Are Gene Patents in the Public Interest

In the field of genetics, a patent can be defined as conferring the right or title to genes, gene variations, or identifiable portions of sequenced genetic material to an individual or organization1.

A patent is a set of exclusive rights granted by a government to an inventor or applicant for a limited amount of time (normally 20 years from the filing date). The term "patent" originates from the term to patent which means to lay open (to public inspection) and the term letters patent, which originally denoted royal decrees granting exclusive rights to certain individuals or businesses. Therefore a patent is a monopoly right2.

In order to debate on the ethics of gene patenting it is important to know how the ‘Patenting of life’, as referred to as by Mae-Wan Ho, came into existence. It can be called a gradual historic event leading genetic resource control into a powerful force of global significance. Genetic Engineering has been commercialised steadily since the 1970’s . Also, the rise of biotechnology alerted the world to the potential value of genetic resources in relation to economic as well as value to humanity as a whole. ’Genentech’, the first corporation was formed by molecular geneticist, Paul Berg, who had earlier signed the Asilomar declaration.

In 1980, the U.S supreme court ruled that genetic engineered micro-organisms could be patented. Also, the U.S federally funded Human Genome Initiative was formed which pioneered the way to ‘Patents on Life’. The Trade-Related Intellectual Property Rights (TRIPS) treaty was introduced to facilitate patenting for commercial exploitation which was later dissolved and the World Trade Organisation (WTO) evolved. In 1987, the U.S. Patent and Trademark Office announced that any genetically altered animal, human gene, cell or organ could be patented.

To patent a gene, an inventor must identify novel genetic sequences, specify the sequence's product, specify how the product functions in nature and also enable one skilled in the field to use the sequence for its stated purpose.Today, Over 3 million genome-related patents have been filed. The subject of gene patenting is highly controversial so the merits and demerits are discussed in detail.

According to Stenson, A J and Gray, T S, Patents evolved to distinguish property from one manufacturer to another. The original intentions of most Intellectual Property forms or patents were not to respect or protect natural entitlements but to act in public interest. Also, it was designed to reward innovators for their service.

Gene patenting signifies that certain organisms can be used commercially by some and not others. Physical living organisms, owned by people, is by itself not controversial. A patent protects the inventor whereby encouraging the invention. It was also encouraged by the government so that eventually it could promote public utility. Importantly for the inventor, the invention is described in the patent and when the public buys it, it can be made public to everyone.

The purpose of the patent law is to promote public disclosure of scientific principles and discoveries. Thus, in exchange for the limited monopoly period awarded to the patent owner, the patent owner must disclose to the public how to make and use the invention3.

A patent is only valid for a maximum of 20 years from the day of filing. If there is no law regulating patents, then many inventors would be unable to move forward with their research stimulating others for further progress, while at the same time, some others, would keep it a secret as long as possible. Also, It allows the inventor to control how the invention is exploited. Even if a technology is patented, it is possible for another country to negotiate a fee and import it to develop its own resources. Trends in patents serve a major tool to access current trends of research for analysis.

It is only right that an inventor should be able to protect his invention. Moreover, other biotechnological companies will pay the necessary dues to the gene patent holder, because even after that the field of new medical treatments is lucrative. There will be many treatments available, as well as affordable screening processes. Many palliative medicines for Aids have been developed through the channels of private, medical research and these channels are driven by the incentive of profit.

Many established biotechnological companies assist research by funding. Patents procures available resources to the company itself. So most biotechnological companies argue that genes must be patented to facilitate recouping of their expenditure. Also, their stock market evaluation is dependent on the revenue from patents, any change would cause a major market upheaval. A technology which is patented claims a higher price for it to be licensed out. At this stage of cutting edge technology, patents are used in a situation where there is a strong possibility that a second competitor may file a patent for the innovation. It would be certainly disadvantageous to the inventor if he is prohibited from using the innovation. So patenting is by far more advantageous to biotechnological companies.

Some holders of gene patents cause unwanted side effects, but that the patent system itself provides sufficient possibilities to prevent these side effects. Patents can be used in such a way to provide medical breakthrough. A 25 year old man in Mumbai, India having severe aplastic anaemia nearly on his death bed has survived due a controversial new stem cell treatment from a little known British company called the Tristem.

Families affected by rare diseases are often the source of valuable information and samples. Sharon Terry , a mother of two children with PXE (Pseudoxanthoma elasticum), worked in collaboration with PXE International, Washington providing samples and family data. She has been named a Co-Inventor on patent for the PXE disease gene, thereby contributing to find the cause of the disease. Similarly, Leslie Gordon, mother of a child with a rapid-aging syndrome called Progeria has worked with a lab resulting in the identification of the causative gene.

Patents applied by Petricoin and the National Cancer Institute’s Lance Liotta were in a broader field of proteomics techniques. Therefore, if this patent is held by the government, it would be for academic uses.

Patents often play a major role towards producing good currency of data. It is the first time the information is ever published as the details have been kept a secret for a long time. About 85% of the information has never been published anywhere else. Also, as they are the first or sometimes only source of information on a technological advance, they are crucial in creating and current awareness. Often information on new patents serve to stimulate interest among researchers and biotechnologists. Wasteful duplication of effort is also prevented.

Concerns of gene patenting were aroused when intellectual property rights were consistently interpreted to aid private interests and public interests at large were ignored. The first concerns during the emergence of patenting were highlighted when the developed countries began to take genetic resources freely from the third word countries and in turn, sold it back as a valuable commodity. The poorer and under-developed fraction of the world held the key to a major genetic diversity. Mae-Wan Ho (1998) calls them ‘Gene-Hunters’ who prospect for commercially lucrative genetic resources.

Concerns over gene patenting begun to surface as a moral issue raised by people from every corner of the world regardless of their diversity. The problem was the concept of breach of human decency over enterprise. Activist Jeremy Rifkin of the The Foundation on Economic Trends, opposes gene patenting at news conferences and demonstrations near the New York Stock Exchange and the Chicago Board of Trade. According to Rifkin "The rich genetic resources of the Earth's biological commons should be shared openly and fairly and not become the exclusive intellectual property of transnational corporations”. Rifkin’s key point is that research into human genetics leads to researchers tampering with gods creation which would eventually lead to designer human beings.

Another issue which merits attention is genetic discrimination in employment and insurance. Anecdotal evidence suggests that people have been denied insurance because genetic screening shows they may be carriers of genes for such illnesses as Huntington's disease and the potential for selective abortions if people reject fetuses with "undesirable" genetic traits.

Some of the greatest criticisms to gene patenting has arisen from religion. One specific instance deals with people who do not consume meat or certain animals. One of the uses of patented genes is to create genetically modified food and crops, but if through genetic modification, an animal gene were to be placed in a plant, then this may pose a problem for certain religions and groups of people.

When innovation is classed under monetary reward because of patenting it excludes other knowledge systems. Therefore, there would be unequal distribution of resources among the third world countries. Intellectual property discriminates people against the protection, availability and usage of information which is unfair. At the end, the individual liberty is compromised. There is no legal framework in most third world countries to monitor and implement patenting.

Patenting involve costly processes for researchers who can be hampered by the lack of funding. Due to its prohibitive costs ,standard tests are restricted to few laboratories and this in turn affects clinical research, health care and quality of service. Public funding aimed at scientific research is biased in most developed countries.

Also concern among lobbyists rose about the hampering of medical research. Allowing these companies to acquire patents on genes is very detrimental to progress in almost all fields of genetic study. The main obstacle in the way of progress is the lack of availability of some genes for research. As a result of patents on genes, companies have the exclusive right to study and test for that gene, "the patent holder could, in fact, prohibit or restrict certain medical tests that would require isolation of that gene. Researchers who are looking to study these patented genes often find themselves literally restricted from access to these genes or restricted by the payments which must be made to the owners of these genes.

Human Genome Sciences (Inc) (HGS) of Rockville , Maryland has had the reputation of methodically sequencing and commercialising human genes and simultaneously getting patents drawn up for them. In 2000, it won a patent for a human gene that plays a key role in HIV infection that resulted in a record high increase in its market share.

This gene had been already discovered by a team lead by Edward Berger and Philip Murphy of the National Institutes of Health. Also, it came as a shock to many scientists working on the gene in relation to HIV treatment. Another key point was that the company (HGS) was not aware of the connection of the gene with AIDS. The strategy of HGS is that it isolates gene sequences as an entry point in research and pharmaceutical development. They also work under stringent targets to produce results and successful pharmaceutical lines. Having won the patent, HGS has licensed the gene to its pharmaceutical partners for HIV drug research and development. Also, the company itself is working on resistance issues relating to HIV infections and possible cure. HGS is reported to have claimed of willingness to share its data and reagents but to use the sequence, the researcher would have to pay a hefty sum. The gene is more beneficial to the medical researchers working on it rather than a company that isolated the gene sequence for merely commercial purposes.

Patents can seriously inhibit scientific research. Myriad, a US biotechnology company won three patents for a diagnostic test for the breast-cancer susceptibility gene and its therapeutic applications. Later, it refused to grant any licences for research on the gene and insisted that all DNA samples must be screened in a laboratory in Utah and acted as an abusive monopoly. Many European research centres and organisations opposed the patent on grounds that it acted as a preventative tool against further research and advancement of the tests. The case was brought to the European Patent Office (EPO) which found major discrepancies with the technique and revoked the patent after 7 years.

Athena Diagnostics, a Massachusetts corporation has acquired exclusive rights to certain tests in the diagnosis of late-onset Alzheimer’s disease. It hampers various laboratories who are conducting similar testing. Testing anywhere else now would violate the patent, but the company charges twice than what it cost originally.

Patents can be used to exploit people of their valuable time and personal resources. A group of parents of children afflicted with Canavan disease provided tissue for research on the disease and aided in identification of other affected families, and three non profit organizations that had developed a confidential database and Canavan disease registry. Physician-researcher Reuben Matalon, who isolated the gene, patented the Canavan gene sequence and developed genetic screening tests for it, and the Miami facilities where he did his research.

During a court trial in the U.S. District Court for the Southern District of Florida, the court ruled in favour of the family for investing time and significant resources. Patents on biomedical research tools, like the one on use of gene arrays, can be destructive for science and researchers. Eric Lander, Todd Golub and others at Whitehead Institute, Cambridge, Massachusetts obtained a patent for a method of using gene expression arrays to analyse clinical samples. This method has been used so far to analyse leukaemia, but the patent restricts further tests by laboratories.

Allowing a single genomic sequence to be patented in several ways such as an EST, a gene, and a SNP, which is called Patent Stacking, may discourage product development because of high royalty costs owed to all patent owners of that sequence; these are costs that will likely be passed on to the consumer.

To compensate the drawbacks of patents, a different approach to Intellectual Rights should be made. One that looks on Intellectual Property Rights instrumentally rather than as a fundamental legal right. Goals should be served while serving to be flexible with the present circumstances.

Property Rights should be respected, certain instrumental uses of property should be forbidden to be used by everyone, whereas, the precise form of Property Rights should be allowed to be altered.

Most biotechnological companies isolate millions of genes for which they do not know its actual function or significance. When someone else discover their functionality , they collect royalties for them. In 2000, the US Patent and Trademark Office (USPTO) came up with certain revisions to put an end to such practices. The proposed guidelines have been set up to issue patents on the basis of its utility standard, referring to why an invention is useful and the written standard, which pertain to disclosure of how an invention is made. This is just a start to slowly make away the controversies.

Extensive criticism of patents is not intended as an argument to completely eliminate but to help look for a alternative of a monopolistic, dominant concept by an instrumentalist concept designed to give access to valuable information for the public good.

References

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Genetics-patient advocate named co-inventor on patent for the PXE disease gene SCIENCE 305 (5688): 1226-1226 AUG 27 2004

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1.Genome Glossary, http://www.ornl.gov/sci/techresources/Human_Genome/glossary/glossary_p.shtml

Patents http://www.patents-info.com/Default.aspx?tabid=177

Protect Your Business with Patents, Copyrights and Trademarks.

http://www.va-interactive.com/inbusiness/editorial/legal/ibt/protect_.html

Technology Transfer Program, http://www.northwestern.edu/ttp/investigators/patents_tradesecrets.html

Get patent protection for your business

http://www.businesslink.gov.uk

Scientists hindered by gene patents

http://www.newscientist.com/article.ns?id=dn1894

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