Human Gene Patent Ruling

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Human Gene Patent Ruling

Introduction

Gene patents are generally not prevented from biomedical research, but there are some problems with a genetic diagnosis is due to gene patents under exclusive license. Patents on genes for therapeutic purposes has been discussed, but have received surprisingly little noise. Instead, genetic diagnoses were very controversial, but rarely discussed: the cases are not tested and there is very little case law to guide policy. Recently, Secretary of the Advisory Board for Genetics Health and Society (SACGHS) released a draft report examines how the patents and licenses, the availability of clinical genetic testing in the United States. SACGHS said that the patents are very damaging to, or facilitate patient access to genetic testing, as well as the damage and the benefits of patents for genetic diagnostics has been exaggerated. Problems arise when the patent is licensed exclusively from one supplier and no alternative is available.

The courts were to change the thresholds of what is patentable and how patents can be applied. Technologies for sequencing, genotyping, and the promise of gene expression to guide clinical decisions in the management of common chronic diseases and infectious diseases, and probably part of personalized medicine. Developing genomic tests may require a landscape mapping of complex intellectual property and cutting the thickets of the patented DNA and related techniques. Preliminary studies indicated that the patent claims, if strictly, might prevent the use of multiple genes, or test data on the entire genome. However, new technologies promise to reduce the cost of whole genome sequencing at prices that are comparable to the genetic testing for one condition. The courts, businesses and policy makers do not seem to allow IP to prevent the development of such technologies, but the prudent policy will depend on careful analysis and forecasting. SACGHS report signs that the U.S. government has paid attention to, and increases the likelihood that the policy is to promote socially beneficial uses of genetic testing, while maintaining incentives for copyright owners and to mitigate problems arising from legal monopolies.

DNA is a relatively uncomplicated, double-stranded molecule, consisting of only four building blocks called deoxyribonucleotides. The key to DNA structure is that opposing nucleotides in the two strands pair in a complementary relationship: the adenine nucleotide (A) pairs only with the thymine nucleotide (T) and the guanine nucleotide (G) pairsonly with the cytosine nucleotide (C). The geometry of these pairings is responsible for maintaining the parallel spacing of the sugar-phosphate backbone of the molecule as it twists to form a helix.

The Patent System

The patent system is based on a bedrock principle going back hundreds of years. In Anglo-American patent law that principle, derived from the Statute of Monopolies passed by the English parliament in 1623, meant that patents were granted to the first and true inventor of a "manner of new manufacture". In continental Europe the most relevant source of modern continental patent law came from the Venetian Republic which, in 1474, created the world's first patent registration system ...