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Objective This paper examines the Intellectual Property (IP) landscape for non‐invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia. Method We explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT. Results There are many patents held by many parties internationally, with litigation over these patents ongoing in many countries. Importantly, there are significant international differences in patent law, with patents invalidated in the USA that remain valid in Europe. Despite the many patents and ongoing litigation, there are multiple providers of testing internationally, and patents do not appear to be preventing patient access to testing for those who can pay out of pocket. Conclusion The patent situation in NIPT remains in a state of flux, with uncertainty about how patent rights will be conferred in different jurisdictions, and how patents might affect clinical access. However, patents are unlikely to result in a monopoly for a single provider, with several providers and testing technologies, including both public and private sector entities, likely to remain engaged in delivery of NIPT. However, the effects on access in public healthcare systems are more complex and need to be monitored., What's already known about this topic? Non‐invasive prenatal testing (NIPT) is a rapidly growing field of testing, with significant commercial involvement and a number of relevant patents.The patents in this field have caused concern about implications for access to testing.Recent court decisions and company acquisitions have settled some of these patent disputes and abated some of the concerns about access to testing in the United States, but significant controversy continues in the rest of the world. What does this study add? This study sets out the current law, including recent cases relevant to NIPT, and considers the implications of this law against the commercial environment in the United States, Europe, and Australia, for the future development and delivery of NIPT internationally.

DNA can be collected from women at high risk of violent crime as a pre-emptive biometric for post-mortem identification. We conducted focus groups with women in a prostitution diversion program that offers pre-emptive DNA collection. In general, the women supported the program but voiced concern for law enforcement collecting DNA. These data provide insights into the challenges of collecting DNA from women whom law enforcement might consider alternately to be victims or vilified. Hearing the voices of these women provides the forensic community an opportunity to design programs to minimize harm and maximize utility of DNA for victim identification., {"references":["Antonopoulou, C., & Skoufalos, N. (2006). Symptoms of post-traumatic stress disorder in victims of trafficking. Annals of General Psychiatry, 5, 120. Couzin-Frankel, J. (2015). Biomedicine. Newborn screening collides with privacy fears. Science, 348(6236), 740-741. Etchegaray, R., Arber, W., Perez, A. A., Archer, M. S., Battro, A., Cabrera, J. N., . . . Vera, G. (2013). Statement on Trafficking in Human Beings. Retrieved from http://www.casinapioiv.va/content/accademia/en/publications/scriptavaria/humantrafficking.html. Felini, M., Hampton, R. Q., Ryan, E., Kader, E., Coleman, M., Felini, L., Breazeal, R. (2012). Prostitute Diversion Initiative annual report 2010-2011. Retrieved from http://www.pdinewlife.org/wp-content/uploads/2012/05/PDI-Annual-Report-2010-2011f.pdf. Felini, M., Talari, D., Ryan, E., & Qualls-Hampton, R. (2013). Prostitute Diversion Initiative annual report 2011-2012. Retrieved from http://www.pdinewlife.org/wp-content/uploads/2013/09/PDI-Annual-Report-2011-2012.pdf. Ferris, S. (2015). Street Sex Work and Canadian Cities: Resisting a Dangerous Order. Edmonton, Alberta, Canada: The University of Alberta Press. Jonassaint, C. R., Santos, E. R., Glover, C. M., Payne, P. W., Fasaye, G. A., Oji-Njideka, N., Royal, C. D. (2010). Regional differences in awareness and attitudes regarding genetic testing for disease risk and ancestry. Hum Genet, 128(3), 249-260. doi:10.1007/s00439-010-0845-0. Katsanis, S. H., & Kim, J. (2014). DNA in Immigration and Human Trafficking. In D. Primorac & M. Schanfield (Eds.), Forensic DNA Applications: An Interdisciplinary Perspective (pp. 539-556): CRC Press. Katsanis, S. H., Kim, J., Minear, M. A., Chandrasekharan, S., & Wagner, J. K. (2015). Preliminary perspectives on DNA collection in anti-human trafficking efforts. Recent Advances in DNA and Gene Sequences, 8(2), 78-90. Kim, J., & Katsanis, S. H. (2013). Brave New World of human-rights DNA collection. Trends in genetics : TIG, 29(6), 329-332. Langreth, R. (2011, 4 January 2011). Why you should fear giant databases with your DNA. Forbes Magazine. Potterat, J. J., Brewer, D. D., Muth, S. Q., Rothenberg, R. B., Woodhouse, D. E., Muth, J. B., Brody, S. (2004). Mortality in a long-term open cohort of prostitute women. Am J Epidemiol, 159(8), 778-785. Quinet, K. (2007). The missing missing: Toward a quantification of serial murder victimization in the United States. Homicide Studies, 11, 319-339. Seidenberg, S. (2013). Slavery continues to haunt the modern world, but efforts to eradicate it are growing. ABA Journal (April 2013). Thomas, R. (2006). Biometrics, International Migrants and Human Rights. European Journal of Migration and Law, 7(4), 377-411. Wahab, S. (2006). Evaluating the usefulness of a prostitution diversion project. Qual Social Work, 5(1), 67-92."]}

The 'Stakeholder Perspectives on Noninvasive Prenatal Genetic Screening' Symposium was held in conjunction with the 2015 annual meeting of the International Society for Prenatal Diagnosis. During the day-long meeting, a panel of patient advocacy group (PAG) representatives discussed concerns and challenges raised by prenatal cell-free DNA (cfDNA) screening, which has resulted in larger demands upon PAGs from concerned patients receiving prenatal cfDNA screening results. Prominent concerns included confusion about the accuracy of cfDNA screening and a lack of patient education resources about genetic conditions included in cfDNA screens. Some of the challenges faced by PAGs included funding limitations, lack of consistently implemented standards of care and oversight, diverse perspectives among PAGs and questions about neutrality, and lack of access to training and genetic counselors. PAG representatives also put forward suggestions for addressing these challenges, including improving educational and PAG funding and increasing collaboration between PAGs and the medical community. © 2016 John WileySons, Ltd.

From 2006–2010, Duke University’s Center for Public Genomics prepared eight case studies examining the effects of gene patent licensing practices on clinical access to genetic testing for ten clinical conditions. One of these case studies focused on the successful licensing practices employed by the University of Michigan and the Hospital for Sick Children in Toronto for patents covering the CFTR gene and its ΔF508 mutation that causes a majority of cystic fibrosis cases. Since the licensing of these patents has not impeded clinical access to genetic testing, we sought to understand how this successful licensing model was developed and whether it might be applicable to other gene patents. We interviewed four key players who either were involved in the initial discussions regarding the structure of licensing or who have recently managed the licenses and collected related documents.

Genetic testing for long QT syndrome exemplifies patenting and exclusive licensing with different outcomes at different times. Exclusive licensing from the University of Utah changed the business model from sole provider to two US providers of long QT syndrome testing. Long QT syndrome is associated with mutations in many genes, 12 of which are now tested by two competing firms in the United States, PGxHealth and GeneDx. Until 2009, PGxHealth was the sole provider, based largely on exclusive rights to patents from the University of Utah and elsewhere. University of Utah patents were initially licensed to DNA Sciences, whose patent rights were acquired by Genaissance, and then by Clinical Data, Inc., which owns PGxHealth. In 2002, DNA Sciences, Inc., "cleared the market" by sending cease-and-desist patent enforcement letters to university and reference laboratories offering long QT syndrome genetic testing. There was no test on the market for a 1- to 2-year period. From 2005-2008, most long QT syndrome-related patents were controlled by Clinical Data, Inc., and its subsidiary PGxHealth. Bio-Reference Laboratories, Inc., secured countervailing exclusive patent rights starting in 2006, also from the University of Utah, and broke the PGxHealth monopoly in early 2009, creating a duopoly for genetic testing in the United States and expanding the number of genes for which commercial testing is available from 5 to 12.

Background Although numerous mouse models of breast carcinomas have been developed, we do not know the extent to which any faithfully represent clinically significant human phenotypes. To address this need, we characterized mammary tumor gene expression profiles from 13 different murine models using DNA microarrays and compared the resulting data to those from human breast tumors. Results Unsupervised hierarchical clustering analysis showed that six models (TgWAP-Myc, TgMMTV-Neu, TgMMTV-PyMT, TgWAP-Int3, TgWAP-Tag, and TgC3(1)-Tag) yielded tumors with distinctive and homogeneous expression patterns within each strain. However, in each of four other models (TgWAP-T121, TgMMTV-Wnt1, Brca1Co/Co;TgMMTV-Cre;p53+/- and DMBA-induced), tumors with a variety of histologies and expression profiles developed. In many models, similarities to human breast tumors were recognized, including proliferation and human breast tumor subtype signatures. Significantly, tumors of several models displayed characteristics of human basal-like breast tumors, including two models with induced Brca1 deficiencies. Tumors of other murine models shared features and trended towards significance of gene enrichment with human luminal tumors; however, these murine tumors lacked expression of estrogen receptor (ER) and ER-regulated genes. TgMMTV-Neu tumors did not have a significant gene overlap with the human HER2+/ER- subtype and were more similar to human luminal tumors. Conclusion Many of the defining characteristics of human subtypes were conserved among the mouse models. Although no single mouse model recapitulated all the expression features of a given human subtype, these shared expression features provide a common framework for an improved integration of murine mammary tumor models with human breast tumors.

The mammary gland, like most tissues, produces measurable amounts of prostaglandin E

Cell-free fetal DNA-based noninvasive prenatal testing (NIPT) could significantly change the paradigm of prenatal testing and screening. Intellectual property (IP) and commercialization promise to be important components of the emerging debate about clinical implementation of these technologies. We have assembled information about types of testing, prices, turnaround times, and reimbursement of recently launched commercial tests in the United States from the trade press, news articles, and scientific, legal, and business publications. We also describe the patenting and licensing landscape of technologies underlying these tests and ongoing patent litigation in the United States. Finally, we discuss how IP issues may affect clinical translation of NIPT and their potential implications for stakeholders. Fetal medicine professionals (clinicians and researchers), genetic counselors, insurers, regulators, test developers, and patients may be able to use this information to make informed decisions about clinical implementation of current and emerging noninvasive prenatal tests.