The U.S. Supreme Court Takes on Gene Patents: Is Your Genetic Information an Invention or a Discovery? and What Difference Will That Make?

Article excerpt

When you think of technology--lifesaving drugs, cars, electronics, etc.--Japan, western Europe, and the United States come to mind. These highly developed regions of the world have public-private infrastructures that include government financial and intellectual property support, biotech hubs, and infusions of venture capital. These infrastructures are a win-win situation for inventors and the public.

In the United States, a diverse group of citizens have questioned this infrastructure, specifically the legality of gene patents. On April 15, the U.S. Supreme Court began hearing arguments on this topic. The case, Association of Molecular Pathology, et al. v. U.S. Patent and Trademark Office, began in 2009 when the American Civil Liberties Union sued Myriad Genetics and the USPTO over patents from the 1990s on two genes, BRCA1 and BRCA2. Patients with specific mutations of these genes have increased rates of breast and ovarian cancer.

The Issues

In the case so far, the Federal Circuit Court specializing in biotechnology upheld the patents. Then the U.S. Supreme Court, which initially rejected the case and remanded it back to the Federal Appeals Court, also upheld the patents. In the hearings, the plaintiffs made unsuccessful arguments based on misperceptions of what exactly a gene patent is and what is actually patented.

The plaintiffs claim that the ownership of genes is immoral. However, in patent law, gene patents do not convey ownership of a gene; rather, ownership of patents are a right guaranteed by the Constitution that temporarily excludes rival companies from receiving financial rewards without a licensing agreement. Furthermore, the Thirteenth Amendment, which abolished slavery, prohibits owning human genes.

The plaintiffs also claim that genes, which are products of nature, are a discovery, not an invention. The courts reason that everything is a product of nature, but is not always natural. Inventors receive patent protection on wood derived from ash trees carved into the shape of baseball bats. As with lifesaving drugs, gene patents are on a molecule, not genetic code. With the discovery of genetic engineering, inventors were able to receive patent protection on synthesized forms of naturally occurring insulin and adrenaline used as drugs.

The plaintiffs further claim that gene patents undermine the free exchange of information, and thereby prevent or delay potential medical discoveries. However, studies, including two by the National Academy of Sciences, have not supported this claim. In contrast, the studies reveal that researchers have managed to adopt solutions or work around patents through licensing, going offshore, using public data, and legal action.

Myriad Genetics subsequently developed a screening test for BRCA mutations that is one of the few success stories in personalized medicine, a once hopeful field that is currently experiencing a bubble. The second major dispute of the lawsuit alleges that, although covered by health insurance, Myriad's $3,000 screening test for BRCA mutations is too expensive and restricts access to medical care. However, a Duke University study found that the BRCA screening test is not particularly costly relative to other tests; rather, systemic transaction costs that exist within the medical industry are responsible for high medical costs. …