Senator Thom Tillis plans to put his USPTO-FDA collaboration bill to a full Senate vote before the end of the year, sources revealed to Managing IP this week.
The bill, which the Senate Judiciary Committee passed unanimously in July, would amend Section 2c of the US Code to allow the USPTO director to create an interagency task force on patents between the office and the Food and Drug Administration (FDA), if enacted.
One government source said the North Carolina senator had been emboldened by the broad support received for the Interagency Patent Coordination and Improvement Act at the committee stage, and that he wanted to seize on the momentum generated before 2023.
“I would encourage you to look at the markup for the bill. One senator called it a ‘simple good governance bill’, while another asked why such a law didn’t already exist.
“It certainly has a good chance of getting through if it’s brought to the full Senate before December 31.”
Tillis’s staff appeared to confirm this ambition. The senator’s communications director, Adam Webb, said Tillis hoped the legislation would pass this year.
“This bill will increase communication and collaboration between the USPTO and FDA, which will ultimately benefit our patent system and its respective stakeholders, and promotes good governance,” he said.
Webb didn’t comment on the bill’s likelihood of passing, despite being asked.
At the Senate Judiciary Committee meeting in July, Senator Sheldon Whitehouse called the legislation a “simple good governance bill”. Senator Jon Ossoff said he’d like to co-sponsor the legislation and that it would reduce prescription drug prices.
Tillis and Senators Dick Durbin and Chuck Grassley introduced the Interagency Patent Coordination and Improvement Act in June in an effort to increase pharmaceutical competition and lower drug prices.
Along with various goals, the legislation was designed to identify and reduce instances of conflicting statements from pharma companies to the FDA and USPTO.
The argument went that pharma firms would tell the FDA their drugs were similar to previously approved drugs to reduce regulatory hurdles, while at the same time informing the USPTO their products were sufficiently different to warrant patent protection.
The newly created task force would carry out certain activities, such as sharing information through workshops or training sessions on the general processes of both agencies, including the information reviewed in applications filed at either agency.
Information sharing would also cover new patent approvals, new human drugs and biological products, new technologies and prior art, and new scientific trends and developments.
Should the Senate pass the bill, as predicted, it would need approval from the House of Representatives before becoming law.
Republicans are now projected to become the majority party in the House next year.
