The exclusion on patenting plant varieties is largely supplanted by the Plant Varieties and Seeds Act , under which plant breeders can obtain a form of protection giving them a monopolistic right to produce new plants for up to 25 years from registration. As well as the specific exclusion for new plant and animal variations, there is provision contained in the same section of the Patents Act preventing the patenting of inventions that would be expected to encourage offensive, immoral or antisocial behaviour.
It would, for instance, be applied if someone were to seek to patent a means of making explosives undetectable by X-rays or sniffer dogs. This provision was unsuccessfully cited by those opposing patents in the Oncomouse and weedkiller cases on the basis that they would encourage cruelty to animals and indiscriminate crop-spraying respectively. This exclusion will not be affected if the European law is implemented, and it could be applied in respect of patent applications that are an affront to public opinion as well as those that are physically harmful.
The exclusion will be relied on by opponents of cloning when the worldwide patent application in respect of Dolly the Sheep is eventually considered by the World Intellectual Property Organisation.
If Watson can harness public opinion behind an argument that to patent parts of the human body is inherently immoral, this could yet frustrate the patenting of genes. Richard Colbey is a barrister. This is the fourth in a short series of articles on intellectual property rights. Prior to this ruling, more than 4, human genes were patented. The Supreme Court's decision invalidated those gene patents, making the genes accessible for research and for commercial genetic testing.
The Supreme Court's ruling did allow that DNA manipulated in a lab is eligible to be patented because DNA sequences altered by humans are not found in nature. This synthetic DNA is produced from the molecule that serves as the instructions for making proteins called messenger RNA. Other chapters in Help Me Understand Genetics. 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. While patenting DNA runs the risk of diminishing respect for human dignity, some risk might be acceptable if the end result were an increase in human well-being. Most people in the biotechnology industry start with this understanding and proceed to the instrumental ethical question: If the goal is to improve human health by the creation of diagnostics and therapeutics, does the patent system help to achieve that goal?
There was almost universal agreement among lawyers and biotech professionals at the conference that some form of intellectual property protection was necessary to encourage investment in the development of new drugs. Investors will not put money into a company without evidence that the firm has secured protection for its intellectual property, Sue Markland Day, president of the Bay Area Bioscience Center, argued.
As an example, she cited the plunge in biotech stock prices when Former President Bill Clinton and British Prime Minister Tony Blair issued a joint statement March 14, , which was interpreted to advocate limits on gene patenting. That does not mean that people in the biotech industry want to ignore the ethical dimension of gene patenting, simply that their ethical questions tend to be not "Whether to?
Kreiner was referring to the guidelines for patentability and how they are applied to biotechnology. There are three key criteria in this regard: novelty, inventiveness, and usefulness.
As the United States and other signatories to the Agreement on Trade-Related Aspects of Intellectual Property Rights TRIPS evaluate whether to grant patents on gene sequences, they must decide whether to apply these standards stringently that is, to set the bar high or loosely to set the bar low. A high bar might require, for example, that applicants state the specific utility of a sequence and include evidence that the gene actually does what the applicant claims.
A low bar might allow applications to rest on the theoretical possibility that a gene might have a certain utility. The issue is complicated by the fact that the science is in such rapid flux.
The discovery of a sequence that might have represented considerable novelty and inventiveness in the s-such as the connection of the BRCA1 gene with breast cancer-might be less impressive now that technology has made it much easier to identify disease susceptibility genes. Another complication has to do with the scope of the patents.
Many applications have been filed for fragments of genes-ESTs and SNPs-and it is unclear whether patents on these fragments extend to uses of the entire gene. These were among the issues that troubled Stanford's Barton, who was a member of the roundtable that produced the Nuffield Council on Bioethics report on the ethics of patenting DNA.
That roundtable concluded:. In general, the law has, in our view, tended to be generous in granting patents in relation to DNA sequences. Not only are many of the patents broad in scope, but they have been granted when the criteria for inventiveness and utility were weakly applied. Many of these patents are broad because an inventor who successfully makes a claim in relation to a DNA sequence will, in effect, obtain broad protection on all uses of the DNA, and sometimes the proteins which the DNA produces.
What does all this have to do with ethics? If the bar for patentability is set too low, it will pervert the incentive structures of the patent system, which should reward new inventions that increase human well-being. Patent holders who may have contributed very little to the understanding of the gene or its function will have too much control over its use in research and development. Especially in the area of genetics, where more than one gene may control a disease process, a company that wants to develop therapeutics may need to buy licenses from multiple patent holders.
That, Kreiner argued, could make research prohibitively expensive. If the bar is set too high, on the other hand, pharmaceutical and biotechnology companies will not put the vast sums necessary into research because they will have no way of protecting their investment. Proper setting of the bar may promote the creation of therapeutics that have the potential to improve human lives. But the ethical story does not end there.
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