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CLE materials for the IPPI 2026 Winter Institute: IP and National Success
For Panel 1: The U.S. as a Leader in Innovation and IP Policy
- Mark Cohen, “The Criminal Bias in U.S. Intellectual Property Diplomacy,” The National Bureau of Asian Research (July 22, 2021), https://www.nbr.org/publication/the-criminal-bias-in-u-s-intellectual-property-diplomacy/
- Mark Cohen, “The 600 Billion Dollar China IP Echo Chamber,” China IPR Blog (May 12, 2019), https://chinaipr.com/2019/05/12/the-600-billion-dollar-china-ip-echo-chamber/
- Mark Cohen, “An Update on Data-Driven Reports on China’s IP Enforcement Environment,” China IPR Blog (July 13, 2020), https://chinaipr.com/2020/07/13/an-update-on-data-driven-reports-on-chinas-ip-enforcement-environment/
- Mark A. Cohen, “Testimony of Mark A. Cohen, Senior Technology Fellow, Asia Society of Northern California and Senior Fellow, University of Akron School of Law” (October 8, 2025), https://www.judiciary.senate.gov/imo/media/doc/4539f98c-f893-95c0-3976-2519d3d06087/2025-10-08%20-%20Testimony%20-%20Cohen1.pdf
- U.S. Chamber of Commerce, “Our 2025 Special 301 Agenda: Reform, Enforcement, and Growth” (January 30, 2025), https://www.uschamber.com/intellectual-property/our-2025-special-301-agenda-reform-enforcement-and-growth
For Panel 2: Litigation Leadership
- Lionel M. Lavenue, Dr. Jochen Herr, LL.M., Daniel F. Seitz, Yi Yang, and Caitlin T. Coverstone, “Global Patent Litigation: Strategic Insights Across U.S., Germany, and China,” Finnegan (December 18, 2025), https://www.finnegan.com/en/insights/articles/global-patent-litigation-strategic-insights-across-us-germany-and-china.html
- Dani Kass, “Patent Litigation Trends To Watch In 2026,” Law360 (January 2, 2026), https://www.law360.com/articles/2423320/patent-litigation-trends-to-watch-in-2026
- Eileen McDermott, “Looking Forward to 2026: IP Predictions and Prospects for the Year Ahead,” IPWatchdog (January 1, 2026), https://ipwatchdog.com/2026/01/01/looking-forward-2026-ip-predictions-prospects-year-ahead/
- Kirti Gupta and Mark Cohen, “The New SEP Powerhouse: How China is Shaping Global Patent Disputes,” LeadershIP (May 7, 2025), https://ipleadership.org/the-new-sep-powerhouse-how-china-is-shaping-global-patent-disputes/
- Carlos Aboim, Gabriel Mathias, Youssef Yunes, and Ana Carolina Marques, “SEPs and War in the Courts: How Anti-Suit Injunctions and Interim Licenses Influenced Global Litigation in 2025,” IPWatchdog (December 30, 2025), https://ipwatchdog.com/2025/12/30/seps-war-courts-how-anti-suit-injunctions-interim-licenses-influenced-global-litigation-2025/
For Panel 3: The Future of the U.S. as a Life Sciences Innovator
Links to white papers, articles, and research relevant to panel topic covered by Tonya Combs (Eli Lilly and Company):
Key Statistics
- Generic usage (BRG): 19% (1984) to 90% (today)
- Generic savings (FDA): 80-85% lower than branded prices
- Average market exclusivity (C4IP): 13-14 years (constant over 20 years)
- Medicine development cost(Tufts): $2.6B average (Tufts University)
- Development timeframe (Tufts): ~10 years from early research to FDA approval
- Clinical trial failure rate (CBO): 88% of candidates fail, based on CBO report that only 12% succeed
- IRA impact (VitalTransformations): 68% drop in VC investment for small molecules
- Source: Duane G. Schulthess, Gwen O’Loughlin, Madeline Askeland, Daniel Gassull, and Harry P. Bowen, “The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments,” Therapeutic Innovation & Regulatory Science 59, 769–780 (April 13, 2025), https://doi.org/10.1007/s43441-025-00773-3
- Projected impact (UChicago): 188 fewer small molecule medicines over next 20 years
- Oncology follow-on indications (Patterson et al; Grabowski & Long; secondary source): 44% of post-approval indications for small molecule medicines were approved 7+ years after initial approval
- Sources:
- Henry Grabowski and Genia Long, “Post-approval indications and clinical trials for cardiovascular drugs: some implications of the US Inflation Reduction Act,” Journal of Medical Economics, 27(1), 463–472 (2024), https://doi.org/10.1080/13696998.2024.2323903
- Secondary source: Julie A. Patterson, James Motyka, Rayan Salih, Robert Nordyke, John M. O’Brien, and Jonathan D. Campbell, “Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act,” Therapeutic Innovation & Regulatory Science 59, 102–111 (2025), https://doi.org/10.1007/s43441-024-00706-6
- PBM/insurer share (BRG): Almost 60% of new brand spending (2022-2023)
- Manufacturer share (BRG): ~50% of total spending, down 16% (2013-2023)
- Lilly U.S. investment: ~$50 billion since 2020
- Industry U.S. investment at risk (CBO): Nearly $200 billion “government savings” at the expense of potential manufacturer investment
- Bipartisan polling (Teneo Market Research): 88% voters + 97% business leaders support strengthening IP
- U.S. medicine access (PhRMA/IQVIA): 85% vs. 52% Australia and Canada (since 2012)
- U.S. time-to-access advantage (PhRMA/IQVIA): 4-33 months earlier than other OECD countries
Key Research Citations
- USC Schaeffer Center: 10% revenue reduction leads to 15% fewer new drug approvals
- Post-approval RCT decline: 40% reduction in post-approval oncology clinical trials following IRA
- Source: Hanke Zheng, Julie A Patterson, and Jonathan D. Campbell, “Early impact of the Inflation Reduction Act on small molecule vs biologic post-approval oncology trials,” Health Affairs Scholar, Volume 3, Issue 8 (August 2025) qxaf152, https://doi.org/10.1093/haschl/qxaf152
- USPTO 2024 Study (C4IP): Multiple patents common across industries, especially complex products
- University of Chicago: $232B R&D reduction projection, 188 fewer medicines
- PhRMA/BRG Study: 50.5% of every dollar spent on brand medicines goes to middlemen, providers, payers, etc.
- Teneo Market Research: Bipartisan IP support (88% voters, 97% business leaders)
- Tufts University: $2.6B average development cost
- ICER/USC Schaeffer: Value-based obesity treatment pricing: $635-$1000/month
For Panel 4: IP and the Startup Economy
- Alliance of U.S. Startups & Inventors for Jobs (USIJ), “USIJ Comments re NPRM – Dkt. No. PTO-P-2025-0025” (December 2, 2025), https://usij.org/wp-content/uploads/2025/12/USIJ-Response-Request-for-Comment-on-NPRM-12.2.25.pdf
- Provided by Robert P. Taylor. Paper filed in response to the USPTO’s Notice of Proposed Rulemaking dated October 17, 2025, related to proposed procedures for dealing with petitions for IPR.
- Zvi S. Rosen, Examining Copyright, 69 J. Copyright Society, 481, (2022), https://copyrightsociety.org/journal-entries/examining-copyright/
- Mark F. Schultz, “Declining Patent Reliability and Venture Capital Reallocation,” Forthcoming in Bringing Medicines to Life: How Intellectual Property Enables Innovation in the Life Sciences, eds. Jonathan M. Barnett and Bowman Heiden, Cambridge University Press 2026, http://blogs.uakron.edu/ualawip/wp-content/uploads/sites/1670/2026/02/Schultz-Declining-Patent-Reliability-and-Venture-Capital-Reallocation.pdf
For Panel 5: Copyright, AI, and National Competitiveness
- Jéssica Dutra and Robert Stoner of Secretariat, Copyright Industries in the U.S. Economy: The 2024 Report, prepared for the International Intellectual Property Alliance (IIPA) (December 2024), https://www.iipa.org/files/uploads/2025/02/IIPA-Copyright-Industries-in-the-U.S.-Economy-Report-2024_ONLINE_FINAL.pdf
- Available on www.iipa.org
- In 2023, the value added by the core copyright industries to U.S. GDP reached more than $2 trillion dollars ($2,096.31 billion), accounting for 7.66% of the U.S. economy. In 2023, the value added by the total copyright industries to GDP4 exceeded $3.3 trillion ($3,369.08 billion), accounting for 12.31% of the U.S. economy.
- Graham Allison, “The National Insecurity of AI,” Aspen Strategy Group (October 16, 2024), https://www.belfercenter.org/research-analysis/national-insecurity-ai
- “For the first decade after the explosion of atomic bombs destroyed Hiroshima and Nagasaki forcing Japan to surrender in WWII, the smartest scientists and strategists in the world grappled with the question of what this meant for strategy, statecraft, and the future of international order. Read what they said and wrote, and examine what they actually did.” (Accessed 2/10/26)
- Maria Pallante, Mary Rasenberger, and Danielle Coffey, “Generative AI is generating astronomical profits by trampling authors and publishers,” The Hill (April 26, 2024), https://thehill.com/opinion/4624330-generative-ai-is-generating-astronomical-profits-by-trampling-authors-and-publishers/
- “As Congress well knows, copyright is a fundamentally important right authorized explicitly by the U.S. Constitution, not a minor inconvenience that can be disregarded by downstream inventors or investors. Copyright is the means by which authors and publishers are incentivized to write, publish, inspire and inform— crucial roles that are more essential than ever in the face of numerous, serious threats to democracy.” (Accessed 2/11/26)
- “[T]he AI Perspectives of U.S Publishers,” Association of American Publishers (March 15, 2025), https://publishers.org/wp-content/uploads/2025/03/White-House-AI-Action-Plan-Association-of-American-Publishers.pdf
- “Global AI leadership goes hand in hand with global copyright leadership. Several countries have framed copyright protection as an impediment to AI development. These countries do not have the IP markets of the United States. By upholding U.S. intellectual property—including the copyright laws that protect and incentivize the ongoing investments of publishers and authors— the United States can signal to other nations that they must not weaken their own copyright laws…At stake are the livelihoods of all creators who have helped to make the United States the leading voice on intellectual property in the digital age and who are integral to the future success of lawful AI products.”