The Ethical and Social Implications of Gene Patenting
by Abrar Ahmed
Introduction
Patents have existed for centuries and have served to protect the financial interests of an inventor. However, the notion that a gene or a DNA sequence can be considered as property has been the cause of intense ethical and social concern for nearly ten years. To appreciate the ethical and social implications that arise from gene patenting one must understand exactly what gene patents are and what constitutes as the criteria for being granted such a patent.
Gene patenting is a relatively general term that can refer to the either the patenting of a specific method for isolating and purifying DNA or to the patenting of other biochemical materials associated with DNA. The simple discovery of a DNA sequence or a gene can not qualify for a patent as it would be in direct violation of the Universal Declaration on the Human Genome and Human Rights and EC Directive 98/44/EC, which state:
‘The human genome in its natural state shall not give rise to financial gain.’ (Article 4 of the UN Declaration).
‘The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.’ (Article 5 of the EC Directive).
How genes are patented
Due to the fact that a gene does not exist in isolation in nature, it was been argued successfully that a gene or DNA sequence, which has been isolated by use of a technical process, can be patentable even if the resulting product is identical to the actual human gene. However, in addition to meeting the above criteria, a gene can only be deemed patentable if it is novel, inventive and useful. The complete sequence must be disclosed in the patent application as well.
In order for DNA to be considered as novel, the resulting product must not have been already disclosed to the public. This issue can be problematic as knowledge of a gene or DNA sequence may already be known. Can the simple act of human intervention really transform a known piece of DNA into an invention’? Can it still qualify as a novel product? Both USPTO (United States Patent Office) and EPO (European Patent Office) state any purified biological material may be eligible for patenting regardless of the knowledge of its existence (Nuffield Council on Bioethics, 2002).
To be inventive, the product should not be obvious to an average skilled worker. With the advent of cutting edge DNA sequencing techniques isolating genes has become routine and has raised questions to their inventiveness’, even if the genes are novel. The emergence of in silico (computer based) approaches have helped avoid labour intensive laboratory techniques altogether, in order to determine the function and practical application of certain DNA sequences. One important point to note is that the EPO has more stringent and practical guidelines than the USPO for a product to be considered inventive. For example, according to the EPO isolating a DNA sequence that has a similar configuration to an already known sequence can not be patented. Additionally, the EPO does not recognize in silico methods to identify DNA sequences as they are not considered to be inventive (Nuffield Council on Bioethics, 2002). However, the USPTO does not discriminate between the methods use to identify DNA sequences and allows the patenting of similar DNA sequences (35 U.S.C 103; In re Deuel, 1995).
To be deemed as useful, a patentable gene must have significant utility such as industrial application or medical diagnostics. The discovery and sequencing of genes concerned with disease can provide the basis for a diagnostic test and are generally considered to be useful’. The EPO and USPO have different interpretations of utility’. The EPO requires a DNA sequence to have a significant industrial application and requires evidence to that effect. According to the USPTO, to meet the criteria of utility’ a DNA sequence only needs have a theoretical application. This has led to considerable concern over the moral implication of patenting DNA sequences that have not been shown to contribute to society.
Argument for gene patenting
It could be argued that if certain genes can meet the criteria set forth by the EPO and USEPO for granting patents, it would be wrong to deny the patenting of those genes. The primary argument for gene patenting is that researchers are rewarded for their efforts and can use subsequent finances gained to recoup initial investment. From a purely moral standpoint, it is ethically justified for researchers or biotechnological industries to profit from their investment.
One can not underestimate the impact that pharmaceutical and biotechnological industries have made in the modern world. The cost of developing a new prescription drug alone has nearly reached a billion US dollars and is predicted to increase (DiMasi et.al., 2003). Without gene patents, there would not be any restriction from others benefiting financially from the inventors work and the pharmaceutical and biotechnological industries would cease to exist. This does not only apply to profit-based organizations, as the Bayh-Dole Act (Boettiger and Bennett A, 2006) permits non-profit organizations to patent their inventions, enabling them to safe guard their research interests. Patents are considered to an extremely efficient method to protect inventions in the pharmaceutical and biotechnological industry (Schacht, 2006).
In addition to providing a monopoly to the inventor, Gene patenting can also promote research. The safe guards that patenting provides encourages industries to invest heavily in research and development (Scott and Valentine, 2004). This in turn leads to more discoveries and ultimately the therapeutic applications of genes. As patenting restricts the use of the invention by others research is directed into new unexplored areas. With the patenting of genes, full information regarding its nature and function is disclosed to the public. This not only promotes research but similar research into identical areas is avoided. The patents are granted only for a limited time, typically twenty years, after which the monopoly ends. This helps prevent anyone from benefiting indefinitely from a single gene and compels further research due to a constant need for new discoveries and applications.
Arguments against gene patenting
Genes are the basis of life and to claim that anyone has a right to own a specific gene in essence means they own a part of what defines us as a species. Patenting of therapeutics treatments or genetic diagnostic methods is considered to be ethically acceptable but not the actual genes themselves. One of the difficult questions to answer is regarding the special status of DNA; ‘Is material or information?’. Even if DNA could be assigned a particular status, with genes being everyone’s common genetic heritage, can people really be denied the right to access the naturally occurring genetic sequence that is part of their DNA? Ironically, many of the arguments that strongly favour gene patenting have been paramount in formulating the arguments against.
With the currently existing criteria regulating the issuance of gene patents, the patent unjustly favours the patentee. The act of simply isolating a gene has become relatively straight forward, which any reasonably skilled person could accomplish. Although the patenting of genes whose function is unknown is not allowed, there is dispute over how much of the function needs to be known. The function of DNA sequences used in diagnosis need not be known. Researchers who determine the actual, alternate or additional function of the patented DNA sequence are penalized as their research will primarily benefit the patentee. Researchers have to negotiate a licence from the original patentee in order to make use of their invention. Furthermore, subsequent patenting of similar genes (orthologues) leads to patent stacking, which only serves to extend the duration of the original patent.
Gene patents provide a monopoly, which can restrict the use of genes in genetic diagnosis and research. Patent owners can literally litigate an organization or even an individual for ‘looking’ at a certain part of the human genome. This is an ethical dilemma in itself as health professionals could be prosecuted for testing people suspected of having a particular genetic condition. Failure to do so would be viewed as malpractice. It is especially characteristic of disease gene patents as they are routinely used in medical diagnosis. Studies indicate that clinical diagnostic centres have been hampered by these patents due to expensive licensing fees and subsequent royalties and has led numerous clinics to cease testing for certain genetic conditions (Mildred et.al., 2003). A prime example of this is the test for Haemochromatosis (Merz et. al., 2002).
Contrary to the fact that gene patenting promotes research, it has been shown to suppress research and cultivate an aura of distrust and secrecy amongst fellow researchers (Taylor, 2007). In some instances, a significant number of universities and other various institutions, up to 46%, have been denied access to materials and previously published research material (Campbell, 2002). Although full disclosure is compulsory for a gene patent to be approved, potential patentees operate in complete secrecy till the patent is actually granted. This leads to a gap in scientific information which could be critical to current research and could very well result in duplicated research efforts by multiple parties. The patent is only awarded to the party that applies for it first, not the one that is invested the most time, effort and money. Additionally, gene patents grant owners absolute authority in regulating the type of research depending on their own financial interests.
This raises several important questions, such as can research be morally justified if it is not shared or if it is ethical to use gene patents as a tool to curb research for monetary gain. This has lead to some countries, such as Canada and Belgium, to implement a research exemption that protects researchers and academic institutions from litigation (Caulfield, 2006).
Example of Issues Raised by Gene Patenting
The ethical and social ramifications of gene patenting can be better understood with some of following examples. The examples illustrate various issues that can arise from gene patenting and what limitations and benefits they can confer.
Canavan Disease
Canavan disease is a fatal neurodegenerative disease that affects children. In 1987, a family with two children diagnosed with Canavan disease approached to research community to persuade research of the lethal disease. To facilitate research, a number of families were convinced to participate in the research and donate tissue samples for subsequent study. Through collaborative research effort the families and researchers the metabolic basis of the disease was established and the gene itself was eventually sequenced. Shortly thereafter, a genetic test for the disease was developed in and people of Ashkenazic background were encouraged to be tested for the gene as the disease affects 1 in 6400 Ashkenazi Jewish children (or 1 in 40 Eastern European Ashkenazic Jews) (Resnik, 2003).
However, a few years after the genetic test was developed, Miami Children’s Hospital, the organization that had funded the genetic research, applied for a patent for the diagnostic test. Miami Children’s Hospital enforced its patent infringement rights and forced all organizations without the required licence to stop offering the test. The Canavan Foundation, an organization that carried out the genetic test for free, also had to stop offering the test as it did not have the licence. This resulted in a limited availability and increased cost of the test. The families, which had provided the tissue for research on the disease, in addition to three non-profit organizations filed a lawsuit against Miami Children’s Hospital. The U.S Supreme Court dismissed a number of the plaintiffs’ claims, which included lack of informed consent, fraudulent concealment of the patent and misappropriation of trade secrets (U.S.D.C., 2003).
This case highlights the primary role families can play in genetic disease research. Without the altruistic donation of the tissue samples by families, research of Canavan disease would not have been possible. This raises several important questions, such as to what extent should donors of genetic information be compensated, if any? Was it ethical for Miami Children’s Hospital to enforce its patent? Was an entire community wronged or were they willing and fully informed participants? According the U.S. law, only those who have made financial or intellectual contributions can stand to gain financially from patents, not those who provide the genetic information.
The Myriad Controversy
Myriad Genetics was the first to clone and sequence the BRCA1 gene in 1994 and a patent was granted in 1997. Subsequently, another variant of the gene, BRCA2, was discovered and Myriad Genetics again filed for a patent and was awarded the patent for the gene a few years later (Matthijs, 2006).
The award of the patent was extremely controversial, mainly in European countries, as it questioned the inventiveness and usefulness of the BRCA1 gene as it covered all possible applications diagnostic methods while failing to display any industrial application. However, Myriad still managed to gain a temporary patent for the diagnostic testing for the BRCA1 gene (Nuffield Council on Bioethics, 2002).
In June 2001, Myriad Genetics claimed that numerous hospitals and other institutions were in violation of its BRCA1 gene patent and has to cease testing for the breast cancer gene. Myriad demanded that all samples would have to be sent to its laboratory in the United States for testing. The test cost around 2500 dollars, which as roughly more than 5 times the average cost of the BRCA1 gene test.
The EPO revoked Myriad’s BRCA2 gene patent on the grounds that another organization, Cancer Research UK, has already submitted a patent application a few hours in advance. The EPO then later revoked Myriad’s BRCA1 patent in 2004, based on the finding the opponents to the BRCA1 patent. They discovered that Myriad had submitted an incorrect sequence of the BRCA1 gene and by the time Myriad has sent in the correct sequence it has already been published elsewhere, making the BRCA1 gene unpatentable (New Scientist, 2004).
Myriad’s attempt to enforce its monopoly on breast cancer testing was a critical event that led to several countries to amend their patenting laws (Caulfield, 2006). For example, in 2001, Canada challenged the right of private companies’ to patent genes and Belgium introduced a research exemption to protect researchers and health professionals from litigation.
Currently, Cancer Research UK holds the BRCA2 patent and permits free use of its patent. It is evident from this example that how a gene patent can easily grant a monopoly to a single organization and suppress research. However, this example also demonstrates that patents can be instrumental in protecting published work and research from financial exploitation.
Monsanto vs Schmeiser
In 1997 Monsanto, a biotech industry, sued Percy Schmeiser in 1997 for allegedly stealing the company’s patented gene present in canola plants. Field agents from Monsanto argued that they found canola plants growing on Percy Schmeiser’s farm near Saskatoon, Saskatchewan. The court upheld Monsanto’s allegation that Percy Schmeiser has stolen the industry’s patented gene despite the fact that a seed had probably blown onto his field. According to Monsanto, Percy Schmeiser should have noticed the plant and notified Monsanto, which would have removed all canola plants free of charge. However, it is argued that by the time a genetically modified seed gets into a crop, the whole field would have to be removed (Philipkoski, 2004).
One issue arising from this example is the whole notion of stealing and how one can even be accused of stealing a gene. If a seed inadvertently blows into a field and results in the growth of certain crops, is a farmer compelled to remove the crops, even at the cost of his livelihood? Would not the seed now be occurring naturally in nature and not subject to patent law? Would the integration of the patented gene into the farmers existing crops transfer ownership to whoever owns the gene? According to patent law any plant or microorganism possessing the patented gene is the sole property of the patentee.
Discussion and Conclusion
Gene patents have shown to have potential benefits for both research and the society but the question remains; at what cost? The debate whether DNA patenting is ethical is now irrelevant. DNA patenting is a common occurrence and one needs to ask; how can one ensure that DNA patenting is ethical? One could infer from the examples, that DNA patenting in itself is not an activity with any moral significance. It is how the patent law is used and enforced by various organizations that makes it ethical or unethical. But can one expect large organizations to have any agenda apart from financial interest. Can the ethical principles, such as do no harm, loving good, and beneficence that apply to individuals, be applied to large organizations?
One inalienable feature of a patent is that it should provide a benefit for the society apart from the patentee. Currently, patent law benefits the patentee rather than the society. The EPO has already made several changes in the patent law regarding DNA patenting, in order to shift the balance. With the bar for DNA sequences set slightly higher, one can expect to see a remarked decrease in patent stacking, which has been one major disadvantage of gene patenting. It has also been suggested that patent offices should seriously consider the involvement of a special ethics team to assess the morality of the DNA patent in question (Gold & Caulfield (2002).
In regards to research all countries should adopt the research exemption law. Although it is reasonable to expect only the patentee to benefit financially, it is unethical that either research or medical diagnosis is impeded due to inability to pay or receive the appropriate patent licensing. Another amendment that needs to be made should ensure that the community that played an active role in development of the new invention also shares some of the benefit. HUGO Ethics Committee has suggested that any company that profits from human genetic material should donate a fraction of the net profit for humanitarian purposes (HUGO, 2000). Ever since the Human Genome was published, the rate at which new genes and therapeutic applications have been discovered has been exponential. The ethical issues that have arisen from DNA patent law need to be globally addressed in order to guarantee that genetic research continues to benefit all of society.
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