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Volume 9 | Number 3

Volume 9 | Number 3 (SYMPOSIUM ISSUE)

You may download and read the Full Edition, or click on a citation below for the individual articles. Journal content dating from 2005 is available on the Lexis-Nexis database. Content dating from 2006 is available on the HeinOnline database. Journal content, starting with Volume 8, is now available on the Westlaw database. (subscriptions required).

REGENERATIVE MEDICINE: AN INTRODUCTION
Dr. Anthony Atala, M.D.
9 Wake Forest Intell. Prop. L.J. 209

This introduction, by the symposium keynote speaker Dr. Atala, provides insight into the burgeoning field of regenerative medicine by discussing what regenerative medicine is, what has been accomplished in the field and what lies ahead in the future of the field. The Wake Forest Intellectual Property Law Journal’s 2009 Symposium “Regenerative Medicine” took place in February of 2009, and featured several speakers who discussed ethics of stem cell research, the patentability of the technology being utilized and the tissues and organs being regenerated, and how the research and technology will be commercialized and utilized in medicine. The introduction provides an overview of the regenerative medicine technology that served as the focus for the other topics explored by the Symposium’s distinguished group of speakers and authors.

ETHICAL ISSUES IN REGENERATIVE MEDICINE
Nancy M. P. King; Chris Nero Coughlin and Mark E. Furth
9 Wake Forest Intell. Prop. L.J. 215

“Regenerative medicine” describes a set of innovative approaches to the treatment of illness, injury, and disability, focusing on the growth, replacement, and repair of cells, organs, and tissues specific to the health needs of particular individuals. The extraordinary breadth of application of this approach is clear from an enumeration of just a few areas of regenerative medicine research, such as stem cells, including embryonic stem cells, pluripotent stem cells produced by genetic reprogramming, and multipotent stem cells from non-embryonic tissues; techniques for stimulating endogenous cell growth and repair for the kidney and pancreas in diabetes, or for digits and limbs injured as a result of trauma; and the growth of replacement tissues and organs, for example, blood vessels, hollow organs like the bladder, and even solid organs like the heart. This enormous diversity of applications, all currently in various stages of research and development, stems from a multidisciplinary research orientation incorporating genetics, informatics, basic research into the structure, mechanics, and development of different tissues, and creative production techniques. Despite its enormous promise, however, at this time regenerative medicine’s many applications constitute a very early step along the road to effective treatments.

Most of the attention to ethical issues in regenerative medicine has been consumed by debate about the use of human embryonic stem cells in research, specifically, the destruction of embryos in order to create cell lines, disputes over the role of federal funding for research with human embryonic stem cells, and concerns about the safety, scientific purity, and adequacy of consent for the research use of human embryonic stem cell lines. Like other novel biotechnologies, however, regenerative medicine raises a number of additional critical research ethics issues that are not new, but that have not yet been adequately addressed. Instead, as is common in new science, familiar and longstanding questions appear in the fresh context of regenerative medicine research and renew old debates. Advances in regenerative medicine therefore provide a much-needed opportunity to reexamine important issues in human subjects research. Moreover, because regenerative medicine has taken a thoroughgoing translational perspective, seeking to anticipate and plan for the issues (scientific, policy, and practical) that are likely to arise along the full research trajectory from bench to bedside to clinical product, it presents a model system for comprehensively identifying and addressing issues and needs in ethics and policy as they arise in translational research involving this developing science.

This article discusses some of the novel technologies within regenerative medicine. The article then examines the range of ethical issues raised by each novel regenerative medicine technology, including but not limited to: the ethics of research design; issues to consider in first-in-humans regenerative medicine research; and informed consent and the therapeutic misconception. The article further considers whether regenerative medicine helps to blur any distinction that may exist between medical treatment and enhancement, possibly creating more ethical issues to address in the long term. The article concludes by advising scholars and policymakers in bioethics to take the opportunity offered by regenerative medicine to move research ethics and policy forward by examining these issues anew through the lens of this groundbreaking medical science.

PATENT LAW AND REGENERATIVE MEDICINE: A CONSIDERATION OF THE CURRENT LAW AND PUBLIC POLICY CONCERNS REGARDING UPSTREAM PATENTS
Vincent J. Filliben III
9 Wake Forest Intell. Prop. L.J. 239

This article focuses on patentability issues concerning biotechnology, with specific emphasis on the status of patent law as it applies to regenerative medicine. The purpose of the article is to consider whether the United States’ protection of patents covering gene sequences and human embryonic stem cells is consistent with traditional patentability standards of patent law. In addition, the article provides an analysis of the impact and potential consequences of providing broad patent protection over what are, essentially, the building blocks of human life and essential keys to the progress of biotechnology.