It is an honor to participate in this conversation among such a distinguished group of scientists and policy makers about the future of stem cell research. As you know, for many years, stem cell research has been embroiled in ethical and political controversy. Moral objections to the destruction of human embryos in the process of embryonic stem cell research has created a political firestorm, resulting in limitations on research funding in the United States and limitations on patent rights abroad.

Beginning in 2006, however, induced pluripotent stem cells have raised the tantalizing possibility that stem cell research could move forward without the significant moral and ethical dilemmas that have paralyzed the field. These cells, known as iPS cells, originate from adult somatic cells, but function in a manner that is almost equivalent to embryonic stem cells. Somatic cells are human cells other than sperm, ova, or the cells from which sperm and ova are
made. Examples include, cells from skin, bones, blood, and connective tissue.¹ Thus, if iPS cell research lives up to its promise, stem cell research, diagnostics, and treatment could be performed by inducing skin cells, for example, to return to a state similar to the state in which they existed in the embryo. This could be accomplished without destroying or in any way interfering with human embryos or their development.

Although much scientific research lies ahead before iPS cell technology can produce reliable and sustainable results, the emergence of iPS cell technology is indeed a historic event. As the research involving iPS cells continues to emerge, it is worth taking a moment to think about the rights that are available for protection under the American patent law system, and the obstacles that lie ahead in obtaining those rights.

While we may be entering a historic moment in stem cell research, we are also facing a historic period in American patent law. Of the five key principles of patentability, three are currently in flux, creating challenges for those who would navigate the system. In the brief space allotted here, we will survey the shifting landscape in American patent law, as it may affect the rights available to iPS cell inventors. This brief overview may serve not only as an alert for scientists in the field, but also as a reminder to those of us in the patent world that our failure to resolve doctrinal uncertainties can have a tangible effect on scientific research.

For the purposes of this symposium, this piece is intended to provide a basic understanding of the legal landscape for those in the science field and a basic understanding of the scientific landscape for those in the legal field. Part II describes the science involved in current iPS cell research. The section includes historic background on stem cell research, an overview of the reprogramming process, a description of five factors that are affecting development in the iPS stem cell research arena, and an explanation of additional scientific challenges in the field.

Part III of the piece describes the legal landscape. It explains why stem cell lines are patentable in the first place, and describes the types of innovations that are potentially patentable in iPS cell technology. This part then identifies three elements of patent law that are currently in flux. It explains the implications of these uncertainties for the types of patent claims that are likely to arise from iPS cell innovation.