Affordable Prescriptions for Patients Act
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Would limit the number of patents a brand-name biologic drug maker can assert in a patent infringement lawsuit against a company seeking to sell a lower-cost biosimilar version of that drug, capping the total at 20 eligible patents — with no more than 10 filed more than four years after the original drug's market approval.
The bill targets a practice known as 'patent thickets,' where brand manufacturers stack large numbers of late-filed patents to delay cheaper biosimilars from reaching patients, a widely debated driver of high prescription drug costs.
What this bill would do
What it would do
The bill would amend federal patent law to cap the number of patents a reference product sponsor — the company that makes an original biologic drug — may assert in an infringement lawsuit against a biosimilar applicant seeking FDA approval. The cap would be 20 eligible patents per suit, of which no more than 10 could have been filed more than four years after the reference product received market approval. It would also clarify that infringement extends to patents on manufacturing methods or products when a biosimilar applicant submits through the abbreviated approval pathway.
The cap would apply only if the biosimilar applicant completes all required steps under the existing Public Health Service Act biosimilar framework. Courts could raise the cap if the interests of justice require or good cause is shown — for instance, if the biosimilar applicant withholds required product information. Patents covering methods of using the biologic in therapy, diagnosis, or prophylaxis would be exempt from the cap entirely. The bill would apply to biosimilar applications submitted on or after the date of enactment.
Key provisions
- 1Would limit reference product sponsors to asserting no more than 20 eligible patents in a single infringement lawsuit against a biosimilar applicant.
- 2Would further restrict that no more than 10 of those 20 patents may have been filed more than four years after the reference product received FDA market approval.
- 3Would allow a court to increase the patent cap if justice requires or good cause is shown, including when the biosimilar applicant fails to share required product information.
- 4Would make the cap conditional on the biosimilar applicant completing all required steps under the Public Health Service Act biosimilar framework.
- 5Would exempt patents claiming methods of using the biologic in therapy, diagnosis, or prophylaxis from the patent cap entirely.
- 6Would clarify that patent infringement extends to manufacturing method and product patents when a biosimilar applicant uses the abbreviated FDA approval pathway.
Who would be affected
Companies seeking FDA approval to sell biosimilar drugs and the biologic drug manufacturers that hold patents on the original reference products. Patients and insurers who rely on biosimilars as lower-cost alternatives to expensive biologics could be indirectly affected by any changes in the pace of biosimilar market entry that result from reduced litigation burden.
Why it matters
If enacted, biosimilar applicants would face a more bounded litigation landscape in patent infringement suits, potentially reducing the cost and delay associated with entering the market. Brand manufacturers would need to choose which patents to assert rather than deploying entire patent portfolios. For patients and payers, faster biosimilar competition can translate into lower drug prices for high-cost biologic therapies.
What would change
Changes to existing law
Amends 35 U.S.C. § 271(e) (Sec. 2)
Adds a cap of 20 asserted patents in biosimilar infringement suits, limits late-filed patents to 10, clarifies infringement scope for manufacturing patents, and sets conditions and court exceptions for the cap.
Effective dates
- Patent cap applies to biosimilar applications submitted on or after enactment
How implementation would work
The bill would be self-executing in federal courts. When a reference product sponsor files an infringement suit against a biosimilar applicant, the 20-patent cap would apply automatically, provided the applicant has completed all prerequisites under the Public Health Service Act biosimilar framework. The biosimilar applicant must demonstrate that compliance. Either party may move the court to increase the cap; courts would weigh factors including the applicant's information-sharing conduct, delays in USPTO patent issuance, material product changes, or other good cause shown. No rulemaking or agency implementation is required.
Legislative status & sources
Latest action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 44.
Official CRS summary
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This bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)
The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.
The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.
Legislative subjects
Civil actions and liability; Commerce; Competition and antitrust; Consumer affairs; Drug safety, medical device, and laboratory regulation; Health care costs and insurance; Inflation and prices; Intellectual property; Judicial review and appeals; Manufacturing; Prescription drugs