Skinny Labels, Big Savings Act provides a safe harbor from patent infringement for drug and biological product applications.
The Skinny Labels, Big Savings Act amends title 35 of the United States Code to establish a safe harbor from infringement of a method of use patent for drugs and biological products. This protection applies to applications submitted under the Federal Food, Drug, and Cosmetic Act, provided that the labeling, promotion, or commercial marketing does not reference the condition or conditions of use claimed in the patent. This Act aims to encourage innovation and competition in the pharmaceutical industry by reducing the risk of patent infringement for certain applications.
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- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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