Intellectual Property/ Biosimilars
March 2009 Update
Akin, Gump, Strauss, Hauer, & Feld conducted a literature review on intellectual property law as it pertains to pharmaceuticals and biosimilars with a particular emphasis on how these rules could affect patients with chronic conditions. The literature review is a comprehensive guide for intellectual property law as it pertains to pharmaceuticals and for biosimilars and includes definitions of terms, background, history, and overview of existing laws. Balch Associates will conduct primary research including focus groups, in-depth-interviews, and message development/testing in early spring 2009. These reports will help us to direct, inform, and design our policy initiatives.
In addition to the literature review, Akin Gump analyzed proposed legislation on intellectual property law as it pertains to pharmaceuticals and on biosimilars and will continue this analysis throughout the 111th Congress. They also have developed two separate sets of domains and values to examine, screen, and compare legislation on both IP and biosimilars which will help us craft our own legislative language. It is uncertain at this juncture how Congress may move on this issue; however, the Council is ready to address any proposals.
Separate case studies reports are being developed using real people with chronic diseases to illustrate how intellectual property rules covering pharmaceuticals and proposed legislation to address biosimilars may affect patients. Our goal is to distribute these booklets to members of Congress in the spring 2009.
This initiative is funded by grants from AstraZeneca, BIO, Eli Lilly, Johnson & Johnson, Merck, PhRMA, Roche, and Wyeth Pharmaceuticals.
Staff contacts: Kevin Cain, Assistant Vice President, Government Affairs and Programs; Dorothy Weinstein, Director, Programs.
