Patented DNA
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Their remarks are available at www. I n the past two decades, there has been an explosion of innovative growth in the field of biotechnology. This growth has resulted in many new products and methodologies that are useful in agriculture, environmental biotechnology, food technology, and the diagnostics and pharmaceutical industries. Other results are new areas of research and development in genomics and bioinformatics.
Biological patent
The Human Genome Project is a global coordinated effort to characterize human genetic material and provide a complete human DNA sequence library by Even though the project is not yet complete, a vast amount of useful DNA sequence information has already been gathered, including sequences of genes and their regulatory regions and genome markers such as expressed sequence tags ESTs and single nucleotide polymorphisms SNPs 1. The United States Patent and Trademark Office USPTO recognizes that many people in the biotechnology community are concerned with the possible impact of patents granted for DNA-related inventions 2 on research and innovation in biomedical research and technology.
Some in the biotechnology community are concerned that patents on ESTs or SNPs may impede cooperation among laboratories and limit the ready availability of data and materials to researchers. Public access to such sequence data has been the subject of much debate. Several bioinformatics companies are building proprietary sequence databases.
A gene patent is the exclusive rights to a specific sequence of DNA (a gene) given by a government to the individual, organization. A biological patent is a patent on an invention in the field of biology that by law allows the This was a landmark ruling, affirming the validity of patents on naturally occurring DNA sequences. However, the U.S. Supreme Court came to the.
On the other hand, some pharmaceutical companies, as well as the National Institutes of Health NIH , are creating public databases of sequence information to ensure public access to such information. Some critics have even suggested that patents should not be granted for these new discoveries and that a new form of intellectual property protection is needed. However, in the USPTO's view, new areas of technology do not create the need for a whole new specialized patent law. In many ways, the arguments currently being used for DNA sequence technology resemble those voiced 30 to 40 years ago when polymer chemistry was an emerging technology.
At that time, people argued that if broad generic claims were granted on the building blocks of basic polymers, it would devastate the industry.
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In fact, no such disaster occurred. For example, the issuing in of a basic patent broadly claiming a vulcanizable copolymer of aliphatic mono-olefins and unsaturated bridged-ring hydrocarbons 3 did not preclude the later issuing of patents to different inventors for several copolymers of this type 4. These patents represent early examples of ethylene-propylene-diene monomer EPDM rubbers, which are highly weather- and ozone-resistant, stable to thermal aging, and have good electrical insulating properties.
These EPDM rubbers have been commercially important as components in tires, weather stripping, radiator hoses, wire insulation, impact modifiers, and roofing. EPDM copolymers were assembled from three basic building blocks that could be combined in many different ways and, as such, generic and specific claims to these copolymers are analogous to claims that may be issued to DNA inventions.
Just as the issuing of broad product claims at the early stages of this technology did not deter development of other new vulcanizable copolymers, the issuing of relatively broad claims in genomic technology should not deter inventions in genomics. Two relevant examples of this in the field of biotechnology are the polymerase chain reaction PCR and the human immunodeficiency virus HIV protease, which were patented and then widely licensed to permit the biotech industry to continue to grow and benefit from these inventions.
The same patentability analysis is conducted for every patent application, regardless of whether the application is for a computer chip, a mechanical apparatus, a pharmaceutical, or a piece of DNA. In every field of technology—whether emerging, complex, or competitive—all the conditions for patentability such as statutory subject matter utility, enablement, written description, novelty, and non-obviousness must be met before a claim is allowed 5. In applying existing patent law to DNA sequence inventions, a first area of concern is whether such inventions constitute patentable subject matter.
As DNA sequences are typically isolated and purified manufactures or compositions of matter under U. In order for DNA sequences to be distinguished from their naturally occurring counterparts, which cannot be patented, the patent application must state that the invention has been purified or isolated or is part of a recombinant molecule or is now part of a vector. This patent was issued to Chakrabarty following the Supreme Court decision, Diamond v.
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Chakrabarty 6 , in which the patentability of a living bacterium, genetically engineered to break down crude oil, was affirmed. Although some SNPs and ESTs may not directly identify genes, they may still be extremely useful and thus satisfy the utility requirement.
SNPs and ESTs may have specific utilities that are separate and distinct from the genes to which they correspond. For example, SNPs can be used to trace ancestry or parentage. ESTs can be used for chromosome identification and gene mapping. Both can be used to identify genes that contribute to predisposition to disease. Claims to DNA elements useful for forensic identification, the identification of tissue type or origin, chromosome mapping, chromosome identification, or tagging of a gene of known and useful function must fulfill the enablement requirement.
In summary, once a product is patented, that patent extends to any use, even those that have not been disclosed in the patent. In response to requests for additional clarity, the Japan Patent Office JPO set forth specific guidelines for biology-related inventions. Science 14 September Vol , Issue Because of this, patent claims limited in scope to a specific novel and nonobvious SNP or EST for example, for forensic identification would not necessarily preclude the future patenting of the corresponding full-length gene of known function discovered later. It is only with the patenting of DNA technology that some companies, particularly small ones, can raise sufficient venture capital to bring beneficial products to the marketplace or fund further research. Chakrabarty 6 , in which the patentability of a living bacterium, genetically engineered to break down crude oil, was affirmed. In the case of the Regents of the University of California v.
For any invention, enablement is satisfied when, by reading the patent application, an individual who has skill in the technology would have been able to make and use the invention as intended without undue experimentation. In fact, it is common for the patentability of DNA elements to hinge on whether sufficient information has been given to enable at least one credible or specific utility. Examples of potentially non-enabled utilities for a DNA sequence fragment include its use to locate disease-associated genes when the disease has no known genetic origin; as an antisense reagent when the corresponding protein to be suppressed is unknown; as a triplex probe to inhibit expression of a protein when the protein and its function are unknown; and to locate and identify genes of unknown utility.
An area of patent law that is still developing relates to the kind of information that must be included in the patent application of a biotechnology-related invention in order to sufficiently identify and distinguish its characteristics from other subject matter in other words, satisfaction of the written description requirement. In the case of the Regents of the University of California v. Eli Lilly 7 , the court held that in order to claim a specific DNA sequence, such as the human DNA encoding insulin, more is required than a mere statement that it is part of the invention, plus a fragment of the claimed nucleic acid, plus a reference to a potential method of isolating the entire sequence.
As a result of the Lilly case and several earlier cases 8 , the USPTO is preparing interim examination guidelines for determining compliance with the written description requirement that should be made available for public comment within the next 3 months. While some feel that a patent on living material is unethical, others [ who? Supporters of this idea suggest that patents allow the public, as well as policy makers, to hold the owner of the patent s accountable.
The Patenting of DNA | Science
They favor biological patents because they require disclosure of information to the public. Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level.
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- DPD: DNA Patent Database.
Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.
The last major ethical issue involving gene patents is how the patents are used post-issuance. A major concern [ who? The ethics of using patents to increase profits are also debated. A typical argument in favor of biotech patents is that they enable companies to earn money that the companies in turn invest in further research. Without these patents, some worry that companies would no longer have the resources or motives to perform competitive, viable biotech research.
From Wikipedia, the free encyclopedia. Biological patents in the United States. Retrieved June 14, Retrieved 10 November , from https: Myriad Misunderstanding of Parke-Davis v. Retrieved 26 Mar Annu Rev Genom Hum Genet. Myriad Genetics , U. Genomics, Ethics, and Intellectual Property. A Handbook of Best Practices.
Ethical Concerns, and the Role of Patent Law.