Genetics Genomics And The Patenting Of Dna

DNA patenting has emerged as a hot topic in science policy and bioethics as private companies and government agencies spend billions of dollars on genetic research and development in a race to identify, sequence, and analyze DNA from human, animal, and plant species. David B. Resnik's Owning the Genome explores the ethical, social, philosophical, theological, and policy issues surrounding DNA patenting and develops a comprehensive approach to the topic. Resnik considers arguments for and against DNA patenting and concludes that only a patent on a whole human genome would be inherently immoral, while the morality of other DNA patents depends on their consequences for science, medicine, agriculture, industry, and society. He also stresses the importance of government regulations and policies in order to minimize the harmful effects of patenting while promoting the beneficial ones.

The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.

Few topics in the life sciences today provoke as much debate as the availability of patent protection on "genetic inventions". Some hold that protection is essential to encourage innovation and development of new products. Others argue that patents ...

This paper questions whether the application of the patent system to DNA sequences achieves its goals of stimulating innovation for the public good and rewarding people for useful new inventions. Even if DNA sequences are considered eligible for patenting, they must also be novel, inventive, and useful. The application of these criteria has not been stringently applied. In future, patents asserting rights over DNA sequences should become the exception rather than the norm.

The history of the CCR5 gene as a lens through which to view such issues as intellectual property, Big Pharma, personalized medicine, and race and genomics. In The Genealogy of a Gene, Myles Jackson uses the story of the CCR5 gene to investigate the interrelationships among science, technology, and society. Mapping the varied “genealogy” of CCR5—intellectual property, natural selection, Big and Small Pharma, human diversity studies, personalized medicine, ancestry studies, and race and genomics—Jackson links a myriad of diverse topics. The history of CCR5 from the 1990s to the present offers a vivid illustration of how intellectual property law has changed the conduct and content of scientific knowledge, and the social, political, and ethical implications of such a transformation. The CCR5 gene began as a small sequence of DNA, became a patented product of a corporation, and then, when it was found to be an AIDS virus co-receptor with a key role in the immune system, it became part of the biomedical research world—and a potential moneymaker for the pharmaceutical industry. When it was further discovered that a mutation of the gene found in certain populations conferred near-immunity to the AIDS virus, questions about race and genetics arose. Jackson describes these developments in the context of larger issues, including the rise of “biocapitalism,” the patentability of products of nature, the difference between U.S. and European patenting approaches, and the relevance of race and ethnicity to medical research.

Genetic science is about to radically alter our lives. Sooner than you can imagine, human beings will be capable of diagnosing their own illnesses, designating the sex of their children, even designing the food they eat -- all as easily as using a cell phone. Now is the time for every one of us to take control of our DNA, and one man is uniquely qualified to show us how: Glenn McGee, bioethicist at the University of Pennsylvania, pioneer in the study of "home genetics," and the acknowledged wunderkind of the exciting world found at the nexus of life science and computer technology. One of the most respected authorities in the field of genomics -- the study of the genetic "software" inside plants, animals, and us -- McGee takes us on an eye-opening journey behind the headlines and into the heart of this formidable cutting-edge science. Probing the far-ranging ethical and legal implications of genomic research, McGee tackles its most controversial and hotly debated aspects -- from patenting your DNA to genetic engineering at the supermarket -- and explodes unnecessary fears about this wondrous new knowledge. We live in a brave new world. Beyond Genetics provides us with the knowledge we need to take the right steps forward into tomorrow ... and beyond.