A gene patent is a patent on a specific gene sequence, its usage, and often its chemical composition. There is controversy over whether these patents advance technology by providing scientists with an incentive to create, or hinder research by creating a lot of red tape and licensing fees to utilize research that is patented. The main question is whether gene sequences are patentable? Are gene sequences a “natural” part of the world that cannot be patented? Or, perhaps despite being part of the natural world, does the isolation of gene sequences still meet the criteria of patent law? Is it “useful”, non-obvious, and novel? In general, do gene patents help foster research and development, or does it harm it? Do gene patents have positive economic effects, or negative ones? Are gene patents helpful to public health, and combating disease, or harmful? Overall, what is the balance of pros and cons? Are gene patents a good idea, or should they be banned?
See also Wikipedia: Gene patents on Wikipedia for more background.
“A person who discovers a new function of a known DNA sequence, such as its previously unknown association with particular disease, can patent a method of using the isolated sequence to detect susceptibility to that disease. Isolated DNA sequences do not occur in nature. They are new.”
According to the US government’s Human Genome Project website, “In general, raw products of nature are not patentable. DNA products usually become patentable when they have been isolated, purified, or modified to produce a unique form not found in nature.”
“The patents claiming genes do not claim products of nature. The simple distinction is that gene claims recite that the genes are “isolated,” thereby putting to rest the canard that a patent holder may ask for a royalty from you because your liver is “using” a patented gene. The cDNA copies of genes that form the basis for human gene patenting are “made by man” and not products of nature because they do not exist in nature prior to being synthesized in a test tube by a scientist.”
Supporters of gene patenting say gene function is not obvious and that genes are not mere discoveries because the genes are patented together with inventive descriptions of how they can be used for diagnosis or therapy.
“Crichton and other critics often ask, ‘How can anyone own my genes?’ The answer is that they cannot. What someone can “own” is a DNA sequence that he or she was the first to isolate and that is useful.”
Gene sequencing is very “useful”, at criteria for patents under US law and elsewhere, as it allows the determination of the effects of genes and how they can be adapted to certain bio-medical or bio-agricultural products.“Patenting life is owning life.” Third World Network
Gene sequencing can certainly be “novel”, another criteria for patenting under USPTO rules, in the sense that it has never been done before. Certainly the knowledge, and possibly the gene modifications can be entirely new.
Gene sequencing can certainly be “non-obvious”, one more US Patenting and Trade Office rule for patents, which means that no other individual skilled in the field could have necessarily easily performed the discovery. This is evidenced by the great investments and technologies that must be used to sequence any gene.
Biodiversity of this planet is the common heritage of humankind. Living organisms are no one’s inventions and therefore never be patented and put under private control. Living organisms should not be placed on the same level as human technnical inventions. Patents may make access to genetic resources more difficult and in some cases block that access altogether.
The very definition of patents suggests that it is related to invention rather than discovery. Opponents of gene patenting argue that genes are pure discoveries, rather than inventions. They also point out that with modern automated gene analysis techniques, the non-obviousness of genes is becoming doubtful.
“whilst I create my carburettor out of materials that have nothing to do with delivering measured amounts of petroleum, I introduce genes or traits into an organism only if they already exist as such in another organism or organisms. Can I patent a car because I fit it with a different kind of carburettor from another car? Therefore breeding and genetic engineering reorganise something existing; they do not create anything de novo. Considering achievements in reorganising as if they were inventions, is a distortion of meaning, with the aim of distorting reality. This distortion is made for a specific purpose, for controlling living things in the same way as one can control machines one has invented.”
Ségolène Aymé, a medical geneticist at the French National Institute for Health and Medical Research in Paris and head of the PPPC, told The Scientist: “What is patentable is the inventive process — if you can describe how to use a gene for a specific purpose — but not the gene itself.”
“I argue that the genome is a commons. There are parts of the world that cannot be owned in any practical sense. Radio spectra are my favorite example. There’s no way to exert ownership over a particular band. […] I argue that genes […] are simply unencloseable. Parents all over the world are reproducing patented genes, technically violating the patents on those genes because they haven’t sought permission and aren’t paying royalties. The idea is absurd, of course. This is why the practice is absurd. Unmodified genes simply cannot be owned, nor should they be.”
“If we use the determination of the nucleic acid sequence constituting a gene as a criterion for patenting, and I understand that this is the case, how would we know that the sequence is unique to the organism being patented? The number of species on earth is estimated to be 10 to 60 million. So far, we know the nucleic acid sequences of all the genes only for one species, the bacterium Escherschia coli. Assuming that the patenting of a nucleic acid sequence can be allowed only if it is new to life, which would make it a genuine invention, could we ever be certain that a nucleic acid sequence which we find in an organism is really new to life? Obviously not. If we allow patenting for a mere determination of nucleic acid sequences, how will we cope with the sequences which are the same but are in different species?”
“In the noise and misinformation about gene patents, basic, common-sense principles are lost. These principles have supported the patent system for over 200 years and have contributed to the technological greatness of this nation and to the benefits that technology brings to humankind. They bear repeating. The inventor brings something new to the world. The patent provides the incentive to bring it to market. And new biomedical and agricultural products improve the human condition.”
“There is little evidence that the problem exists. There is lots of social angst, but no good data showing a widespread patent thicket/anti-commons phenomenon. A large 2007 study by the American Association for the Advancement of Science found “very little evidence of an ‘anticommons problem.’” A 2005 study done for the National Academy of Sciences found only 1 percent of the scientists surveyed reported suffering a project delay of more than 1 month due to patents.”
“It is also not a monopoly, even though the right extends to a class of things, because a monopoly is defined by market power. As many a disappointed inventor well knows, having a patent is no guarantee of commercial success. Quite simply, a patent is granted to provide the inventor and/or his company or investors the incentive to undertake the costly and risky process of further development and commercialization. They will do so because they can charge enough for the product to recover their investment. […] In return, the public gets the invention, but not for free. What it gets for free is the new technical knowledge to build on because the patent must disclose how to make and how to use the invention in terms that a person skilled in that technology can understand. And, after the patent expires, the public even gets the invention for free.”
“The invention must be described in a manner to enable other people skilled in that technology to make and use it. This permits others in the field to build on the new knowledge. Finally, the invention must be clearly claimed so that the public knows the scope of the limited property right.”
Advocates for gene patents put for ward the point that Gene Patents is a necessity to understand the tiniest of details of nature and its organisms through R&D.
“Myriad Genetics, owns the BRCA1 and BRCA2 genes associated with hereditary forms of breast and ovarian cancer. They also own the only currently available diagnostic test for these genes, which they sell for a little over three thousand dollars. And they control the right to allow testing and experimentation on these genes. It is no exaggeration to say that Myriad controls every facet of those genes. As a result, many women have been unable to get vital health information, and scientists have been unable to perform important research without paying large sums of money to Myriad.”
“Vital medical research aimed at developing screening methods and cures for congenital diseases is being stifled by the rush to patent human genes and the corporate use of those patents to maximise profits. A poll of American laboratory directors found that a quarter of them had received letters from lawyers acting for biotechnology companies ordering them to stop carrying out clinical tests designed to spot early warning signs for Alzheimer’s disease, breast cancer and an array of other disorders.”
“Apologists for gene patents argue that the issue is a tempest in a teapot, that patent licenses are readily available at minimal cost. That’s simply untrue. The owner of the genome for Hepatitis C is paid millions by researchers to study this disease. Not surprisingly, many other researchers choose to study something less expensive.”
U.S. District Judge Robert W. Sweet of New York ruled in November of 2009 that a case against gene patents by Myriad Genetics of Salt Lake City could proceed. This was on the basis that Gene patents grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas and basic human knowledge and thought, and that this could violate the First Amendment’s protections over freedom of thought.
“In those twenty years of a patent’s duration, any prospective research is carried out in fear of recriminations and law-suits from the patent-holder. Academic medical scientists are scared into discontinuing research lest there institution be hit by a costly law-suit from a patent holder.”
“Changing Australian law to explicitly rule out patents being applied to human genes would drive research jobs and investment dollars offshore, an expert panel says. […] The potential change, now under consideration by a Senate inquiry, also threatened to ‘bring the Australian biotech industry to its knees’, says the Institute of Patent and Trademark Attorneys of Australia (IPTA), which staged the panel event on Thursday. […] ‘It would seriously affect the biotechnology industry in that it would be difficult to attract investment in research that has commercial opportunities if it couldn’t be protected,’ IPTA councillor Trevor Davies said while at the event in Sydney.”
Genetically engineered plants and animals, such as GM maize or lab mice designed to be prone to cancer, should be patented as they help bring about invention of new medicines through research on them. This may lead to major breakthroughs in the field of medicines and other related fields in diagnosis of various diseases.
“patents to non-new discoveries [such as gene sequences] does not encourage innovation, and sitting on what are essentially laws of nature, so far upstream, actually stifles downstream innovation.”
“Most research is not done by private companies. The Human Genome Project has contributed by far the greater amount of knowledge in this area. In some cases it seems that private companies have speedily patented genes, which public scientists claim to have discovered first. The percentage of ‘Biotechnology’ firms’ budgets spent on R&D is minimal. Indeed, banning patenting actually protects the public investment into genome research which could become wasted if private companies stifle attempts to research into genes, on which they hold a patent.”
The commercialization of genes, through gene patents, creates a perverse incentive for the fast paced growth or commercial exploitation.
A naturally-occurring gene can be patented as an isolated sequence, which could mean paying the patent holders for naturally occurring genes as the species evolve.
Adversaries of Gene Patents argue that at sometime in future,advancement in Science may lead to Identical genes,leading to “Human beings” becoming merely puppets in the hands of Gene Patent holders.
The Anti-Gene Patents flock states that Gene patents could lead to Duplicity of Human Beings,which could lead to people being replaced by other people(Exactly like them) without anyone finding out.This would give rise to the most covert type of crimes.
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