On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.), and Dick Durbin (D-Ill.). Passage of one or both may alter patent portfolio management and patent litigation strategy for pharmaceuticals and biologics.
The Affordable Prescriptions for Patients Act
The first of these bills, the Affordable Prescriptions for Patients Act,[1] is intended to target so-called “patent thickets.” The Act limits the number of patents a branded drug company can bring into an infringement suit involving biosimilars. A “patent thicket” refers to the practice of covering a product with an overlapping set of patent rights, forcing those seeking to commercialize that product to obtain multiple licenses or risk infringing multiple patents.
The Affordable Prescriptions for Patients Act would limit a branded biologic maker to a total of no more than 20 patents in an infringement action against a generic biologic maker. The Act further limits the number of patents that can be asserted based on their dates of issuance. Also included, however, are provisions to enable courts to increase the total number of patents allowed into the litigation under certain circumstances.
A version of this bill passed the Senate in 2024, but was never voted on in the House of Representatives.[2]
The Drug Competition Enhancement Act
The second bill, the Drug Competition Enhancement Act,[3] targets so-called “product hopping” in response to an abbreviated new drug application or biosimilar biological product license application by making it a violation of the Federal Trade Commission Act. According to the Federal Trade Commission,[4] “[p]roduct hopping is a strategy where a brand-name pharmaceutical company seeks to shift demand from a brand-name drug that faces generic competition to newly patented and/or exclusivity protected drugs that do not face generic competition.” A company could do this by, for example, making non-therapeutic changes to a drug or biological product, patenting those changes, and shifting consumer demand to that new product.
Editor: Brenden S. Gingrich. Ph.D.
[1] Affordable Prescriptions for Patients Act of 2025, S. ___, 119th Cong. (2025) (https://www.grassley.senate.gov/imo/media/doc/affordable_prescriptions_for_patients_act.pdf).
[2] Affordable Prescriptions for Patients Act of 2023, S. 150, 118th Cong. (2023–2024) (https://www.congress.gov/bill/118th-congress/senate-bill/150/all-actions).
[3] Drug Competition Enhancement Act of 2025, S. ___, 119th Cong. (2025) (https://www.judiciary.senate.gov/imo/media/doc/drug_competition_enhancement_act.pdf).
[4] Report on Pharmaceutical Product Hopping, Federal Trade Commission (Oct. 2022) (https://www.ftc.gov/system/files/ftc_gov/pdf/p223900reportpharmaceuticalproducthoppingoct2022.pdf).
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