S1041

The Affordable Prescriptions for Patients Act (S1041) was introduced in the Senate on March 13, 2025, by Senator Cornyn (R-TX) with bipartisan cosponsors including Senators Blumenthal, Grassley, and Durbin. It passed the Senate on April 10, 2025, and was received in the House on July 21, 2026, where it is currently held at the desk. The bill amends Title 35 of the U.S. Code to limit the number of patents that a biologic drug manufacturer (reference product sponsor) can assert in a patent infringement lawsuit against a biosimilar applicant. Specifically, the sponsor may assert no more than 20 patents total, with no more than 10 that issued after a certain date. This directly targets the practice of 'patent thickets' that delay biosimilar entry. The bill does not authorize or appropriate any funding; it changes the rules of patent litigation. The mechanism is a statutory cap on patent assertions, which reduces the cost and uncertainty for biosimilar developers. The obligated parties are originator biologic companies (e.g., AbbVie, Johnson & Johnson, Roche) that must now prioritize which patents to assert. The direct consequence is that biosimilar applicants face lower legal barriers, enabling faster market entry and increased competition. The convergence with related bills S891 (Bipartisan Health Care Act) and HR1768 (Lower Costs for Everyday Americans Act) indicates a broader congressional focus on reducing prescription drug costs. While these bills have different specific mechanisms, they share the objective of lowering healthcare expenses, creating a supportive legislative environment for biosimilar competition. Structural winners are pure-play biosimilar companies like Coherus ($CHRS), which have no originator revenue to lose and stand to gain from accelerated biosimilar launches. Amgen ($AMGN) is a more complex case: its biosimilar business benefits, but its originator portfolio faces headwinds. However, given Amgen's strategic shift toward biosimilars, the net effect is positive. Losers include originator-heavy companies with large patent portfolios, such as AbbVie ($ABBV) and Johnson & Johnson ($JNJ), which may see earlier biosimilar competition. The timeline: The bill is in the House, where it may be referred to committee or brought to a vote. Given bipartisan support and the current legislative calendar, passage in the 119th Congress is plausible but not guaranteed. Investors should monitor House action.