Sen. Chris Coons. Photo: Tierney L. Cross/Getty Images
Sen. Chris Coons plans to file an amendment to the PREVAIL Act during Thursday's Senate Judiciary markup aimed at addressing criticism that the legislation would largely benefit Big Pharma.
The big picture: Coons, the lead Democratic sponsor, said his amendment would enable patient advocacy groups and generic drug companies to bring challenges in administrative proceedings before the Patent Trial and Appeal Board.
What they're saying: "We have an amendment to specifically take that concern into account and address it," Coons told Axios when asked about the criticism that the pharmaceutical industry will disproportionately benefit from the bills.
Details: Amendment text shared with Axios would alter language in the PREVAIL Act to allow 501(c)(3)s or those with a genuine interest in competing, such as generic drug companies, to bring challenges before the board.
- The amendment is aimed at tamping down concerns that PREVAIL would close the patent board to "worthy challengers without undercutting PREVAIL's core purpose: making PTAB the faster, cheaper forum to litigate patent disputes that it was always meant to be," per a Coons spokesperson.
- The spokesperson also noted that the standing for patent challenges is "technology-agnostic" and the patent reform process is not just about pharmaceuticals.
What we're watching: Whether the clarifying language assuages the concerns.
- Patients for Affordable Drugs communications director Emma Sands said the group still opposes the legislation and that the amendment "fails to address the fundamental issues we have with the bill."
- "It's also unclear whether the changes would effectively resolve the concerns raised by nonprofits, universities, smaller orgs" and others, Sands said.
- A close vote in Judiciary could dampen the chance that the measures could be included in a year-end health package.
