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INTELLECTUAL PROPERTY
Patents by their very nature limit what others can do, offering a period of exclusive rights over the invention to the patent holder in return for public disclosure of information about the patented invention so that other inventors can build on it-for example, by making a better mousetrap out of other materials. In the case of a human gene sequence, however, the "invention" is the information. Consequently, disclosure of that information does not allow others to build on it. Gene patents, especially, limit what can be done in the realm of scientific research and medical care because there are no alternatives to a patented gene in diagnosis, treatment, and research (1-4). When gene patents are granted improperly and in an overly broad manner, those problems are compounded.
U.S. patent law requires that subject matter be useful (5), novel (6), and non-obvious (7) and fulfill four basic disclosure requirements: written description, enablement, best mode, and definiteness (8). When a patent is issued, the patent holder gains the right to exclude others from making, using, selling, offering to sell, or importing the invention for 20 years (9).
Evaluating Gene Patent Claims
To gain an understanding of whether the claims contained within issued patents covering human genetic material meet the existing statutory requirements under U.S. patent law (10), we undertook a multiyear project overseen by an advisory board that included two geneticists, two consumer advocates, and the head of an organization that runs a nonprofit tissue bank.
Eleven project personnel (including lawyers, licensed members of the Patent Bar, law students, and molecular biologists) identified human gene patents that represented a range of genetic diseases-from single gene to multigene disorders, from diseases where the genetic predisposition has been identified to those where the causal nexuses are still being identified. We used the term "human gene patent" to include not only patents on complete human gene sequences, but patents that cover any human genetic material, such as mutations in a gene, or diagnostic methods that utilize human genetic material that would effectively preclude the use of that material by others. We chose genetic diseases that were subject to public attention and for which problems in gene patents could potentially have an impact on research and health care....