BTECH 511 Ethical Issues in Life Sciences

Patenting Organisms

16.05.2013

Damla Taykoz 2020110077

What is Patenting?
A 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 public inspection).

Definition by dictionary
http://www.thefreedictionary.com/patenting

patent originates

Biological patent

Biological patent is a patent relating to an invention or discovery in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things.

http://www.isisinnovation.com/news/articles/Patentsin21stCentury.html

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 patent system added the fuel of interest to the fire of genius.

http://www.whitehouse.gov

Patents on microorganisms, such as bakers yeast, were already granted in the 19th century; however, only at the end of the 20th century, with the rise of genetic engineering, was patent law applied more broadly to living organisms. Today, genetically modified microorganisms, plants and animals are patentable, including the US, Japan and Europe. Still, there are many rejections to the concept of patents on life.

http://www.za.all.biz/bakers-compressed-yeast-g4467#!prettyPhoto

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
www.sciencetweets.eu http://www.ibbl.lu

www.sciencedaily.com

Patenting Organisations
Japan Patent Office (JPO)

United States Patent and Trademark Office (USPTO)

Israeli Patent Office African Regional Intellectual Property Organization (ARIPO) The European Patent Convention (EPC)
www.patentdocs.org

www.meti.go.jp

www.eforpatent.com

For inventions in the medical and biotechnological area, a number of specific provisions exist. Plant and animal varieties and essentially biological processes for the production of plants and animals (Art. 53(b) EPC) and methods for treatment of the human or animal body by therapy or surgery and diagnostic methods practised on the human or animal body (Art. 53(c) EPC) are excluded from patentability. Based on older European patent law traditions, inventions, the commercial exploitation of which would be contrary to ordre public or morality are also excluded from patentability

www.patentdocs.org

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 or produced 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.

Futhermore examples
The European Patent Office (EPO) defines totipotency as the capability of the cell to differentiate into all somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extraembryonic tissues such as the placenta European Commission and UK Patent Office, which stated that human totipotent cells have the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from patentability. The Patent Office will therefore not grant patents for human totipotent cells The exclusion from patentability should obviously be justifiable for human totipotent cells that are created by natural process of fertilization whether located inside the human body or isolated from the human body. Conversely, the exclusion from patentability is probably not justifiable for human totipotent cells that are produced outside the human body by other techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself

www.sciencecases.org European Patent Office. Note under C12N5/06 of the European Patent Classification Directive 98/44/EC of 6 July 1998 of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions; 1998; OJ (L 213).

Futhermore examples

There are many unresolved legal and practical implications of the ethical issues when someone improves upon a variety that another has developed. An example is XA21 gene in rice. This gene is coding an important disease resistance, and based on earlier research by the International Rice Research Institute and its partners in India and Mali, have been patented by the University of California, Davis. After long negotiation University in Davis released the patent for development purposes and even did developed a benefit share mechanism for profits derived from the commercial use of the patent.

www.flickr.com

The ocial goal of the patent system is to protect a particular type of intellectual property, namely technological inventions. A patent grants to its holder the exclusive right to turn the invention into money, provided that its exploitation does not contradict any law or legal regulations.

Are human organisms patentable subject matter under the terms of the US Patent Code, as interpreted by the courts? The ethical question is: should they be?
The question of patenting human life involves many complicated questions about what a human organism is 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 route to the issue of the patenting of human life, itself a significant ethical concern. In other words, there is some real importance to this issue in itself-there is a moral aspect unique to the matter of the patenting of human life.
A change in the patent law excluding human organisms from patentability would, therefore, need to be carefully crafted so as not to take in too much or too little and not to unduly burden the biotech industry.

Conclusion
It is generally believed that patents are an important catalyst for biotechnology research and product development. Biotechnology uses living organisms or parts of organisms to create products and processes that are useful to society. The contributions of biotechnology are already visible in agriculture, food technology, law enforcement and medicine, etc.

Social and ethical issues require careful analysis and debate in order to evaluate and, possibly, to reform the basis for the issuing life form patents. Bioethics combines risk assessment, the concept of avoiding harm, with an assessment of benefits, the concept of doing good or beneficence.

Bibliography
Berthold Rutz, From bench to market: Life science patents in Europe, Biotechnol. J., 7, 171175, 2012 Hans Radder, Exploiting abstract possibilities: a critique of the concept and practice of product patenting, Journal of Agricultural and Environmental Ethics, 17: 275291, 2004 Jess M. Arrieta, Sophie Arnaud-Haond, and Carlos M. Duarte, What lies underneath: Conserving the oceans genetic resources, PNAS, 107 (43), 1831818324, 2010 Katja Triller Vrtovec, Bojan Vrtovec, Commentary: Is Totipotency of a Human Cell a Sufficient Reason to Exclude Its Patentability Under the European Law?, Stemcells; 25:30263028, 2007 Kosana KONSTANTINOV, Sneana MLADENOVIC DRINIC, Violeta ANDELKOVIC and Milosav BABIC, Ethics in scientific results application: gene and life forms patenting, Genetica, 42 (1),195 208, 2010 Susan J. Friedman, Patenting Life: Issues and Controversies, Washington State Bar Association Animal Law Section Newletter, 1 (3), Fall 2003 The ethics of patenting DNA a discussion paper, ISBN 1 904384 02 1 July 2002 http://bioethics.georgetown.edu/pcbe/background/workpaper8.html