Gene patent

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Patent law (patents for inventions)

Overviews

Patents · History Economics · Criticism

Processes

Application · Prosecution Licensing · Infringement

Patentability

Patentable subject matter Novelty  · Utility Inventive step and non-obviousness Industrial applicability Person skilled in the art Prior art · Inventorship

By region / country

Europe Japan United States

Subject-matter

Biological patent · Gene patent Business method · Tax patent Chemical patent · Software patent

Category List of concepts

v • d • e

A gene patent is a patent on a specific gene sequence, its usage, and often its chemical composition. Other gene patents claim processes. A single patent can contain both composition of matter claims and process claims. There is controversy over whether these patents advance technology by providing scientists, companies, and universities with an incentive to create or hinder research by creating legal uncertainty over who has proprietary rights to products and processes. Some critics^[who?] also charge that the costs of licensing patents result in higher prices for genetic testing.

History

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The United States has been patenting chemical compositions based upon human extractions for over 100 years. The first patent for such a chemical was granted in 1907 for adrenaline. Insulin followed adrenaline as the second patent in 1923.^[1] 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 States alone. All pending applications are made public at 18 months after filing unless otherwise requested by the applicant.^[2]

The Supreme Court decision in Diamond v. Chakrabarty decided 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.^[2]

Criticism

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The major legal issues are themselves a great topic of controversy ^[3][4] 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^[5], the ability of multiple patents on different aspects of a single idea to be owned by many different individuals or organizations.^[6] 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 of the patents thus increasing the overall cost for the patient.

Patents can hinder the scientific process by limiting research and increasing the cost.^[7][8] They can also limit medical testing.^[9]

Moore v. Regents of the University of California involved a hairy-cell-leukemia patient, 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.

See also

• Human Genome Project

References

External links

• Open and Public Debate on Gene Patents, sponsored by the Intellectual Property Research Institute of Australia and Center for Ideas and the Economy
• The Human Genome Project information pages
• Guardian Newspaper Special Reports on the Ethics of Genetics
• Consumer Project On Technology - Biotechnology and Gene Patents
• Wired News - New Quest: Mapping Gene Patents
• The Center for the Study of Technology and Society
• Council for Responsible Genetics
• Center for Genetics and Society
• Genetics and Patenting
• The USPTO Genetic Sequence Database
• The University of Sussex PATGEN Project & Final Report