Cape News

U.S. Senators Josh Hawley, Peter Welch, and Amy Klobuchar have introduced the ETHIC Act to address what they describe as "patent thickets" in the pharmaceutical industry. This legislation aims to curb practices by large pharmaceutical companies that may drive up drug prices and limit market access for generic drugs.

Senator Hawley stated, "Big Pharma knows exactly what it’s doing in monopolizing the U.S. patent system: driving up drug costs for Americans while preventing generic-drug manufacturers from getting their foot in the market." He described the bill as a means to dismantle these anticompetitive structures.

Senator Welch emphasized the impact on consumers, particularly those paying high out-of-pocket costs for necessary medications. "For decades, Big Pharma has exploited U.S. courts and the patent system through anti-competitive practices," he said, adding that this legislation could help reduce drug costs nationwide.

The ETHIC Act targets complex webs of patents—referred to as "patent thickets"—that can protect a single drug with numerous overlapping patents. These patents cover various aspects such as compounds and manufacturing processes, potentially extending exclusivity periods beyond initial expirations.

If enacted, this legislation would restrict how pharmaceutical companies use patents against generic competitors and could result in savings of $16 billion over ten years. It would apply specifically to patents related to generic and biosimilar drug manufacturers without affecting other industries.

One provision allows only one patent per 'terminally disclaimed group' against competitors; if one is invalidated in court, all similar patents would also be nullified.