Genetics Home Reference has merged with MedlinePlus. Learn more. The information on this site should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health. Can genes be patented? From Genetics Home Reference. Topics in the Genetic Testing chapter What is genetic testing? What are the different types of genetic tests?
The review found that Among the articles published in GCCCJ indexed journals, 11 articles were supportive of gene patents, while eight articles were against and four provided a neutral perspective.
For the articles that supported gene patenting, On the contrary, of the four articles authored by ethics scholars, three articles objected to the patenting of human genes, and one article did not express an explicit opinion. Only two articles contributed by the legal profession argued against gene patents. When discussing issues related to the patenting of human genes in the Chinese context, 41 articles expressed their opinions on whether China should recognize gene patents.
Among these articles, overwhelmingly, The positive claims were formed based on various considerations. In addition to the claim that patent systems can promote inventions and protect inventors discussed or mentioned in 32 articles , researchers also provided other arguments in support of gene patents, e. In contrast, only 9. Finally, The proposed legal and policy recommendations can be summarized into four categories: 1 improvements in the standards for granting a gene patent; 2 increased concerns for the protection of human rights in the gene patent system; 3 protection of the interests of providers of genetic resources, and 4 establishment of a patent pool.
The most commonly proposed suggestion was to increase the importance of the standard for practical applicability in the assessment of gene patent applications, which was suggested in 12 articles.
In addition, nine articles argued that the gene patent regime should protect the interests of the providers of human genetic resources, insisting that providers should be able to use the patented genes for free. One article suggested that a mandatory licensing mechanism be implemented in situations that involve public health and policy. The finding of this study indicates that debates about human gene patents have captured the attention of Chinese scholars, and that discussions have explored important issues associated with the patenting of human genes, e.
It is noteworthy that the gene patent controversy, though, primarily a matter of legal issues, has drawn considerable contributions from disciplines other than the legal profession such as liberal arts, health sciences, and, in particular, related government departments, i.
The wide-ranging participation in the debate indicates the complex nature of the issue. At the same time, it also demonstrates that patent protection for genes involves a variety of stakeholders in the field of genetic technology innovation and its commercialization.
Chinese scholars have contributed relatively balanced analyses of both benefits and risks associated with gene patents. However, they have been overwhelmingly in favor of the patenting of human genes in China.
Some of the cited benefits and reasons for supporting a Chinese patent regime for genes are commonly mentioned in the western literature when discussing patent protection for human genes, e. Nonetheless, some of the arguments made by Chinese scholars are unique and consider the relationship between developing countries, such as China, and developed countries.
For example, a frequently raised rationale is that a patent regime can help to protect the genetic resources of developing countries. These articles warned of the possibility that developed countries would use up Chinese genetic resources if a functional patent mechanism is not put in place.
According to Chinese scholars, developing countries, in general, are rich in genetic resources but weak in technological research and development, while developed countries possess advanced technologies but with limited genetic resources. As a result, if developing countries do not have patent protection for human genes, developed countries can deprive China of its genetic resources easily and freely. This finding is consistent with research by Chen et al. Their study indicates that a few incidents of bio-piracy that occurred in the late s had alerted the Chinese government and heavily impacted later regulatory measures regarding genetic research and development in China [ 24 ].
In this regard, many Chinese scholars hope that using patent protection will prevent developed countries from free access to the Chinese genetic resources.
For instance, before the Guidelines , when the patentability for gene patents was not clear, articles commonly encouraged recognitions of patentability of human genes by emphasizing the standard of practical application, one of the requirements when considering an approval for a gene patent under the Patent Law of the PRC. After , scholars began to argue for a more rigorous examination of the practical applicability of the genes so as to limit the scope of gene patents. Such claims have been increasingly prominent in the article published after This study explored the Chinese academic articles coverage of human gene patents.
As such, this paper explores the background of the author s , benefits and risks associated with gene patents, reasons for and against the gene patent regime and the patentability of human genes, as well as the suggestions for improving Chinese IP system for the patenting of genes.
This study indicates that the development of genetic technology has been considered an important component of Chinese national economic development. Chinese academic scholars have engaged in the debate over human gene patents, and the majority of their published academic articles are supportive of the patenting of human genes in China.
In general, Chinese scholars view a patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China.
In this regard, the patent regime has been accepted as a pipeline to develop the national economy and occupy genetic resources. The instrumentalism of the patent regime is so favored that even the risks and benefits of gene patents have been discussed by Chinese scholars in a balanced manner, yet they still prefer to support a gene patent system in China. Routine use of microbial whole genome sequencing in diagnostic and public health microbiology. Google Scholar. Chen J. The Chinese market for DNA sequencing.
BCC Research. Accessed 31 Jan Cyranoski D. Article Google Scholar. Holman CM. This is clearly not a desirable outcome for society because it means we fail to protect vulnerable people who fear they have an illness from exploitation.
Not only does it prevent monitoring of whether internal processes are producing the correct result, it disallows people from seeking a second opinion. The decision of the High Court of Australia to uphold its previous decision now puts Australia out of step with the US Supreme Court and raises the question of just how much knowledge it has on matters it does not routinely deal with.
But what it means for Australia is probably very little; the current patent held by Myriad Genetics will expire within a relatively short period of time. Portsmouth Climate Festival — Portsmouth, Portsmouth. Edition: Available editions United Kingdom. Become an author Sign up as a reader Sign in. Most of these substances were the subjects of costly, protracted legal battles over patent rights.
Genetic mutations can confer an inherited increased risk of cancer and other diseases. Patents are held on individual genes, their mutations, and on the tests developed to screen for the mutations.
These patents have incited among the loudest and most widespread outcries against gene patenting. The controversy includes concern that monopolies on genetic tests make their prices unacceptably high and that these monopolies may reduce incentives to correct flaws in the tests or to adopt new technologies. The most widely known gene patent controversy is the scientific and public furor that erupted over patenting BRCA1 and BRCA2, genes that affect the risk of cancer.
Myriad Genetics, a company in Utah, secured the patents to the genes, their mutations, and the screenings tests. These letters, many sent in , triggered outrage by researchers, doctors, breast cancer advocates, and governments. In effect, the Canadian patents are being ignored.
A BRCA2 patent was then granted to the Cancer Research Campaign, a cancer research charity in the United Kingdom, which has stated its intent to enable unrestricted access to and use of the gene. The licensee in that region is allowing nonexclusive licensing, but recent indication is that the Australian patent may be enforced. On the other hand, it is hard to attribute problems directly to patents. Genetic tests for colon cancer have no one dominant patent holder, and yet they are comparable in cost and present similar technical challenges in the form of false negatives and positives.
One of the greatest fears about gene patents is that they could inhibit scientific progress. Making genes in the laboratory is essential for many kinds of research, and restrictions on the use of patented genes would be difficult to work around.
In a case, Madey v. Duke, the Court of Appeals for the Federal Circuit made clear that academic institutions could be held liable for patent infringement even in nonprofit research. In practice, however, no research institution has been sued for studying a gene or using it in academic research.
This is partly because the patent holders stand to benefit from research that reveals how their patented genes work, and partly because of the difficulty in proving damages from mere use in research. But there has been litigation involving companies that supply transgenic animals, which incorporate patented genes and are themselves subject to patents, and companies using research tools aimed at creating commercial products and services.
One gray zone is the use of materials or processes with gene patents in clinical research, such as genetic testing in the context of a clinical trial.
Allowing too many patents for incremental inventions increases the risk of the anticommons effect.
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