Patents

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.