Tag Archives: FDA

Watch: Strategies for In-House Counsel Selecting Trademarks for Pharmaceuticals and Biologics

Naming pharmaceutical and biologic products presents unique challenges from both trademark and regulatory perspectives. In addition to the traditional marketing goals of trademark selection, companies evaluating names for medications must also consider safety issues, false advertising concerns, and more. Importantly, pharmaceutical trademarks must pass muster not only with the Patent and Trademark Office (PTO), but also with the Food and Drug Administration (FDA). The recent advent of a market for biosimilars presents new questions and challenges.… More

A Difference With A Distinction: The Second Circuit Upholds Preliminary Injunction In Parallel Imports Case

twIn Abbott Laboratories, et al. v. H&H Wholesale Services, Inc., et al., the United States Court of Appeals for the Second Circuit affirmed a preliminary injunction issued in a trademark case focused on the parallel importation of diabetes test strips.  One defendant had hoped to overturn the injunction order by arguing that its place in the supply chain shielded it from direct liability for consumer confusion. … More

FDA Issues Final Guidance on Proprietary Names for Drugs and Biological Products

Dozens of prescription medicine bottles in a jumble. This collection of pill bottles is symbolic of the many medications senior adults and chronically ill people take.

The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency’s evaluation process for proposed proprietary names for drug and biological products.  The guidance applies to all prescription and nonprescription drug products, innovator and generic drug products, and biological products.  Drug products that may be legally marketed without an approved application are excluded (e.g., OTC drugs legally marketed under a tentative or final monograph). … More

Supreme Court Paves The Way For Lanham Act Claims Against FDA-Regulated Competitors

pomThe Supreme Court issued a unanimous decision last week in Pom Wonderful LLC v. Coca-Cola Co., a case pitting the false advertising provisions of the Lanham Act against the beverage labeling standards of the federal Food Drug & Cosmetics Act (FDCA).  Pom Wonderful, maker of 100% pomegranate juice and other pomegranate-based products, brought false advertising claims against Coca-Cola, accusing its Minute Maid Pomegranate Blueberry drink of misleading consumers into believing they were drinking more pomegranate and blueberry juice than they in fact were. … More

Milk Dud? False Advertising Lawsuit Against Makers of Muscle Milk Illustrates Interplay Between Lanham Act, FTC and FDA

MM1In a lawsuit recently filed in the Southern District of Florida, Global Beverage Enterprises, Inc. (“Global”), the manufacturer of specialty carbonated beverages like Mr. Q. Cumber Sparkling Cucumber Beverage, brought Lanham Act claims against CytoSport, Inc., alleging false advertising of CytoSport’s popular Muscle Milk line of beverages.  The basis of the claim is that the Muscle Milk beverages contain no milk and, therefore, the product name is false and misleading. … More

Mind Your Xs and Zs: Are These Letters Too Common in Pharmaceutical Trademarks?

x and z 

An interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA) regarding whether the letters X and Z are used too frequently in pharmaceutical trademarks.

As most of our readers are well aware, the touchstone of whether any two trademarks can coexist in the U.S. — on the United States Patent and Trademark Office (PTO) registers and in the marketplace —… More