Sterne Kessler Obtains Preliminary Injunction Win in Hatch-Waxman Case on Behalf of American Regent

Washington, D.C. (July 15, 2025) – A team from Sterne, Kessler, Goldstein & Fox PLLC has secured a rare preliminary injunction win in a Hatch-Waxman case on behalf of American Regent. The decision in In re: Selenious Acid Litigation (D. N.J., Case No. 2:24-7791-BRM-CLW) protects one of only a handful of branded products from American Regent, an industry-leading injectable drug manufacturer.

In his decision, Judge Brian Martinotti of the U.S. District Court for the District of New Jersey ruled that American Regent had shown a likelihood of success on the merits. Specifically, Judge Martinotti held that Defendants failed to raise a substantial question that the patents are invalid for lack of written description or were likely not to be infringed. The Court also found that absent an injunction prior to trial, American Regent would be irreparably harmed and that the balance of equities and public interest favored an injunction.

The Sterne Kessler team representing American Regent includes Directors Dennies Varughese, Uma Everett, and Robert Millonig; Counsel Christina Dashe; Associates Adil Moghal, Andrew Barnett, Ryan Conkin, Maddie Richards, and Madeleine Bond; and Student Associate Lais Ghiraldeli.

To read the injunction order, please click here.

About Sterne, Kessler, Goldstein & Fox

Based in Washington, D.C. and renowned for more than four decades for dedication to the protection, enhancement, and enforcement of intellectual property rights, Sterne, Kessler, Goldstein & Fox is one of the most highly regarded intellectual property specialty law firms in the world. Its team of attorneys, registered patent agents, technical specialists, specialized trademark paralegals, and law clerks include some of the country’s most respected practitioners of IP law, tackling innovations across a broad spectrum of industries. The firm’s practitioners represent Fortune 500 companies, entrepreneurs, start-ups, inventors, venture capital firms, and universities in a client service driven environment that is welcoming, inclusive, and intellectually stimulating. Visit the firm online at sternekessler.com.