From bi-racial to tri-racial: Towards a new system of racial stratification in the USA

In this article I argue that the bi-racial order (white vs non-white) typical of the United States is undergoing a profound transformation. Because of drastic changes in the demography of the nation as well as changes in the racial structure of the world-system, the United States is developing a complex, Latin America-like racial order. Specifically, I suggest that the new order will have two central features: three loosely organized racial strata (white, honorary white, and the collective black) and a pigmentocratic logic. I examine some objective, subjective, and social interaction indicators to assess if the Latin Americanization thesis holds some water. Although more refined data are needed to conclusively make my case, the available indicators support my thesis. I conclude this article by outlining some of the potential implications of Latin Americanization for the future of race relations in the United States.     

Diversifying the biological sciences: past efforts and future challenges

I am honored to receive the E. E. Just Award for 2010. In my invited essay, I have opted to discuss the state of diversity in the biological sciences with some recommendations for moving forward toward a more positive and inclusive academy. The need to develop cohorts of minority scientists as support groups and to serve as role models within our institutions is stressed, along with the need to ensure that minority scientists are truly included in all aspects of the academy. It is imperative that we increase our efforts to prepare for the unique challenges that we will face as the United States approaches a "majority minority" population in the next 50 years.     

Guardians at the gate: Patent protection for therapeutic monoclonal antibodies—part 1

Patents provide one of the few protections companies can avail themselves of to help protect their therapeutic monoclonal antibody products. Just as the therapeutic monoclonal antibody field is constantly evolving, so too is the legal environment surrounding these inventions. In a series of articles, the general state of the law surrounding therapeutic antibodies will be explained, and important challenges to this technology area will be discussed. Much is at stake when companies market therapeutic monoclonal antibodies; therefore, a firm understanding of this important form of protection is critically important for anyone developing such products.Key words: patent, therapeutic, monoclonal antibodies, KSR, life cycle management     

Need for Legal Protection Against Weight Discrimination in the United States

The steady rise in the prevalence of obesity has had a negative impact for people living with obesity. This includes health care and social disparities that lead to diminished quality of life and social prosperity. Even though discrimination based on weight has a negative impact on people’s health and wellness, there is only one state in the United States, Michigan, that has an antiweight discrimination law. Massachusetts and some cities in the United States have been working to ensure that weight is added as a civil protection over the years. This perspective describes the importance of a weight discrimination law in the United States as well as summarizes the currently existing protections in the country.     

Patenting nonassociated polymeric structures (NAPS): implications for structural genomic data release

The intellectual property laws that govern patent rights should provide a reasonable balance between the competing concerns of open access and exclusivity. Open access can facilitate knowledge dissemination and collaboration in furthering science. On the other hand, exclusivity can ensure interest and financial investment in scientific research and development.In recent days, the appropriate balance between open access and exclusivity has been a focus of public debate, particularly with regard to genomic inventions and their applications. In seeking to reconcile the timing of structural genomic data release with certain efforts to secure intellectual property rights, the International Structural Genomics Organisation joins others confronting this controversy.This paper seeks to inform the discussion with an overview of the U.S. standards for patenting nonassociated polymeric structures (NAPS), which include polynucleotides or polypeptides of unknown biological significance, and their corresponding structural data. In the United States, the present ability to obtain patent rights to these discoveries appears problematic given the requirement of specific, substantial and credible utility, among other things. Without demonstrable utility, NAPS and NAPS-related data likely will not be entitled to patent protection, whether the U.S. Patent & Trademark Office rejects NAPS claims as unpatentable in the first instance, or the U.S. federal courts invalidate NAPS claims in later patent litigation. As such, the improbability of obtaining enforceable patent rights to NAPS might undermine the rationale for delaying structural genomic data release to allow for the filing of patent applications in this regard.Abbreviations: ESTs, expressed sequence tags; ISGO, International Structural Genomics Organisation; NAPS, nonassociated polymeric structures; SNPs, single nucleotide polymorphisms; USPTO, U.S. Patent & Trademark Office     

Patenting antibodies in Europe

As a complement to the series of articles beginning in this issue on obtaining, maintaining and enforcing antibody patents in the United States, this article provides a comparison of the requirements for patenting antibodies in the United States and Europe and provides examples illustrating the application of European patent law to antibodies.     

Public Opinion About Laws to Prohibit Weight Discrimination in the United States

Weight discrimination is pervasive in American society and impairs quality of life for obese persons. With approximately two‐thirds of Americans now overweight or obese, vast numbers of people are vulnerable to weight prejudice and its consequences. Currently, no laws exist to prohibit weight discrimination. This study conducted an online survey with a national sample of 1,001 adults (representing demographics of the United States) to examine public support for six potential legislative measures to prohibit weight discrimination in the United States. Results indicated substantial support (65% of men, 81% of women) for laws to prohibit weight discrimination in the workplace, especially for legal measures that would prohibit employers from refusing to hire, terminate, or deny promotion based on a person's body weight. Laws that proposed extending the same protections to obese persons as people with physical disabilities received the least support, suggesting that Americans may not be in favor of considering obesity as a disability. Findings also highlight specific predictors of support (related to sex, age, education, income, body weight, and political ideology). These findings can be used to inform policy makers in efforts to develop antidiscrimination laws. Such measures will rectify health disparities for overweight Americans and facilitate public health efforts to address obesity.     

Plans of mice and men: from bench science to science policy

The transition from bench science to science policy is not always a smooth one, and my journey stretched as far as the unemployment line to the hallowed halls of the U.S. Capitol. While earning my doctorate in microbiology, I found myself more interested in my political activities than my experiments. Thus, my science policy career aspirations were born from merging my love of science with my interest in policy and politics. After receiving my doctorate, I accepted the Henry Luce Scholarship, which allowed me to live in South Korea for 1 year and delve into the field of science policy research. This introduction into science policy occurred at the South Korean think tank called the Science and Technology Policy Institute (STEPI). During that year, I used textbooks, colleagues, and hands-on research projects as my educational introduction into the social science of science and technology decision-making. However, upon returning to the United States during one of the worst job markets in nearly 80 years, securing a position in science policy proved to be very difficult, and I was unemployed for five months. Ultimately, it took more than a year from the end of the Luce Scholarship to obtain my next science policy position with the American Society for Microbiology Congressional Fellowship. This fellowship gave me the opportunity to work as the science and public health advisor to U.S. Senator Harry Reid. While there were significant challenges during my transition from the laboratory to science policy, those challenges made me tougher, more appreciative, and more prepared to move from working at the bench to working in the field of science policy.     

A preliminary report on my life in science

I describe my wanderings from the United States to East Germany and back. I hope this gives a glimpse of science in East Germany and encourages people who do science under less than favorable conditions. Although elements of my story are unique, the main points are general: don't be afraid to start something new; it pays to be persistent; and science is a passion--if it feels like fun, you've probably got it right.     

How to succeed in science: a concise guide for young biomedical scientists. Part I: taking the plunge

Biomedical research has never been more intellectually exciting or practically important to society. Ironically, pursuing a career as a biomedical scientist has never been more difficult. Here I provide unvarnished advice for young biomedical scientists on the difficulties that lie ahead and on how to find the right laboratories for training in the skills that you will need to succeed. Although my advice is geared towards succeeding in the United States, many aspects apply to other countries.     

United States patent prior art rules and the neem controversy: a case of subject-matter imperialism?

A recent United States patent covering an improvement to the naturally-occurring pesticide in neem tree seed oil might have been rejected as 'obvious' if United States patent law recognized certain forms of prior inventive activity on a par with similar activity occurring within the United States' borders. But the US only recognizes prior 'knowledge, use or invention' as blocking a claim to a patent when those activities take place within US borders, or are evidenced by publications accessible in the US, or, more commonly, by foreign patents. Neither of these last forms of tangible 'prior art' is likely to be available to block patents on biodiversity inventions – most notably because of the fact that most developing nations do not allow patents on pharmaceutical or agricultural inventions, categories subsuming most biodiversity-related advances. Although the United States patent only has direct force within the United States, it is nonetheless highly significant to this global dispute, since the United States and other developed nations stand to be the major markets for the end-products of neem. This paper argues that the border-drawing distinctions in US patent law are archaic, counter to stated policy directives and are disproportionately influencing the developing world's stance towards GATT and its intellectual property rights provisions.     

Neutrons, magnets, and photons: a career in structural biology

The purpose of Reflections articles, it seems, is to give elderly scientists a chance to write about the "good old days," when everyone walked to school in the snow. They enjoy this activity so much that your editor, Martha Fedor, must have known that I would accept her invitation to write such an article, no matter how much I demurred at first. As everyone knows, flattery will get you everywhere. It may comfort the apprehensive reader to learn that there is not going to be much walking to school in the snow in this story. On the contrary, rather than thinking how hard I had it during my scientific career, I find it inconceivable that anyone could have had a smoother ride. At the time I began my career, science was an expanding enterprise in the United States that welcomed the young. Only in such an opportunity-rich environment would someone like me have stood a chance. The contrast between that world and the dog-eat-dog world young scientists confront today is stark.     

DNA barcoding of catfish: species authentication and phylogenetic assessment

As the global market for fisheries and aquaculture products expands, mislabeling of these products has become a growing concern in the food safety arena. Molecular species identification techniques hold the potential for rapid, accurate assessment of proper labeling. Here we developed and evaluated DNA barcodes for use in differentiating United States domestic and imported catfish species. First, we sequenced 651 base-pair barcodes from the cytochrome oxidase I (COI) gene from individuals of 9 species (and an Ictalurid hybrid) of domestic and imported catfish in accordance with standard DNA barcoding protocols. These included domestic Ictalurid catfish, and representative imported species from the families of Clariidae and Pangasiidae. Alignment of individual sequences from within a given species revealed highly consistent barcodes (98% similarity on average). These alignments allowed the development and analyses of consensus barcode sequences for each species and comparison with limited sequences in public databases (GenBank and Barcode of Life Data Systems). Validation tests carried out in blinded studies and with commercially purchased catfish samples (both frozen and fresh) revealed the reliability of DNA barcoding for differentiating between these catfish species. The developed protocols and consensus barcodes are valuable resources as increasing market and governmental scrutiny is placed on catfish and other fisheries and aquaculture products labeling in the United States.     

What should the standard of proof be in scientific misconduct proceedings relating to public health service-funded research?

This article discusses the nature and purposes behind the three standards of proof commonly used in the United States. It summarizes the analytical constructs or standards of review courts commonly use to determine the constitutional validity of standards of proof (as well as other procedural protections) in physician disciplinary proceedings. It applies these constructs to the context of scientific misconduct and an illustrative case, and shows that sound policy and morals as well as procedural due process and equal protection provisions of the United States and some state constitutions require the use of the clear and convincing evidence standard of proof in scientific misconduct proceedings. That standard is necessary to protect scientists from misuse of scientific misconduct charges and proceedings, entailing, as they do, vast discretion in bureaucratic officials as well as staggering costs. The imminent rule making proceedings at the federal level will provide a special opportunity to right a wrong that long has been long visited upon academic scientists throughout the United States.     

Mass immunisation programmes: some philosophical issues

Most countries promote mass immunisation programmes. The varying policy details raise a raft of philosophical issues. I have two broad aims in this paper. First, I hope to begin to remedy a rather curious philosophical neglect of immunisation. With this in mind, I take a broad approach to the topic hoping to introduce rather than settle a range of philosophical issues. My second aim has two aspects: I argue that the states should have pro-immunisation policies, and I advance a view on the subsequent and more specific question as to which sorts of pro-immunisation policies they should prefer. I use the immunisation policies of the United States and New Zealand to frame my discussion of these substantive questions. Immunisation is effectively compulsory in the United States. New Zealand, by contrast, requires evidence not of immunisation but of immunisation status upon school enrolment: New Zealand's policy effectively makes immunisation choice compulsory. I argue that, as between the pro-immunisation policies of the United States and New Zealand, the latter should be preferred. Though the threshold question as to whether states should have pro-immunisation policies should be answered affirmatively, the move to compulsory immunisation cannot be justified.     

以PD-1 为靶点的抗肿瘤药物专利现状分析

PD-1(程序性死亡受体1)是一种重要的免疫抑制分子,其与癌症的治疗密切相关。目前FDA(美国食品药品监督管理局)已经批准了PD-1抑制剂抗体作为癌症治疗药,因此,PD-1具有极高的研究和应用价值。目前在专利领域,全球各大药企均已经开始专利布局,而在中国申请的专利也是日趋增多,对于我国企业来说,把握时机提前布局专利申请,有利于识别竞争对手,抢占市场。本文通过分析以PD-1为靶点的药物专利现状,特别是研究的重点领域,专利申请的国内重点布局等方面,为国内的申请人未来的研发方向和专利布局提供适当的指引。     

Regulating Transgenic Crops: A Comparative Analysis of Different Regulatory Processes

Transgenic crops have the potential to benefit both developed and developing countries. To ensure safe crops to humans and the environment, a strong, but not stifling, regulatory system needs to be established and properly implemented. This paper explores some essential components of a strong regulatory structure for transgenic crops. First, five different regulatory systems for transgenic crops--the United States, the European Union, South Africa, Taiwan, and Argentina--are described and explained. The major components of those systems are then compared to components necessary to a regulatory system that ensures safe products and engenders public trust. The key components discussed include: (1) mandatory pre-market approval; (2) established safety standards; (3) transparency; (4) public participation; (5) use of outside scientists for expert scientific advice; (6) independent agency decisions; (7) post-approval activities; and (8) enforcement authority and resources. Although no one of the existing systems analyzed adequately achieves all the necessary components of a strong regulatory system, those systems serve as models for deciding which regulatory procedures should be emulated and which should be avoided. A mandatory pre-market approval system that applies established safety standards in procedures that are transparent and allows for public participation with no pre-conceived notions or biases will best achieve both safe products and consumer trust.     

基于专利计量分析的抗HIV 药物发展趋势研究

近年来,艾滋病感染人数急剧增加,已成为威胁人类健康的重大疾病。为了对抗HIV药物的研究现状和发展趋势进行深入分析,本文通过在Derwent Innovations Index数据库中检索2006-2012年的抗HIV药物专利。对采集的专利信息用TDA软件进行数据清洗,利用专利计量分析方法,借助可视化的分析工具,从专利申请数量、优先权国、专利技术机构和专利技术领域等方面进行分析。研究发现近几年抗HIV药物专利申请数量较为平稳;专利申请主要集中在美国、加拿大和中国;抗HIV药物的技术领域主要集中在天然产物、发酵工业和杂环化合物等方面。美国在专利申请数量方面远远领先于其他国家,足以见美国在抗HIV药物研发的活跃和强劲的技术实力。我国虽然在专利申请数量方面具有一定优势,但是与国外相比仍有较大差距。     

Legal Regulation of Plant Genome Editing with the CRISPR/Cas9 Technology as an Example

The product-oriented and the process-oriented legal approaches to the regulation of genome editing technologies, CRISPR/Cas9 in particular, are considered. The relevant legislation of the United States and the European Union and some international treaties are analyzed. The issue of genome editing that is within the scope of GMO legislation and general legislation on risk assessment and regulation is addressed. The issue of patenting of gene editing technologies in the legislation of the United States and the European Union and under international law is considered. “Patent wars” between research teams that developed the CRISPR/Cas9 technology are described. The possibilities of obtaining patent protection for plants produced by genome editing are considered.     

The United States of the United Races: a rejoinder

I respond to a review by C. Matthew Snipp, revisiting how my book connects abolitionist leanings to acceptance of racial mixing in the Early Republic. I reiterate that, contrary to the reviewer's claims, the book does not suggest that the defence of interracial marriage has been a thriving social movement. I correct his reading of my chapter on the Civil War era, referring to both the variety of voices present, and the claims of reformers' opponents, who were the only ones who claimed racial mixing was an aim of the abolitionist movement. Lastly, I defend The United States of the United Races against Professor Snipp's characterization of it as a work anticipating a ‘post-racial’ ideal, embodied by racially mixed people, who would be the end point of the obsolescence of race as a relevant analytic tool.