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Patents

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.

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 thousands of proteins that perform most of the body's essential chores. Proteins contain amino acids and enzymes that catalyze hormones, biochemical reactions, and major structural development, a process known as protein synthesis.

The legal controversy surrounding DNA patenting intensified during 1988 when Congress initiated the Human Genome Project (HGP), a 15-year, $3 billion dollar research project designed to map and sequence the entire human genome. The HGP goal is to develop diagnostic tests and treatments for more than 5,000 genetically-based diseases. A rough draft of the entire genome was completed in June 2000.

In 1995 a group of more than 200 Catholic priests, Protestant ministers, Jewish rabbis, and other religious leaders gathered in San Francisco at the annual Biotechnology Industry Organization conference to attack the laws that have allowed scientists to patent the DNA of various organisms. They argued that such laws violate the sanctity of life by unlocking divine secrets and enabling scientists to patent God's creations. Environmentalists, who assert that nature is devalued by laws enabling corporations to reduce a species and its molecules to ownership, have leveled a variation of this criticism. They raise questions about what will happen to society when its most basic notions about the distinctions between animate and inanimate objects are blurred, as human life becomes just another commodity to be bought and sold on the open market.

Some of the strongest criticism has come from the scientific community itself. Certain members of that community have argued that patenting human DNA sequences hampers the free flow of information necessary to most research projects. They contend that having to invest time in tracking down a patent holder, entering into licensing agreements, and paying royalties drives up costs, slows research, and provides disincentives for scientists to undertake research in the first place. They observe that two companies, Incyte Pharmaceuticals Inc. and Human Genome Sciences Inc., own more than half of the U.S. patents on human genetic structures, and thus can exact exorbitant fees from HEALTHCARE companies hoping to put their discoveries to use.

Proponents of DNA patenting point to the groundbreaking discoveries that have already been patented, including genetic links to breast cancer, colon cancer, multiple sclerosis, tuberculosis, diabetes, cystic fibrosis, Huntington's disease, and Alzheimer's disease. Proponents maintain that the speed at which these discoveries were made was dramatically increased by laws making them a commercially valuable, patentable invention.

FURTHER READINGS

Lyon, Jeff, and Peter Gorner. 1995. Altered Fates: The Genetic Re-Engineering of Human Life. New York: Norton.

Weissman, Gerald. 1995. Democracy and DNA: American Dreams and Medical Progress. New York: Wang and Hill.

Wilkie, Tim. 1993. Perilous Knowledge: The Human Genome Project and Its Implications.Los Angeles: Univ. of California Press.

However, the 2001 Supreme Court case J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Intern., Inc., 534 U.S. 124, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001), affirmed that newly developed plant breeds are patentable subject matter. In an opinion written by Justice CLARENCE THOMAS, the Court said that plants were patentable under the general utility patent statute. To obtain patent protection, a plant breeder must show that the plant it has developed is new, useful, and non-obvious, and must provide written description of plant and deposit of seed that is publicly accessible.

A process that uses a NATURAL LAW, fundamental principle, or mathematical equation can be patented. For example, in the 1981 decision of Diamond v. Diehr, 450 U.S. 175, 101 S. Ct. 1048, 67 L. Ed. 2d 155, the U.S. Supreme Court decided that an industrial process could be patented in spite of the fact that it depended upon a mathematical equation and involved the use of a computer program.

The Diamond ruling upheld a patent to two inventors for an improved process for molding rubber articles. A patent examiner had previously ruled against the inventors, finding that they sought patent protection for a computer program, which the Supreme Court had expressly said could not be patented. The process in question, which was patented, was developed to calculate with greater accuracy the amount of time required to obtain uniform curves in synthetic rubber molds.

As a further requirement for an invention to be patentable, it must meet three criteria: (1) novelty (it does not conflict with a prior pending patent application or a previously issued patent); (2) utility (virtually any amount of usefulness suffices); and (3) nonobviousness (the invention is not obvious to a person of ordinary skill in the art to which the invention pertains).

It is not always easy to determine what is an "ordinary level of skill" or what is "obvious" in deciding whether an invention meets the criterion of nonobviousness. The U.S. Supreme Court decision in Graham v. John Deere Co., 383 U.S. 1, 86 S. Ct. 684, 15 L. Ed. 2d 545, 148 U.S.P.Q. 459 (1966), provides the analytical framework in which to decide whether an invention is nonobvious. Just because all the parts of an invention may be found in a prior art does not necessarily make the invention obvious.

Patents may be rejected for nonutility when their only use is a violation of public morals, such as a tool that can only be used to commit a crime.

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