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What are patents, and how do they work? The patentability of inventions under U.S. law is determined by the Patent and Trademark Office (USPTO) in the Department of Commerce. A patent application is judged on four criteria. The invention must be "useful" in a practical sense (the inventor must identify some useful purpose for it), "novel" (i.e., not known or used before the filing), and "nonobvious" (i.e., not an improvement easily made by someone trained in the relevant area). The invention also must be described in sufficient detail to enable one skilled in the field to use it for the stated purpose (sometimes called the "enablement" criterion). In general, raw products of nature are not patentable. DNA products usually become patentable when they have been isolated, purified, or modified to produce a unique form not found in nature. The USPTO has 3 years to issue a patent. In Europe, the timeframe is 18 months. The USPTO is adopting a similar system. Patents are good for 20 years from filing date. In the United States, patent priority is based on the "first to invent" principle: whoever made the invention first (and can prove it) is awarded property rights for the 20-year period. Inventors have a one-year grace period to file after they publish. All other countries except the Philippines, however, follow a "first inventor to file" rule in establishing priority when granting patents. Many biotech patents have been applied for as provisional patents. This means that persons or companies filing the provisional patent application have up to one year to file their actual patent claim. The provisional patent must contain a written description of said invention and the names of the inventors. This one-year grace period does not count as one of the 20 years that the patent is issued for. When a biotechnology patent involving an altered product of nature is issued, the patent holder is required to deposit a sample of the new invention into one of the 26 worldwide culture depositories. Most DNA-related patents are issued by the USPTO, the European Patent Office, or the Japanese Patent Office. Currently over three million genome-related patent applications have been filed. U.S. patent applications are confidential until a patent is issued, so determining which sequences are the subject of patent applications is impossible. Those who use sequences from public databases today risk facing a future injunction if those sequences turn out to be patented by a private company on the basis of previously filed patent applications. Patenting Genes, Gene Fragments, SNPS, Gene Tests, Proteins, and Stem Cells In terms of genetics, inventors must Genes and Gene Fragments The 300- to 500-base gene fragments, called expressed sequence tags (ESTs), represent only 10 to 30% of the average cDNA, and the genomic genes are often 10 to 20 times larger than the cDNA. A cDNA molecule is a laboratory-made version of a gene that contains only its information-rich (exon) regions; these molecules provide a way for genome researchers to fast-forward through the genome to biologically important areas. The original chromosomal locations and biological functions of the full genes identified by ESTs are unknown in most cases. Patent applications for such gene fragments have sparked controversy among scientists, many of whom have urged the USPTO not to grant broad patents in this early stage of human genome research to applicants who have neither characterized the genes nor determined their functions and uses. In December 1999, the USPTO issued stiffer interim guidelines (made final in January 2001) stating that more usefulness—specifically how the product functions in nature—must now be shown before gene fragments are considered patentable. The new rules call for "specific and substantial utility that is credible," but some still feel the rules are too lax. The patenting of gene fragments is controversial. Some say that patenting such discoveries is inappropriate because the effort to find any given EST is small compared with the work of isolating and characterizing a gene and gene product, finding out what it does, and developing a commercial product. They feel that allowing holders of such "gatekeeper" patents to exercise undue control over the commercial fruits of genome research would be unfair. Similarly, allowing multiple patents on different parts of the same genome sequence --say on a gene fragment, the gene, and the protein-- adds undue costs to the researcher who wants to examine the sequence. Not only does the researcher have to pay each patent holder via licensing for the opportunity to study the sequence, he also has to pay his own staff to research the different patents and determine which are applicable to the area of the genome he wants to study. SNPs Variations in DNA sequence can have a major impact on how humans respond to disease; environmental insults such as bacteria, viruses, toxins, and chemicals; and drugs and other therapies. This makes SNPs of great value for biomedical research and for developing pharmaceutical products or medical diagnostics. Scientists believe SNP maps will help them identify the multiple genes associated with such complex diseases as cancer, diabetes, vascular disease, and some forms of mental illness. These associations are difficult to establish with conventional gene-hunting methods because a single altered gene may make only a small contribution to the disease. In April 1999, ten large pharmaceutical companies and the U.K. Wellcome Trust philanthropy announced the establishment of a non-profit foundation to find and map 300,000 common SNPs (they found 1.8 million). Their goal was to generate a widely accepted, high-quality, extensive, publicly available map using SNPs as markers evenly distributed throughout the human genome. The consortium planned to patent all the SNPs found but to enforce the patents only to prevent others from patenting the same information. Information found by the consortium is freely available. Gene Tests Proteins All living organisms are composed largely of proteins, which have three main cellular functions: to provide cell structure and be involved in cell signaling and cell communication functions. Enzymes are proteins. Proteins are important to researchers because they are the links between genes and pharmaceutical development. They indicate which genes are expressed or are being used. Important for understanding gene function, proteins also have unique shapes or structures. Understanding these structures and how potential pharmaceuticals will bind to them is a key element in drug design. Stem Cells Cell lines and genetically modified single-cell organisms are considered patentable material. One of the earliest cases involving the patentability of single-cell organisms was Diamond v. Chakrabarty in 1980, in which the Supreme Court ruled that genetically modified bacteria were patentable. Patents for stem cells from monkeys and other organisms already have been issued. Therefore, based on past court rulings, human embryonic stem cells are technically patentable. A lot of social and legal controversy has developed in response to the potential patentability of human stem cells. A major concern is that patents for human stem cells and human cloning techniques violate the principle against the ownership of human beings. In the U.S. patent system, patents are granted based on existing technical patent criteria. Ethical concerns have not influenced this process in the past, but, the stem cell debate may change this. It will be interesting to see how patent law regarding stem cell research will play out.(1)
Research scientists who work in public institutions often are troubled by the concept of intellectual property because their norms tell them that science will advance more rapidly if researchers enjoy free access to knowledge. By contrast, the law of intellectual property rests on an assumption that, without exclusive rights, no one will be willing to invest in research and development (R&D;). Patenting provides a strategy for protecting inventions without secrecy. A patent grants the right to exclude others from making, using, and selling the invention for a limited term, 20 years from application filing date in most of the world. To get a patent, an inventor must disclose the invention fully so as to enable others to make and use it. Within the realm of industrial research, the patent system promotes more disclosure than would occur if secrecy were the only means of excluding competitors. This is less clear in the case of public-sector research, which typically is published with or without patent protection. The argument for patenting public-sector inventions is a variation on the standard justification for patents in commercial settings. The argument is that postinvention development costs typically far exceed preinvention research outlays, and firms are unwilling to make this substantial investment without protection from competition. Patents thus facilitate transfer of technology to the private sector by providing exclusive rights to preserve the profit incentives of innovating firms. Patents are generally considered to be very positive. In the case of genetic patenting, it is the scope and number of claims that has generated controversy. What are some of the potential arguments for gene patenting?
What are some of the potential arguments against gene patenting?
What does U.S. patent policy say about gene patenting?
How does genome information placed in the public domain work? Who can use it? All genome sequence generated by the Human Genome Project has been deposited into GenBank, a public database freely accessible by anyone with a connection to the Internet. For an introduction on how to search GenBank and other nucleotide databases at the National Center of Biotechnology Information, see the Gene and Protein Database Guide and a related tutorial available at Gene Gateway, an online guide to learning about genes, proteins, and disorders. Disseminating information in the public domain encourages widespread use of information, minimizes transaction costs, and makes R&D; cheaper and faster. Of particular relevance to research science, a vigorous public domain can supply a meeting place for people, information, and ideas that might not find each other in the course of more organized, licensed encounters. Information in the public domain is accessible to users who otherwise would be priced out of the market. Related LinksPatent and Intellectual Property Organizations
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References 1. T. A. Caufield. From human genes to stem cells: new challenges for patent law? Trends in Biotechnology 21: 101-103. March 2003. Information on this page was compiled from numerous sources including but not limited to HUGO, Science, The Scientist, Gene Letter, Signals Magazine, and Human Genome News. A special thanks to Chris Dummer at Oak Ridge National Laboratory for her review and comments on this page.
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Last modified: Thursday, September 16, 2004
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