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76 UMKC L. Rev. 505
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UMKC Law Review

Winter, 2007

Symposium: Proteins, Patents and Progress: The Interface of Bio-Technology and

Intellectual Property Law
Article
*505 IT'S HARD TO FIND A GOOD PAIR OF GENES: SO WHY MAKE THEM FREE FOR THE
TAKING?
Julie D. Cromer [FNa1]

Copyright 2007 Curators of the University of Missouri; Julie D. Cromer

I. INTRODUCTION
In the past decade, significant advances have been made in the identification and development of genes,
particularly the human gene. The Human Genome Project challenged the scientific world to finish a com-
plete sequence [FN1] of the human genealogical makeup; and its successor, HapMap, provides a model for
mapping the human genome and identifying those particular genes which may be successfully modified to
improve the quality of human life. Genetic research remains at the forefront of scientific discovery.

The preference has been to give these discoveries a direct pathway to the public domain, bypassing all
claims of intellectual property. Although simple in concept, in practice, scientists have recognized the inher-
ent value in genomic data and have attempted to exert monopolistic rights over those portions of the genes
which they have discovered. As Professors Eisenberg and Rai point out: "[d]ata have long been scientists'
stock in trade, lending credibility to their claims while highlighting new questions that merit future research
funding." Some disclosure is necessary in order to claim these benefits but "data disclosure may also benefit
one's research competitors." [FN2] An exemplar of this controversy is Celera Genomics, which raced the
Human Genome Project to achieve the blueprint of the human genome. [FN3] It lost the race, but managed
to secure hundreds of patents over gene sequences in the meantime, including those sequences allegedly
building on the discoveries by Human Genome Project scientists. [FN4]

The problems that the Celera situation illustrates have led scholars and scientists to question the wisdom
of directing the entry of genetic data into the public domain. Once in the public domain, the principle that no
person can profit from the information begins to deteriorate. One contributing to public domain information
cannot preclude second-comers from profiting from its existence, nor *506 can it protect those who have
made contributions to the project from seeing others profit from their work. As Jeffrey Weeden observed in
his thoughtful Note, "[i]f genetic information is not protectible, then no one is accountable for stealing, us-
ing, selling, or otherwise wrongfully appropriating . . . genetic information." [FN5]

However, the existing intellectual property structures are not necessarily beneficial to genetic research.
This is marked by the "growing concern in the scientific community about the trend to . . . protect scientific
research through intellectual property, particularly by the abuse of patent applications for biotechnology re-
search." [FN6] In addition, because the subject matter of the intellectual creation falls outside any clearly
defined intellectual property framework to date, "it is not entirely clear what rights are held over the data
that is being offered." [FN7] The seemingly opposite goals achieved by either not protecting or protecting
genetic databases have caused several scholars to propose alternate schemes, most using the same con-
strained intellectual property frameworks that predate the discovery of DNA.

This Article examines the attempts to force genetic information either into the public domain or into an

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intellectual property regime for which it is not entirely suited. Part II examines the background behind those
attempts, examining in particular the public domain, patent, copyright, trade secret, and contract law, and
examines identified problems with each of the legal paths heretofore suggested. Part III reviews some pos-
sible changes suggested by scholars in the area. Part IV reviews sui generis database protections as they
have applied to databases in Europe and other places and how it could be used effectively in the field of hu-
man genomic research. Finally, Part V reviews how such a system would work and suggests a scheme com-
prising a sui generis right with compulsory licensing.

II. USE OF EXISTING REGIMES TO PROTECT GENETIC DATABASES

The tendency of the law is to build on that which is familiar. The Supreme Court has explained the need
to turn carefully to precedent and past decisions when examining a new type of intellectual property is con-
cerned:
It is the duty of this court, before it allows property to be sacrificed, even if the words of an act are
clear and free from doubt on their face; to look carefully at the intention of the legislature, to look at the
spirit of the law and its consequences, and at the old law, the mischief and the remedy. [FN8]

*507 In Wheaton v. Peters, the Court considered whether intellectual property rights applied to the re-
porting of judicial decisions, a subject of first impression at the time. The Court noted "[t]hat a man is en-
titled to the fruits of his own labours must be admitted; but he can enjoy them only, except by statutory pro-
vision, under the rules of property which regulate society, and which define the rights of things in general."
[FN9] This method may be difficult when considering the challenge of awarding a new or previously uncon-
sidered product that comprises intellectual creation not able to be placed in any one category of intellectual
property. Using the conventions of the current system, it may be difficult to fit such a new product into one
area of intellectual property.

Genetic information represents one such form of intellectual creation. Research challenges in genetics
include exercises in problem-solving which may not traditionally fit into one area of intellectual property or
another. For example, to date, the Human Genome Project has invested much of its time in DNA sequen-
cing, the process of determining the exact order of the three billion bases making up the twenty-four human
chromosomes, and developing the map that could provide the blueprint for human makeup. [FN10] Even
though the final product was "completed" in 2003, researchers continue to create more drafts, providing ad-
ditional detail for each chromosome, comparing DNA sequences across populations, and cataloging muta-
tions. [FN11] Scientists will spend significant time and resources in the coming decades in several concrete
areas to achieve a specific result that may not result in any cognizable intellectual property rights: gene
number, exact locations, and functions; DNA sequence organization; and chromosomal structure and organ-
ization. [FN12]

With respect to this genetic and genomic information, five different approaches have been used to deal
with the intellectual property rights, with each approach having varying degrees of success. First, accords
have attempted to reserve genetic information for the public domain, ignoring property rights altogether.
[FN13] Second, researchers seeking property interests in human gene sequences have tried to protect them
as patentable material. [FN14] Third, the nature of human genes as information could categorize them as
data, which gathered into an original database, could be viewed as covered under copyright. [FN15] Fourth,
if a researcher takes care not to disclose genetic information to protect from usage by *508 outside parties,
the information could gather status as a trade secret. [FN16] Finally, elaborate licensing schemes demon-
strate reliance on private contractual law to ensure which rights in human genetic material may be secured
and which may be freely used. [FN17]

A. Public Domain
From the scientist's point of view, advances in scientific research should be free for all so that today's

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discovery can be tomorrow's building block. "Public domain" is "[t]he universe of inventions and creative
works that are not protected by intellectual-property rights and are therefore available for anyone to use
without charge," [FN18] or whose patent or copyright has expired. [FN19]

Many researchers favor this avenue. In 1996, the International Human Genome Sequencing Consortium,
an international group of scientists who were engaged in genomic DNA sequencing, passed a unanimous
resolution, referred to as the Bermuda Statement, which provided that "all human genomic sequence inform-
ation, generated by centres funded for large-scale human sequencing, should be freely available and in the
public domain in order to encourage research and development and to maximi[z]e its benefit to society."
[FN20]

The first problem that arises with making genome sequences available upon identification is misuse in
competition. "In 1998, a member of the [Human Genome Sequencing] Consortium created the company Cel-
era Genomics, which set off immediately to finish the sequence of the human genome before the Consortium
did." [FN21] When both the Human Genome Project and Celera announced their intentions to map the hu-
man genome in 2000, a race to the finish resulted. [FN22] In some ways, it fostered competition for a posit-
ive result; the Human Genome Project was completed ahead of schedule in 2003. [FN23] However, it did so
amid allegations that Celera had "stolen" the Human Genome Project information in order to complete its
sequence, over which it later claimed intellectual property protection. [FN24]

Moreover, if genetic information is distributed immediately to the public domain, a question of control
of potentially sensitive information arises. More than ever, the public is educated about the importance of
DNA identification and *509 its potential medical possibilities. Yael Bregman-Eschet describes genetic in-
formation as an important sub-class of medical information:
It includes information that may be retrieved from an individual's DNA that, with the growing un-
derstanding of the human genome and its mapping, may reveal three levels of sensitive information:
personal information about the individual such as genes, traits, and predisposition to certain diseases;
medical information about an individual's kinship that can be attributed to one's genes; and information
about the heritage of the individual, e.g. the routes and origin of her ancestors. [FN25]

With the potential value of the data and, perhaps even more so, the potential value of the misuse of that
data, the question of control rises in importance. If genetic data is automatically placed into the public do-
main, key questions of privacy result.

B. Patent
The alternative to placing genetic information into the public domain is to allow researchers to assert
some form of intellectual property rights over it. The question then becomes which form the intellectual
property should take. Because of the scientific nature of genetic research, it makes sense that patents could
apply to appropriate discoveries. Human genetic materials, as they exist in nature, cannot be patented in the
United States; [FN26] because "physical phenomena" are not patentable. [FN27] "[C]hemicals isolated from
nature through human intervention[, however,] are patentable." [FN28] They represent "a nonnaturally oc-
curring manufacture or composition of matter - a product of human ingenuity 'having a distinctive name,
character and use."' [FN29] Thus, in scientific discoveries requiring the intervention of humans, a property
element may be available.

Although discovery of a gene sequence, a naturally occurring phenomenon, appears not to apply in this
instance, the U.S. Patent Office has extended patent protection. "This precedent has been applied to the spe-
cific polynucleotide sequences in human genetic materials. Patents have been granted for years on the isol-
ated polynucleotide sequences per se, as well as on processes for identifying and isolating (purifying) the se-
quences and on methods of using them." [FN30]

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*510 At the Canada-United States Law Institute Conference on Comparative Aspects of Innovation in
Canada and the United States, Professor Naimark goes on to explain why patent would apply to genetic se-
quencing:
As with other kinds of invention, to obtain a patent involving human genetic materials the inventor
must show that the invention falls in the class of patentable subject matter and is new, useful, and not
obvious to someone skilled in the particular field. In particular the inventor must be able to identify the
novel genetic sequence, specify the product of the sequence and how it functions in nature, and show
that it has utility. The utilities of the nucleotide sequences patented to date include their role in gene
regulation, in encoding for therapeutic proteins, as diagnostic probes, as receptors used for identifying
molecular targets for therapeutic drug development, as immunogens, and gene replacement therapies.
[FN31]

The U.S. Patent Office has embraced patents for select sequences, already granting to Celera Genomics
some three hundred patents by the year 2000. [FN32]

A primary problem that ensues from using patents to protect a portion of the human genetic sequence
can be identified as this:
When the holder of a patent on an invention involving human genetic materials, sets prices that are
excessive, fails to supply the market, or refuses to license the patent on reasonable terms, ability to gain
access to a beneficial health innovation either for research or clinical use may be significantly impaired
and the achievement of the objective of mutual advantage of producers and users may be frustrated.
[FN33]

There are express concerns that genomic patents "can be used to unfairly restrict the potential benefits
of discovery of the genome, and that unreasonable exploitation of the entitlements of a patent holder will be
detrimental to the [public's] health and well being." [FN34]

Moreover, the economic reality of patent ownership cannot be ignored.

Many scientists question whether, in an era of high throughput automated DNA sequencing, some
patents provide undue potential reward for minor advances that would in any case have been made by
others working in the public domain and impose cost burdens on researchers working on fundamental
problems in molecular genetics. [FN35]

*511 Especially in a Celera-type situation where later patented research is allegedly based upon re-
search predestined for the public domain, allowing a patent over a genetic sequence appears to give an unfair
advantage to those who wait and let others develop groundbreaking work. [FN36]

Further, there are problems with the international application of patent law to these types of sequences
as well. A new genetic sequence claimed in the United States is automatically considered non-obvious.
However, in the European Patent Office, applicants are required to "demonstrate either that obtaining the se-
quence was in fact a technical achievement or that they have discovered a new or unexpected property asso-
ciated with the gene." [FN37] The mere location of a researcher also provides for disadvantages within the
scientific community itself, even if dealing with a similar gene sequence.

C. Copyright
Despite the scientific nature of a gene sequence, it is possible that the sequences could instead be con-
strued as a database of genetic information. The database, in turn, could also be considered a work of author-
ship, thus qualifying it for copyright protection. Databases comprise valuable information, and, despite the
limiting seminal U.S. Supreme Court decision of Feist Publications, Inc. v. Rural Telephone Services Co.,
[FN38] copyright treats them as such. In the United States, compilations are expressly protected by the U.S.

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Copyright Act, [FN39] to the extent that the compilation can demonstrate originality. [FN40]

The inherent problem with protecting genetic information through copyright is the lack of originality
capable within the selection, coordination, or arrangement of the data themselves. According to the U.S.
Copyright Act, the selection, coordination and arrangement of a database are able to be protected as original,
but that protection does not extend to the underlying data. [FN41] The Feist decision clarified that distinc-
tion. In Feist, the work of authorship at issue was a white-pages telephone directory. [FN42] The Supreme
Court held that there could be no originality in the selection of the data, because the telephone company was
*512 required to keep a list of all subscribers. [FN43] Similarly, there could be no originality in the arrange-
ment or the coordination of the data themselves, because a telephone directory only makes logical sense
when expressed in a last name, first name, address, telephone number sequence. [FN44]

The human genome expressed as a database has comparable limitations. Approximately 99.9% of gen-
omes between any two humans are identical, with the variations forming an infinitesimal amount. [FN45] As
such, little creativity can be employed when evaluating the selection of the data; they are already predeter-
mined. The little creativity that can exist when reporting genetic information results from sequencing, but
covers only the expression of the data, and not the data themselves. In the United States, "the copyright in a
compilation . . . extends only to the material contributed by the author of such work, as distinguished from
the preexisting material employed in the work, and does not imply any exclusive right in the preexisting ma-
terial." [FN46]

Assuming that sufficient creativity in the coordination or arrangement of human chromosomes can exist
to satisfy 102(a) of the Copyright Act, [FN47] it is uncertain whether genetic information sufficiently falls
outside of the limitations of 102(b). The Copyright Act mandates that "[i]n no case does copyright protec-
tion for an original work of authorship extend to any idea, procedure, process, system, method of operation,
concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or em-
bodied in such work." [FN48] Because the appropriate gene sequencing could be classified as a "discovery,"
it may fall outside the purview of copyright altogether. Moreover, depending on which entity financed the
discovery of the nucleotide sequence, the sequence may be consequently redirected to the public domain, at
least in the United States. For example, if the research were sponsored by the U.S. Department of Energy,
the U.S. government exemption to authorship of copyrighted works would come into effect. [FN49]

In addition to the technical difficulties that arise when attempting to put copyright protection over gen-
omic databases, other downsides impair the application of copyright. It may be hard to argue around a claim
of fair use, since the use of information for public heath is inherently in the public interest, may be *513
non-commercial, and may not affect the financial ability of the author. More troubling is the time. Copyright
lasts for a duration of the author's life plus seventy years or, if a corporate author is claiming a work made
for hire, a period of ninety-five years from publication or one hundred and twenty years from creation,
whichever expires first. [FN50] One hundred and twenty years ago, Louis Pasteur had only recently created
an immunization against anthrax, and scientists had discovered bacteriologic agents for diseases such as
"tuberculosis, diphtheria, typhoid, and yellow fever." [FN51] Offering unqualified protections for a scientif-
ic development could stymie the exponential growth that public health demands.

D. Trade Secret
Another way to exert protection over human genome sequences is by classifying certain discovered se-
quences as trade secrets. [FN52] "Absent statutory protection, such as a patent or copyright, that survives
beyond disclosure, a standard commercial strategy for preserving the value of data and databases has been
secrecy, or more accurately, restricted [i.e., internal] access." [FN53] Because trade secret protection exists
until disclosure, it is possible for a private actor to maintain part of the genomic sequence for some time
without risking losing it to a second-comer. Moreover, given the confidentiality required to maintain trade

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secrecy, protection in this manner may assuage the fears of those concerned about privacy violations by the
distribution of genetic data.

Protecting genetic information as a trade secret presents drawbacks. Professors Eisenberg and Rai note
that use of trade secrets to restrict access to this type of information is "wasteful from a social perspective."
[FN54] The dissemination of information is curtailed, diminishing information's social value as opposed to
augmenting it through disclosure. [FN55] Professors Eisenberg and Rai also note that unnecessary duplica-
tion could occur when a second researcher knows nothing of the first research, and it is more difficult to ag-
gregate data from multiple sources if the source chooses not to disclose. [FN56] Additionally, duplicated ef-
fort may negate any economic value of a trade secret, if an identical discovery is made and then either pro-
tected via a different proprietary device or, in the alternative, disclosed.

*514 E. Contract
Outside from intellectual property, genetic databases have also properly been the subject of contractual
law, to great effect. Contracts can be fashioned to achieve disparate means regarding the proprietary nature
of genetic information, achieving anything from the limited disclosure of the genetic sequence to the man-
datory entry of the sequence into the public domain. Of particular note is the HapMap Project, "'an approx-
imately $100 million public-private effort to create the next generation map of the human genome' with the
purpose of 'speeding the discovery of genes related to common illnesses such as asthma, cancer, diabetes
and heart disease."' [FN57] From November 2003 to January 2006, the HapMap Consortium made at least
twenty separate data releases to the Internet, but implemented a "free, non-exclusive, non-royalty-bearing li-
censing agreement to obtain access to certain types of the data the project had collected on individuals' DNA
sequences, specifically the genotypes." [FN58] While intending to place much of its information in the pub-
lic domain, the HapMap Consortium stressed that the licensing scheme was temporary, providing that "re-
searchers could file patents once they were able to link a particular haplotype with an associated physical
characteristic." [FN59] The Consortium did change its licensing policy, and one year later, published its full
results. [FN60]

The flexible nature of contracts permits protection of genetic information on a case-by-case, project-
by-project basis. However, Professor Donna M. Gitter noted several shortcomings to the HapMap Project's
open source data access policy that seem endemic to the use of contracts to protect genetic information in
general. First, the policy does "not preclude patenting by licensees who violate the policy." [FN61] Second,
"the policy does not bind third parties who obtain the data through means other than the HapMap web site."
[FN62] Third, "[t]he HapMap Project's open source data access policy lacks a clear enforcement mechanism
and suitable remedy." [FN63] Finally, although a click-through license for data may be legally sound under
contract law in the United States, [FN64] comparable protections may not exist under the laws of other na-
tions. [FN65]

*515 III. PROPOSALS USING THE CURRENT REGIMES

Current proposals dealing with genetic data either attempt to utilize one of the traditional intellectual
property models to encompass the genomic databases or explicitly try to avoid them. At one extreme is the
proposal by U.S. Congressman Xavier Becerra (D-CA), the Genomic Research and Accessibility Act,
[FN66] which proposes "putting an immediate end to patenting any and all portions of the human genome."
[FN67]

While this plan would eliminate one type of intellectual property from covering genetic databases, it
would not necessarily send the information into the public domain; the legislation remains silent regarding
other types of intellectual property for coverage. Still, practitioners are highly suspicious of the proposed le-
gislation, noting that "[i]f gene patents are eliminated, [Congress is] just assuring that cures won't be found,
because it's highly unlikely that major biotech companies like Amgen or Genentech would be willing to in-

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vest millions or billions of dollars" [FN68] in researching additional gene sequences without any hope of
compensation. Practitioners also take the bleak view that "without gene patenting or licensing, no company
would bring a drug to market." [FN69]

Arnold Naimark, founding chairman of the Canadian Health Services Research Foundation and Cana-
dian Biotechnology Advisory Committee, takes an opposing view to Congressman Becerra and embraces the
patent system. [FN70] Dr. Naimark focuses both on using the patent system as a core for protection, but also
incorporates a licensing scheme. [FN71] The Canadian Biotechnology Advisory Committee recommends
that the examination of genetic patents be more rigorous and more easily challenged. [FN72] The committee
has called for voluntary mechanisms to limit restrictive licensing practices, and also has proposed to amend
the United States Patent Act to exempt research from claims of infringement when the infringing use is for
non-commercial purposes. [FN73]

Outside of the patent framework, Professor Gitter offers the solution of a nonexclusive, non-royalty
bearing licensing policy for data, modeled after a policy adopted by Incyte Corporation. [FN74] The bene-
fits, Professor Gitter hopes, would be that this type of compulsory licensing would impede patenting of ge-
netic information, would bind third parties to the property rights found in this information, would increase
the damages available in litigation, and would *516 facilitate the international enforcement of the property
rights. [FN75] However, she does recognize problems with her model. She notes the international agree-
ments such as the Bermuda Agreement favor the release of data into the public domain. She also acknow-
ledges the fear that scientific progress would suffer, the lack of a market for non-exclusive licenses, the dif-
ficulty of maintenance of trade secrecy, and the disincentive provided to smaller contributors of research.
[FN76]

Professor Andres Gonzalez also focuses on a licensing system, but suggests more of an open source ap-
proach. The easiest comparable license is an open source software license for computer programs, which al-
lows "later modifications by the user or other developers by providing access to its source code through the
use of a permissive license." [FN77] Professor Gonzalez envisions an open science license modeled after the
Creative Commons license, which provides that licensees may not use technology to restrict access to an un-
derlying copyrighted and licensed work; but they are granted the right to copy, distribute, display, digitally
perform, and make verbatim copies of the work. [FN78]

IV. A SUI GENERIS DATABASE RIGHT

While each proposal solves one of the problems inherent in providing (or not providing) proprietary
protection for genetic databases, each assumes that genetic databases should be treated as if they are subject
to the traditional notions of intellectual property. For the various reasons stated above, this is not the case.
Leaving genetic material in the public domain, while socially desirable from a researcher's perspective,
leaves information with little protection and potentially exposes large collections of individuals' genetic in-
formation to misappropriation. Modifying patent law does not address the problem that not all nations would
accept as patentable genetic sequences, thus offering protection to some researchers but not others. The sub-
ject matter of genetic sequences, even viewed as databases, may not be appropriate under copyright as a
properly sequenced genome lacks the requisite originality for copyright protection, and treating genomic
sequences as trade secrets would suppress further research and development using those sequences. Creating
a licensing scheme ignores the problems inherent in contract law, such as applicability to third parties, the
ability of later-comers to patent without challenge from the Human Genome Project or other public sources
of genomic data, and again, the difference internationally in standards for contract. Finally, creating an
"open science" model presupposes that intellectual property exists in the first place, without carving out a
specific intellectual property model to apply, and ultimately resting entirely on contracting.

The current models and proposals reinforce the problem of forcing genetic sequences into some type of

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intellectual property where no current form provides *517 a suitable model. Additionally, contracting pro-
tects one party at at time, and does not vest the researcher with a right to his sequence before it has been per-
fected by some sort of consideration. Yet some form of overarching protection for genetic information
seems to be in order. The interest paramount in providing this property right is not necessarily for the benefit
of the author. The notion that one entity could "own" part of the genetic sequence is unpalatable to many,
and may raise questions of First Amendment protection. Instead, the right would be to prevent those who
would misappropriate sequences and incorporate them into material otherwise properly patentable, thus se-
curing patent claims for those sequences for themselves. The goals of this right are fourfold: (1) retain attri-
bution of discovery for the author; (2) prevent the economic or property exploitation of genetic sequences by
persons outside their research; (3) provide mild compensation for the author's investment in the sequence;
and (4) preserve the sequence for inexpensive use in further research and development.

It may be possible to achieve these goals by specifically protecting the genetic sequences as databases.
Professor Gonzalez has noted, "the legal protection of data bases is a subject that is not fully [harmonized] at
the international level, where different jurisdictions apply a wide range of legal figures and levels of protec-
tion to this type of intellectual work." [FN79] One such model is that of the European Union, which grants
value to databases and the underlying data. [FN80] The European Commission recognized the inherent value
of data-gathering as an intellectual creation in the 1996 European Union Database Directive (the "Direct-
ive"), which creates a sui generis database right targeted for the protection of databases and their content.
[FN81] This database right extends to all databases representing a collection of "data or other materials ar-
ranged in a systematic or methodical way and individually accessible by electronic or other means" [FN82]
and covers the protection of databases "in any form." [FN83] To protect the database, the creator must show
a substantial investment in obtaining, verifying, or presenting the contents of the database. [FN84] That in-
vestment may be evaluated qualitatively or quantitatively. [FN85] If protection is merited, the creator can
prevent *518 a party from "extracting" substantial amounts of the data from the database or from repeatedly
and systemically extracting insubstantial parts of the database. [FN86] Also, the creator may be able to pre-
vent a party from "reutilizing" the data in its own product or from repeatedly or systematically reutilizing in-
substantial amounts of the data. [FN87]

The Directive is not without flaws. Because it is legislation at the supranational level, all of its missives
are left for interpretation by the member states. Moreover, as written, the preventions against extraction and
utilization are undeniably broad, possibly extending to a single piece of data as long as the database creator
can identify the substantial investment that the single piece of data represents. Courts in various jurisdictions
have extended protection to a list of self-help groups, [FN88] a real estate listing, [FN89] and telephone dir-
ectories on the Internet. [FN90]

However, the Directive does not extend to, and specifically creates an exemption for, data used in non-
commercial scientific research, with certain limitations. Article Nine of the Directive states that member
states may provide that:
lawful users of a database which is made available to the public in whatever manner may, without
the authorization of its maker, extract or re-utilize a substantial part of its contents . . . in the case of ex-
traction for the purposes of illustration for teaching or scientific research, as long as the source is indic-
ated and to the extent justified by the noncommercial purpose to be achieved. [FN91]

*519 The Directive specifies that member states "should be given the option of providing for exceptions
to the right to prevent the unauthorized extraction and/or reutilization of a substantial part of the contents of
a database in the case of extraction for . . . scientific research." [FN92] In addition, member states are com-
mitted to provide an exception to unauthorized use of the contents of the database "where there is use for the
sole purpose of illustration for teaching or scientific research." [FN93]

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For a law intended to assist European database creators to compete with the United States, it is interest-
ing that this distinction is created, especially when this is exactly the type of database that survives a recent
limitation imposed by the European Court of Justice. The European Court of Justice recently held that "in-
vestment" should "be understood to refer to the resources used to seek out existing independent materials
and collect them in the database, and not to the resources used for the creation as such of independent mater-
ials." [FN94] In other words, if the database creator simultaneously creates the data that he is seeking to pro-
tect using the Directive, the substantial investment is not considered to be in data-gathering, and the data-
base right does not apply.

V. PROPOSED MODEL: DATABASE RIGHT WITH COMPULSORY LICENSING SCHEME

On the other hand, the Human Genome Project and data collected for genetic research appears to be ex-
actly the type of information that should be protected by a sui generis, Directive-type database right. The in-
formation of value is the genetic sequences, which are not created by the research, but merely gathered by
the researcher, seeming to trigger the type of database the European Court of Justice would be willing to
protect. Admittedly, "[w]hile some value may be created by interactions between creators and users of data
when creators control access to data, broad dissemination often better serves the mission of public sponsors
to advance science." [FN95] As such, despite its shortcomings, a Database-Directive model with a compuls-
ory license could present a viable option to provide limited protection to the development of genetic data-
bases.

However, in order to be effective, the provisions of the Directive need to be tailored to the goals of ge-
netic research and development. This includes removing provisions intended to create rights of exclusion
and instead reinforce notions of attribution and prevention of misappropriation. [FN96] Key aspects of this
*520 Proposal include a limited duration, specific rights tailored to the recognition of the effort put into the
sequence, and a compulsory license for subsequent uses of the work.

A. Duration
For example, at present, the Directive provides for a fifteen-year right to the database creator. [FN97]
However, in the protection of genetic databases, the lifespan of this right to the genetic sequencer [FN98]
should be further curtailed to a duration of not fewer than five years, but not more than ten. The brevity of
this right would provide compensation to the sequencer and deter misappropriation, but would not persist so
long as to stifle research efforts by the sequencer or those seeking to use the sequence for further research.

B. Rights Reserved to the Sequencer

The rights needed to be secured for the sequencer and against free-riders are, (1) the right of attribution,
borrowed from moral rights; (2) the right of distribution, borrowed from copyright; and (3) the right against
reutilization, borrowed from the Directive.

The right of attribution, in a moral rights context, is "the right to claim authorship of the protected
work." [FN99] In the context of genomic sequencing, it focuses on the publication of the sequencer's portion
of the genome and the sequencer's right to be associated with that sequence. Unlike moral rights, however,
the sequencer's right of attribution is conceived as fully alienable, enabling an individual researcher to profit
from his work. In addition, the *521 sequencer has the ability to create the sequence as part of a work made
for hire, redirecting attribution to the employer. [FN100]

The distribution right and the right against reutilization go hand-in-hand as preventative measures
against the economic exploitation. The right of distribution has its origins in copyright. Under the U.S.
Copyright Act, "the owner of copyright under this title has the exclusive rights to do and to authorize . . .
[the distribution of] copies or phonorecords of the copyrighted work to the public by sale or other transfer of
ownership, or by rental, lease, or lending." [FN101] As all copyrights, the right to distribute guarantees eco-

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nomic rights to the copyright owner, [FN102] perhaps more so than the right to reproduction of the copy-
righted work, since it suggests multiple copies for public sale. By securing the right of distribution to the se-
quencer, this Proposal aims to prevent another party using the sequence for pecuniary gain.

Similarly, the right of reutilization encompasses "any form of making available to the public all or a
substantial part of the contents of a database by the distribution of copies, by renting, by on-line or other
forms of transmission." [FN103] In order to prevent the exploitation of the database by a free-rider, the right
of reutilization should also be guaranteed the sequencer.

C. Compulsory License
The above rights would provide limited protection to the sequencer, but are not intended to stymie the
use of the sequence for research or development - just to prevent another party from using the sequence and
attempting to secure intellectual property protection over it. Thus, a mechanism is necessary to ensure that
the sequence is not removed from the public altogether. This can be accomplished in the form of compulsory
licensing.

As noted above, Professor Gitter's compulsory license would be nonexclusive and non-royalty bearing.
However, in 2001, Professor Gitter suggested a "reasonable licensing fee," based on the market value of any
invention incorporating the sequence. Writes Professor Gitter:
The compulsory-licensing system proposed here would require a later scientist to give written no-
tice to, but not to request the consent of, the patentholder before beginning research, in return for a reas-
onable after-the-fact royalty. By eliminating pre-use license negotiations and up-front *522 payments
while still protecting a patentee's rights to a reasonable royalty, this compulsory-licensing system will
foster innovation. [FN104]

This system of compulsory licensing in this manner would achieve the goals of some compensation to
sequencers and preserving the ability of others to use the sequence for research and development. However,
as Professor Gitter herself noted, such a compulsory license could interfere with Trade-Related Aspects of
Intellectual Property Rights ("TRIPS"), negotiated as a part of the General Agreement on Tariffs and Trade
("GATT"). [FN105] Moreover, a compulsory license based on a percentage of after-the-fact royalties would
involve substantial administrative and reporting costs.

Instead of a compulsory license based on a percentage, a cleaner way to incorporate the compulsory li-
cense may be to add a "finder's fee" structure to genomic sequencing. In many respects, this is an accurate
representation of what the sequencer has accomplished: "finding" the sequence of human DNA. In theory,
administrative costs could be avoided if industry players self-policed implementation, and recording costs
could be avoided because the amount would be the same for any use of the sequence. In its implementation,
the amount of the finder's fee would have to be set in a way to reinforce promotion of research and develop-
ment, while providing at least some recognition of the effort put in to determining the sequence. [FN106]

VI. CONCLUSION
A natural criticism of proposals to extend intellectual property protection to genomic sequences is the
overpropertization of intellectual creations. In fact, the author agrees. The extension of traditional regimes to
new forms of what is arguably intellectual property has resulted in confusing application, inconsistent stand-
ards, and the impermissible monopolization over works more appropriately left to the public domain. Gene
sequences are without question among these works.

Because of the repeated efforts to force certain types of works into the traditional regimes, and courts'
and legislatures' apparent willingness to allow those works to be so protected, the creation of sui generis in-
tellectual property protection becomes necessary. This necessity is not to recognize the originality, *523

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novelty, or identity of the work, but to keep individuals from hijacking such products and preventing their
free incorporation into later works. In light of this new reality, it is surprising that regimes continue to focus
on the expansion of fair use and other defenses instead of removing the question of impropriety of the
second use from that use in the first place. These types of protections cannot be applied too expansively, or
they will meet the same fate of the European Union Database Directive. They must be narrowly tailored to
specific subject matters which can be monitored by an industry inherently interested in their preservation.

Genomic sequences present the ideal situation for sui generis protection. Experts like the ones refer-
enced in this paper have recognized the intellectual property problems that genetic sequencing pose. Be-
cause genetic sequences possess this informational nature, a framework can exist from which to draw and
adapt a means of protection that the human genome deserves.

[FNa1]. Assistant Professor of Law, Thomas Jefferson School of Law. The author would like to thank Chris
Holman, Steve Semeraro, Linda Keller, Claire Wright, Jeff W. Slattery and Deven Desai for their helpful in-
sights.

[FN1]. A "sequence" is the exact order of the three billion chemical bases in deoxyribonucleic acid, or DNA.
DNA is the double-stranded molecule that encodes genetic information, held together by weak bonds
between base pairs of nucleotides. The base pairs consist either of adenine and thymine (A-T) or cytosine
and guanine (C-G). See Human Genome Project Information, Genome Glossary, ht-
tp://www.ornl.gov/sci/techresources/Human_ Genome/glossary/glossary.shtml#nucleotide. The goal of
achieving the entire sequence was achieved by the Human Genome Project in 2003, but it continues to un-
dergo revision. See infra text accompanying notes 10-12.

[FN2]. Rebecca S. Eisenberg & Arti K. Rai, Harnessing and Sharing the Benefits of State-Sponsored Re-
search: Intellectual Property Rights and Data Sharing in California's Stem Cell Initiative, 21 Berkeley Tech.
L.J. 1187, 1189 (2006).

[FN3]. Donna M. Gitter, Resolving the Open Source Paradox in Biotechnology: A Proposal for a Revised
Open Source Policy for Publicly Funded Genomic Databases, 43 Hous. L. Rev. 1475, 1500 (2007).

[FN4]. Id.

[FN5]. Jeffrey Lawrence Weeden, Note, Genetic Liberty, Genetic Property: Protecting Genetic Information,
4 Ave Maria L. Rev. 611, 616 (2006).

[FN6]. Andres Guadamuz Gonzalez, Open Science: Open Source Licenses in Scientific Research, 7 N.C.
J.L. & Tech. 321, 321 (2006).

[FN7]. Id. at 349.

[FN8]. Wheaton v. Peters, 33 U.S. 591, 609 (1834). But see Thompson, J., dissent:
It was certainly against the power of the crown to allow it as private property, without being protec-
ted by any royal privilege. It could be done only on principles of private justice, moral fitness and
public convenience, which, when applied to a new subject, make common law, without a precedent;
much more when received and approved by usage."
Id. at 671 (Thompson, J. dissenting).

[FN9]. Id. at 592.

[FN10]. Human Genome Project Information: Genomics, Facts About Genome Sequencing, ht-
tp://www.ornl.gov/sci/techresources/Human_ Genome/faq/seqfacts.shtml#2006.

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[FN11]. Id.

[FN12]. Id.

[FN13]. See discussion infra Part II.A and accompanying text.

[FN14]. See discussion infra Part II.B and accompanying text.

[FN15]. See discussion infra Part II.C and accompanying text.

[FN16]. See discussion infra Part II.D and accompanying text.

[FN17]. See discussion infra Part II.E and accompanying text.

[FN18]. Black's Law Dictionary (8th ed. 2004).

[FN19]. Id.

[FN20]. Julia Clague, Beyond Beneficence: The Emergence of Genomorality and the Common Good, Brave
New World?: Theology, Ethics, and the Human Genome 189, 214 (Celia Deane-Drummond ed. 2003).

[FN21]. Gonzalez, supra note 6, at 334.

[FN22]. Id.

[FN23]. Human Genome Project Information: Genomics, Facts About Genome Sequencing, ht-
tp://www.ornl.gov/sci/techresources/Human_ Genome/faq/seqfacts.shtml#2006.

[FN24]. See discussion infra, Part II.B and accompanying text.

[FN25]. Yael Bregman-Eschet, Genetic Databases and Biobanks: Who Controls Our Genetic Privacy?, 23
Santa Clara Computer & High Tech. L.J. 1, 7 (2006).

[FN26]. Arnold Naimark, Innovation in Biotechnology, Proceedings of the Canada-United States Law Insti-
tute Conference on Comparative Aspects of Innovation in Canada and the United States, 32 Can.-U.S. L.J.
220, 222 (April 8, 2006) (citing The Center for Intellectual Property Policy, Genetic Patents and Health Care
in Canada (2005), available at http:// www.cipp.mcgill.ca/data/publications/00000015.pdf.

[FN27]. Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

[FN28]. Naimark, supra note 26, at 221.

[FN29]. Chakrabarty, 447 U.S. at 309-10 (quoting Hartranft v. Wiegmann, 121 U.S. 609, 615 (1887)).

[FN30]. Naimark, supra note 26, at 221.

[FN31]. Id. at 222.

[FN32]. Gonzalez, surpa note 6, at 335. However, by the year 2000, Celera Genomics had applied for 6,500
patents. Id.

[FN33]. Naimark, supra note 26, at 225.

[FN34]. Id. at 224-25 (citing Canadian College of Medical Geneticists, Patenting of the Human Genome

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(2002) available at http:// ccmg.medical.org/pdf/ccmg_genome.pdf) (position statement approved by the

CCMG Annual General Meeting, September 21, 2002)).

[FN35]. Id. at 222.

[FN36]. The problem is not necessary one of enforcing patent rights over genomic sequences against later
users, but instead one of exploiting the patent which covers the portion of the genomic sequence. Before
U.S. President Bill Clinton and U.K. Prime Minister Tony Blair publicly announced in 2000 that the human
genome would not be patented, "PE-Celera had publicly said its business strategy was to sequence the hu-
man genome, patent it and then license it to pharmaceutical firms developing new drugs." See James Cruick-
shank, Gene Project Mired in Rift Over Patent; Billions at Stake After Welcome Trust Revelation, The Inde-
pendent, July 23, 2000, at B1.

[FN37]. Naimark, supra note 26 at 222 (citing A Patent System for the 21st Century (S.A. Merrill, R.C. Lev-
in, & M.B. Myers, eds., The National Academies Press 2004)).

[FN38]. 499 U.S. 340 (1991).

[FN39]. Copyright Act, 17 U.S.C. 101-1332 (2006).

[FN40]. 17 U.S.C, 103.

[FN41]. 17 U.S.C 101.

[FN42]. Feist, 499 U.S. 342-43.

[FN43]. Id. at 362-63.

[FN44]. Id. at 362.

[FN45]. Gitter, supra note 3, at 1482.

[FN46]. 17 U.S.C. 103(b). "The copyright in such work is independent of, and does not affect or enlarge
the scope, duration, ownership, or subsistence of, any copyright protection in the preexisting material." Id.

[FN47]. 17 U.S.C. 102(a) states that copyright protection subsists "in original works of authorship fixed in
any tangible medium of expression, now known or later developed, from which they can be perceived, re-
produced, or otherwise communicated, either directly or with the aid of a machine or device."

[FN48]. 17 U.S.C. 102(b).

[FN49]. 17 U.S.C. 105 ("Copyright protection under this title is not available for any work of the United
States Government, but the United States Government is not precluded from receiving and holding copy-
rights transferred to it by assignment, bequest, or otherwise.").

[FN50]. 17 U.S.C. 302(a), (c).

[FN51]. Comm. for the Study of the Future of Pub. Health Div. of Health Care Serv. Inst. of Med. et al., The
Future of Public Health 63 (1988), available at ht-
tp://books.nap.edu/openbook.php?record_id=1091&page=63.

[FN52]. A trade secret includes "information, including a formula, pattern, [or] compilation, . . . that derives
independent economic value from not being generally known to others who could profit from its use and is

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the subject of efforts that are reasonable under the circumstances to maintain its secrecy." Unif. Trade
Secrets Act 1(4) (amended 1985).

[FN53]. Eisenberg, supra note 2, at 1196.

[FN54]. Id.

[FN55]. Id.

[FN56]. Id.

[FN57]. Gitter, supra note 3, at 1480 (quoting News Advisory, Nat'l Human Genome Research Inst., Nat'l
Insts. of Health, International Consortium Launches Genetic Variation Mapping Project (Oct. 2002), avail-
able at http:// genome.gov/10005336); The HapMap Project examines haplotypes, defined as ways of denot-
ing the collective genetic constitution of a number of closely linked loci (DNA positions or regions) on a
chromosome. See Human Genome Project Information, Genome Glossary, ht-
tp://www.ornl.gov/sci/techresources/Human_ Genome/glossary/glossary.shtml#H.

[FN58]. Gitter, supra note 3, at 1482-83.

[FN59]. Id. at 1484.

[FN60]. Id. at 1485.

[FN61]. Id. at 1486-88.

[FN62]. Id at 1488-91.

[FN63]. Id. at 1489-90.

[FN64]. See ProCD, Inc. v. Zeidenberg, 86 F.3d 1447, 1448 (7th Cir. 1996).

[FN65]. Gitter, supra note 3, at 1491.

[FN66]. H.R. 977, 110th Cong. (2007) (proposing an amendment to 35 U.S.C. 106).

[FN67]. Jeanne Wright., No More Gene Patents? Cal. Lawyer, Jun. 2007, at 11. Specifically, H.R. 977
states, "no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally
occurring products it specifies." H.R. 977, 110th Cong. (2007).

[FN68]. Id. (quoting Stefan Kirchanski, Venable LLP, Los Angeles, CA).

[FN69]. Id. (quoting Sharon Terry, president and CEO of Genetic Alliance).

[FN70]. Naimark, supra note 26, at 220-21.

[FN71]. Id. at 228-33.

[FN72]. Id. at 228-29.

[FN73]. Id.

[FN74]. Gitter, supra note 3, at 1491-95.

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[FN75]. Id. at 1493

[FN76]. Id, at 1505.

[FN77]. Gonzalez, supra note 6, at 326.

[FN78]. Id. at 341.

[FN79]. Id. at 347.

[FN80]. See Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the Leg-
al Protection of Databases, [hereinafter Database Directive], available at ht-
tp://eur-lex.europa.eu/LexUriServ/LexUriServ.do? uri=CELEX:31996L0009:EN:HTML (last visited Feb.
11, 2008).

[FN81]. Database Directive, supra note 80, at art. 3 (noting the selection and arrangement constituting the
author's own intellectual creation shall be protected by copyright and the protection "shall not extend to the
contents" of the database).

[FN82]. Id. at art. 1, 2.

[FN83]. Id. at art. 1, 1.

[FN84]. Id. at art. 7, 1.

[FN85]. Id. The "investment" component of the Database Directive directly counters what the Feist court did
in holding that the "sweat of the brow" theory - "the underlying notion . . .that copyright was a reward for
the hard work that went into compiling facts" - was invalid under the Copyright Act. See Feist 499 U.S. at
352, 359-60.

[FN86]. Database Directive, supra note 80, at art. 7, 2, 5. Under the Database Directive, "extracting" data
is the "permanent or temporary transfer of all or a substantial part of the contents of a database to another
medium by any means or in any form." Id. 2.

[FN87]. Id. at art. 7 2(b). The "reutilization," defined as "any form of making available to the public all or
a substantial part of the contents of a database by the distribution of copies, by renting, by on-line or other
forms of transmission," must also be of a quantitatively or qualitatively substantial portion of the contents of
the database, or consist of the repeated and systemic reutilization of an insubstantial part. Id. at art. 7, 1,
2(b), 5.

[FN88]. See UNMS v. Belpharma Communication, Ct. of Brussels, Mar. 16, 1999 (enjoining the defendant
from infringing the plaintiff's pamphlet of information on self-help groups for French speakers).

[FN89]. See NVM v. De Telegraaf, President Ct. of the Hague, Sept. 12, 2000 (holding that the defendant's
search engine's retrieval of real estate listing from plaintiff's web site amounted to unauthorized extraction
and reutilization of data).

[FN90]. See KPN v. XSO, President Dist. Ct. of the Hague, Jan. 14, 2000 (finding that the defendant operat-
or of a search engine infringed plaintiff's database right by providing data from plaintiff's online telephone
directory without referring to the plaintiff's site and thereby depleting advertising revenue).

[FN91]. Database Directive, supra note 80 at art. 9(a)-(b). The only definition of "scientific research" ap-
pears in clause 36, which explains that "scientific research . . . covers both the natural sciences and the hu-

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man sciences." Id.

[FN92]. Id. at cl. 50. However, Clause 51 of the Directive states that member states may win permission to
use data for teaching or scientific research for "certain categories of teaching or scientific research institu-
tion." Id. at cl. 51.

[FN93]. Id. at art. 6 2(b).

[FN94]. Case C-203/02, British Horseracing Bd. Ltd. v. William Hill Org., 2004 E.C.R. I-10415, para. 1.

[FN95]. Eisenberg, supra note 2, at 1196.

[FN96]. The goal to prevent misappropriation may raise questions of whether a tort of misappropriation
could be a viable alternative to the protection of databases. In the United States, attempts to create a federal
tort for the misappropriation of databases have failed. For a discussion of the tort of misappropriation for the
legal protection of databases see Daniel Gervais, The Protection of Databases, 82 Chi.-Kent L. Rev. 1109,
1146 (2007). However, "the misappropriation tort is unreliable as it exists only in a few states and may very
well be preempted" constitutionally. See Estelle Derclaye, An Economic Analysis of the Contractual Protec-
tion of Databases, 2005 U. Ill. J. Tech. & Pol'y 247, 250 n.25 (2005) (the misappropriation tort may also
have similar unreliability in international application).

[FN97]. See Database Directive, supra note 80 at art. 10 1.

[FN98]. The author has opted for the term "sequencer" in lieu of "author," which suggests adherence to the
copyright regime, or "creator," which imperfectly indicates that a human genetic sequence may be "created."
Should the application of this framework be expanded at some point to include those scientific databases not
directly connected with genomic sequencing, another term should be adopted at that point.

[FN99]. See Peter K. Yu, Reconceptualizing Intellectual Property Interests in a Human Rights Framework,
40 U.C. Davis L. Rev. 1039, 1081 n.166 (2007). For a discussion of moral rights see generally, Roberta
Rosenthal Kwall, "Author-Stories:" Narrative's Implications for Moral Rights and Copyright's Joint Author-
ship Doctrine, 75 S. Cal. L. Rev. 1 (2001); Ilhyung Lee, Toward an American Moral Rights in Copyright, 58
Wash. & Lee L. Rev. 795 (2001); Thomas F. Cotter, Pragmatism, Economics, and the Droit Moral, 76 N.C.
L. Rev. 1 (1997); Neil Netanel, Alienability Restrictions and the Enhancement of Author Autonomy in
United States and Continental Copyright Law, 12 Cardozo Arts & Ent. L.J. 1 (1994); and Roberta Rosenthal
Kwall, Copyright and the Moral Right: Is an American Marriage Possible?, 38 Vand. L. Rev. 1 (1985).

[FN100]. It is anticipated that independent creation or independent discovery would be an absolute defense
to violation of any of these rights.

[FN101]. 17 U.S.C. 106(3).

[FN102]. See Roberta Rosenthal Kwall, Copyright and the Moral Right: Is an American Marriage Possible?,
38 Vand. L. Rev. 1, 2 (1985).

[FN103]. See Database Directive, supra note 80 at art. 7 2(b).

[FN104]. Donna M. Gitter, International Conflicts Over Patenting Human DNA Sequences in the United
States and the European Union: An Argument for Compulsory Licensing and a Fair-Use Exemption, 76
N.Y.U. L. Rev. 1623, 1683 (2001).

[FN105]. See id. TRIPS calls for prior efforts on the part of the user of intellectual property to negotiate a li-

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cense before granting a compulsory license." Id.(citing General Agreement on Tariffs and Trade-Multilateral
Trade Negotiations (The Uruguay Round): Agreement on Trade-Related Aspects of Intellectual Property
Rights, Including Trade in Counterfeit Goods, Dec. 15, 1993, 33 I.L.M. 81 (1994), 31(b)).

[FN106]. For a candid discussion critiquing the merits of the finder's fee approach in connection with the
protection of newly discovered antiquities, see Peter T. Wendel, Protecting Newly Discovered Antiquities:
Thinking Outside the "Fee Simple" Box, 76 Fordham L. Rev. 1015, 1048-50 (2007).

END OF DOCUMENT

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