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ABSTRACT LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades. [ABSTRACT FROM AUTHOR]

Compulsory psychiatric treatment is the norm in many Western countries, despite the increasingly individualistic and autonomous approach to medical interventions. Community Treatment Orders (CTOs) are the singular best example of this, requiring community patients to accept a variety of interventions, both pharmacological and social, despite their explicit wish not to do so. The epidemiological, medical/treatment and legal intricacies of CTOs have been examined in detail, however the ethical considerations are less commonly considered. Principlism, the normative ethical code based on the principles of autonomy, beneficence, non-maleficence and justice, underpins modern medical ethics. Conflict exists between patient centred commentary that reflects individual autonomy in decision making and the need for supported decision making, as described in the Convention on the Rights of Persons with Disabilities (CRPD) and the increasing use of such coercive measures, which undermines this principle. What appears to have been lost is the analysis of whether CTOs, or any coercive measure in psychiatric practice measures up against these ethical principles. We consider whether CTOs, as an exemplar of coercive psychiatric practice, measures up against the tenets of principalism in the modern context in order to further this debate. [ABSTRACT FROM AUTHOR]

Making data broadly accessible is essential to creating a medical information commons (MIC). Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the authors discuss various reports within the journal on topics including data sharing in a Medical Information Commons, Findable, Accessible, Interoperable and Re-usable data principles, and tension between the open science movement and data protection laws.

Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the data describe. [ABSTRACT FROM AUTHOR]

The article examines the effectiveness of foundational technologies such as CRISPR for human suffering. Use of technologies in the market for fundamental research and therapeutic applications, is highlighted. Also emphasized are the patents on foundational technologies and human right to apply in the community such as research institutes, scientists and patient organizations.

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent enforcers, and patent policy stakeholders often seems to work against the commercialization goals of the Bayh-Dole Act and is difficult to explain or justify on any basis other than the pursuit of revenue. [ABSTRACT FROM AUTHOR]

The Human Genome Project modeled its open science ethos on nematode biology, most famously through daily release of DNA sequence data based on the 1996 Bermuda Principles. That open science philosophy persists, but daily, unfettered release of data has had to adapt to constraints occasioned by the use of data from individual people, broader use of data not only by scientists but also by clinicians and individuals, the global reach of genomic applications and diverse national privacy and research ethics laws, and the rising prominence of a diverse commercial genomics sector. The Global Alliance for Genomics and Health was established to enable the data sharing that is essential for making meaning of genomic variation. Data-sharing policies and practices will continue to evolve as researchers, health professionals, and individuals strive to construct a global medical and scientific information commons. [ABSTRACT FROM AUTHOR]

This Viewpoint investigates how products developed from taxpayer investment should be managed and made accessible, and how updating the Bayh-Dole Act could help accomplish these goals. [ABSTRACT FROM AUTHOR]

Prospects have never seemed better for a truly global approach to science to improve human health, with leaders of national initiatives laying out their vision of a worldwide network of related projects. An extensive literature addresses obstacles to global genomic data sharing, yet a series of public polls suggests that the scientific community may be overlooking a significant barrier: potential public resistance to data sharing across national borders. In several large United States surveys, university researchers in other countries were deemed the least acceptable group of data users, and a just-completed US survey found a marked increase in privacy and security concerns related to data access by non-US researchers. Furthermore, diminished support for sharing beyond national borders is not unique to the US, although the limited data from outside the US suggest variation across countries as well as demographic groups. Possible sources of resistance include apprehension about privacy and security protections. Strategies for building public support include making the affirmative case for global data sharing, addressing privacy, security, and other legitimate concerns, and investigating public concerns in greater depth. [ABSTRACT FROM AUTHOR]

A review of the article "Thought Leader Perspectives on Participant Protections in Precision Medicine Research" by C.M. Hammack, K.M. Brelsford, and L.M. Beskow, which appears in the same issue of the journal, is presented, and it mentions human genetics research.

A review of the article "Living Donation by Individuals with Life-Limiting Conditions" by L.F. Ross and J. R. Thistlethwaite, which appears in the same issue of the journal, is provided, and it mentions permissible organ donation practices, terminally ill donors, and death by organ donation.

The article focuses on the recent U.S. Supreme Court's jurisprudence on patents and the use of policy that ensure access to research tools in the U.S. Topics discussed include lack of coherent legislative reform by making reference to the court case Madey v. Duke University, and litigation over Myriad Genetics' patents on BRCA genes associated with risk of breast and ovarian cancer in the court case Association for Molecular Pathology (AMP) v. Myriad Genetics.

Some claims in patents on individual genes and methods of detecting variations appear to be infringed by whole-genome and all-exome sequencing and genomic analysis. But what is the real risk of infringement liability? The risk is probably low. This is partly because it will rarely make sense to sue, but also because the patent-holder may well lose if they do sue. Courts have recently narrowed standards of patentable subject matter, invalidating broad method claims and DNA-based claims for sequences that would be found in nature. Moreover, claims broad enough to cover WGS are likely to be invalid on other grounds, and not worth risking a lawsuit to enforce. [ABSTRACT FROM AUTHOR]

In the forty-year history of U.S. bioethics commissions, these government-sanctioned forums have often demonstrated their power to address pressing problems and to enable policy change. For example, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established in 1974, left a legacy of reports that were translated into regulations and had an enormous practical impact. And the 1982 report Splicing Life, by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, became the basis for the National Institutes of Health's Recombinant DNA Advisory Committee as well as for the Food and Drug Administration's developing 'Points to Consider' when contemplating the introduction of recombinant DNA into human beings. Some efforts of bioethics commissions, however, are not tightly connected to policy change or to outcomes directly linked to a specific report. While direct policy impact is indeed a useful metric for government bioethics commissions, it is not their only legitimate utility. For instance, bioethics commissions can also be incubators for deliberation on a hot topic, giving policy-makers time to think through options while the political heat has some time to dissipate. Or a bioethics commission may stake out a position that enables a politician to take action while not necessarily following its recommendations. [ABSTRACT FROM AUTHOR]

The article discusses the U.S. Supreme Court case Association for Molecular Pathology v. Myriad Genetics which deals with patenting human genes. It says that the court's decision was focused on the definitions of the genetic and patent codes, in which all nine Justices have agreed that the DNA segments making up human genes are not patentable under section 101 of the Patent Act2. Furthermore, the implications for health care and the biotechnology industry are discussed.

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. [ABSTRACT FROM AUTHOR]

Background: The development of Herceptin® is welcomed as a major advance in breast cancer treatment, while Myriad's development of BRACAnalysis® is a widely used diagnostic. However useful and successful this product is, its presence in the public eye is tainted by predominantly negative press about gene patenting and business practices. Discussion: While retrospection invites a sharp contrast between Genentech's triumphal narrative of scientific achievement and Myriad's public image as a controversial monopolist, a comparative history of these companies' products reveals two striking consistencies: patents and public discontent. Despite these similarities, time has reduced the narrative to that of hero versus villain: Genentech is lauded - at least for the final outcome of the Herceptin® story - as a corporate good citizen, Myriad as a ruthless mercenary. Since patents undergird both products yet the narratives are so different, the stories raise the question: why have patents taken the fall as the scapegoat in current biotechnology policy debate? Summary: A widely publicized lawsuit and accompanying bad press have cast Myriad as a villain in the evolving narrative of biotechnology. While the lawsuit suggests that this villainy is attributable to Myriad's intellectual property, we suggest through a comparative case study that, at least in the Myriad case, it is not simply about the patents but also other business strategies the company chose to pursue. Patents were a necessary but not sufficient cause of controversy. [ABSTRACT FROM AUTHOR]

More than 40 years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the high price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate over whether companies should receive more restricted rights to products originating with government funding. This article traces the history leading to the enactment of the Bayh-Dole Act and critically assesses its strengths and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, the authors propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying government use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions. [ABSTRACT FROM AUTHOR]

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 postdiscovery 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Context: The Bayh-Dole Act of 1980, which gave federal grantees and contractors the right to patent and license inventions stemming from federally funded research, was intended to encourage commercial dissemination of research that would otherwise languish for want of a patent incentive. The case of Columbia University's Axel patents, which claimed a scientific method to introduce foreign proteins into nucleated cells, illustrates a secondary outcome of the Bayh-Dole Act: the incentive for federal grantees and contractors to pursue royalty revenues from patented research, even for inventions for which commercial use did not require patents. Methods: This article describes oral interviews with two of the three inventors and a former high-ranking administrator at Columbia; correspondence with several faculty members at Columbia to obtain key royalty figures and information about Columbia's licensing strategy; patent searches; examinations of legal records of court proceedings; and analysis of citation trends for the seminal papers disclosing the invention of cotransformation. Findings: Columbia University and the inventors profited handsomely from the Axel patents, earning $790 million in revenues through licensing arrangements that tapped profits from end products made by biotechnology and pharmaceutical companies. Columbia's aggressive effort to extend the patent duration also led to considerable legal expenditures and fierce controversy. In particular, obtaining and enforcing a 2002 patent proved costly, politically difficult, and financially fruitless and attracted intense criticism for behavior unbecoming a nonprofit academic institution. Conclusions: This case study raises several important questions about the logic and future revisions of the Bayh-Dole Act: Are revenue generation and financial rewards for inventing valuable technologies legitimate goals for this act? If so, does the federal government need credible mechanisms for oversight of, or checks and balances on, the rights conferred? [ABSTRACT FROM AUTHOR]

The article discusses the gene patenting controversies which drew numerous scrutinies from the academic and policy literature. The author inferred that a large number of gene patents and their rightful owners will make it hard to assume the rights to all important research inputs that may result in the underuse of valuable technologies. Thus, the author believed that a strengthened research exemption may address the restricted access problems due to patents, particularly in diagnostic testing.

Innovation in the life sciences depends on how much information is produced as well as how widely and easily it is shared. Policies governing the science commons – or alternative, more restricted informational spaces – determine how widely and quickly information is distributed. The purpose of this paper is to highlight why the science commons matters and to analyse its structure and function. The main lesson from our analysis is that both the characteristics of the physical resources (from genes to microbes, plants and animals) and the norms and beliefs of the different research communities – think of the Bermuda rules in the human genome case or the Belem declaration for bioprospecting – matter in the institutional choices made when organising the science commons. We also show that the science commons contributes to solving some of the collective action dilemmas that arise in the production of knowledge in Pasteur's Quadrant, when information is both scientifically important and practically applicable. We show the importance of two of these dilemmas for the life sciences, which we call respectively the diffusion–innovation dilemma (how readily innovation diffuses) and the exploration–exploitation dilemma (when application requires collective action). [ABSTRACT FROM AUTHOR]

This article discusses the interaction between intellectual property and cancer treatment. CellPro developed a stem cell separation technology based on research at the Fred Hutchinson Cancer Center. A patent with broad claims to bone marrow stem cell antibodies had been awarded to Johns Hopkins University and licensed to Baxter Healthcare under the 1980 Bayh–Dole Act to promote commercial use of inventions from federally funded research. CellPro got FDA approval more than two years before Baxter but lost patent infringement litigation. NIH elected not to compel Hopkins to license its patents to CellPro. CellPro went out of business, selling its technology to its competitor. Decisions at both firms and university licensing offices, and policies at the Patent and Trademark Office, NIH, and the courts influenced the outcome. [ABSTRACT FROM AUTHOR]

Studies that involve getting information from people about other people, including pedigree studies, create obligations to those other people. Defining them as "human subjects," however, does not solve the ethical problems and will, in some cases, make important lines of study impractical or even impossible. The more important task is to define what the ethical obligations are and how to ensure that they are carried out. Some heuristics based on the study of families with inherited Alzheimer's disease suggest that consultation with family members and attention to confidentiality should more directly address the ethical problems than try to treat families merely as collections of people with individual rights. The individual-based approach will necessarily fail when different family members differ in their judgments about the risks and benefits of disclosing information, which will, in turn, lead to the most restrictive individual controlling what others in the family can disclose. This solution is unlikely to be supported in practice by families or researchers or to be sanctioned by the courts. The current policy of the federal Office for Human Research Protections, based on an interpretation of the definition "human subject," is incoherent and will need to be changed, preferably through a process that involves broad debate among all stakeholders but most particularly involving members of families being studied. [ABSTRACT FROM AUTHOR]

Focuses on genetic testing and its power to expose the body's most intimate secrets. Collaboration between Nancy Wexler and the Hereditary Disease Foundation on Huntington's research; Works on the Human Genome Project; Effects of genetic testing on employment and insurance; Conflict over prenatal testing for congenital conditions; Scientific racism raised by the genetic testing; Genetic determinism model.

Presents case studies from the field missions of the Physicians for Human Rights (PHR) on human rights investigations and documentation. Human rights violations and its health consequences; Cases of violations of medical neutrality; Documentation of refugee health crises; Injuries caused by mines and chemical weapons; Torture, deliberate injury and rape cases; Forensic investigations; Limitations.

Discusses the investigations done by the U.S. Army medical researchers on allegations of chemical weapons use against the Hmong in Laos and the poison-gas attack against the Iraqi Kurds. Use of an epidemiologic approach for the survey interview; Need to design the study for the analysis of response consistency to judge the validity of the testimony; Importance of securing samples of the putative agent.

The author discusses the rulings of the U.S. District Court for Southern New York for the patents given to Myriad Genetics Inc. for genetic testing for breast and ovarian cancer from BRCA1 and BRCA2 genes. He comments on this lawsuit which made one company against another for the patent rights. He informs that the claims by individuals and organization having objects on the Myriad's Patents include laboratory directors offering BRCA testing, physicians for testing, and women as samples.

The author discusses an August 2012 decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) on the Association of Molecular Pathology (AMP) vs. U.S. Patent and Trademark Office (USPTO) and Myriad Genetics lawsuit regarding the patenting of BRCA cancer genes. The CAFC ruled that engineered DNA could be patented, but the judges disagreed about the patentibility of isolated DNA molecules found in nature. The author also looks at the pending appeal to the U.S. Supreme Court.

The Human Genome Project began a decade ago, its early momentum fueled by two reports. A report from the National Research Council (NRC) in February 1998 endorsed the project and provided the basis for the first joint plan by the National Institutes of Health (NIH) and the Department of Energy (DOE). A report from the Office of Technology Assessment (OTA) in April 1988, provided Congress with a means to assess the roles of NIH and DOE. Both reports highlighted the importance of genomics and emphasized the need for a concerted research program. The committees did not predict the large investment of private funds or the extensive patenting of sequences, and they underestimated the rate of progress. Overall, though, the consensus-building provided by the committees helped to set the blueprint for one of the great success stories in modern biology. [ABSTRACT FROM AUTHOR]

Comments on human genome research and its relation to international health. Impact of the genome project on medicine; Methods and instruments that can be generated from genome research; Details of genome research programs by several national governments; Social implications of genome research.

The article reflects on genetic testing patent and detect tumor derived DNA in people with cancer. It mentions that cell-free fetal DNA (cffDNA) in the blood of pregnant women and polymerase-chain reaction amplification of Y-chromosome DNA sequences from pregnant women's serum and plasma. It mentions that the decision of U.S. Supreme Court in the cases on patent Sequenom v. Ariosa Diagnostics, Mayo Collaborative Services v. Prometheus Laboratories and Parke-Davis v. H .K. Mulford.

An introduction is presented in which the editor discusses various reports within the journal on topics including data sharing in a Medical Information Commons (MIC), medical research, and data sharing-related by laws and regulations.

The article focuses on technical and scientific progress in the publication of human genome, as of February 2021. It presents views of several scientists including Kathryn Maxson Jones, Amy R. Bentley, Kathryn A. Phillips and Dorothy E. Roberts on topics including data sharing on human DNA sequence, global impact of human genomics on human history and biology, value and affordability in precision medicine and genetics-based claims of racial purity.

The article discusses the implications for research, innovation, business, and patients of a U.S. Supreme Court decision that the breast cancer (BRCA) gene is not patentable. Topics include the Court's unanimous decision on June 13, 2013, in the case of the Association of Molecular Pathology (AMP) v. Myriad Genetics, that genes and the information contained within them, called genomic DNA (gDNA), are not patent-eligible subject matter, the patent eligibility of complementary DNA (cDNA), which are DNA molecules synthesized in a laboratory, and the impact of the Court's ruling on diagnostic service monopoly models, such as Myriad Genetics'. Also discussed is Myriad Genetics' genetic test for mutations of BRCA 1 and 2.

A review of the article "Breastfeeding with HIV: An Evidence-Based Case for New Policy" by Dr. Marielle Gross and others, which appears in the same issue of the journal, is presented, and it mentions the ethics of breastfeeding and health benefits for women living with HIV.

The traditional living donor was very healthy. However, as the supply-demand gap continues to expand, transplant programs have become more accepting of less healthy donors. This paper focuses on the other extreme, asking whether and when individuals who have life-limiting conditions (LLC) should be considered for living organ donation. We discuss ethical issues raised by 1) donation by individuals with progressive severe debilitating disease for whom there is no ameliorative therapy; and 2) donation by individuals who are imminently dying or would die by the donation process itself. [ABSTRACT FROM AUTHOR]

Open science has recently gained traction as establishment institutions have come on-side and thrown their weight behind the movement and initiatives aimed at creation of information commons. At the same time, the movement's traditional insistence on unrestricted dissemination and reuse of all information of scientific value has been challenged by the movement to strengthen protection of personal data. This article assesses tensions between open science and data protection, with a focus on the GDPR. [ABSTRACT FROM AUTHOR]