McDonnell Boehnen Hulbert & Berghoff LLP partner Dr. Kevin E. Noonan authored a book chapter entitled, “The Patenting Landscape for Human Embryonic Stem Cells.” The chapter appears in a book entitled, “Regenerative Medicine Ethics,” that was published in early 2014 by Springer Science+Business Media. Patent protection in regenerative medicine, like patenting generally in biomedicine, is an area fraught with controversy over the past decade. For a time, patent eligibility, particularly in the USA, was broadly granted based on expansive language from the US Supreme Court’s decision in Diamond v. Chakrabarty, 447 U.S. 303. Although the U.S. Patent and Trademark Office has relied on that language for more than 30 years, recently some have questioned the wisdom of providing patent protection for human-derived molecules. These include composition of matter claims to molecules such as DNA as well as claims to diagnostic methods. Opposition to such patents has arisen for religious and political grounds, but also based on a fear that patenting may inhibit innovation in this area. While there is little empirical support for this sentiment, the fear persists and can influence courts and policymakers. In this chapter Dr. Noonan provides a review of some of these issues and how they have affected patent protection in regenerative medicine. He begins by reviewing some key elements of patents, particularly as they relate to patenting living biological entities. A brief history of efforts to patent stem cells and reaction to these efforts follows, including the application of the US law from legislative actions regarding federal funding of stem cell research, Congressional patent reform activities and recent relevant court cases in the USA and Europe. Future prospects are also discussed. View the chapter