Tuesday, March 27, 2012

Patenting Genes -- The Commercialization of Life



[excerpted] "The Supreme Court on Monday ordered an appeals court to reconsider its decision to uphold patents held by Myriad Genetics on two genes associated with a high risk of breast and ovarian cancer...."

Majia here: This is an important case because it addresses the issue of whether genes can be patented.

The law currently stipulates that products of nature cannot be patented.

However, universities and companies seeking to patent genes have in the past argued successfully to the courts that the process of sequencing a gene is distinct from the gene itself and that the sequencing is an artificially derived product that can be patented.

Below find an excerpt from my book Governmentalilty, Biopower, and Everyday Life in which I discuss patenting of genes. 

I argue critically that patenting life itself illustrates the commercialization of nearly all aspects of society under neoliberalism.

[excerpted from my book] Critics express concerns over the commercial patenting of the human genome. In 2005, The Wall Street Journal reported at least 18.5% of human genes were covered by U.S. patents (Westphal, 2005). 

Science Magazine concluded many patents were granted improperly and in “an overly broad manner” consequently limiting research on gene sequences by those other than the patent holder (Paradise, Andrews, & Holbrook, 2005, p. 1566). Critics fear commercial patenting will limit the scope of medical investigation to only those research trajectories promising significant financial returns.
 
Currently, utility patents are available for the following biotechnological innovations:
•    A process of genetically altering or otherwise inducing a single or multi-celled organism to:
o    Express an exogenous nucleotide sequence
o    Inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence
o    Express a specific physiological characteristic not normally associated with that organism
•    Cell fusion procedures yielding a cell line that expresses a specific protein (e.g. monoclonal antibody)
•    A method of using a product produced by the above manipulations. (“What can be,” n.d.)
 
Plant patents can also be granted to anyone who invents or discovers and asexually reproduces distinct and new varieties of plants. In September 2005, a U.S. Court of Appeals for the Federal Circuit upheld a previous ruling that patents could not be granted on DNA strands binding genes whose functions are unknown (Kintisch, 2005). In a dissent, federal Judge Rader claimed the decision would harm support for early-stage research providing “a cognizable benefit for society” (cited in Kintisch, 2005, p. 1799).
 
Not surprisingly, the patenting of life forms, whether human, animal, or plant, DNA or RNA, produces considerable controversy. Are the basic elements and processes of life subject to capitalization? U.S. courts have ruled affirmatively. 

In 1976, the state of California’s Supreme Court concluded a cancer patient, Mr. Moore, had no control over a cell line called “MO” that had been removed from his spleen because products of nature are patentable once isolated to produce forms not found outside of laboratory conditions (Council for Responsible Genetics, 2000). The abstraction of the sequence in the form of “information” renders the process impersonal and almost “virtual,” and has the odd effect of depoliticizing the commoditization because of these characterizations.
 
The market potential of genetic innovations results in huge capital investments by for-profit corporations (mainly pharmaceutical, biotechnology, and genomic start-up firms) and by public universities seeking to subsidize their operations through government grants and private research funds. 

Justification for genetic capitalization comes in all forms. Pharmaceutical companies will develop drugs for previously untreatable diseases such as cancer. Biotechnology companies will genetically engineer bacteria capable of breaking down pollutants (Fialka, 2004). Economic security, national competitiveness, and health maximization are represented as contiguous terms in neoliberal formulations of health marketization....

...Genetic engineering, involving recombinant DNA and cloning, is employed to develop new forms of “biocapital,” as explicated recently by Kaushik Rajan (2006) in his genealogy of postgenomic bioengineering. Recombinant DNA has produced bioengineered agricultural crops such tomatoes, rice, and cotton. 

Opportunities for bio-capitalization today govern genetic engineering’s approach to studying human diseases, susceptibilities, and “traits.” Consequently, pharmaceutical applications dominate bioengineering agendas pursued by both biotech and pharmaceutical companies. As explained by Rajan, “upstream” research, which identifies lead compounds, is primarily pursued by biotech companies; while “downstream” research, which manufactures and markets therapeutic molecules, is primarily pursued by established pharmaceutical companies (p. 21).

Majia here again. In my essay "The Biopolitics and Bioeconomics of Autism" I address the problems stemming from patenting genes:

[excerpted] The search for gene alleles, SNPs, and mutations implicated in conferring risk for developing the constellation of symptoms described as autistic mesmerizes the market and the popular imagination. Many genomic researchers acknowledge the mediating role of (unknown) environmental “factors,” but are transfixed by the agentive power of gene alleles in shaping “autistic” outcomes. The discourse of the gene seduces, promising simultaneous cure and capitalization.
 
Autism susceptibility genes are biocapital. Once sequenced in the laboratory they can be patented. The World Intellectual Property Organization recognizes patents on at least two autism susceptibility genes (Application No. PCT/1B2005/002630 and Application No PCT/1B2005/002319). The U.S. Patent office has patented a method for screening genetic markers associated with autism (Application No. 95117 filed in 1998).
 
Patents dictate and restrict research trajectories. Patents on autism genes can be used to generate revenue streams. Autism is big business for bioengineering and pharmaceutical companies. Autism circulates in a growing bio-economy that is viewed as vital to re-establishing national economic competitiveness. 

Although geneticists studying autism formally acknowledge the role of environmental mediations, it is their ability to target susceptibility genes (over environmental contributions) that produces commercial revenue streams.
 
Marketization of autism seduces because it promises products, magical devices, for normalizing impaired children, while simultaneously stimulating economic development of the biotech sector. In effect, marketization of autism promises to reduce the economic burden of autism for the state as market forces are positioned as the agents for redressing autistic deficits. Furthermore, within neo-mercantile logics, the growths of industries that specialize in biocapital enhance national economic competitiveness. 

Additionally, by shifting our focus from environment to genes, the marketization of autism absolves the state of regulatory responsibility for monitoring and governing those diverse contaminants known also to confer risk and susceptibility to development disorders, such as lead, mercury, etc.

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