The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.
In a potential victory for drug pricing reform, the U.S. Senate on Thursday unanimously passed a pharma patent reform bill that could help promote generic and biosimilar competition for prescription drugs and lower their costs.
The bill, sponsored by Sens. John Cornyn (R-Tex.) and Richard Blumenthal (D-Ct.), limits the number of patents that pharma companies can assert in infringement litigations. These limits are “subject to exceptions and waivers” such as how long the product has secured regulatory approval from the FDA.
The original bill also prohibited product-hopping, which the senators defined as the industry practice of replacing an older product with a newer treatment that is covered by a later-expiring patent. However, the legislation that passed the Senate vote on Thursday did not include these prohibitions, according to Endpoints News.
The Pharmaceutical Care Management Association (PCMA) heralded the bill as “critical” to helping “end anti-competitive practices” including patent thickets, a common tactic of layering patents on top of a single product to extend its market protections and deter other companies from introducing generic or biosimilar versions.
Patent thickets “game the patent system, blocking more affordable generic and biosimilar options from entering the prescription drug market,” according to PCMA, a lobbying group that represents pharmacy benefit managers (PBM) across the U.S.
PCMA in its statement insisted that “patent abuse legislation should be the top consideration” in Congress’ campaign to lower drug prices. However, the Federal Trade Commission (FTC) released a report earlier this week pointing to PBMs as a major reason for inflated drug prices in the U.S.
According to the FTC’s interim report, PBMs “wield enormous power” over patients’ ability to afford drugs and “significantly influence what drugs are available and at what price.” The FTC is gearing up to sue the three biggest PBMS—CVS’ Caremark, UnitedHealth’s OptumRx and Cigna’s Express Scripts.
In addition to Coryn and Blumenthal’s bill, Sens. Peter Welch (D-Vt.), Mike Braun (R-Ind.) and Amy Klobuchar (D-Minn.) introduced similar legislation in January 2024 aiming to “streamline drug patent litigation” and promote competition to reduce drug prices. This bipartisan bill would allow pharma companies to assert only one patent per thicket in litigation.
