Skinny Labels, Big Savings Act
Skinny Labels, Big Savings Act amends the patent law (title 35) to create a safe harbor from patent infringement for certain method-of-use patents on drugs and biological products. The core idea is to allow generic drug applicants (and biosimilar applicants) to seek approval and market products with “skinny labels”—labels that do not reference the patented use—without facing infringement liability for those method-of-use claims, so long as the labeling and promotions stay away from the patented indications. The safe harbor applies to both small-molecule drugs and biologics (including biosimilars) and is tied to FDA-listed patents for listed drugs and for biosimilar reference products. The bill also clarifies that these protections apply to conduct before, on, or after enactment, including pending litigation. In practical terms, the bill aims to speed and broaden access to lower-cost medicines by permitting generic/biosimilar entrants to carve out narrow indications in their labeling and marketing, while leaving room for patent disputes over other indications to proceed separately.
Key Points
- 1Safe harbor for method-of-use patents on listed drugs and biological products: The bill creates protection from direct, induced, or contributory infringement for certain actions tied to listed drug patents (as identified under FDA’s listing rules) when those actions involve labeling or activities that do not reference the patented use.
- 2Eligible activities for generics:
- 3- Filing or seeking approval under FDA’s 505(j) (ANDA) or 512(b)(2) or under 505(b)(2), with labeling that includes the proposed method-of-use in the application.
- 4- Promoting or commercially marketing the drug with that labeling.
- 5- Describing the drug as a generic or therapeutically equivalent to the listed drug referenced in the application.
- 6Biosimilars safe harbor: A parallel safe harbor for biosimilars (reference products) under the Public Health Service Act, including:
- 7- Submitting a 351(k) application and describing the biosimilar as biosimilar or interchangeable with labeling that does not reference the patented use.
- 8- Promoting or marketing with that labeling.
- 9- Describing the biosimilar as biosimilar or interchangeable with the reference product, when not approved for the patented condition.
- 10Definitions and scope: The bill defines terms such as “biological product,” “biosimilar,” “interchangeable,” “reference product,” “commercial marketing,” and “labeling” to align with existing FDA concepts. It also clarifies that “promoting” includes advertising and labeling use.
- 11Conditions for safe harbor: The protections apply only if the labeling, promotion, or marketing avoids referencing the patented condition(s) claimed in the patent and identified in the FDA patent listing process.
- 12Effective date and reach: The act applies to conduct before, on, or after enactment and to all pending proceedings as of enactment, expanding potential impact to existing cases.