AuthorJeffrey Lehman, Shirelle Phelps

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Rights, granted to inventors by the federal government, pursuant to its power under Article I, Section 8, Clause 8, of the U.S. Constitution, that permit them to exclude others from making, using, or selling an invention for a definite, or restricted, period of time.

The U.S. patent system is designed to encourage inventions that are useful to society by granting inventors the absolute right to exclude all others from using or profiting from their invention for a limited time, in exchange for disclosing the details of the invention to the public. Once a patent has expired, the public then has the right to make, use, or sell the invention.

Once a patent is granted, it is regarded as the PERSONAL PROPERTY of the inventor. An inventor's property rights in an invention itself are freely transferable and assignable. Often employees who invent something in the course and scope of their employment transfer and assign their property rights in the invention to

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their employer. In addition, a patent holder, or patentee, can grant a license to another to use the invention in exchange for payment or a royalty.

Inventors are not required to participate in the patent system, and they can elect instead to try to keep their invention a trade secret. However, if the inventor begins to sell his or her invention or allows the public to use it, others can study the invention and create impostor products. If this happens, the original inventor has no protection because he or she did not obtain a patent.

There are three types of patents: (1) design patents, (2) plant patents, and (3) utility patents. Design patents are granted to protect a unique appearance or design of an article of manufacture, whether it is surface ornamentation or the overall configuration of an object. Plant patents are granted for the invention and asexual reproduction of a new and distinct variety of plant, including mutants and hybrids. Utility patents are perhaps the most familiar, applying to machines, chemicals, and processes.

Governing Laws

Patent law in the United States is based upon statutes located in Title 35 of the U.S. Code, including the Patent Act of 1952. The rules of the PATENT AND TRADEMARK OFFICE, found in Title 37 of the CODE OF FEDERAL REGULATIONS, provide additional authority. In addition, the GENERAL AGREEMENT ON TARIFFS AND TRADE (GATT) has led to significant changes in U.S. patent law that are designed to bring some aspects of U.S. law into conformity with those of the country's trading partners. The GATT Implementation Act was signed into law in 1994, and those of its provisions that impact U.S. patent law began to take effect in 1995.

Patent Duration

One important change in U.S. patent law resulting from GATT is the duration of U.S. patents. Patents were originally given 14-year terms from the date of issue, until that was changed in 1861. From 1861 until the implementation of GATT, the term of a patent was 17 years from the date of issue. Under GATT, all patents issued after June 7, 1995, have a term of 20 years from the effective filing date. GATT contained a retroactive component which provided that all patents that had been issued, but not yet expired, as of June 7, 1995, would have a term that is the longer of 20 years from its effective filing date or 17 years from the date of issue. The effective filing date is the date on which the earliest U.S. application is filed under which priority is claimed. In the United States, patent rights begin when the patent is issued.

Upon expiration of the term, the invention becomes public property and is freely available for use, reproduction, or sale. Patents can be extended for up to five years under limited circumstances, including interference proceedings (proceedings to determine the priority of an invention), secrecy orders, and appellate review.

Patentable Inventions

The Patent Act provides a broad definition of what can be patented: any new or useful process, machine, manufacture, composition of matter, or any new and useful improvement thereof. Although these categories of patentable subject matter are broad, they are also exclusive, and any item that does not fall into one of them is not patentable.

As defined by the Patent Act, a process is a method of treating certain material to produce a specific physical change in the character or quality of that material. A machine is a device that uses energy to get work done. The term manufacture refers to a process whereby an article is made by the art or industry of people. A composition of matter is a compound produced from the combination of two or more specific ingredients that has properties different from, or in addition to, those separately possessed by each ingredient.

An improvement is any addition to, or alteration in, a known process, machine, manufacture, or composition that produces a useful result. The right to a patent of an improvement is restricted to the improvement itself and does not include the process, machine, or article improved.

Naturally occurring substances, such as a type of bacteria or an element, are not patentable. But a genetically engineered bacterium is patentable. The law of gravity and other laws of nature are not patentable. Other abstract principles, fundamental truths, calculation methods, mathematical algorithms, computer programs, and bookkeeping systems are not patentable. Ideas, mental theories, or plans of action alone, without concrete means to implement them, are not patentable, irrespective of how revolutionary and useful to humanity they might be.

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Is the Human Genome Patentable?

Deoxyribonucleic acid (DNA) is often called the "blueprint of life." Between 1980 and the early 2000s efforts were made to patent the human genome, which contains the entire genetic code for the human species. These efforts have generated controversy, especially between members of the scientific and religious communities. In 1980 the U.S. Supreme Court contributed to the controversy by ruling that live, human-made microorganisms are patentable subject matter under the federal Patent Act. Applying the Supreme Court's ruling to the human species, the U.S. PATENT AND TRADEMARK OFFICE (USPTO) extended patent protection to isolated and purified strands of the human genome.

The U.S. Constitution gives Congress the power to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." U.S.C.A. Const. Art. I Section 8, Clause 8. Pursuant to this authority, Congress enacted the Patent Act of 1952. July 19, 1952, c. 950, 66 Stat. 797. Section 101 of that act allows a patent to be obtained by anyone who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." 35 U.S.C.A. 101. Congress also created the USPTO to issue patents.

A patent is like a legally protected MONOPOLY over a specific INTELLECTUAL PROPERTY. Patents grant inventors the exclusive right to make, use, or sell their inventions for a period of 20 years. 35 U.S.C.A. 154. Patent holders can prevent anyone else from using their invention, even someone who innocently infringes on the patent holder's intellectual property rights by subsequently developing the same invention independently. Alternatively, patent holders can require that subsequent users pay licensing fees, ROYALTIES, and other forms of compensation for the right to make commercial use of an invention. In exchange for this broad, exclusive right over an invention, patent holders must disclose their invention to the public in terms that are sufficient to allow others in the same field to make use of it. 35 U.S.C.A. 112.

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 as 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 three years to issue a patent.

As of 2003 over 3 million genome-related patent applications have been filed. U.S. patent applications are confidential until a patent is issued. The human genome represents a biological map of the DNA in a body's cells. The human body is made up of roughly 1 trillion cells. Every cell contains 23 pairs of chromosomes, and each chromosome houses a single DNA molecule. The chief DNA task is to provide cells with instructions for building...

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