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

“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

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:

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

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/