Although isolating the gene from other genetic material renders the gene "made by man," various other requirements must be met in order to gain patent protection. For example, in order to be patentable the gene must have a substantial and credible use. Thus, a patent on a gene would not be allowed if the only use described in the patent application was for the use of the gene in some area that was totally unrelated to the function of genetic sequence.
Patents may be obtained for specific DNA sequence information as well as for RNA and amino acid sequences, and for the use of these sequences in various methods. For example, some patents are directed to the use of genetic information in tests to diagnose disease or in test compounds that might be useful to fight disease. Other "methods" patents include the use of the genetic information for tests to identify people with a predisposition to acquiring a certain disease. Other patents are directed toward gene therapy to replace defective genes.
Patent laws apply to gene patents in the same way that they apply to mechanical inventions. In the United States, there is a "first to invent" standard that must be met. This standard means that whoever first invents, discovers, purifies, or isolates a gene is entitled to all patent rights arising from that invention. The law specifies that the invention must have been made by the individual submitting the application. It also requires that the genetic information be "novel." This means that it cannot have been described in a printed publication more than one year prior to the filing of the patent application. Further, the genetic information cannot have been known or used by someone other than the inventor more than one year prior to the invention by the person who has filed the patent application. If the gene is newly described and has not been publicly disclosed, the novelty requirement is usually easily met. Unlike the United States, however, most countries do not have a one-year grace period between the disclosure of the gene and the filing of a patent application. In those countries it is therefore much more difficult to meet patent law requirements.
To qualify as patentable, genetic information must also be "unobvious." This means that the gene cannot be an obvious modification of something that is already known. It is usually easy to meet this requirement when DNA, RNA, or amino acid sequences are involved. However, complications sometimes arise when variants of the genetic information are already known.
The patent application must also provide a description of the "best mode" contemplated for making and using the gene. In addition, there are "written description" and "enablement" requirements. These requirements mean that the application must include a description of the gene, its function, and use that is sufficiently thorough to enable someone "skilled in the art" to reproduce the invention. In some cases, meeting the enablement requirement requires that the inventor provide a deposit of the biological material that is being patented. For example, an applicant seeking to patent genes produced using recombinant DNA technology would have to provide a sample of the genes to a biological materials patent depository, and would have to guarantee that the material will be available for the life of the patent.