PATENTING:GENE AND DNA SEQUENCE PATENTING, PATENTING TRANSGENIC

By,Pillai Aswathy viswanathPG 2 BotanySt. Thomas college kozhencherry

PATENT A patent is an exclusive right granted by a

country to the owner of an invention to make, use ,manufacture and market the invention

This right implies that no one else can make, use, manufacture and market that invention with out the consent of the patent holder

Patents represent a contract between an inventor and society.

Patents are a form of intellectual property

WHAT IS INTELLECTUAL PROPERTY? Intellectual property refers to creations of

the mind Intellectual property is divided into two

categories: Industrial Property: includes patents for inventions,

trademarks, industrial designs and geographical indications.

Copyright : covers literary works (such as novels,

poems and plays), films, music, artistic works (e.g., drawings, paintings, photographs and sculptures)etc..

Intellectual property (IP) is a legal term

Intellectual property rights are the rights given to persons over the creations of their minds.

They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.

Granting Patents A granted patent application must

include one or more claims that define the invention.

A patent may include many claims, each of which defines a specific property right.

These claims must meet relevant patentability requirements, such as novelty, usefulness, and non obviousness.

The exclusive right granted to a patentee in most countries is the right to prevent others, or at least to try to prevent others, from commercially making, using, selling, importing, or distributing a patented invention without permission.

WHAT CAN BE PATENTED? Today, patents have been granted

for a range of different biotechnological processes and products,

include: Therapeutically active

proteins Monoclonal antibodies Microorganism Transgenic organisms

Genetically altered microbes such as

bacteria , fungi, algae, viruses enzyme nucleotide sequences derived or isolated from the human body

GENE AND DNA SEQUENCE PATENTING Genes are defined as a region of DNA. A gene is a unit of heredity that is

transferred from a parent to offspring and is held to determine some characteristic of the offspring.

Human beings share mostly the same genes.

In the case of gene patents: Firstly, genes are naturally occurring,

We can't patent snow, eagles, or gravity, and we shouldn't be able to patent genes

And while much intellectual effort may have gone into discovering them within the DNA sequence

Yet by now one-fifth of the genes in our body are privately owned. 

if the genes are isolated or otherwise produced by means of technical process, they can be patented

Human DNA and nucleotide sequence may be patented when they satisfy the basic criteria of patentability

They have to be novel , inventive and industrially applicable

Novelty: A gene in a body can not be patented

Patentability of human genes is thus,limitted to artificial structure outside the human body containing the information about the human genome

Inventive step Industrial applicability:eg; therapeutic use The earliest genetic patents were issued

in 1982, following the U.S. Supreme Court case of Diamond vs. Chakrabarty, which opened the door to patenting biotechnology discoveries. 

submitted an application to the US Patent Office in 1972 for a new strain of the bacterium, Pseudomonas. The novel bacteria were intended to clean up oil spills in water by degrading the crude oil,

For example, Canavan disease is an inherited disorder that affects children starting at 3 months; they cannot crawl or walk, become paralyzed and die by adolescence.

Formerly there was no test to tell parents if they were at risk. Families enduring the heartbreak of caring for these children engaged a researcher to identify the gene, and produce a test.

Canavan families around the world donated tissues

When the gene (Mutations in the ASPA gene cause Canavan disease)was identified in 1993, the families got the commitment of a New York hospital to offer a free test to anyone who wanted it.

But the researcher's employer, Miami Children's Hospital Research Institute, patented the gene

The parents did not believe genes should be patented and so did not put their names on the patent. 

PATENTABILITY OF TRANSGENIC ORGANISM

The organism whose genetic make up is manipulated using recombinant DNA technique , is called  genetically modified organism or transgenic organism

In several countries including USA,Japan , Europe etc transgenic organism can be protected through patent

Animals and plants have been modified through breeding programmes for many centuries

Transgenic animals or plants can now breed with specific genetic characteristics ,these helps in the following way:-

1. To investigate new medicine2. Can produced therapeutic proteins3. Other techniques of genetic

engineering of an animal make possible tests of promising new cancer treatments

4. Improve the food supply as well as quality of plants

5. Disease or insect resistance plants

Both transgenic animals and plants are patentable for their production characteristic

Patenting of transgenic animals and plants is justified to prevent copying

It is not possible to patent life The patenting of transgenic animals

has been safeguarded from the ethical point of view also

Before any animal experimentation can be undertaken, licenses are required

Example: Genetic engineer Ananda Mohan

Chakrabarty, working for General Electric, had developed a bacterium 

(derived from thePseudomonas genus and now known as Pseudomonas putida)

capable of breaking down crude oil, which he proposed to use in treating oil spills.

General Electric filed a patent application for the bacterium in the United States listing Chakrabarty as the inventor,

The OncoMouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Philip Leder and Timothy A Stewart of Harvard University to carry a specific gene called an activated oncogene.

The activated oncogene significantly increases the mouse’s susceptibility to cancer, and thus makes the mouse suitable for cancer research

Glofish, The First Genetically Modified Animal To Be Sold As A Pet

ETHICS

The patenting of genes is a controversial issue in terms of bioethics

First, some believe it is unethical to patent genetic material because it treats life as a commodity.

Second, some say that living materials occur naturally, and therefore cannot be patented.

While some feel that a patent on living material is unethical, others believe that not allowing patents on biotechnological inventions would also be unethical.

Another area of controversy in genetic patenting is how gene samples are obtained.

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.

Since the evolution of patent legislation, there has been a greater input on the role of ethics in the patenting process

In europe an invention is excluded from being patented if its publication or exploitation would generally be considered immoral or other wise contrary to public order

More specifically patent legislation prohibits protection for invention in the following fields:-

1. Processes for the reproductive cloning of human beings

2. Processes for modifying the germ line genetic identity of human beings

3. Use of human embryos for industrial or commercial purpose

Patents Have Been Granted by india for different Products

A process for the preparation of an herbal therapeutic product extracted form the

pulp of a species Eugenia jambolana in 2002

A process for isolation of oligosaccharides having immuno-stimulating activity from donkey’s milk in 1998

A process for the preparation of a composition used for the detection of latent finger prints in 1996

A herbal antidiabetic drug in 1999 Genetically engineered clone of

hepatitis E virus (HEV) gnome which is infectious, its production and uses in 2000

Artificial Heart Valve in 2002 A process for the preparation of an

extract of Annona squamosa of the treatment of diabetes in 2003

Earth quake alarm in 2001

Reference Sobti R.C , Suparna pachauri,Essentials of

biotechnology,(2009) published by Ane books pvt Ltd

Erics Grace,biotechnology unzipped, (1997) ,published by universities press pvt Ltd hyderabad

From Wikipedia, the free encyclopedia Kumar H.D,Modern concepts of

biotechnology,(1998),vikas publishing house pvt

MichaelCrichton.com | Patenting Life http://www.genome.gov/19016590 http://www.bioethicsinternational.org