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Tag Archives: Follow-on Biologics
IP Professors: 12-Year Data Exclusivity a Win-Win for Patient Access & Biotech Innovation
David E. Adelman of the University of Texas School of Law and Christopher M. Holman of the University of Missouri – Kansas City School of Law recently published analysis on the “sideshow” of the data exclusivity debate in Washington.
Adelman and Holman use a cost-benefit analysis that incorporates the most important legal precedents and case law today in concluding that “policymakers should focus on mitigating the systematic barriers to entry that pose much greater and longer-term obstacles to lower-cost biotech drugs.” Specifically, the draft paper provides solid analysis of the need for 12-year data exclusivity, which the authors describe as a perfect balance between providing access to important medicines to patients, and creating the incentives needed for investors and companies to prepare (and survive) the regulatory approval process for follow-on biologics.
House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars
House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars Strong bipartisan support for inclusion of pathway in health care reform legislation Washington, D.C. (July 31, 2009) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the approval of an amendment to create a regulatory pathway for biosimilars by the House Energy and Commerce Committee in today’s mark-up of the America’s Affordable Health Choices Act Read More >
BIO CEO: Patient Groups Join Call for Data Protection
Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies.
For July 4: Let’s Thank the Inventors
My hope for America this July 4? I hope, in 100 years, the response time to human and environmental suffering will be immediate. Until that day arrives (thanks to scientific breakthroughs funded by individual citizens) — let’s thank our scientists, investors, and inventors who work and play around us.
Finally, let’s also thank the founding fathers for knowing America’s innovative potential without seeing it for themselves.
Holman: Follow-on Biologics Bill Threatens Innovation By Weakening Patent Rights
Chris Holman, Professor at the University of Missouri-Kansas City School of Law and author of Holman’s Biotech IP Blog, recently posted a great summary of the patent provisions in the follow-on biologics bill currently under consideration in Congress.
