Patents, Drug Prices, Clinical Trials and the Economics of Medicine | IPWatchdog Unleashed

This week on IPWatchdog Unleashed, I spoke with Brent Bellows, a partner with Knowles Intellectual Property Strategies (KIPS). We discussed a variety of issues including Hatch-Waxman, Orange Book listings, paragraph IV certifications, skinny labels, generic entry, clinical trial costs, regulatory exclusivity, and the enormous financial risk associated with bringing new drugs to market. Gene and Brent explore the tension between public demand for lower drug prices and the need for durable incentives that make high-risk drug development economically viable, particularly for oncology, Alzheimer’s, Parkinson’s, antibiotic resistant bacteria, and other difficult-to-treat conditions. The episode closes with a broader innovation-policy message: patents are not a peripheral feature of drug development—they are a core operating asset that enables private-sector investment, supports breakthrough therapies, and ultimately drives the availability of future generic medicines.

CAFC Says ‘Words of Approximation’ in Patent Claims Must Be Sufficiently Explained to Avoid Indefiniteness

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday in a precedential decision authored by Judge Lourie affirmed a district court’s ruling determining certain claims of Enviro Tech Chemical Services, Inc.’s patent for a method of poultry treatment indefinite. Enviro Tech’s U.S. Patent No.10,912,321is titled “Methods of Using Peracetic Acid to Treat Poultry in a Chill Tank During Processing.” Enviro Tech sued Safe Foods Corp. for infringement of a number of claims of the patent in the U.S. District Court for the Eastern District of Arkansas.

EU Returns to Special 301 Report’s Watch List for First Time Since 2006

On April 30, the Office of the U.S. Trade Representative (USTR) released this year’s Special 301 Report, which surveys the effectiveness of intellectual property (IP) rights and enforcement abroad and identifies foreign nations where IP protections are uncertain or disregarded. The 2026 report marks the first time in 13 years that a Priority Foreign Country (PFC) has been named, with Vietnam being identified as a PFC for persistent failures to address several long-standing IP concerns. The USTR has also added the European Union (EU) to the Special 301 Report’s Watch List, the first time since 2006 that the continental government has been identified for IP-related concerns in addition to individual European nations.

What the USPTO’s Reexamination Remand for HID Means for Estoppel, Timing and Strategy

The U.S. Patent and Trademark Office (USPTO) issued a significant Decision on Remand on Monday, April 27, 2026, clarifying when estoppel under 35 U.S.C. § 315(e)(1) attaches and—critically—what it means to “request” a proceeding “before the Office.” The ruling arises from an increasingly common set of circumstances—HID had initially filed an inter partes review (IPR) against CPC Patent Technologies’ U.S. Patent No. 9,665,705, and subsequently requested ex parte reexamination requests of that same patent. Monday’s decision clarifies that a party is estopped from “requesting” ex parte reexam at the moment the IPR final written decision issues when the USPTO has yet to order ex parte reexam.

Other Barks & Bites for Friday, May 1: EU Lands on USTR’s Special 301 Watch List; Battery Recycling Patent Families Increase Seven-Fold in Past Decade; and Google Cert Petition Challenges Settled Expectations Doctrine

This week in Other Barks & Bites: the U.S. Trade Representative issues its annual Special 301 Report listing the European Union as a Watch List nation for IP-related issues; Senators Dick Durbin (D-IL) and Maria Cantwell (D-WA) publicly oppose the Trump Administration’s decisions to cut federal funding for science and upend the National Science Board; and more.

UNC Charlotte Highlights the Power of Invention at 2026 Invention of the Year Awards

The University of North Carolina at Charlotte brought together leaders from government, academia, industry, and the defense community for its 2026 Invention of the Year Awards, an evening that showcased the university’s growing role as a national engine of innovation, commercialization, and technological impact.

The Latest Attempt to Expose SAWS Highlights Structural Flaws at the USPTO

Whether or not the United States Patent and Trademark Office (USPTO) wants to admit it, over most of the last generation there has been a secret examination docket. Not surprisingly, such a secret examination docket is strictly prohibited by federal law. A newly filed joint status report in Morinville v. USPTO brings this issue to the fore and underscores the lack of transparency and accountability of secret internal patent review programs at the USPTO. Procedurally, the latest filing seeks to expose the USPTO shadow docket through a new round of discovery, which is currently being considered by the United States District Court for the District of Columbia.

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