Technical corrections only. The engrossed version of the bill removes an extraneous period, cleans up cross-reference formatting, and updates a section title by removing a non-substantive phrase. No substantive policy changes were made between v2 and v3.
Affordable Prescriptions for Patients Act
- Sponsor
- Sen. Cornyn, John [R-TX]
- Committees
- Judiciary Committee (primary)
- Last action
- Jul 21, 2026
Bottom line
This bill aims to streamline patent litigation for biological products, potentially accelerating the market entry of biosimilars by limiting the scope of patent disputes initiated by brand-name manufacturers.
What it actually does
This bill amends Title 35 of the U.S. Code to limit the number of patents a brand-name biological product manufacturer (reference product sponsor) can assert in an infringement lawsuit against a biosimilar applicant. It sets a cap of 20 patents, with further restrictions on patents issued more than 4 years after product approval or those claiming manufacturing methods not used by the sponsor. The bill also specifies conditions under which this limit can be increased by a court or does not apply, notably exempting method-of-use patents from the cap.
Proponents argue
Supporters argue that this bill will curb 'patent thicketing' and 'evergreening' tactics by brand-name pharmaceutical companies, which use large numbers of patents to delay biosimilar competition. By limiting the number of patents that can be asserted in litigation, it will reduce legal costs and accelerate the availability of more affordable biosimilar drugs, ultimately benefiting patients and healthcare costs.
Opponents contend
Opponents, typically brand-name pharmaceutical companies and their allies, contend that limiting patent assertions undermines intellectual property rights and discourages innovation. They argue that complex biological products require extensive patent protection to incentivize the massive R&D investments needed to bring new therapies to market, and that this bill could weaken those protections, leading to fewer new drug discoveries.
The bill is short but its legal and technical nature requires careful reading to understand its implications for patent law and the pharmaceutical industry.
Section 2(a)(1), amending 35 U.S.C. 271(e)(2)
Broadening Scope of Infringement for Biosimilar Applications
This provision clarifies that when a biosimilar applicant submits an application, the act of infringement extends not only to patents claiming the biological product or its use, but also to patents claiming a method or product used to manufacture the biological product. This expands the types of patents that can be considered infringed by a biosimilar application, offering broader protection to brand-name manufacturers.
Supporters argue
Supporters of this specific clarification argue it ensures comprehensive protection for the complex intellectual property involved in biological product manufacturing, incentivizing innovation in production methods.
Critics contend
Critics might argue that this broadens the scope of potential litigation, potentially making it harder for biosimilar applicants to navigate the patent landscape and increasing legal costs.
Tradeoffs
Balances the desire to protect manufacturing process innovation with the goal of facilitating biosimilar market entry.
Section 2(a)(2), adding 35 U.S.C. 271(e)(7)(A)
Cap on Patents Asserted in Biosimilar Infringement Actions
This provision limits the reference product sponsor to asserting a total of not more than 20 patents in an infringement action against a biosimilar applicant. Furthermore, no more than 10 of these patents can have issued after a specific date (defined in 42 U.S.C. 262(l)(7)(A)), which typically relates to the initial patent exchange process. This aims to prevent overwhelming biosimilar applicants with excessive patent claims.
Section 2(a)(2), adding 35 U.S.C. 271(e)(7)(B)
Defining Eligible Patents for Assertion Cap
This section specifies that the patents subject to the 20-patent limit must claim the biological product (or its use) or a manufacturing method/product, be included on the patent list exchanged during the biosimilar application process (under 42 U.S.C. 262(l)(3)(A)), and either have an actual filing date more than 4 years after the reference product's approval or include a claim to a manufacturing method not used by the reference product sponsor. These criteria aim to focus the cap on patents potentially used for delaying tactics.
Section 2(a)(2), adding 35 U.S.C. 271(e)(7)(C) and (D)
Judicial Discretion to Increase Asserted Patent Cap
A court may increase the 20-patent limit if the request is made without undue delay and if 'the interest of justice so requires' or 'for good cause shown.' Good cause can be established if the biosimilar applicant fails to provide required information, or may be established due to material changes in the biosimilar product, delays in patent issuance by the USPTO, or other reasons deemed appropriate by the court. This provides a safety valve for exceptional circumstances.
Section 2(a)(2), adding 35 U.S.C. 271(e)(7)(E)
Biosimilar Applicant Compliance for Patent Cap to Apply
The 20-patent limitation only applies if the biosimilar applicant completes all required actions under specific paragraphs of section 351(l) of the Public Health Service Act, which govern the information exchange and patent dispute resolution process ('patent dance'). Additionally, the limitation does not apply to patents claiming methods of using the biological product in therapy, diagnosis, or prophylaxis (e.g., indications or methods of treatment).
The limitation on the number of asserted patents (the 20-patent cap) shall not apply with respect to any patent that claims a method for using the biological product in therapy, diagnosis, or prophylaxis, such as an indication or method of treatment or other condition of use.
Section 2(a)(2), adding 35 U.S.C. 271(e)(7)(E)(ii)
Why it matters:This is standard legislative practice to define the scope and exceptions of a new rule. However, it's also a substantively important carve-out that could significantly impact the bill's overall effect on biosimilar competition.
Case for: Proponents would argue that this exception is necessary to protect innovation in new uses or indications for existing biological products, which often require significant R&D and clinical trials. Without this protection, companies might be less incentivized to pursue new applications for their drugs.
Case against: Critics might argue that this exception could be exploited by brand-name manufacturers to maintain market exclusivity through 'evergreening' by continually developing and patenting new, minor indications, even after the primary product patents have expired or been challenged. This could still delay biosimilar entry.
Estimated impact: This provision could allow brand-name manufacturers to continue asserting a potentially unlimited number of method-of-use patents, even if their product patents are capped, thereby reducing the overall impact of the 20-patent limit on biosimilar market entry.