Hassan urges FTA, patent office to act to move generic drugs to market faster

May 26—Citing worry about "patents of questionable validity," Sens. Maggie Hassan, D-N.H., and Bill Cassidy, R-La., are urging closer cooperation between the Food and Drug Administration and the U.S. Patent and Trademark Office.

Generic drugs are typically cheaper than brand names, but patenting drugs lets drug companies keep generics off the market for several years — in theory, allowing drug companies to recoup the cost of researching and developing a new drug, and make a profit.

But in a letter sent Wednesday to the director of the patent office and the commissioner of the FDA, Cassidy and Hassan argue that drug companies are gaming this process and filing new patents on existing drugs to keep competitors out of the market for longer.

Hassan and Cassidy's letter raises the prospect that drug makers are giving conflicting information to the FDA and the patent office, and that some of the patents on medications may not be valid.

For example, the senators wrote, a manufacturer cannot submit a patent application for a process it has already been using for a year or more — but the senators said the patent office has granted patents for processes that drug makers told the FDA have been in use for a year.

There is a process for the patent office and the FDA to talk to each other, the senators wrote. "However, the lines of communication between the agencies appear not to be working," they wrote.

They asked several questions about how the agencies communicate, and urged more coordination.

Hassan and Cassidy have worked together on issues related to generic drugs before. Last year, President Joe Biden signed into law a bill introduced by the pair that directs the FDA to create a website to educate providers and patients on generic versions of biologic drugs, known as "biosimilars."