Foreign Price Controls: A Risk to U.S. Medical Innovation and Patient Access As policymakers consider the future of American healthcare, it is imperative to recognize the potential dangers of adopting foreign price controls for life-saving medications. These price controls, which are referred to as foreign “reference pricing,” would tie the price of medicines in the United States to prices set by foreign governments that are paid in other countries with vastly different healthcare systems. While this approach may initially sound appealing, the reality is that foreign reference pricing imports the failed models of other countries rather than rewarding innovation or recognizing the true value of breakthrough therapies. It pegs prices here to bureaucratic decisions made abroad and threatens to undermine the very engine of medical innovation that has made the United States a global leader in life sciences and benefited millions of patients.
https://ipwatchdog.com/2025/07..../13/foreign-price-co

Hatch-Waxman Safe Harbor: Lessons from Recent Court Precedent We recently wrote an introductory overview of navigating the Common Law Research Exemption and the Hatch-Waxman Safe Harbor and an exploration of the application of the Common Law Research Exemption. Here, we take a closer look at the Hatch-Waxman safe harbor under 35 U.S.C. § 271(e)(1), particularly through treatment by the courts over the past decade.
https://ipwatchdog.com/2025/06..../10/hatch-waxman-saf

The Impact of Price Controls and Biologics on the Future of U.S. Pharmaceutical Innovation and Investment Over the last several years the pharmaceutical industry has come under increased pressure. While many often say the pharmaceutical industry has the most powerful lobby, the truth is many politicians have grown increasingly frustrated with what they characterize as high drug prices; or at least much higher than in virtually every other country around the world. This has led to patents being blamed, with billboards and buses in Washington, DC, wrapped with slogans like “patents kill”.
https://ipwatchdog.com/2025/06..../08/impact-price-con

FTC Renews Campaign to Remove ‘Junk’ Inhaler and Device Patents from Orange Book Listings Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agency’s challenge to dozens of patent listings in the U.S. Food & Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. The FTC’s redoubled effort to improve consumer access to generic drugs by removing patent listings from the FDA’s list of approved New Drug Applications (NDAs), which continues under the FTC’s new Republican leadership, targets inhaler and drug delivery device patents without addressing decades of calls from the pharmaceutical industry seeking clarity on the guidelines for listing device patents in the Orange Book.
https://ipwatchdog.com/2025/05..../22/ftc-renews-campa

Navigating the Narrow Confines of the Common Law Experimental Use Exemption In a previous article, we analyzed the contours of the common law experimental use exemption. Now, we will explore the application of the exemption to common research activities, including those at universities and research institutions, in cases spanning recent decades. These cases illustrate the narrow confines of the experimental use exemption and its limited applicability in scenarios involving activities with direct or indirect commercial or business-related objectives. As a result, researchers should tread carefully and not count on the exemption to shield them from liability for patent infringement.   
https://ipwatchdog.com/2025/05..../20/navigating-narro