Download - Gene patenting
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ASSIGMENT ON
“GENE PATENTING”
SUBJECT: BIOETHICS
SUBMITTED BY:
Hina Zamir (04)
SUBMITTED TO: GUL-E-SAHRA
BBT 7th_ SEMESTER
CENTRE OF BIOTECHNOLOGY AND MICROBIOLOGY
UNIVERSITY OF PESHAWAR DATE: 2-JAN-2017
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“Gene patenting”
Patent:
A patent is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a
limited period of time in exchange for detailed public disclosure of an invention. An invention is
a solution to a specific technological problem and is a product or a process. Patents are a form of
intellectual property
Biological patent:
A biological patent is a patent on an invention in the field of biology that by law allows the
patent holder to exclude others from making, using, selling, or importing the protected invention
for a limited period of time.
Gene patent:
A gene patent is the exclusive rights to a specific sequence of DNA (a gene) given by a
government to the individual, organization, or corporation who claims to have first identified
the gene. Once granted a gene patent, the holder of the patent dictates how the gene can be used,
in both commercial settings, such as clinical genetic testing, and in noncommercial settings,
including research, for 20 years from the date of the patent. Gene patents have often resulted in
companies having sole ownership of genetic testing for patented genes.
History:
In June 2000, the Human Genome Project announced that the human genome was almost
completely mapped. Since then, individuals and groups, both private and public, have been
requesting patents for genes and ESTs (Expressed Sequence Tags), which are small pieces of
gene fragments.
Diamond v. Chakrabarty, 447 U.S. 303 (1980):
In 1980, U.S. Supreme Court made a decision (5 to 4) that genetically engineered bacteria were
patentable. This was based on the reason that genetically altered bacteria were not the subject of
natural occurrence. Chakrabarty’s modified bacteria were modified to dissolve oil. After
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Diamond v. Chakrabarty, USPTO started issuing patents to whole genes with known functions.
However, recent increase in requests for patents on DNA sequences that are less than a whole
gene necessitated USPTO to create guidelines on gene patenting. Finally, in January 2001,
USPTO issued guidelines, partly to stop patenting sequenced genes before finding out their
functions.
Gene Patent Purposes:
Gene patents break down generally into four categories: diagnostics, functional use, process and
compositions of matter. These patents might be on a single gene, but more often than not, they
are on a process involving genetic material or on a small strand of linked genes, and they
generally focus on the parts of genes involved in the production of proteins.
When it comes to diagnostics, gene researchers are looking to patent methods that test
for genetic differences or abnormalities. These types of patents are occasionally referred to as
disease gene patents, because they are most often associated with spotting genetic markers
involved in ailments such as cancer, Alzheimer's disease and cystic fibrosis. Things get
complicated in this category of gene patents because one gene can have many different
mutations, or one test can analyze different genes for the same disease -- and all of the different
combinations of engineered mutations and tests can be patented.
Functional use patents stem from research that discovers the roles played by various genes in
causing disease in the body or in regulating bodily functions. These patents are typically issued
for drugs which affect the functioning of genes.
Process patents are relatively self-explanatory and are used to protect a method by which genes
are extracted or manipulated. In the furor surrounding gene patenting, these types of patents are
relatively benign, as they patent a process rather than actual human genetic material.
Composition of matter patents are filed to protect "inventions" that generally stem from
combining different genetic material and are typically filed for drugs and vaccines such as
insulin and human growth hormone (HGH). This type of patent is at the heart of much of the
legal controversy surrounding genetic patents, as we'll see in the next section.
Regulations:
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General requirements:
A patent is granted upon review of an application by U.S. Patent and Trademark Office
(USPTO) in the Department of Commerce. There are four criteria for deciding whether a patent
should be given or not: usefulness, novelty, non-obviousness, and enablement. The invention
should be new or something that was not in use before. It should be something that is useful and
not easy to be invented by other people. Also, the description of the invention should allow
others who are trained in the same field to be able to use the invention for same purpose.
Requirements for gene patenting:
In order to get an approval for a gene patent, it is required that the subject of application is not a
raw product of nature. Genes or their products have to be “processed” before they become
eligible for patents. Once received a patent for their invention, the patent holders have to deposit
a sample into one of the 26 worldwide culture depositories, which are regulated by the Budapest
Treaty on International Recognition of the Deposit of Microorganisms.
Other regulations:
Currently, patents are issued within 3 years after the submission of the applications, and they are
in effect for 20 years. Patents are given to the first one who can prove their invention. A one-
year grace period is given to inventors after the publication of their invention. Many of the
biotech companies, first, file provisional patents, which allows one-year period for the claimer to
apply for the actual patent. It is important that the provisional patent includes a description of
invention and names of inventors
Ethics and Gene Patenting:
Dignity:
When the average person expresses reservations about patenting DNA, they are often reacting to
the idea of owning something fundamental to human personhood. A lawyer would probably
respond that a patent doesn't confer ownership. John Barton, professor of law at Stanford
University , described intellectual property protections as "a set of statutory exclusion rights." In
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other words, the holder of a DNA patent does not own the gene sequence; he or she simply has
the right, for a limited period of time, to prevent others from using it.
Promoting Human Health:
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?
Accessibility:
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. Sometimes, our patent policies
produce good medicines that are simply too expensive to reach all of the people who need them.
Future aspects :
There are over 3 million filed gene-patent applications right now. Because the applications are
confidential while they are being reviewed, people who use public databases for sequences can
be banned from usage in the future. Some of the upcoming legal problems include prioritizing
two patents that shares a fragment of a gene. For example, if a patent was granted for a piece of
DNA, then a person who applies for larger piece of the DNA, including the part that was already
patented, would either be needed to either obtain a license from the previous person, or be able to
apply for patent without the permission from the previous person
References: Patent. (2016, December 19). In Wikipedia, The Free Encyclopedia. Retrieved 12:30,
December 19, 2016, from https://en.wikipedia.org/w/index.php?
title=Patent&oldid=755661587
https://en.wikipedia.org/wiki/Biological_patent
ghr.nlm.nih.gov/handbook/testing/genepatents
http://science.howstuffworks.com/life/genetic/gene-patent3.htm
https://www.scu.edu/ethics/focus-areas/bioethics/resources/ethics-and-gene-patenting/
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