Protecting Innovation and Patient Access: Why Congress Must Reject Anti-Patent Legislation

Innovation often comes in increments. The first smartphones could not record video or take front-facing photos, and there certainly was no Face ID – something that’s hard to fathom today.

Life science innovation in the United States is no different. Unfortunately, however, the intellectual property framework that has led to this innovation is at risk, much to China’s delight.

As the Senate Judiciary Committee prepares for its upcoming markup session, lawmakers are preparing to consider several pieces of legislation that threaten to undermine the intellectual property framework that has made America the global leader in biopharmaceutical innovation for generations.

These bills are based on 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 intellectual property (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.

Should this type of innovation not come from the U.S., it will come from elsewhere.

China, for one, would eagerly fill that void. China has been red-flagged by the Office of the United States Trade Representative’s annual Special 301 report every year since 1989, actively working to expose any weakness in the U.S. ecosystem.

Legislation that disincentivizes R&D effectively weakens America’s innovative life sciences and opens the door for China to make up ground. Stakes are high. A recent study found the U.S. bioscience industry exceeded $3.2 trillion in economic impact in 2023, employing more than 2.2 million Americans.

Our global leadership in medical innovation is not guaranteed—it requires consistent policy support and robust IP protections that reward risk-taking and breakthrough discoveries.

Before eroding U.S. intellectual property rights, Washington would be wise to consider the ripple effect any such legislation will have. The health of our nation—and our economy—depends on preserving the IP framework that continues to deliver life-changing innovations to patients worldwide and ensures we remain competitive against rising global challengers.