The Senate Judiciary Committee has voted to advance a comprehensive package of six bipartisan bills designed to address rising pharmaceutical costs and enhance market competition. The legislation targets multiple aspects of the drug pricing ecosystem, from patent strategies to pharmacy benefit manager (PBM) practices, signaling a potential shift in the regulatory landscape for the pharmaceutical industry.
The bills collectively aim to close loopholes that critics argue have allowed pharmaceutical companies to maintain high prices by delaying generic and biosimilar competition. Notably, all six bills received support from both Republican and Democratic committee members, increasing their chances of consideration by the full Senate.
Patent Limitations for Biologics Litigation
The Affordable Prescriptions for Patients Act would establish new constraints on patent litigation involving biologics. Under the proposed legislation, reference product sponsors would be limited to asserting no more than 20 patents in Biologics Price Competition and Innovation Act (BPCIA) litigation against biosimilar applicants.
This cap addresses concerns about "patent thickets" – large portfolios of patents that can overwhelm potential competitors with litigation costs. Importantly, the bill includes exceptions for certain patents, such as method of treatment patents, and allows courts to approve additional patent assertions beyond the 20-patent limit in appropriate circumstances.
Clarifying Boundaries for Settlement Agreements
Building on the Supreme Court's 2013 decision in FTC v. Watson that prohibited certain "pay-for-delay" agreements, the Preserve Access to Affordable Generics and Biosimilars Act would establish clearer guidelines for permissible settlements in pharmaceutical patent disputes.
The legislation would grant the Federal Trade Commission (FTC) specific authority to pursue civil actions against companies engaging in anticompetitive settlement practices. It creates a presumption that agreements providing "anything of value" to generic or biosimilar applicants are anticompetitive, though with notable exceptions.
Settlement terms that would remain permissible include agreements on pre-expiration launch dates, reasonable litigation expense reimbursement, and covenants not to sue for patent infringement.
Preventing "Product Hopping" Tactics
The Drug Competition Enhancement Act targets the controversial practice known as "product hopping," where branded manufacturers introduce new patented formulations while withdrawing or disadvantaging older versions to impede generic competition.
The bill defines two forms of potentially anticompetitive behavior: "hard switches," where manufacturers discontinue older products around the time of generic approval, and "soft switches," where companies take actions that "unfairly disadvantage" existing products relative to follow-on versions.
If enacted, these practices would be classified as unfair competition subject to enforcement actions, though the legislation includes specific exclusions for legitimate product improvements and business justifications.
Curbing Misuse of FDA Citizen Petitions
The Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act addresses perceived abuses of the FDA's citizen petition process. Some pharmaceutical companies have been accused of filing petitions primarily to delay generic approvals rather than to address legitimate safety concerns.
The bill would empower the FTC to bring civil actions against entities filing "sham petitions," with substantial penalties of up to $50,000 per day or the revenue earned from the branded product, whichever is greater. Petitions could be classified as shams based on objective unreasonableness, intent to delay generic approval, or as part of a pattern of similar filings.
Improving Patent Quality Through Agency Coordination
The Interagency Patent Coordination and Improvement Act seeks to enhance patent quality by facilitating information sharing between the FDA and the U.S. Patent and Trademark Office (USPTO). The legislation would establish a joint task force to develop processes for patent examiners to access relevant information from FDA applications while maintaining appropriate confidentiality protections.
This coordination aims to address situations where information relevant to patentability may be submitted to the FDA but not disclosed to patent examiners. The bill specifically highlights the potential to improve determinations about prior public availability of inventions.
Increasing Transparency in the Pharmaceutical Supply Chain
The final bill in the package, the Prescription Pricing for the People Act, would require the FTC to publish a comprehensive report analyzing the pharmaceutical supply chain, with particular focus on PBM pricing practices. The legislation directs the FTC to describe complaints received about sole-source drug manufacturers and evaluate the agency's existing authority to address anticompetitive behavior in the pharmaceutical market.
Industry stakeholders have expressed mixed reactions to the legislative package. Pharmaceutical Research and Manufacturers of America (PhRMA) has raised concerns that some provisions could undermine innovation incentives, while the Association for Accessible Medicines, representing generic manufacturers, has generally supported the measures aimed at increasing competition.
Healthcare policy experts note that while these bills address important aspects of drug pricing, they represent just one part of a complex ecosystem that influences pharmaceutical costs. The legislation now moves to the full Senate for consideration, though the timing for a floor vote remains uncertain.
