Illustration: Shoshana Gordon/Axios
Senators and consumer groups are growing frustrated that patent overhaul bills aimed at lowering drug prices have languished despite bipartisan support over multiple congresses.
Why it matters: The measures amount to low-hanging fruit in broader efforts to lower health care costs. They target drug industry attempts to game the patent system that nearly all senators think should be stopped.
- But although the bills have advanced out of the Senate Judiciary Committee, there's not a clear path to signing them into law.
Driving the news: The measures were again approved by Judiciary with strong bipartisan votes this month.
- One bill targets "patent thickets," in which manufacturers take out an array of patents on the same product, which can delay competition from cheaper generic drugs.
- Another bill would crack down on "product hopping," a practice that critics say drug companies use to make small tweaks to a drug to extend its period of market exclusivity.
- A third would target "pay for delay" deals, in which a branded drug company pays a generic company to delay entry of a competitor drug.
Yes, but: Senate Judiciary marked up similar bills on a bipartisan basis in the last Congress, and they did not make it into law. Some have been repeatedly introduced dating to the first Trump administration.
- The frustration was on display at the latest markup.
- "What's wrong with the Senate meeting five days a week so we can get some of this legislation [done] and be more than just a confirming body for members of the executive branch of government?" asked Chair Chuck Grassley.
- Sen. Amy Klobuchar introduced her pay-for-delay bill by saying "This is our pay-for-delay bill that we've been delayed on for, I don't know, 10 years."
Between the lines: A big reason for the delay is that narrow bills like these tend not to be brought up for floor debate, which would eat up time in the Senate, but instead are candidates for must-pass packages like a spending bill.
- Even a handful of objections can prevent inclusion in a big package, and some of these bills do face a smattering of concerns.
- Sens. Mike Lee and Chris Coons, for example, worried that promising new treatments could get swept up in the crackdown on product hopping.
- And House Republicans generally have had less interest in these measures than their Senate counterparts.
The big picture: Part of the issue stems not from the particulars of the bills but from broader congressional dysfunction.
- For example, lawmakers last year decided that the patent thicket bill had the broadest support. Indeed, the full Senate passed it by unanimous consent, a rarity for a health bill of any consequence.
- It was wrapped into the broader health package attached to the December government funding deal, but President Trump and Elon Musk subsequently blew it up.
What they're saying: Pharmaceutical industry opposition to the bills also remains an obstacle.
- "It's frustrating," Merith Basey, executive director of Patients for Affordable Drugs, said of the delay. "We do still see a path forward. But I think the reality is that pharma is working pretty hard to kill these bills."
- PhRMA objects in particular to the product hopping measure, which it says would hinder innovations that occur after the initial FDA approval of a drug.
- "We are concerned about policies that could undermine the value of our intellectual property system, such as placing limits on lawfully issued patents, which threatens the very foundation of our nation's ability to foster meaningful medical advancements," said PhRMA spokesperson Andrew Powaleny.
What's next: Basey expressed hope that the executive order on drug pricing that Trump issued this week would highlight the issue and ignite action on the Hill.
- The order didn't dwell on patent issues but did call for increasing the availability of generics and biosimilars and referenced how corporations can profit by keeping health care business practices concealed.
- "We prevailed for the public against Big Pharma with the Medicare price negotiation bill, and these bills are a critical next step in lowering costs across the board," Klobuchar said in a statement.
