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16.05.2013

BTECH 511 Ethical Issues in Life Scienc

Patenting Organisms

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What is Patenting?

Definition by dictionaryA grant made by a government that confers upon the

creator of an invention the sole right to make, use, and

sell that invention for a set period of time.The word patent originates from the Latin patere, which

means "to lay open" (i.e., to make available for publicinspection).patent originates

http://www.thefreedictionary.com/patenting

http://www.isisinnovation.com/new

Biological patent is a patent relating to an invention ordiscovery in biology. It can be a composition of matter, a

method for obtaining or using one or more thereof, or aproduct combining such things.

Biological patent

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The patent system has evolved over many centuries and has proven successful in stimulating

innovation that is of benefit to society, or as Abraham Lincoln put it:

The patentsystem added the fuel of interest to the fire of genius.

Patents on microorganisms, such as bakers yeast, were already granted in the 19th century; h

end of the 20th century, with the rise of genetic engineering, was patent law applied more b

organisms.

Today, genetically modified microorganisms, plants and animals are patentable, including thEurope. Still, there are many rejections to the concept of patents on life.

http://www.za.all.biz/bakers-com

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Examples for Patenting in Biotechnologies

o DNA and proteins

o Antibodies, antisense, RNAi

o Surgical methods

o Patient groups

o Dosage and dosage regimen

o Human embryonic stem cells

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Patenting Organisations

Japan Patent Office (JPO) United States Patent and Trademark Office (USPTO) Israeli Patent Office African Regional Intellectual Property Organization (ARIPO)

For inventions in the medical and biotechnological area, a number of specific provisions eanimal varieties and essentially biological processes for the production of plants and animals (

and methods for treatment of the human or animal body by therapy or surgery and diag

practised on the human or animal body (Art. 53(c) EPC) are excluded from patentability. B

European patent law traditions, inventions, the commercial exploitation of which would be co

public or morality are also excluded from patentability

The European Patent Convention (EPC)

www.patentdocs.org

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DNA and proteins

The EU Biotech Directive and the rules in the EPC derived

from it clearly set out that biological material (i.e. material

containing genetic information and capable of reproducing

itself or being reproduced in a biological system) is

patentable when isolated from its natural environment orproduced by means of a technical process even if it

previously occurred in nature (Rule 27(a) EPC).

Nucleic acids and proteins are patentable. This also

includes antibodies, antisense oligonucleotides, short

interfering RNA and the like.

Dosage and dosage regimen

Although methods of treatment by therapy are excluded

from patentability under the EPC, the compounds or

compositions for such use (i.e. medicaments) can be

patented.

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Futhermore examples

The European Patent Office (EPO) defines totipotency as the capability of the cell to dif

somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extraembryonic

the placenta

European Patent Office. Note under C12N5/06 of the European Patent Classification

European Commission and UK Patent Office, which stated that human totipotent cells h

to develop into an entire human body. In view of this potential, such cells are not patentahuman body at the various stages of its formation and development is excluded from p

Patent Office will therefore not grant patents for human totipotent cells

The exclusion from patentability should obviously be justifiable for human totipotent cells

by natural process of fertilization whether located inside the human body or isolated from

Conversely, the exclusion from patentability is probably not justifiable for human totipote

produced outside the human body by othertechniques which human beings alone are cainto practice and which nature is incapable of accomplishing by itself

Directive 98/44/EC of 6 July 1998 of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions; 1998; O

www.scien

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There are many unresolved legal and practical implications of the ethical issues when some

a variety that another has developed. An example is XA21 gene in rice. This gene is c

disease resistance, and based on earlier research by the International Rice Research Instit

in India and Mali, have been patented by the University of California, Davis. After long negoDavis released the patent for development purposes and even did developed a benefit sh

profits derived from the commercial use of the patent.

Futhermore examples

www.flick

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Are human organisms patentable subject matter under the terms of the US Patent C

the courts? The ethical question is: should they be?

The question of patenting human life involves many complicated questions about what

and what the patent law says about products of a patented process.

Patenting may not be the best route to the general ethical questions, but it is the only ropatenting of human life, itself a significant ethical concern. In other words, there is so

this issue in itself-there is a moral aspect unique to the matter of the patenting of huma

A change in the patent law excluding human organisms from patentability would,

carefully crafted so as not to take in too much or too little and not to unduly burden the

The official goal of the patent system is to protect a particular type of intellectu

technological inventions. A patent grants to its holder the exclusive right to turn the in

provided that its exploitation does not contradict any law or legal regulations.

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Conclusion

It is generally believed that patents are an important catalyst for biotechnology res

development. Biotechnology uses living organisms or parts of organisms to create prod

that are useful to society. The contributions of biotechnology are already visible technology, law enforcement and medicine, etc.

Social and ethical issues require careful analysis and debate in order to evaluate and, po

basis for the issuing life form patents. Bioethics combines risk assessment, the concep

with an assessment of benefits, the concept of doing good or beneficence.

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Bibliography

Susan J. Friedman, Patenting Life: Issues and Controversies, Washington State Bar

Anim al Law Sect ion Newlet ter, 1 (3), Fall 2003

The ethics of patenting DNA a discussion paper, ISBN 1 904384 02 1 July 2002

Kosana KONSTANTINOV, Sneana MLADENOVIC DRINIC, Violeta ANDELKOVIC

BABIC, Ethics in scientific results application: gene and life forms patenting, Genetica

208, 2010

Berthold Rutz, From bench to market: Life science patents in Europe, Biotechnol . J., 7,

Katja Triller Vrtovec, Bojan Vrtovec, Commentary: Is Totipotency of a Human Cell a Suff

to Exclude Its Patentability Under the European Law?, Stemcells; 25:30263028, 2007

Jess M. Arrieta, Sophie Arnaud-Haond, and Carlos M. Duarte, What lies underneath: Coceans genetic resources, PNAS, 107 (43), 1831818324, 2010

http://bioethics.georgetown.edu/pcbe/background/workpaper8.html

Hans Radder, Exploiting abstract possibilities: a critique of the concept and practice of pr

Journ al of Agricul tural and Environmental Ethics, 17: 275291, 2004