Senate Judiciary Committee Advances Pharma Patent Bills IP Advocacy Says are Backed by Faulty Data
“While Senator Lee agreed that minimizing sham petitions would be beneficial, he argued that legislating such a presumption would turn a company’s day in court into ‘a blunted opportunity for due process.'”
The U.S. Senate Committee on the Judiciary on Thursday convened an executive business meeting during which the full committee voted on a series of six drug patent-related bills towards a vote on the full floor of the Senate. While many of these bills were hailed by committee members as strong steps toward reining in consumer drug prices, the perceived problems addressed by these bills have been fomented by controversial data reports, leading to questions as to whether these bills will achieve their intended cost reductions without negatively impacting the next generation of pharmaceutical innovation.
Senator Lee Amendments to Stop STALLING Act Fail Roll Call Vote
“For too long, consumers have been at the mercy of drug companies that can keep prices high by blocking competition and abusing the system,” said Judiciary Committee Chair Senator Chuck Grassley (R-IA) during his opening remarks. Grassley noted that these bills were reported favorably by the Senate Judiciary Committee during previous sessions of Congress. He added that “we cannot solve this country’s issues if we can’t come together more than two and a half days a week to do business.” Senator Mazie Hirono, D-HI, expressed her support for all the proposed bills but raised concerns about the Federal Trade Commission (FTC)’s ability to carry out various investigative and enforcement activities as these bills would mandate. Senator Grassley pointed out that, despite the Trump Administration’s decision of firing two Democratic commissioners at the FTC, the agency has reportedly halted its legal proceedings against the major pharmacy benefit managers (PBMs). This is because 16 CFR SS 4.14.
gives the FTC the authority to operate and conduct business with fewer than 5 commissioners. Lee’s amendment to S.1040 (the Drug Competition Enhancement Act) would allow companies who are taken to court over allegedly hopping from one patent to another to extend market exclusivity – which the bill would define as anticompetitive behaviour – to show that the new product represents an improvement in safety, efficacy or patient care. S.1040 with Lee’s amendment was approved via voice vote by the full committee.
Cornyn Comments on Humira Patents Show Continued Reliance on I-MAK Data
Lee’s proposed amendments to S.1095, the Stop STALLING Act, did not fare as successfully. One amendment would have removed the presumption in the bill that citizen petitions submitted to the U.S. Food & Drug Administration by the Secretary of Health & Human Services are shams. Lee acknowledged that reducing sham requests would be beneficial but argued that the legislation would reduce the opportunity for a company to receive due process. Another Lee amendment proposed that civil penalties would be capped by the net profits of the drug sales that were referenced in the sham request, not the revenue from those sales. Again urging against overcorrection, Lee contended that the threat of losing all net profits from drug sales was a sufficient deterrent to prevent companies from using the FDA petitioning process to delay generic approval.
Senator Amy Klobuchar (D-MN) dismissed Lee’s concerns, arguing that both amendments would significantly weaken the Stop STALLING Act’s eventual impact. She argued that limiting civil penalties to net profit would allow pharmaceutical companies retain salaries and bonuses for those involved in sham-petition schemes. Removing the bill’s provision regarding the sham-petition presumption, would reduce the FTC reliance on HHS Secretary’s conclusions. Lee responded by saying that the bill’s current language could lead to an unfair “gotcha” moment in court, denying companies the right to due process. The Senate Judiciary Committee members may have the best of intentions, but comments made at the meeting show that data sets that are biased against drug patent holders continue to influence lawmaker decisions. Cornyn, who was commenting on S.1041, The Affordable Prescriptions for Patient Act, said that limiting biological patents asserted as evidence in an infringement lawsuit would help to address overpatenting. “One of the most notorious examples of this is the case of a manufacturer who has filed… closer than 130 patents on a single drug,” Cornyn stated. Professor Adam Mossoff questioned I-MAK data in early 2022 in a Hudson Institute policy memo, which found inconsistencies in I-MAK patent totals compared to those reported by government sources. After Senator Thom Tillis, R-NC, requested additional information about the underlying data in June last year, the FDA and U.S. Patent and Trademark Office released a report that IP stakeholders claimed proved I-MAK’s manipulation of data.
Steve Brachmann graduated from the University at Buffalo School of Law in May 2022, earning his Juris Doctor. He served as the president of the Intellectual
