A gene patent is a
patenton a specific gene sequence, its usage, and often its chemical composition. There is controversy over whether these patents advance technology by providing scientists with an incentive to create or hinder research by creating a lot of red tape and fees to utilize research that is patented.
The United States has been patenting chemical compositions based upon human extractions for almost 100 years. The first patent for such a chemical was granted in 1907 for
adrenaline. Insulinfollowed adrenaline as the second patent in 1923. [Dutfield, Graham. "DNA Patenting: Implications for Public Health Research." Bulletin of the World Health Organization, May 2006, Volume 85, Issue 5.] But prior to the 1970s it was almost unheard of to submit an application to the United States Patent and Trademark Office (USPTO) for an organism. As a rule, raw natural material is generally rejected for patent approval by the USPTO.
It is only after a DNA product is isolated, purified, or modified that a patent is considered. Over three million gene related patents have been applied for in the
United Statesalone. Only approved applications are made public, and all pending applications are confidential."Genetics and Patenting", Human Genome Project Information" ( [http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml] )]
The Supreme Court decision in
Diamond v. Chakrabartydecided certain genetically engineered bacteria were patentable because they were not naturally occurring. Since this important decision, patents have been issued on genes whose function is known.
The major legal issues are themselves a great topic of controversy [ [http://becerra.house.gov/HoR/CA31/News/Press+Releases/2007/02-09-07+REPS+BECERRA+WELDON+INTRODUCE+BILL+TO+BAN+THE+PRACTICE+OF+GENE+PATENTING.html Article about the Bill to ban Gene Patenting] ] [ [http://www.nytimes.com/2007/02/13/opinion/13crichton.html Patenting Life - New York Times ] ] because there hasn't yet been a clear definition of what exactly can and cannot be patented .
One of the legal issues is patent stacking [http://genome.rtc.riken.go.jp/hgmis/publicat/hgn/v11n1/09patent.html] , the ability of multiple patents on different aspects of a single idea to be owned by many different individuals or organizations. [ [http://www.genomicglossaries.com/content/intellectual_property.asp Biopharmaceutical legal & Intellectual property glossary ] ] This alone can increase the sheer cost of using any gene therapy, or technique. The person administering the treatment technique must first get legal permission from each individual owner(s) of the patents thus increasing the overall cost for the patient.
Patents can hinder the scientific process by limiting research and increasing the cost [ [http://www.sciencemag.org/cgi/content/summary/307/5715/1566 INTELLECTUAL PROPERTY: Patents on Human Genes: An Analysis of Scope and Claims - Paradise et al. 307 (5715): 1566 - Science ] ] [ [http://www.guardian.co.uk/genes/article/0,,191864,00.html Rush to patent genes stalls cures for disease | Special reports | Guardian Unlimited ] ] .
John Moore v. the Regents of the University of Californiainvolved a hairy-cell- leukemiapatient, John Moore, and his physician (a Dr. Golde) at UCLA Medical Center. Moore underwent a splenectomy, and in 1981 a patent was awarded to others than Moore, on uses of the cell line descended from the removed organ.
Human Genome Project
* [http://genomics.energy.gov/ The Human Genome Project information pages]
* [http://www.guardian.co.uk/genes/ Guardian Newspaper Special Reports on the Ethics of Genetics]
* [http://www.cptech.org/ip/health/biotech/ Consumer Project On Technology - Biotechnology and Gene Patents]
* [http://www.wired.com/news/medtech/0,1286,42214,00.html Wired News - New Quest: Mapping Gene Patents]
* [http://www.tecsoc.org/biotech/focuspatents.htm The Center for the Study of Technology and Society]
* [http://www.gene-watch.org/ Council for Responsible Genetics]
* [http://www.genetics-and-society.org/index.asp Center for Genetics and Society]
* [http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml Genetics and Patenting]
* [http://www.stn-international.com/stndatabases/databases/usgene.html The USPTO Genetic Sequence Database]
* [http://www.sussex.ac.uk/spru/1-4-3-1-2.html The University of Sussex PATGEN Project & Final Report]
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