A patent is a legal right granted by the government that gives the patent-holder the exclusive right to manufacture and profit from an invention. While naturally occurring substances in their natural form are not patentable, a very wide range of biological materials have been the subject of patents. In 1980 the U.S. Supreme Court decision in Diamond v. Chakrabarty indicated that "anything under the sun made by man" is patentable. Under certain conditions, patent protection is available for genetic information, plants, non-human animals, bacteria, and other organisms.
For naturally occurring substances, patent protection can only be obtained if someone has changed the substance so that it is no longer the same as it is found in nature. For genes, this means that the particular gene of interest must be isolated from other genetic material, such as a chromosome. Although the Chakrabarty decision involved bacteria that were modified using recombinant DNA technology, this case has been viewed as mandating the patentability of other living organisms; nonnaturally occurring, nonhuman multicellular organisms such as transgenic animals, genetic materials, and purified biologically produced compounds such as enzymes. Other cases, such as the 1977 In re Application of Bergy and 1979's In re Kratz, have provided further support for the patentability of various biological materials, including cells, proteins, and organisms.
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.
The Patent Process
Once the patent application is filed, the application is assigned to a patent examiner, who then has the responsibility of reviewing the application and determining whether the invention is entitled to patent protection. Often, the examiner initially rejects the claims that indicate what the inventor wants to protect. This occurs when the examiner finds these claims to be too broad or unfounded. This leads to a procedure known as the "prosecution" of the application, in which the examiner and the patent attorney or patent agent attempt to resolve the problems. If they are successful, a patent will be issued; otherwise, the examiner will refuse allowance of the patent. If the patent is denied, the inventor can then either appeal the decision or simply abandon the efforts to gain patent protection.
There are various other considerations in filing for patent protection in the United States and other countries. For example, in the United States there is a "duty of candor." This means that anyone filing a patent application must provide truthful information to the examiner, along with copies of all publications and other materials that might be relevant to the examination of the application. Failure to meet these honesty requirements can result in the invalidation of patents, the disbarment of the patent attorney or patent agent involved, or both.
In addition to patent protection in the United States, many inventors apply for protection in other countries. Most countries, including Japan, Mexico, Canada, Australia, and the nations of Western Europe, recognize genes as being patentable subject matter. However, these other countries have different standards for patentability than those followed in the United States, and many do not allow patents for medical devices. Although there are some patent attorneys who are licensed to practice both in the United States and abroad, most inventors employ the services of foreign patent attorneys who are familiar with the patent laws and rules in the foreign country of interest.
see also Attorney; Biotechnology Entrepreneur; Legal Issues; Transgenic Animals.
Kamrin T. MacKnight
Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).
In re Application of Bergy, 563 F.2d 1031, 195 USPQ 344 (CCPA 1977).
In re Kratz, 592 F.2d 1169, 201 USPQ 71 (CCPA 1979).
U.S. Patent and Trademark Office. Manual of Patent Examining Procedure. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 2000.