Innovation and IP Challenges in Key Sectors: Insights from LeadershIP 2025

By Anne Pritchett

I recently had the pleasure of moderating a panel at the 2025 LeadershIP Conference, featuring experts across sectors discussing innovation and intellectual property (IP) challenges inside and outside the United States. The conversation focused on the current state of the U.S. and global IP systems, key challenges for innovators both in the United States and abroad, as well as potential policy solutions to promote innovation and U.S. economic security.

Panelists included:

• Tom DiLenge, Senior Partner, Global Public Policy, Regulatory & Governmental Strategy at Flagship Pioneering
• Hemal Shah, Senior Director for Trade and IP policy at Gilead Sciences
• Dr. Stephen J. Susalka, Chief Executive Officer of AUTM;
• Laurie Self, Senior Vice President and Counsel of Government Affairs at Qualcomm.

These panelists represented key IP-intensive sectors that are not only critical to innovation but also drive significant economic growth. According to one report, IP-intensive industries represent 41 percent of U.S. gross domestic product, while IP-intensive manufacturing industries account for over 83 percent of U.S. manufacturing research and development (R&D) investment – five times more than non-IP-intensive industries. R&D investment per employee in IP-intensive manufacturing industries averages more than 12 times that of non-IP-intensive manufacturing industries. Such R&D investment is a determinant of IP intensity and, frankly, is dependent on the certainty provided by IP rights.

The U.S. innovation ecosystem is built on a foundation of strong IP protections and robust tech transfer policies. These policies reward investment in areas with great scientific and technological promise yet great uncertainty by providing predictability and fostering collaboration as well as competition. These economic impacts include:

• The software industry adds more than $1.4 trillion per year to the U.S. economy.
• The biopharmaceutical industry, from small start-ups to multinational firms, contributes $1.65 trillion in economic output in the United States alone while supporting 4.5 million jobs.
• In the biosciences more broadly, the industry’s economic impact has risen to more than $3.2 trillion.
• Through the licensing of patents, university inventors and nonprofits contributed up to $1.9 trillion to the U.S. economy and supported 6.5 million jobs over the last 25 years.

These figures reinforce the central point that strong IP rights underpin U.S. leadership in innovation— from biopharmaceuticals to software to aerospace and many other areas.

Key Policy Challenges and Solutions

As U.S. policymakers grapple with how to maintain and grow U.S. economic strength, resilience, and global competitiveness, the panel reinforced recommendations from a new CSIS report that urges the Administration to reinforce strong IP rights as a cornerstone of U.S. economic and national security.

Laurie Self raised the important role that U.S. trade policy has historically played as a signaling effect through statements of support for strong IP rights. She spoke to how different administrations and Congress have, over time, equivocated about the importance of IP rights, and how that can lead other countries to be less respectful of and potentially discriminatory towards U.S. IP owners. Hemal Shah discussed the negative signals sent by the prior Administration in supporting the World Trade Organization’s TRIPS waiver for COVID-19 vaccines and praised the new U.S. Trade Representative’s positive references to IP protection at his nomination hearing and the Trump Administration’s recognition that IP was not a barrier to COVID-19 vaccine access and that use of such a waiver could disincentivize the development of future treatments and cures.

The panelists also discussed the need for additional education of policymakers on the value and importance of IP and to address myths and misconceptions. Tom DiLenge, for example, said the most fundamental misunderstanding he has seen perpetuated for decades is the notion that patents create unfair monopolies to prevent competition, when, in fact, they promote competition to the point where in the biopharma sector, brand medicines often face brand-to-brand competition in less than two years. He also noted that the second- and third-in-class medicines are often better treatment options for patients than the first-in-class medicines and would not be possible without patents.

Steve Susalka highlighted the lack of appreciation for the economic impact of technology transfer. He cited AUTM data that each year, 900 to 1,000 start-ups are responsible for a wide range of early-stage technologies that contribute to societal health, economic growth, and national security—all outgrowths of successful tech transfer resulting from strong IP protections that allow innovations to advance towards application and commercialization. Hemal Shah added that within the biopharma space, IP enables a wide range of collaborations with suppliers and small and large firms, as well as allows voluntary licensing to trusted partners to support broader access to medicines around the globe.

All of the panelists reinforced key findings from the recently released CSIS report: as Laurie Self put it, “we live at a point in time where economic security and national security are inextricably linked and that technology leadership is the crown jewel…and that you cannot have a coherent innovation, economic security, and national security policy from a U.S. perspective without intellectual property as a cornerstone.”

The Road Ahead

Looking forward, the panel called on the new Administration and Congress to make strong IP rights a strategic priority, noting that IP cannot be treated as ancillary or an impediment to innovation policy. The panelists outlined several additional areas of opportunity for the Trump Administration and Congress, including:

• Strengthening IP rights to incentivize R&D leadership, which is linked to growing U.S. manufacturing.
• The need for U.S. leadership in global standard-setting organizations, such as 3GPP (the Third-Generation Partnership Project, the lead standards body for developing foundational cellular technologies). Such organizations provide a rule-of-law-based system that allows new technologies to advance based on merit while addressing IP polices that enable licensing.
• Reinforcing the role and value of the Bayh-Dole Act, including ensuring that the march-in right provisions are not used inappropriately as an effort by government to control prices in any sector.
• The need to modernize IP policies for artificial intelligence (AI), particularly given the role of AI technologies in supporting resilient and secure supply chains. Some were concerned that the United States’ definition of what’s patentable is much more narrow than other countries’; others underscored  that the U.S. could fall further behind from a globally competitive standpoint, particularly in the area of generative AI, which can play a key role in drug development and technologies developed by the software industry.

Conclusion

All the panelists agreed: the United States is engaged in a competition for technological and innovation leadership with China and other nations, and the United States must make strong IP rights a strategic priority, not an afterthought. Strong, clear, and consistent IP policies—through strong trade policies and engagement in key multilateral organizations—are foundational to supporting the robust U.S. innovation ecosystem that not only generates substantial societal benefits but also sustains and grows the U.S. economy.

Anne Pritchett, PhD, is a senior associate (non-resident) with Renewing American Innovation at the Center for Strategic and International Studies and President of Pritchett Policy Associates, LLC.

This piece was originally published on April 15th with the Renewing American Innovation Project at the Center for Strategic and International Studies in Washington, D.C.