GENEWATCH
 
FREEDOM OF GENES
By Debra Greenfield
 

In the reporting and coverage of the case against the United States Patent and Trademark Office and Myriad Genetics, the company holding the patents on the BRCA 1 and BRCA 2 genes, little has been written about the ACLU's involvement as counsel for the plaintiffs. Litigation regarding the rarified nexus of the science of human genetics and the law of patents appears at first glance to be different from the historic and well-established causes for which the famous advocacy group is known. When considering the issues involved in the process of patenting human genes and genetic information, however, it becomes clear that the case is thematically related to those same traditions. Constitutional rights and civil liberties are at stake: the granting of exclusionary patents to human genes and the information they embody restricts and infringes upon the guarantees of the First Amendment, freedom of speech and expression. Although the decision of the lower district court in the case now under appeal at the Federal Circuit did not reach the free speech issue argued by the ACLU, the concepts involved in the argument are important for an understanding of the broader context in which the gene patent case developed. 

Unique and emerging technologies of the "information age" present novel questions for scholars considering the scope and meaning of the First Amendment. Yochai Benkler's description of the creation of the digital environment and its resultant expansion of intellectual property rights in information is representative of this new consideration in First Amendment jurisprudence and methodology. He asserts that the challenge of supporting traditional goals of free speech and expression, "robust democratic discourse and personal autonomy" is made more difficult by the information economy. Simply put, "To create property rights in this economy, government must often prohibit speech." He describes the particular concern as "the enclosure movement in our information environment.  In other words, our society is making a series of decisions that will subject more of the ways in which each of us uses information to someone else's exclusive control," and notes that as intellectual property, we will expect "information to be owned, and to be controlled by its owner," blinding us to "the cost that this property system imposes on our freedom to speak."1   

This evolving tension between the law of intellectual property as delineated in the United States Constitution, Article 1, §8, clause 8 and the First Amendment has primarily been situated in the law of copyright, but a similar tension is developing between freedom of speech and the patent system, where similar 'speech costs' undermine the system's Constitutional directive of "promoting the progress of science and the useful arts."2 Defined by the Patent Act as a property right granted by the government, inventors are rewarded with a twenty year monopoly forbidding anyone other than the inventor from "making, using, selling, offering to sell, or importing their invention."3 These grants are no longer concerned with just artifacts of technology. Now, as commentator John R. Thomas notes, "Patent claims, cut loose from physical moorings, have grown more abstract." Examples include voter and consumer surveying techniques, marketing and sales techniques, and patented teaching methods of language, music, vocabulary acquisition, dialogue writing, and mathematics.4

Thus, these unique questions as to what the framers meant by freedom of speech are raised not only in emerging information technologies but also in the emergence of new practices in biotechnology. Descriptions of the science and language of the biotechnology involved in human DNA is frequently analogized to the science and language of computer technology; the metaphors are abundant. Similar comparisons can be made when considering how the intellectual property grant of human DNA patents results in tensions with the First Amendment. When DNA molecules and DNA sequences, DNA sequences with single nucleotide polymorphisms (SNPs), replicated human DNA sequences (cDNA), and methods and materials for determining a relationship between a particular DNA genetic sequence and the presence or absence of a genetic susceptibility are patented, speech concerns are raised. 

A careful consideration of the decision of the lower district court as well as the briefs being filed in the appeal by Myriad reveal the importance of the basic underlying question in the case considered within the context of gene patenting and civil rights and liberties: What exactly is the nature of the human BRCA 1 & 2 DNA molecules and genes, and how can one characterize exactly what it is that is being patented? The briefs for Myriad describe the molecule isolated from its natural environment as simply "a chemical compound," not distinctive from any other similarly patented composition. The district court found the claimed isolated DNA to be in all respects, identical to the same molecule or sequence as that found in the body, known as native DNA, and that they have identical functions, the ability to express BRCA 1 and 2 proteins. It is this structure and function that the court relied upon to describe the essence of the patent claims as "embodied information," and thus distinctive from other chemical compositions. "What is being patented is the three-dimensional structure of the chemical bases that, in their ordering, direct the synthesis of other molecules in the body-namely proteins."5

Thus newly characterized, the law in the case this far is following the observations and writing of social scientists remarking on the nature of DNA in the information age, where "...biology is information, and crucially, that information is both material and immaterial."  This embodied information may arguably be characterized either as a "law of nature" or a scientific principle, both of which represent exceptions to the categories of patent eligible subject matter according to the statute. When these laws or principles, i.e., human DNA or a genetic sequence are patented, the grantee is given its exclusive use, the information is privatized and the public's ability to use the informational content is restricted or denied.

This embodied information can simultaneously be considered to belong to both a part of a body of collective knowledge, i.e. the "human genome," as well as existing within any one individual's particular and unique genome, one's own DNA. Thus the patenting of human DNA and genetic sequences can possibly infringe both any one individual's First Amendment rights to the information in the shared human genome, as well as infringe upon that person's ability to have access to the information regarding their own genetic profile.

Benkler's First Amendment concerns regarding the enclosure of information are implicated as rights inherent in the guarantees of free speech: the ability to communicate or publish "scientific speech" is infringed when the actions or information necessary for the formulation of that speech, the available precursors to speech, are unavailable. This occurs when the right to gather information necessary for the formulation of speech is restricted or denied. Real life implications arise when this knowledge is unavailable or restricted due to exclusive or high licensing costs, and the numerous policy arguments being made in the Myriad case reveal that harms to women and public health occur as a result. Innovation and progress in medical research is impeded when researchers are precluded from using and studying the BRCA 1 and 2 genes. The privatization of the information and knowledge embodied by human genes also have "speech costs" and can be seen to threaten the core of our civil liberties.

 Particular types of patents which are granted on claims covering methods of using genes and genetic information for specific diagnostic purposes also implicate First Amendment guarantees to the precursors necessary for the formulation of speech. Drafted to cover the precise functions a physician might employ, these claims are often written as describing a correlation, a relationship between particular DNA or DNA genetic sequence and the presence or absence of a genetic susceptibility to a particular illness or condition. Myriad's method claims to the correlations involving the BRCA 1 and 2 genes and a susceptibility to breast and ovarian cancer are illustrative. When these exclusionary patents are granted, the ability for others to similarly consider the correlation is denied, and the First Amendment guarantee of freedom of thought, fundamental to the ability to formulate speech, is infringed. In the coming era of the much discussed "$1000 genome," using such informational tools, any person wishing to think about their own susceptibility to breast or ovarian cancer will be infringing Myriad's patents when determining if the correlation exists in their own body.

The emerging science of epigenetics suggests that exposure to various environments and personal choices can suppress gene expression, thus affecting and contributing to the structure and function of our personal genomes. This science will help to diffuse the problematic political and cultural implications of our human identities, our natures being constructed or determined by our DNA, our biology at the molecular level.6 Nonetheless, our own unique genomes consist of and reveal important information about ourselves. Thus, per commentator Jonathan Kahn: "As genes play an increasingly powerful role in contemporary legal and political culture, individuals are called upon to refer to genetic information as a basis for assessing their rights and duties."7 The plaintiffs and the ACLU are to be thanked for asserting our Constitutional First Amendment rights in their case against Myriad Genetics.

 

Debra Greenfield, JD, is Adjunct Assisstant Professor at the UCLA Center for Society & Genetics.

 

1. Yochai Benkler, Free as the Air to Common Use: First Amendment constraints on Enclosure of the Public Domain, 74 N. Y. U L. Rev. 354 (1999); Yochai Benkler, "Constitutional Bounds of Database Protection: The Role of Judicial Review in the Creation and Definition of Private Right in Information," 15 Berkeley Tech. L. J. 535 (2000)' Yochai Benkler, "Siren Songs and Amish Children: Autonomy, Information and the Law," 76 N. Y. U. L. Rev. 23 (22001)            

2.  U.S. Const. Art. I, §8, cl.8

3. 35 U. S. C.

4. John Thomas, SYMPOSIUM 2002: THE FUTURE OF PATENT LAW: LIBERTY AND PROPERTY IN THE PATENT LAW, 39 Hous. L. Rev. 569 at 570

5. Eugene Thacker, The Global Genome: Biotechnology, Politics and Culture (2005) at 20; Dan Burk, "The Problem of Process in Biotechnology," 43 Hous. L. Rev. 561, 582-587 (2006).

6. See. e.g., Dorothy Nelkin & M. Susan Lindee, The DNA Mystique: The Gene as a Cultural Icon 1-18 (1995)

7. Jonathan Kahn, "What's the Use? Law and Authroity in Patenting Human Genetic Material" 14 Stan. L & Pol'y Rev. 417 at 417-418

 
 
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The purpose of the Genetic Bill of Rights is to introduce a global dialogue on the fundamental values that have been put at risk by new applications of genetics.
 
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Rapid developments in biotechnology over the last two decades have enabled corporations and scientists to alter nature's handiwork for commercial profit. The patent, a tool originally created to insure that inventors could share in the financial returns and benefits deriving from the use of their nventions, has become the primary mechanism through which the private sector advances its claims to ownership over genes, proteins, and entire organisms.
 
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