This House would allow the patenting of genes
Due to the achievements of molecular biology and biotechnology over the past 30 years, culminating in the successes of the Human Genome Project (an international collaboration of scientists, as well as the contribution of private, ‘genomics’ corporations), we now have identified the entirety of the human genomic sequence. This enables us to identify genes in that sequence and to correlate changes in particular genes with the likelihood that those changes result in disease, such as cancer. It is believed that it is only a matter of time before this new knowledge leads to a tangible improvement in treatments of this disease.
The first patent on a recombinant DNA method was granted in December 1980, six months after the US Supreme Court ruling Diamond v. Chakrabarty, that a living, genetically engineered bacteria could be patented. The recombinant DNA patent, shared by Stanford University and the University of California, laid the groundwork for using cells to produce useful proteins and turning them into valuable drugs. Well before the Supreme Court decision, in 1977, the University of California had applied for patents on genes for insulin and growth hormone; the patent for insulin was granted in 1982 and the one for growth hormone in 1987. Gene patents were seen an extension of the legal doctrines that permitted patents on hormones, vaccines, and other “natural products” that had been turned into useful forms. 1
As of 2010, there were, in the US alone, roughly 40,000 patents held on genes2 but only 6,000 on human genes. A patent grants to its owner the right to exclude others from making, using or selling a patented machine or composition of matter, or using a patented method, typically for a period of 20 years from the date of filing a patent application. The difference between trade secrets (which must be kept secret by their owner and do not protect against independent invention) and patents is that patents require disclosure that teaches the world how to make and use an invention, rewarding the inventor with a period of exclusivity during which time profits may be earned from its commercialization.
Even though there has been quite some time the practice of awarding patents on genes, upheld by the courts, it has come under scrutiny and criticism by some scientists, legal scholars, and politicians. The subject of gene patenting involves various ethical, legal, and economic components. Questions raised are both of a practical and more principal nature – What should constitute a patent? How long should a patent last? As well as an equally difficult, moral one: Should we patent the ‘building blocks of life’? Should medicine be an area for profit at all?
Patenting is a process that is very common in the developed world; before a product is patented it is examined by a patent agency (e.g., the European Patent Office, the US Patent and Trademark Office). Gene patents have been granted by the USPTO since 1980, proving that the processes and systems are in place to handle and grant gene patents.
Afterwards, a patent to a gene provides the “negative right” that no third party is permitted to “practice” the invention for 20 years from the filing date, without the patentee’s permission. Once that 20 year period expires, the invention claimed by the patent can be practiced freely by anyone without restriction (except for regulatory agency requirements in the appropriate instance). Unauthorized practice of a patented invention raises liability for infringement which is resolved by a lawsuit between the parties.4
The outcome of such a lawsuit can be settlement, money damages or an injunction for the prevailing patentee; the accused infringer can prevail by convincing the judge or jury that she does not infringe or that the patent is invalid.
1. Deegan R., Gene patents, The Hastings Center, http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174, accessed 07/20/2011
2. Brown, J. ‘Can Genes Be Patented’, PBS, http://www.pbs.org/newshour/bb/health/jan-june10/patents_04-02.html, accessed 07/20/2011
3. Merz J., Mildred K., What are gene patents and Why are people worried about them ?, Community Genetics 2005 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2220018/, accessed 07/20/2011
4. ibid
N.B. since this debate was written the US Supreme Court in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. has ruled that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated" however this is still a live issue as the EU at least still considered genes to be patentable stating “an element isolated from the human body or produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention.”
Points For
Genes are intellectual property thus patentable
The patenting office stipulates that a successful patent applicant must have found something in nature, isolated it, and found a way to make something useful with it.The genome research of companies satisfies these criteria, so why should it be any different? The genome companies have invested resources to create intellectual property (patents), which refers to “creations of the mind.” Under US law includes intellectual property inventions, literary and artistic works, symbols, names, images, designs, and trade secrets. The law states, that any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.” In biomedicine the patentable inventions include materials, such as new drugs or new cell lines, and methods for deriving or growing them, such as extraction or cloning techniques.1
COUNTERPOINTOf course genes should be treated different from any product or other invention; genes are the very basis for human life and to claim that anyone has the right to be regarded as the ‘owner’ of a particular gene, which we all share in our bodies, shows a venal disregard for humanity. If companies want to patent treatments which target specific genes, then that’s okay, but not the genes themselves.The University of Colorado explains: “Inventions include new processes, products, apparatus, compositions of matter, living organisms, and/or improvements to existing technology in those categories can be patented. Abstract ideas, principles, and phenomena of nature cannot be patented.”1
1. Patents FAQPatents FAQ, University of Colorado,
Patenting enables knowledge sharing
Patents are typically granted for twenty years only. After this period the monopoly ends. All companies ask is that for a limited time they are able to benefit from their investments, and that in that period if another company wishes to pursue a project in their area then they should have to give their permission for the use of the patent. Patenting does not mean withholding information in secrecy.
On the contrary, patents actively encourage openness in science, because if you were not able to disclose your findings without fear of exploitation, then you would keep your findings secret. This would be to the detriment of medical advancement.
For example the Human Genome Sciences’ patented their discovery of the CCR5 receptor gene, which was then discovered by other scientists at the National Institutes of Health, that the small number of people missing the receptor appear to be immune to HIV 1. This could be done because Human Genome Sciences has a policy that "we do not use our patents to prevent anyone in academics or the nonprofit world from using these materials for whatever they want, so long as it is not commercial.2"
Patenting makes sure that the information is registered and shared. The other option, whereby companies do not patent the information and keep it as a “trade secret”, hurts everybody much more and slows down the rate of scientific progress.
1. Dutfield G., DNA patenting: implications for public health research, WHO
COUNTERPOINTIn the twenty years of a patent’s duration, any prospective research is carried out in fear of recriminations and law-suits from the patent-holder. Laboratories offering patented genetic tests for research studies have been asked to “cease and desist” unless they refer materials to or get a license from the patent holder 1. Where one company has the right of exploitation, they possess a monopoly and inevitably will be able to charge what they like. It is only after countries threatened or actually invoked provisions of the WTO Treaty, for example, that companies offered to decrease the price of their Aids medicines for African countries 2. Those provisions would have permitted the governments to grant compulsory licenses.Further on, gene-patent holders can often control the useof ‘their’ gene; if they have the claim for the test, they can prevent a doctor from testing a patient’s blood for a specific genetic mutation and can stop anyone from doing research to improve a genetic test or to develop a gene therapy based on that gene 3.So any further research is in the mercy of the patent owner. Even if information is public, if it is not possible to use it and build upon it without permission. It is therefore possible for the patent holder simply to horde patents and prevents any research using that patent to the detriment of science, medicine and the patients who could be benefiting.
1. Cook-Deegan R., Gene patents, The Hastings Center, http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174, accessed 07/20/2011
2. BBC News, “Brazil to break AIDS drug patent”, http://news.bbc.co.uk/1/hi/world/americas/6626073.stm, accessed 15/9/2011.
3. CRS Report for Congress, Gene Patents: A Brief Overview of Intellectual Property Issues, 2006, http://ipmall.info/hosted_resources/crs/RS22516_061003.pdf, accessed 07/21/2011
Points Against
Genes are intellectual property thus patentable
The patenting office stipulates that a successful patent applicant must have found something in nature, isolated it, and found a way to make something useful with it.The genome research of companies satisfies these criteria, so why should it be any different? The genome companies have invested resources to create intellectual property (patents), which refers to “creations of the mind.” Under US law includes intellectual property inventions, literary and artistic works, symbols, names, images, designs, and trade secrets. The law states, that any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.” In biomedicine the patentable inventions include materials, such as new drugs or new cell lines, and methods for deriving or growing them, such as extraction or cloning techniques.1
COUNTERPOINTOf course genes should be treated different from any product or other invention; genes are the very basis for human life and to claim that anyone has the right to be regarded as the ‘owner’ of a particular gene, which we all share in our bodies, shows a venal disregard for humanity. If companies want to patent treatments which target specific genes, then that’s okay, but not the genes themselves.The University of Colorado explains: “Inventions include new processes, products, apparatus, compositions of matter, living organisms, and/or improvements to existing technology in those categories can be patented. Abstract ideas, principles, and phenomena of nature cannot be patented.”1
1. Patents FAQPatents FAQ, University of Colorado,
Patenting enables knowledge sharing
Patents are typically granted for twenty years only. After this period the monopoly ends. All companies ask is that for a limited time they are able to benefit from their investments, and that in that period if another company wishes to pursue a project in their area then they should have to give their permission for the use of the patent. Patenting does not mean withholding information in secrecy.
On the contrary, patents actively encourage openness in science, because if you were not able to disclose your findings without fear of exploitation, then you would keep your findings secret. This would be to the detriment of medical advancement.
For example the Human Genome Sciences’ patented their discovery of the CCR5 receptor gene, which was then discovered by other scientists at the National Institutes of Health, that the small number of people missing the receptor appear to be immune to HIV 1. This could be done because Human Genome Sciences has a policy that "we do not use our patents to prevent anyone in academics or the nonprofit world from using these materials for whatever they want, so long as it is not commercial.2"
Patenting makes sure that the information is registered and shared. The other option, whereby companies do not patent the information and keep it as a “trade secret”, hurts everybody much more and slows down the rate of scientific progress.
1. Dutfield G., DNA patenting: implications for public health research, WHO
COUNTERPOINTIn the twenty years of a patent’s duration, any prospective research is carried out in fear of recriminations and law-suits from the patent-holder. Laboratories offering patented genetic tests for research studies have been asked to “cease and desist” unless they refer materials to or get a license from the patent holder 1. Where one company has the right of exploitation, they possess a monopoly and inevitably will be able to charge what they like. It is only after countries threatened or actually invoked provisions of the WTO Treaty, for example, that companies offered to decrease the price of their Aids medicines for African countries 2. Those provisions would have permitted the governments to grant compulsory licenses.Further on, gene-patent holders can often control the useof ‘their’ gene; if they have the claim for the test, they can prevent a doctor from testing a patient’s blood for a specific genetic mutation and can stop anyone from doing research to improve a genetic test or to develop a gene therapy based on that gene 3.So any further research is in the mercy of the patent owner. Even if information is public, if it is not possible to use it and build upon it without permission. It is therefore possible for the patent holder simply to horde patents and prevents any research using that patent to the detriment of science, medicine and the patients who could be benefiting.
1. Cook-Deegan R., Gene patents, The Hastings Center, http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174, accessed 07/20/2011
2. BBC News, “Brazil to break AIDS drug patent”, http://news.bbc.co.uk/1/hi/world/americas/6626073.stm, accessed 15/9/2011.
3. CRS Report for Congress, Gene Patents: A Brief Overview of Intellectual Property Issues, 2006, http://ipmall.info/hosted_resources/crs/RS22516_061003.pdf, accessed 07/21/2011
Patenting drives up the cost of therapies and renders them unaffordable to the poor
The government and its laws should take care of all their people. Because the state is a construct built by all the people, who all pay taxes to support it, laws should also be based to benefit the greatest amount of people possible.In the case of the Myriad company, which holds, together with the University of Utah Research Foundation, rights over tests for ovarian cancer, it prevented cheaper tests being offered to the public. As a result, Myriad is the only company that can market a test for the mutations, and it charges as much as $3,000. That is a price that for many is inaccessible. Patients’ state: “There is no other, cheaper test that you could go get in another laboratory, because they have the exclusive patent,” she explained, adding that Myriad also controls the efficacy of the test—second opinions are only available for certain surgeries 1.Because patenting harms the accessibility of diagnostics and testing, it should not be allowed.
1. Pratt P.A., Court Rules That DNA Is Information, Not Intellectual Property, published March 30th 2010, http://www.scienceprogress.org/2010/03/gene-patents-ruling/, accessed 07/20/2011
COUNTERPOINTFirstly, it is not self-evident, that people have a right to use and possess something, such as medicine that they did not create.So why should people have the right to use a product that someone else discovered through the power of their own cognitive abilities. Actually demands to not patent and just research for the greater good are contradictory to the government taking care of all their people. The best way for the government to encourage medical research that provides these benefits is through patents. Patenting of genes is therefore a right that is based on the right to ownership of your own thoughts and should therefore be granted to the companies / individuals. There is no consistent legal basis for deciding that genes are not patent-eligible without deciding that many other ‘natural products’ are also ineligible.
Patenting inhibits research and therapeutics
The prevailing belief is that this is an area of such great importance and potential benefit to mankind, as such there should be no, self-interested impediment to genome research. The only barriers should be those of conscience.
The Human Genome Project is one of the government funded projects that makes all its research freely and publicly available. They are not driven by profit and offer information on their discoveries for free enabling others to build upon their findings.
The problem with patents is that companies claim ownership without regard towards moral issues. It is purely in the pursuit of their profits that they decide not to allow others to build on their findings and make the process of discovering treatments far more difficult. An example of this is the Myriad company which, whilst holding patents on BRCA 1 & 2, genes connected with breast cancer, prevented the University of Pennsylvania from using a test for these genes which was substantially cheaper than the company’s own screening procedure. 1
Instead of protecting their research investment, companies should have a moral duty to facilitate in any way they can to the development of cheap, available treatments and screenings for diseases which are so dangerous to so many people.
COUNTERPOINTPatenting in general is creating more possibilities for patients than if there was no patenting and less competition for development. Even if treatments and diagnostics for some diseases are expensive, they are at least there and are beginning to benefit the people that need them most. If the government is that concerned for the well-being of its poor patients, the issue of private and public dis-allocations is far more troubling than patents.
However, if the government does believe that such a treatment in necessary for the greater good of the country, which happens in very few cases, there still are mechanisms to loosen patent rights. The Hastings Center explains that governments and other organizations can encourage research on needed therapies, such as a malaria vaccine, by setting up prizes for innovation related to them or by promising to purchase the therapies once they are developed 1. Other measures rely on voluntary action. Patented drugs can be sold at little or no mark-up in poor countries. Scientists and their employers can decide not to patent an invention that might prove useful to other researchers, or they might patent it but license it strategically to maximize its impact on future research and its availability to people in need. For example, when the scientist Salk believed he has developed a vaccination that should be basic health care, he decided not to patent his polio vaccine, which saved millions 2.Also, companies like GlaxoSmithKline have initiatives for having drugs made more available and affordable to poor countries 3. Governments and NGOs can also contribute.
Experts in research analysis (Professors Walsh, Cohen, and Charlene Cho) concluded that patents do not have a “substantial” impact upon basic biomedical research and that “...none of a random sample of academics reported stopping a research project due to another’s patent on a research input, and only about 1% of the random sample of academics reported experiencing a delay or modification in their research due to patents 4.”Most of the newly developed gene therapies / genes are not that essential to be for free for everyone and further on for those few, that are, there are different methods of abuse prevention.
1. Cook-Deegan R., Gene patents, The Hastings Center, http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2174, accessed 07/20/2011
2. Josephine Johnston, Intellectual Property in Biomedicine, The Hastings Center, http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2186, accessed 07/21/2011
3. IB Times, “GSK lead initiative to help poorer countries”, http://uk.ibtimes.com/articles/20110606/gsk-lead-initiative-to-help-poorer-countries.htm accessed 07/20/2011
4. CRS Report for Congress, Gene Patents: A Brief Overview of Intellectual Property Issues, 2006, http://ipmall.info/hosted_resources/crs/RS22516_061003.pdf, accessed 07/21/2011
Immoral to own a human life
Patenting genes and DNA fragments is immoral because of their significance for human life and welfare. It is immoral to own building blocks of the human life. Commercialization of human genes degrades value of human life.
Once we give people the possibility to put an ownership tag on genes (basics of life), there is people who value human life merely based on monetary value. Bidding for the best gene, highest price and making the basics of life the same as buying a car.
Andy Miah in his essay on Ethical Issues in Genetics argues: "Evidence of such disaffection has appeared most recently from the emergence of Ron's Angels, a company set up for the auctioning of female eggs and male sperm to infertile couples seeking 'exceptional' children. Whilst numerous companies of this kind now exist, Ron's Angels is interesting not simply for having arranged a standard and reasonable price for such genes; far from it. Rather, as indicated above, eggs and sperm are awarded to the highest bidder."1 Thus making the perception of human life what people believe is "fair to pay" and creating a race to figure out the cheapest ways of buying parts of the human body.
1 10) Miah, A., Patenting Human DNA. In Almond, B. & Parker, M. (2003) Ethical Issues in the New Genetics: Are Genes Us?
We are happy to put a price on our ideas and knowledge, which are as much building blocks of life as our genes. Each individual already sells his ideas and has a price tag so patenting makes no further devaluation than that which is already there.Even if ownership of another person’s parts is immoral, morality never had a lot to do with gene patenting.Patent agencies allow such immoral things as poisons, explosives, extremely dangerous chemical substances, devices used in nuclear power stations, agro-chemicals, pesticides and many other things which can threaten human life or damage the environment to be patented. This is despite the existence of the public order and morality bar in almost all European countries.1So why make a difference with gene patenting, which does not harm, but may actually benefit a great amount of people.
1. Annabelle Lever , Is It Ethical To Patent Human Genes?, UCL 2008,
Bibliography
Cook-Deegan R., Gene patents, The Hastings Center,
CRS Report for Congress, Gene Patents: A Brief Overview of Intellectual Property Issues, 2006,
Dutfield G., DNA patenting: implications for public health research, WHO
Johnston, Josephine,Intellectual Property in Biomedicine, The Hastings Center,
Lever, Annabelle, Is It Ethical To Patent Human Genes?, UCL 2008,
Ravilious K., Private companies own human gene patents, published 10/14/2005,
Schwartz J., Judge Invalidates Human Gene Patent, published 03/29/2010,
Patents FAQ, University of Colorado,
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