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

Latest Trump Executive Order Redirects Drug Pricing Debate On Sunday, May 11, President Donald Trump announced on Truth Social that he would sign an Executive Order today aimed at lowering prescription drug prices. The order refocuses the drug pricing debate, which often is centered around patents, on “equalizing” pricing among developed nations.    In his social media post, Trump blamed pharmaceutical companies for chalking up the high price of drugs in the United States to research and development costs. “It was always difficult to explain and very embarrassing because, in fact, there was no correct or rightful answer,” Trump wrote. He also implied that Democrats have resisted efforts to lower prices due to campaign contributions from the industry and said the Order signed today will reduce drug prices “almost immediately, by 30% to 80%” via a “most favored nations” policy that will mandate U.S. citizens pay the same price as the nation paying the lowest price.
https://ipwatchdog.com/2025/05..../12/latest-trump-exe