PATENT BILLS HELD OVER — The Senate Judiciary Committee again held over two patent bills Thursday that have drawn opposition from patient advocacy groups focused on lowering drug costs. The bills were initially scheduled to be marked up in September, but the panel delayed action for a week — a common practice for the committee. Lawmakers then left town early before the October recess to beat Hurricane Helene, which hit the Gulf Coast. The legislation: One measure would overhaul the patent review process at the Patent Trial and Appeal Board to require petitioners to have standing — namely, to have been sued or charged with patent infringement before filing for a review. The second would expand the processes eligible for patents to include “a use, application, or method of manufacture of a known or naturally-occurring process.” Both bills are led by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.). The pair said they’re making progress on winning over support from committee members but need more time to address concerns raised by some colleagues. Each senator suggested that outside groups are misrepresenting what the bills would do. “It’s going to get marked up, so those who may be trying to undermine progress of either [bill] … need to get at the table before they get on the table,” Tillis said. Coming attractions: Coons said he’s drafted a manager’s amendment to the PTAB bill to incorporate provisions to address concerns from three Democrats — Sens. Richard Blumenthal (D-Conn.), Amy Klobuchar (D-Minn.) and Peter Welch (D-Vt.) — that the measure’s standing requirement would preclude generic drugmakers and patient advocates from challenging patents at the agency. Lobbying groups for both interests have said the bills would make it easier for big drug companies to use the patent system to their advantage. Two Republicans — Sens. Ted Cruz (R-Texas) and Marsha Blackburn (R-Tenn.) — asked Coons to delay a vote on the bill so they could continue negotiating potential amendments, the Delaware Democrat said, adding he hopes to advance it at the panel’s next markup. PANDEMIC LESSONS LEARNED — Top officials from the CDC, the FDA and the NIH told lawmakers Thursday the lessons they learned during the pandemic response and how they’ll apply them in the future, at the final hearing of the House Select Subcommittee on the Coronavirus Pandemic. Dr. Henry Walke, the CDC’s Office of Readiness and Response Director, said his institution released guidance that was too technical for the public to understand during Covid and the agency has since improved its communication. It’s done the same for its test development process, which famously failed in the pandemic’s early days. Now, the CDC is trying to work with other partners to develop tests for avian influenza and oropouche, a viral tropical infection reported in parts of Central and South America and the Caribbean. Dr. Hillary Marston, the FDA’s chief medical officer, said the agency has found ways to better mitigate supply disruptions leading to drug and medical device shortages, which were also prominent in the pandemic’s early days. Lawrence Tabak, NIH’s principal deputy director, said the agency has improved its oversight system for awarded grants. That came after documents the select subcommittee released showed one grantee, the EcoHealth Alliance, did not fully comply with reporting requirements over its NIH-funded work with a virology lab in Wuhan, China, the city where the pandemic started. The lab has been at the center of a theory that the virus that caused the pandemic came from a lab accident, not an infected animal. Why it matters: While the hearing aimed to showcase how to be better prepared for the next pandemic, the steps agencies took to address their shortcomings while responding to Covid might not matter as a new Trump administration prepares to take over in January. Kennedy said this weekend he would replace 600 people at the NIH, ABC reported. He also wants to fire the FDA’s nutrition workforce, which he believes has failed at regulating food to keep Americans healthy.
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