Skinny Labels, Big Savings Act
Sponsored By: Senator John Hickenlooper
Introduced
Summary
Creates a statutory safe harbor for skinny-labeled generics and biosimilars. The bill says seeking FDA approval, marketing, or describing a product as generic or biosimilar with FDA-approved skinny labeling will not count as infringement of method-of-use patents under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, subject to limits tied to what patent owners have told the FDA about patented uses.
Show full summary
- Generic and biosimilar manufacturers can submit or seek approval and market products with skinny labeling without facing direct, induced, or contributory infringement claims for method-of-use patents when done in connection with FDA approval pathways such as 505(j) or 351(k).
- Brand patent owners lose the ability to sue over those specific activities when the safe harbor applies, but the protection does not cover labeling, promotion, or marketing that references the patented condition the patent owner identified to the FDA.
- The safe harbor covers conduct that occurred before, on, or after enactment and applies to judicial or other proceedings that are pending.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
New patent safe harbor for generic drugs
This bill would create a safe harbor for method-of-use patents tied to listed drug products. If you file an ANDA, a 505(b)(2), or a related animal-drug filing, submitting the application, using the proposed labeling, marketing with that labeling, or calling the product generic or therapeutically equivalent would not be treated as patent infringement. The protection would only apply if you include the required statement in your application and if labeling, promotion, or marketing does not reference the patented condition(s) previously identified to the FDA under 21 C.F.R. 314.53. If enacted, this could lower legal risk for generic and 505(b)(2) applicants and help some products reach the market sooner.
New safe harbor for biosimilars
This bill would create a safe harbor for method-of-use patents tied to reference biological products. If you file a 351(k) biosimilar or interchangeable application, submitting the application, describing the product as biosimilar or interchangeable using the approved labeling, or marketing the product with that labeling would not be treated as patent infringement. The protection would only apply if the labeling, promotion, or marketing does not reference the patented condition(s) that appear in the prescribing information. If enacted, this could lower legal risk for biosimilar developers and ease market entry for some biologics.
Definitions and retroactive safe harbor
This bill would adopt standard definitions for words used in the safe harbors, relying on existing FDA and PHSA definitions for terms like "biosimilar," "labeling," and "commercial marketing." It would also make the new safe-harbor rules apply to conduct before, on, or after enactment and to pending judicial or other proceedings. If enacted, these changes would reduce legal uncertainty and let companies and courts apply the safe harbor to past and ongoing matters.
Sponsors & CoSponsors
Sponsor
John Hickenlooper
CO • D
Cosponsors
Peter Welch
VT • D
Sponsored 1/9/2025
Sen. Cotton, Tom [R-AR]
AR • R
Sponsored 1/9/2025
Sen. Collins, Susan M. [R-ME]
ME • R
Sponsored 1/9/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov