This guide will facilitate legal research on the issue of patentability of genes using
As described by the United States Patent and Trademark Office, "A patent is an intellectual property right granted by the Government of the United States of America to an inventor 'to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States' for a limited time in exchange for public disclosure of the invention when the patent is granted."
Interpretation of the US Supreme Court, October 2012 Term
The US Supreme Court took a centrist position in its June 13, 2013, landmark ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) on whether genes can be patented. The Court held that patents on isolated, natural human genes, as found in nature, are invalid. Patents on synthesized DNA, which includes complementary DNA (cDNA), synthesized from a messenger RNA (mRNA) template are valid because the cDNA structure, devoid of segments called introns, is not a structure that is found in the body, and thus nature. The Court also emphasized that patents on methods of analyzing DNA are still valid. The fact that both sides are claiming victory speaks to the ambiguity that still remains.
The importance of identifying, isolating and sequencing genes, and gene mutations associated with disease, is not unique to the BRCA1 and BRACA2 genes involved in the Myriad case. Myriad discovered and isolated the mutations of the BRACA1 and BRACA2 genes for which mutations can predict risk of breast cancer. Myriad's patents, however, will expire in 2015. The real importance of the Supreme Court decision is how it will affect future genetic research.
The benefits of looking across many cancer genomes. This article from the National Cancer Institute website describes the efforts of The Cancer Genome Atlas (TCGA), a joint venture of the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI).
Correlation of gene mutations and disease is very important in the diagnosis and possible treatment of disease. The question remains, did the Supreme Court strike the appropriate balance of exclusivity versus incentive for encouraging scientific research? Some feel that if exclusive rights are too strong, it will prevent other researchers from expanding on the patented knowledge. On the other hand, if exclusivity is too restricted, researchers may not have the incentive to invest time and resources into the development of new technologies for diagnosing and treating diseases.
"A patent is essentially a limited monopoly whereby the patent holder is granted the exclusive right to make, use, and sell the patented innovation for a limited period of time. The U.S. Patent Act, 35 U.S.C. §§ 1 et seq., was enacted by Congress under its Constitutional grant of authority to secure for limited times to inventors the exclusive right to their discoveries. See Article I, Section 8, Clause 8. Granting exclusive rights to the inventor is intended to encourage the investment of time and resources into the development of new and useful discoveries. In exchange for this limited monopoly, immediate disclosure of the patented information to the U.S. Patent and Trademark Office (PTO) is required. Once the term of protection has ended, the patented innovation enters the public domain." Legal Information Institute (LII), Cornell Law School.