World IP Day 2025: Preserving America's Leadership in Biopharmaceutical Innovation

This Saturday, we observe World Intellectual Property Day, a moment to reflect on how intellectual property (IP) rights enable innovation to flourish. In the United States, a robust intellectual property system is the engine of innovation, propelling the nation to the forefront of global medical science.

Over the past several decades, IP protections have driven the development of thousands of new therapies for serious conditions such as cancer, heart disease, and rare diseases. These breakthroughs are possible because innovators have the legal protection and confidence to invest in developing new treatments; on average it takes 10-15 years and around $2.2 billion to bring a new therapy to market.

To learn more about why strong intellectual property protections are essential to medical innovation check out a previous blog from WWFH’s Executive Director Dan Leonard: 10 Reasons Biopharma Innovation Needs Strong IP Protections.

The American IP system has long struck a delicate but effective balance between encouraging innovation and ensuring affordability—thanks to thoughtful, bipartisan policymaking. But today, that balance is at risk due to policy proposals driven by misconceptions.

Congress is considering legislation that threatens to undermine the intellectual property framework that has made America the global leader in biopharmaceutical innovation for generations. These changes are driven by misleading narratives about the role of patent protections in developing new treatments. For example, critics wrongly claim that manufacturers routinely engage in a practice known as “product hopping” where a company makes minor changes to already FDA-approved medications to maintain market exclusivity. These claims ignore the role of post-approval research & development (R&D) in bringing improved dosage forms and formulations of existing medicines and disregard the fact that IP protections on these innovations do not prevent generic or biosimilars of earlier versions from coming to market.  

A robust IP system is a cornerstone of American medical innovation. It’s what enables the R&D necessary to discover transformative treatments that improve and save lives. This carefully balanced system has fostered breakthrough therapies for previously untreatable conditions while simultaneously creating pathways for generic competition when patents expire.

To learn more about why lawmakers should reject these misguided proposals, check out a blog post from earlier this month: Protecting Innovation and Patient Access: Why Congress Must Reject Anti-Patent Legislation.

Bringing Policy Back to Reality—With a Real Solution

Rather than pursue sweeping changes that risk weakening the IP system, policymakers should focus on the real barriers to patient access and affordability. As WWFH Co-Chair Tom Kowalski emphasized in a recent blog post, misguided policies like the Inflation Reduction Act’s “pill penalty” may discourage investment in small molecule drugs—some of the most cost-effective and innovative treatments available. Thankfully, a recently re-introduced piece of legislation, the Ensuing Pathways to Innovative Cures (EPIC) Act, offers a solution by leveling the playing field around small molecule drugs and biologic drugs before price setting can start.

This World IP Day, let’s remember what IP protections are really about: ensuring patients have access to life-saving treatments today, while paving the way for tomorrow’s medical breakthroughs.

Learn more about the importance of IP protections in pharmaceutical innovation at weworkforhealth.org/ip