A gene patent is a patent on 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.
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. Only approved applications are made public, and all pending applications are confidential.
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.
One of the legal issues is patent stacking, the ability of multiple patents on different aspects of a single idea to be owned by many different individuals or organizations. 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 .
John Moore v. the 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.