A Senate panel has advanced three sets of bipartisan bills purportedly aimed at reforming the intellectual property (IP) landscape and lowering the cost of prescription drugs. Together, these bills seek to address issues with product hopping and patent thickets. The bills also seek to improve the efficiency of patent examiners and Food and Drug Administration (FDA) officials, as well as pharmaceutical logistics, through the creation of specific task forces. Despite their well-meaning goals, however, these bills may actually introduce new challenges for innovators trying to secure and protect their valuable IP.
The first set of bills may pose risks for drug manufacturers seeking to introduce follow-on products and enforce existing IP by targeting so-called anticompetitive tactics that allegedly delay the entry of generic drugs and biosimilars into the market. For example, the Drug Competition Enhancement Act (Bill S 1040) aims to prohibit “product hopping” by preventing manufacturers from withdrawing an original drug product from the market when launching a follow-on version and from marketing newer versions in ways that may disadvantage generics. The bill grants the Federal Trade Commission (FTC) authority to enforce these restrictions. Similarly, the Affordable Prescriptions for Patients Act (Bill S 1041) targets “patent thickets” by capping the number of patents manufacturers of brand-name biologics may assert against biosimilar competitors. While the bill permits an increase in asserted patents if the manufacturer shows “good cause,” it may still burden manufacturers of brand-name biologics by limiting their ability to protect IP through legitimate patent groupings.
The second set of bills may create obstacles for pharmaceutical companies looking to avoid costly litigation with generic firms or to submit citizen petitions to the FDA voicing legitimate safety concerns regarding generic drugs. For example, the Stop STALLING Act (Bill S 1095) allows the FTC to penalize companies for filing citizen petitions with the FDA if the FTC determines that the filings were intended solely to delay generic approval (e.g.,filed at the 11th hour with no substantial evidence backing any assertion of safety concerns). The Preserve Access to Affordable Generics and Biosimilars Act (Bill S 1096) seeks to ban so-called pay-for-delay deals—in which makers of brand-name drugs compensate generic or biosimilar competitors to delay product launches—by establishing a presumption of anticompetitive behavior in such cases. In line with prior court decisions, however, the bill recognizes that these agreements may be legitimate when they are part of litigation settlements or other pro-competitive arrangements.
The final two bills—namely, the Interagency Patent Coordination and Improvement Act of 2025 (Bill S 1097) and the Prescription Pricing for the People Act of 2025 (Bill S 527)—aim to improve efficiency and transparency in the pharmaceutical sector. Bill S 1097 calls for a collaborative task force between the US Patent and Trademark Office and the FDA to enhance the exchange of information relevant to pharmaceutical patents, such as drug labeling updates and approval histories. Meanwhile, Bill S. 527 directs the FTC to investigate the role of intermediaries like pharmacy benefit managers in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations.
The proposed bills reflect a broad bipartisan effort to address long-standing concerns in IP. The enactment of these prospective laws, however, may create challenges for innovators and brand-name manufacturers. Pharmaceutical companies will need to remain informed and consider these proposed changes as they develop and secure strong IP portfolios.
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