Republicans and Democrats on the Senate Judiciary Committee on Tuesday both acknowledged the need for further reforms on how pharma patents are reviewed and how the system functions.
The issue of drug patent reform appears to have brought members from both sides of the aisle together. Senators said at Tuesday’s hearing that they were inundated with stories from their home states on unaffordable medicines. There was a frequent mention of AbbVie’s Humira, the blockbuster drug that has become a poster child for patent thickets — webs of legal protection that can delay the entry of competitor drugs.
While no Republicans voted for the Inflation Reduction Act’s drug price negotiations when they passed in 2022, Sen. Lindsay Graham (R-SC) and others made clear that they think the patent system is being abused. Others offered similar sentiments to advance a series of reforms that some of the witnesses argued don’t go far enough.
“You don’t think there’s a problem with pharmaceutical companies playing games to keep generics out of the market?” Graham asked PhRMA VP Jocelyn Ulrich during the hearing.
Ulrich said she thinks “that the system has the correct checks and balances in place.”
“Yeah, well I don’t,” Graham responded. “And count me in on trying to fix that.”
Other senators like John Cornyn (R-TX), John Kennedy (R-LA) and Peter Welch (D-VT) pushed for Senate Majority Leader Chuck Schumer (D-NY) to bring five bipartisan bills to the floor for a vote.
The bills, passed out of the Judiciary Committee in February 2023, would increase interagency coordination between FDA and the US Patent and Trademark Office (PTO) on pharma patents, prohibit pay-for-delay deals between generic and brand name companies, ban product hopping, and cut out baseless citizen petitions that can slow generic or biosimilar competition.
Other witnesses suggested that the government could do a better job making sure that irrelevant patents are never listed in the FDA’s Orange Book by committing to a more thorough review.
“The FDA currently serves a purely ministerial role,” said William Feldman, associate physician at Harvard’s Brigham and Women’s Hospital. “It doesn’t look at the data. The companies can submit whatever they want. Give the FDA the authority and the resources to review patents.”
On product hops, which often occur when companies reformulate a brand-name drug to extend their monopoly, Feldman also testified that the bill may not go far enough.
“Although product hops may occur well ahead of generic drug applications, this bill could help limit at least some forms of product hopping designed to stifle generic competition,” he wrote in his written testimony.
PhRMA, meanwhile, pushed back on the idea of a closer relationship between the FDA and PTO.
“There have been discussions and legislation proposed about requiring enhanced collaboration between the USPTO and FDA. Data have not been presented suggesting there is a systemic issue warranting such legislation,” Ulrich wrote in her testimony.