November 14, 2024
Thursday already, gang. And we have the latest on how a pair of patent bills that could affect drug manufacturing were abruptly pulled from a Senate markup this morning.
- We'll be back in your inbox Monday unless there's more breaking news before then, which definitely would not surprise us.
1 big thing: Patent overhaul bills pulled from markup
The Senate Judiciary Committee this morning pulled two controversial bills that would have altered the patent system with big implications for biotechs and pharmaceutical companies, Victoria reports.
Why it matters: It's a sign of lingering bipartisan concern over the PREVAIL and PERA acts, which critics view as friendly to pharmaceutical interests, and lowers their odds of being wrapped into a year-end deal.
What they're saying: Sponsors Chris Coons and Thom Tillis abruptly announced during a scheduled markup that the bills were being yanked because they needed more time to court support from panel members.
- Coons later said that two bill supporters he wouldn't identify were absent and that two others were still on the fence and needed more time to understand the issues better and possibly offer amendments.
- Sen. Marsha Blackburn asked for more time, and Sen. Ted Cruz was concerned about ways to make the patent process easier for small and independent inventors, Coons said at the hearing.
- Coons told reporters that most senators aren't up to speed on patent policy and that "there are some widely varying characterizations of the function and role of the [Patent Trial and Appeal Board], and I'm having to go to members individually and walk through here's what's true, here's what's happening."
Tillis told Victoria after the hearing that although he was hearing some eleventh-hour concerns from both sides of the aisle, he was committed to hearing them out and working on the legislation.
- "The people who didn't want this to move forward should not view today as a win," Tillis said. "They should view it as an indication that we've got momentum and I've got commitment."
Friction point: Democratic senators including Sen. Sheldon Whitehouse who've squared off with pharmaceutical interests declined to stake out a position on the bills this week.
- Coons acknowledged concerns of Sens. Peter Welch, Richard Blumenthal and Amy Klobuchar about the effects the bills could have on drug pricing, and the way PREVAIL could prevent generic competitors and patient advocates from using the patent board to challenge drugmakers' IP.
- But Coons said he had worked with those senators to address those concerns and had added amendments to fix those issues.
What's inside: Both PREVAIL and PERA could have significant ripple effects in the life sciences.
- The PREVAIL Act would raise the bar for challenging patents by requiring petitioners to have standing, either by having been sued or threatened with a patent infringement lawsuit.
- PERA would amend what kinds of inventions are eligible for patent protection and make it easier for certain scientific discoveries like gene therapies to be patented.
What we're watching: Whether Coons and Tillis can get enough support and have enough time on the calendar to reschedule another Senate Judiciary markup on the bills before the December recess.
- Both senators told Victoria they were going to push for another markup by the end of the year.
2. Cassidy to chair HELP panel with Rand Paul move
Sen. Bill Cassidy will be the HELP Committee chair next year after Sen. Rand Paul today opted to lead the Homeland Security and Governmental Affairs panel, Peter reports.
Why it matters: The move was expected and cements Cassidy's perch over health policy — an assignment the physician-lawmaker signaled he'll approach with enthusiasm.
- Paul's seniority made him the next Republican in line to claim the HELP gavel.
What they're saying: "I am excited to work closely with President Trump and my Republican colleagues to implement a pro-America agenda and deliver real solutions for Louisiana and American families," Cassidy said in a statement.
State of play: He did not get into his planned agenda for the committee.
- But there are clues, based on the array of white papers and requests for information he has put out, including on AI in health care, the 340B program and modernizing the NIH.
- Chris Gillott, Cassidy's longtime legislative director and now a principal at Invariant, pointed to "leveraging AI technology, protecting patient health information, and improving the functioning of NIH, CDC and FDA" as possible priorities.
- Robb Walton, a former health policy adviser to Cassidy who's now a principal at BGR Group, said he expects Cassidy to work with the new administration on setting priorities, and that the senator can be a "coalition builder" on bipartisan action outside of reconciliation.
Between the lines: Paul's ascension to the Homeland Security chairmanship also could have health care ramifications, including potential investigations into COVID-related matters.
- Paul also has concerns with the Biosecure Act that cracks down on Chinese biotech, which could pose a complication if the bill does not get done during the lame duck.
3. Catch me up: MAHA movement, hospitals' status
- MAHA movement: A sprawling drive built around concerns over the food supply and drug industry profiteering is poised to shake up health policy in the new Trump administration, Axios' Maya Goldman reports.
- Charity care: The American Medical Association voted to support stricter standards for determining which hospitals are eligible for tax-exempt status because of their charity care.
- Unneeded surgeries: Medicare spent $2 billion on unecessary back surgeries over three years, the Lown Institute found.
✅ Thank you for reading Axios Pro Policy, and thanks to editors Adriel Bettelheim and David Nather and copy editor Brad Bonhall. Do you know someone who needs this newsletter? Have them sign up here.
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