tragedy of Anticommons in Biotechnology Innovation, supra note 15 at 168; Demaine et al ., ibid. at 419-421.
(*19) On the other hand, there are also similarities between DNA and chemistry in the sense that both DNA and chemical compounds, e.g.
vigra and aspirin, are multifunctional. That is, both of them have various different functions and applications. See Sven J. R. Bostyn,
Patenting DNA sequences (polynucleotides) and scope of protection in the European Union: an evaluation, Background study for theEuropean Commission within the framework of the Expert Group of Biotechnological Inventions, European Commission, EUR 21122, 2004,
at 60.
(*20) It is argued that granting such complete protection in exchange for a disclosure resulting from the work of one of the machines now
available for automatic sequencing of DNA is far from the basic principle of the patent system.
(*21) Louis Kaplow and Steven Shavell, Property Rules Versus Liability Rules: An Economic Analysis, 109 Harv. L. Rev. 713 (1996) at 716.
(*22) Copyright Act of 1976 § 102(b) and title 17 of the United States Code of 1993, section 102(b) (17 U.S.C. § 102(b) (1993)).
(*23) Australia Law Reform Commission, Issue Paper 27 Gene Patenting and Human Health, Part F Other Intellectual Property Issues,[hereinafter
Australia
Law
ReformCommission,
Gene
Patentingand
Human
Health],availableat
http://www.austlii.edu.au/au/other/alrc/publications/issues/27/16._Copyright_Trade_Secrets_and_Designs.doc.html,
accessed on August 21, 2006.
(*24) Neil Boorstyn, personal communication. See Willem P.C. Stemmer, Nature Biotechnology, vol.20, March 2002, at 217, [hereinafterStemmer, Nature Biotechnology]..

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IIP Bulletin 2007

without copying a copyright-protected music
file.
When a genomics company publishes its
DNA sequences, the company might lose thepossibility to receive a patent for the DNA
sequences.(*32) Most genomics companies are
reluctanttopublishtheir
genomics
sequences
and
thus,
most
genomics
sequences remain inaccessible to thescientific community. By using ‘music file’approach and making unauthorized copying
such a digital music file constitute copyright
infringement, genomics companies would be
able to publish their DNA sequences andretain IPRs for their published sequences.

that a DNA sequence could be protected bycopyright when sufficient skill, labor andeffort were involved in clarifying thesequence.(*25) Proponents of gene copyrightoften rely on the analogy between genetic
sequences and computer programs.(*26) Like acomputer program, a DNA sequence may beconsidered a set of instructions.(*27) A DNA
molecule is a machine that makes
functions.(*28) DNA sequences are both achemical and an information carrier. The
chemical structure of a DNA sequence isgenerally independent of its function causedby the information.(*29)
An important difference between DNA
sequences and computer programs would
exist in that while programs have a numberof ways of expression to cause a specificfunction, DNA sequences have no alternative
expression. Thus, copyright protection of
DNA sequences is inappropriate because
copyrighting DNA sequences may result inprotection of processes coded by DNA
sequences. Additionally, a DNA sequence
cannot be copyrighted because DNA
sequences are not an original work of any
humans.(*30)
Recently
WillemP.
C.
Stemmersuggested that DNA sequences can beprotected by copyright.(*31) According to his
proposal, genomics companies can make theirsequences available to the public while
retaining some IPRs. DNA sequences existed
in genomics companies’ databases would betransformed into ‘music file’ (e.g. mp3 file) by
the companies. An external database user
would copy this music file, transfer the copy
to himself, and re-convert the music file into
DNA sequences using a back-translation
program. Although this back-translated DNA
sequences itself would not be protected bycopyright, copyright protection may exist inthat the user cannot access a DNA sequence

IV Conclusion
DNA sequences are not suitablesubject-matter of copyright protection. Tradesecret cannot protect some of gene
innovations involved in marketed products
because trade secret does not protect what is
not secret. Patent protection is inappropriate
because patent rights are too strong
compared with the contribution by theinventor.
In order to solve these problems, it isnecessary to find a rule that could provide
the first innovator with incentives to invest
resources into R&D, and at the same time,
follow-on innovators with free access to thefirst innovator’s innovation. It is also needed
for public institutions to effort to place genes
and gene fragments within the public domain.
In fact, as a result of the joint efforts of public
institutions, databases comprising raw DNA
sequences from human and other organisms
are now publicly available. The more genefragments make their way into the publicdomain, the more difficult to prove that a
particular sequence is novel and non-obvious.

(*25) Australia Law Reform Commission, Gene Patenting and Human Health , supra note 23 at para. 16.24; See also Sue Coke, Copyrightand Gene Technology, 10 Journal of Law and Medicine 97 (2002) at 102.
(*26) Iver P. Cooper, Biotechnology and the Law, 2005 Revision, (Eagan, Minn, U.S: Thomson/West Group, 2005) at 14-21, [hereinafter
Cooper, Biotechnology and the Law]; Irving Kayton, Copyright in Living Genetically Engineered Works, 50 Geo. Wash. L. Rev. 191 (1982).
(*27) Cooper, ibid. at 14-23.
(*28) Ibid. at 14-36.
(*29) Program text and function are generally independent.
(*30) Cooper, Biotechnology and the Law, supra note 26 at 14-31.
(*31) Stemmer, Nature Biotechnology, supra note 24 at 217.
(*32) Conditions on grace period are different in jurisdictions..

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The absence of proprietary rights in open
source software allows for various uses andimprovements of the products. There is nofear of being accused by a proprietary
software company.(*33) In this respect, basic
concepts of a new legal system would befound among liability regimes rather than
exclusive proprietary ones. The new regime
should solve the critical issue of therelationship between the first comer andsecond comers in sequential innovation, i.e.
encouraging innovation without impeding
follow-on innovations.

(*33) Disadvantages of open source software are the lack of guarantee that development will happen, and the possibility of being accessed bypatent holders who are trying to detect infringement through the accessible source code.

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