ABSTRACT

Stem Cells ...................................................................................................260 17.4 United States Patent Climate: Why Obtaining Patent Protection for

Regenerative-Related Technology Is Problematic ...................................... 262 17.4.1 Early Stage Technologies and Speed ............................................... 262 17.4.2 Scrutiny ........................................................................................... 262 17.4.3 Competition ..................................................................................... 263

17.5 Strategies ..................................................................................................... 267 17.6 Regenerative Medicine Patent Landscape ..................................................268 17.7 Strategic Alliances and Partnership in Regenerative Medicine

Patent Landscape......................................................................................... 270 17.8 Wisconsin Alumni Research Foundation (WARF) Patents ........................ 270 17.9 Stem Cells ................................................................................................... 272 17.10 Human Embryonic Stem Cell Therapy Landscape..................................... 273 17.11 Non-Embryonic Stem Cell Landscape ........................................................ 273 17.12 Induced Pluripotent Stem Cell Patent Landscape ....................................... 274 17.13 Tissue Engineering and Replacement Organ Patent Landscape ................. 275 17.14 Conclusions ................................................................................................. 278 References .............................................................................................................. 279

In the United States, when one thinks of regenerative medicine, the –rst things that typically come to mind are embryonic stem cells and cloning. According to the National Institutes of Health (NIH), regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to disease , damage, congenital defects, or age (Regenerative Medicine 2006). Accordingly, the subject area is much broader than that initial impression and can include arti–cial skin, organ scaffolds, organ replacement and regeneration, etc. However, due to the politics and the public arguments surrounding the subject, the focus on embryonic stem cells and their use has exerted an effect that goes beyond the ability to obtain federal funding.