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A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
1/10/2025, 11:56 AM
Summary of Bill S 43
The bill seeks to provide protection for healthcare providers, pharmacists, and other entities who use patented drugs or biological products in accordance with FDA-approved labeling. This safe harbor would prevent these entities from being held liable for patent infringement when using a drug or biological product for an approved purpose, even if the use falls outside the scope of the patent.
The purpose of this legislation is to encourage the use of innovative drugs and biological products by ensuring that healthcare providers can use them without fear of infringing on method of use patents. This, in turn, is intended to promote access to new and potentially life-saving treatments for patients. Overall, Bill 119 s 43 aims to strike a balance between protecting the rights of patent holders and promoting access to innovative drugs and biological products for the benefit of public health.
Congressional Summary of S 43
Skinny Labels, Big Savings Act
This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs.
Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics.
The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act:
- submitting or seeking approval of a skinny label for a generic or biosimilar drug;
- promoting or commercially marketing a drug with skinny labeling approved by the FDA; or
- describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug.
The bill also applies the safe harbor to similar actions under the Public Health Service Act.
