Journal of Intellectual Property Law & Practice Advance Access published online on May 14, 2009
Journal of Intellectual Property Law & Practice, doi:10.1093/jiplp/jpp073
| ||||||||||||||||||||||||||||||||||||||||||||||||||
© The Author (2009). Published by Oxford University Press. All rights reserved.
Microbicide development: an argument for broadening the experimental use exception
Legal context: Microbicides, a female-controlled method for preventing the transmission of human immunodeficiency virus (HIV) and other sexually transmitted infections, have the potential of substantially mitigating the global HIV/AIDS pandemic. Despite growing support in the international community and among US policymakers, there are numerous IP challenges that researchers face in microbicide research and development. The experimental use exception, a common law exception to the US Patent Act, could potentially remedy many of the IP challenges that microbicide researchers face. However, the Federal Circuit's 2002 decision in Madey v Duke University [307 F.3d 1351, 1362 (Fed. Cir. 2002) (holding a research university liable for patent infringement for performing basic research with a patented laser)] so narrowly construed the experimental use exception that some experts claim for all intents and purposes it was rendered non-existent.
Key points: A narrow experimental use exception in the USA, juxtaposed against a broader experimental use exception abroad, causes scientists justified concern that research will be outsourced to other countries. This article argues that the case study of microbicide development provides a lens through which US lawmakers could reassess the scope of the experimental use exception in the USA.
Practical significance: In the current economic crisis, US lawmakers have the potential to implement laws, such as broadening the experimental use exception, to create a context in which scientists are given the freedom to innovate. US lawmakers must use this narrow window of opportunity to intervene in order to prevent the USA from continuing on its current trajectory to economic demise and global isolationism.
Correspondence: Email: rebecca.wolf{at}american.edu
* Rebecca L. Wolf is an International Access to Medicines Research Fellow at the Program on Information Justice and Intellectual Property (PIJIP). Ms. Wolf holds a Juris Doctor from American University Washington College of Law (as of May 24, 2009) and is a Master of Arts Candidate in International Affairs at American University School of International Service. She has primarily focused her studies on international law, health, and human rights. Ms. Wolf recently received the American University Award for Outstanding Scholarship at the Graduate Level 2009. She would like to thank Dr Fulvia Veronese and Dr Jim Turpin, microbicides experts, for providing helpful information regarding microbicide research and development (all statements provided are from their own perspectives, and should not be taken as representing the viewpoint of the Department, NIH, or NIAID). She would also like to thank Professor Sean Flynn, Professor Josh Sarnoff, and Tanya Woods for their scholarly input. She is ever grateful to her parents, William and Marie, and sister, Bonnie, for their unwavering love and support.