Gene Patenting — The Supreme Court Finally Speaks Kesselheim, Aaron S; Cook-Deegan, Robert M; Winickoff, David E ...
The New England journal of medicine,
08/2013, Volume:
369, Issue:
9
Journal Article
Peer reviewed
Open access
In June 2013, the U.S. Supreme Court unanimously ruled that the patents on BRCA1 and BRCA2 held by Myriad were not valid because human genes are products of nature and therefore not patentable. The ...authors discuss the implications of this long-awaited decision.
Are human genes patentable? On June 13, the Supreme Court gave its long-awaited answer — a unanimous “no.” The case,
Association for Molecular Pathology v. Myriad Genetics,
1
has generated enormous interest among medical institutions, industry organizations, patient advocacy groups, and scientists. “Life's instructions,” James Watson asserted in one of 49 amicus curiae briefs, “ought not be controlled by legal monopolies created at the whim of Congress or the courts.” For some, the gene patents were symbols of a shrinking public domain and an overreaching patent system that traded too much monopolistic power for too little innovation. For others, the challenge . . .
A genetic marker known as apolipoprotein E provides a clear signal of a person's risk of developing Alzheimer's disease and thus that person's future need for long-term care. People who find that ...they have the variant of the trait that increases Alzheimer's disease risk are more likely to purchase long-term care insurance after receiving this information. If the information is widely introduced into the insurance market, coverage rates could be affected in different ways, depending on who possesses that information. Policymakers will eventually need to confront the issue of the use of this and other markers in the pricing of long-term care insurance.
Over the past two decades, genomics has evolved as a scientific research discipline. Genomics research was fueled initially by government and nonprofit funding sources, later augmented by private ...research and development (R&D) funding. Citizens and taxpayers of many countries have funded much of the research, and have expectations about access to the resulting information and knowledge. While access to knowledge gained from all publicly funded research is desired, access is especially important for fields that have broad social impact and stimulate public dialogue. Genomics is one such field, where public concerns are raised for reasons such as health care and insurance implications, as well as personal and ancestral identification. Thus, genomics has grown rapidly as a field, and attracts considerable interest.
One way to study the growth of a field of research is to examine its funding. This study focuses on public funding of genomics research, identifying and collecting data from major government and nonprofit organizations around the world, and updating previous estimates of world genomics research funding, including information about geographical origins. We initially identified 89 publicly funded organizations; we requested information about each organization's funding of genomics research. Of these organizations, 48 responded and 34 reported genomics research expenditures (of those that responded but did not supply information, some did not fund such research, others could not quantify it). The figures reported here include all the largest funders and we estimate that we have accounted for most of the genomics research funding from government and nonprofit sources.
Aggregate spending on genomics research from 34 funding sources averaged around $2.9 billion in 2003-2006. The United States spent more than any other country on genomics research, corresponding to 35% of the overall worldwide public funding (compared to 49% US share of public health research funding for all purposes). When adjusted to genomics funding intensity, however, the United States dropped below Ireland, the United Kingdom, and Canada, as measured both by genomics research expenditure per capita and per Gross Domestic Product.
Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic—human genetic engineering—was the subject of sustained ...public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)—the Recombinant DNA Advisory Committee (RAC)—agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.
When it comes to gene patenting, policy makers may be responding more to high-profile media controversies than to systematic data about the issues. Gene patenting has attracted intense scrutiny for ...decades, raising a host of ethical, legal and economic concerns.
In 1980, the U.S. Supreme Court ruled that engineered organisms could be patented (1). For 30 years, genes have likewise been presumed to be eligible for patents. Recent events suggest that the Court ...may reverse established practice in biotechnology patents, by making DNA molecules whose sequences are found in living organisms ineligible to be patented.
Patents in genomics and human genetics Cook-Deegan, Robert; Heaney, Christopher
Annual review of genomics and human genetics,
01/2010, Volume:
11, Issue:
1
Journal Article
Peer reviewed
Open access
Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even ...greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts-and sometimes fails to adapt-to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive post-discovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents, but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.
Sole-source business models for genetic testing can create private databases containing information vital to interpreting the clinical significance of human genetic variations. But incomplete access ...to those databases threatens to impede the clinical interpretation of genomic medicine. National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing. They can create incentives for sharing data and interpretive algorithms in several ways, including: promoting voluntary sharing; requiring laboratories to share as a condition of payment for or regulatory approval of laboratory services; establishing - and compelling participation in - resources that capture the information needed to interpret the data independent of company policies; and paying for sharing and interpretation in addition to paying for the test itself. US policies have failed to address the data-sharing issue. The entry of new and established firms into the European genetic testing market presents an opportunity to correct this failure.
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