You Don't Own Me But I'm Your Genome - A Primer On Why Genetic Material Is Patentable This post answers a call to the Bag and Baggage request line from Frank Paynter, who noticed that legal developments can sometimes divert me from more critical blogging concerns like whether Doc has made it safely home to the Southland (occupational hazard, both ways). Frank is interested in gene patents, and asks "How can they patent that?" This question continues to spark much debate in intellectual property and biotechnology circles. To understand the answer, it helps to break things down piece by piece. Patents. Patents protect inventions, and allow the patent owner to prevent others from selling, using or making the particular item, usually for a term of twenty years. The United States Patent and Trademark Office (USPTO) recognizes three types of patent: (1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or compositions of matters, or any new useful improvement thereof. (2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture; and (3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plants. In addition to falling within one of the classes listed above, to qualify for a patent an invention must be new (something that no one has created and made public), useful (more than merely theoretical) and unobvious (something that others in the field do not generally know about or take for granted). Gene Patents. Most of the debate about patents for gene-based inventions has focused on whether they satisfy the usefulness prong. The widespread availability of modern gene analysis tools also raises questions about the obviousness of these inventions. The law in this area is far from settled and differs from country to country, but here in the United States the USPTO addressed the major challenges to gene patenting in commentary and guidelines issued last year. The USPTO presumably will continue issuing gene patents in accordance with these guidelines until Congress enacts contrary legislation, or until the Federal Circuit (the U.S. Court of Appeals that hears patent matters) or the Supreme Court takes issue with the USPTO's reasoning in a case involving a challenge to a gene patent. Specific Challenges To Gene Patents And The USPTO Response. "Discoveries are not patentable." The USPTO rejects the argument that while inventions are patentable, discoveries are not. It feels that discoveries are patentable as long as the various statutory requirements (of newness, utility and nonobviousness) are met. The USPTO points out that the U.S. Constitution uses the word "discoveries" where it authorizes Congress to promote progress made by inventors. It also notes that the patent statutes themselves authorize the issuance of patents to those who "invent or discover" new things. "Thus, an inventor's discovery of a gene can be the bases for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it." One cannot patent the bare "nucleic acid molecular structure for a newly discovered gene." Instead, the inventor must provide "a specific, substantial, and credible utility for the claimed isolated and purified gene." When these requirements are satisfied, a patent may be granted. "Genes exist in nature, are part of our heritage and are not inventions." According to the USPTO, isolated and purified genes and synthetic DNA compounds do not occur in nature in those forms. Looking to historical examples, it observes that there is nothing new about patenting compositions or compounds isolated from nature, such as Louis Pasteur's patent on yeast. "A patent of a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. Thus, the concern that a person whose body 'includes' a patented gene could infringe the patent is misfounded. The body does not contain the isolated and purified gene because genes in the body are not in the patented, isolated and purified form. When the patent issued for purified adrenaline about one hundred years ago, people did not infringe the patent merely because their bodies naturally included unpurified adrenaline." Moreover, Congress intended patentable subject matter to be "anything under the sun that is made by man." The U.S. Supreme Court concurs that a patent may cover "a nonnaturally occurring manufacure or composition of matter - a product of human ingenuity." Thus, the USPTO concludes that "DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified, and when the [patent] application meets the statutory criterial for patentability." "Genes are at the core of what it means to be human, and no person should be able to own/control something so basic." In response to this challenge, the USPTO tries to clear up a common misconception - that a patent confers "ownership." It doesn't. A person holding a patent simply has the right to "exclude other people from making, using, offering for sale, selling, or importing the composition for a limited time. That is, a patent owner can stop infringing activities by others for a limited time." (Sounds a lot like ownership, though, doesn't it?) The Biotechnology Industry Organization (BIO) is quick to make this distinction as well: "A patent on a gene ... does not confer ownership of the invention to a company or university. The patent protects their invention from third party theft by a second company or university engaged in commercial activity." "Gene patents are overbroad because they may cover uses which are unattainable, unproven or unforeseen." The USPTO responds that a patentee is required to disclose just one "utility" for the invention in order to obtain a patent. "The patentee is not required to disclose all possible uses, but promoting the subsequent discovery of other uses is one of the benefits of the patent system ... Other inventors who develop new and nonobvious methods of using the patented compound have the opportunity to patent those methods." Additionally, although a gene patent permits the patent owner to keep competitors from using the gene for any purpose during the life of the patent, when a new use is discovered "that new use may qualify for its own process patent, notwithstanding that the DNA composition itself is patented." "Patents on genes will delay or discourage medical research." The USPTO does not agree, and believes instead that "the incentive to make discoveries and inventions is generally spurred, not inhibited, by patents." For its part, BIO likewise asserts that "a patent has no impact on an academic researcher not engaged in commercial activity." Academic researchers are protected from patent infringement actions by an "experimental use" exemption. "DNA sequencing has become so routine that determining the sequence of a DNA molecule is not inventive." The USPTO rejects the argument that gene-based inventions should be assumed to fail the "obviousness" test. It prefers to review the applications on a case-by-case basis. "Whether a claimed DNA molecule would have been obvious depends on whether the particular structure of the DNA would have been obvious to one of ordinary skill in the art at the time the invention was made." "Genes only should be patentable when the complete sequence is disclosed and a function for the gene product has been determined." The USPTO thinks such a requirement would set the bar too high. It is enough to "adequately describe the compound" - such as by structure, formula, chemical name or physical properties - and disclose how to make use of it. Given the USPTO's positions on these and related arguments, genes are and will remain patentable in the U.S. unless Congress or the courts step in to impose broader limitations. For some thought-provoking further reading, check out Professor Lessig's The Future Of The Commons: The Fate Of Ideas In A Connected World, James Boyle's Shamans, Software and Spleens, and Seth Schulman's Owning The Future. And, in other words - all your [nucleotide] base are belong to us.