Table of Contents > Genomics > Genetics and patenting Print

Genetics and patenting

Image

Related terms
Background
Methods
Research
Implications
Limitations
Safety
Future research
Author information
Bibliography

Related Terms
  • Bioethics, DNA, DNA patenting, ethics, EST, EST patenting, expressed sequence tags, gene, gene fragments, gene therapy, human genome, human rights, intellectual property, proteins, recombinant proteins, single nucleotide polymorphisms, SNP, stem cells.

Background
  • In recent years, many great advances were made in DNA and genome research. These advances have allowed the genomes, or complete sets of genetic material, of several organisms (including humans) to be sequenced. New DNA sequences continue to be produced each day, and scientists are working to identify pieces of DNA that may be useful in research and medicine.
  • From this emerging world of genome research, the concept of "gene patenting" has arisen. A patent for an invention grants the holder exclusive property ownership rights. In the United States, patents are issued by the United States Patent and Trademark Office (USPTO). According to the USPTO, a patent holder has "the right to exclude others from making, using, offering for sale, or selling" an invention in the United States or importing such a thing into the United States.
  • There are many gene sequences that are useful in research and some have current or potential therapeutic uses. Because a patent gives its holder the sole rights to market an invention, many research groups have been motivated to patent pieces of DNA that are potentially useful or profitable.
  • More than three million patents have been filed for gene-related products in the United States alone. Most DNA patents are issues by the USPTO, the European Patent Office, or the Japanese Patent Office.
  • There is much controversy surrounding the patenting of DNA. Some of this controversy has to do with the implication that a person or organization would therefore own some aspect of a human.

Methods
  • Before 1980, one could not patent a "life form" or something that was not a human invention. Then, a Supreme Court decision stated that certain genetically engineered bacteria were able to be patented because they were not naturally occurring. Since this decision, patents may only be issued on genetic material if the specific function is known. Today, more than three million patents have been filed for gene-related products in the United States alone.
  • The ability to patent an invention under U.S. law is determined by the United States Patent and Trademark Office (USPTO) in the Department of Commerce. Outside of the United States, most patents are issued by the European Patent Office or the Japanese Patent Office.
  • Patent applications are judged on four criteria: 1) the invention must be useful, 2) novel 3) non-obvious, 4) and described in enough detail to enable someone skilled in the relevant area to use it for the stated purpose. Generally, raw products of nature are not able to be patented. A patent is considered once a DNA product is isolated, purified, or modified to produce a unique form not found in nature.
  • The USPTO has three years from the date of application to issue a patent, while the European entity has 18 months. Like all U.S. patents, patents on DNA are good for 20 years.
  • Gene patents often cover the gene sequence and the link between a gene mutation and a disease or condition. Patents may have beneficial effects on the development of new tools for diagnosing and treating diseases, but they may also have negative effects on the delivery of genetic services. Potential negative effects of DNA patents include the increased costs of genetic research and testing. Whether a patent is regarded as positive or negative may depend on how the individual patent holder manages it.
  • Patenting different parts of the same genome sequence, such as the gene fragment, the gene, and the protein, adds additional cost for other scientists who want to examine the sequence. In that case, the researcher has to pay each patent holder in order to study the sequence.
  • Gene sequences identified by various research efforts (including the Human Genome Project) have been cataloged in GenBank, a public database that is freely accessible to anyone. However, GenBank does not indicate which of these sequences are patented.

Research
  • Expressed sequence tags: Since the complete mapping of the human genome in the year 2000, patent applications have surged. Many of these applications were filed for sequences called expressed sequence tags (ESTs), which are small portions of a gene that can be used to identify unknown genes and locate them in a genome.
  • EST patenting has caused controversy among scientists, many of whom think that granting patents at this early stage in research of a gene is inappropriate. It is also not possible to know the function and use of genes from ESTs, information that is central to a patent application.
  • Gene fragments: The United States Patent and Trademark Office (USPTO) has issued a few patents for gene fragments, although the full sequences and functions of these fragments are not known. Since 2001, the USPTO has required that "specific and substantial utility that is credible" is provided before patents may be considered for gene fragments. This has raised questions regarding the point in time, from the discovery of a gene fragment to the development of information gained into useful products, one can claim exclusive rights to a gene.
  • Gene tests: As the functions of various genes are determined, gene tests are developed to screen for their presence. A sample from any body tissue, including blood or body fluids, may be taken to analyze a person's DNA for genetic abnormalities. There are different types of DNA tests. Some involve DNA probes that are complementary to mutated genetic sequences. These probes are added to the person's DNA sample, and if the patient has a genetic mutation, the probe binds to it, signally a genetic abnormality. Another type of DNA test compares the patient's DNA sequence to a healthy version of the gene.
  • These tests are generally patented and licensed by the patent owners. Royalties are paid to the patent holder each time the test is administered. Only licensed entities, such as diagnostic companies, may conduct the tests. Some people fear that this may cause genetic testing to become prohibitively expensive, such that the costs prevent the potential benefits from reaching patients. However, proponents of patenting cite it as a means of recouping significant money spent on research and development.
  • Single nucleotide polymorphisms (SNPs): DNA is made up of four nucleotides (A, T, C, and G) and the order in which these nucleotides appear is the "sequence" of the DNA. Single nucleotide polymorphisms (SNPs) are single-nucleotide variations in DNA sequences. Many SNPs in genes or the regions of genes that regulate activity do not affect gene function, but some may predispose people to disease or affect the way people respond to a chemical or a drug. SNPs are valuable because they may eventually help scientists predict how people will respond to various drugs and/or know what diseases they are likely to develop. A non-profit organization, named the UK Wellcome Trust, found and mapped 1.8 million common SNPs. The organization patented the SNPs in order to make them publicly available.
  • Proteins: Genes essentially contain the genetic code for performing various biological functions, including the instructions for making proteins. Proteins perform many functions in the cell, such as protecting the body from pathogens or repairing tissue after an injury. Scientists are able to isolate certain genes and use them in the laboratory to make synthetic proteins or "recombinant" proteins. These can be used in research or in therapy.
  • For example, some researchers have patented a protein that has much greater activity than regular insulin. Some people with diabetes must inject insulin to allow blood sugar to be used by the body. The use of this insulin product in therapy would allow patients with diabetes to use much less insulin to attain the same effect on blood sugar.
  • Applications such as this may represent financial gains for biotechnology and pharmaceutical companies.
  • Stem cells: By studying stem cells, scientists may better understand the process of embryonic development. Furthermore, stem cell research may reveal how healthy cells replace damaged cells in adult organisms. Areas of potential use for stem cells include Parkinson's disease, Alzheimer's disease, osteoarthritis, rheumatoid arthritis, diabetes, spinal cord injuries, stroke, and heart disease.
  • Several things distinguish stem cells different from other cells: they are unspecialized, that is, they are not destined to grow into a specific cell or tissue of the body. They can proliferate, or self-renew, for long periods of time. Under special circumstances, stem cells can develop into specific types of cells. This process, called differentiation, produces specialized cells, such as nerve cells and muscle cells.
  • Patents have already been issued for stem cells from monkeys and other organisms. Technically, human stem cells may be patented, but this is surrounded by much controversy. One major concern is that these patents would violate the principle against ownership of human beings.

Implications
  • Arguments for patenting: Proponents argue that when genetic information is patented, the process requires a significant amount of information to be disclosed.
  • Proponents also state that patenting protects inventions without keeping them from the public.
  • When gene-related products are patented, they may allow the industry to recoup the money invested in research and development. This financial gain may also be used to fund additional research. Because scientists are rewarded for their work, gene patenting may encourage further research.
  • Furthermore, patenting discourages duplication of work and encourages new discoveries.
  • Arguments against patenting: Many scientists are concerned that the patenting of genetic material may essentially remove knowledge from the public domain, making information unavailable.
  • Only approved applications are made public, and all pending patent applications are confidential. It is therefore not possible to know what sequences are the subjects of patent applications. Because patent applications are kept confidential until granted, other research groups may waste resources developing a similar product.
  • In addition, people who use sequences from public databases risk facing a future penalty if those sequences turn out to be patented by a private company. This can be especially complicated if a patent has been submitted by one party, a second party uses the material that is the subject of the patent application for research purposes, and then the patent is granted to the first party.
  • The patent holders may essentially develop monopolies on certain genetic materials. When a patent is granted to another party, researchers may face unanticipated licensing costs that may discourage additional investigation.
  • Opponents of gene patenting also argue that patent filings may replace journal articles as a means of public disclosure, and the body of scientific literature may decrease.
  • Another major concern is whether it is ever appropriate to allow someone to basically own all or part of another organism.

Limitations
  • Not applicable.

Safety




Future research
  • One of the main goals associated with the completely mapped human genome is the ability to analyze individual variations and provide personalized medicine. There is therefore a struggle between the need to access information and the patent system's award of exclusive rights to patent holders.
  • Some argue that the patenting of DNA is reducing access to information that could be used to increase scientific understanding and technological and medical advances.
  • Much of the future publications relevant to genetics and patenting will likely discuss the balance between these two perspectives and what ultimately will be most beneficial.
  • It remains to be seen whether researchers will continue to publish their scientific findings in peer-reviewed journals or to simply file patents to secure exclusive rights to genetic information.

Author information
  • This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Bibliography
  1. Brody B. Intellectual property and biotechnology: the European debate. Kennedy Inst Ethics J. 2007;17(2):69-110.
  2. Caulfield T, Bubela T, Murdoch CJ. Myriad and the mass media: the covering of a gene patent controversy. Genet Med. 2007;9(12):850-855.
  3. Dutfield G. DNA patenting: implications for public health research. Bull World Health Organ. 2006;85(5):388-392.
  4. Human Genome Project Information (NHGRI).
  5. Matthijs G, Hodgson S. The impact of patenting on DNA diagnostic practice. Clin Med. 2008;8(1):58-60.
  6. Merz JF, Cho MK. What are gene patents and why are people worried about them? Community Genet. 2005;8(4):203-208.
  7. Natural Standard: The Authority on Integrative Medicine. .
  8. Nunnally AC, Webster CJ, Brown SA, et al. Genetic patent protection in the pharmaceutical and biotechnology industries. Community Genet. 2005;8(4):209-216.
  9. Solomon LM, Sieczkiewicz GJ. Impact of the US patent system on the promise of personalized medicine. Gend Med. 2007;4(3):187-192.
  10. United States Patent and Trademark Office (USPTO). .

Copyright © 2011 Natural Standard (www.naturalstandard.com)


The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

Search Site