Bill > S43

This bill, called the "Skinny Labels, Big Savings Act", amends title 35 of the United States Code to create a "safe harbor" for generic drug and biological product manufacturers, protecting them from patent infringement lawsuits under certain conditions. Specifically, the bill allows generic drug and biological product manufacturers to submit applications, seek approval, and commercially market their products without being sued for patent infringement, provided they do not reference or promote the specific patented use conditions of the original drug or biological product. The bill applies to both pharmaceutical drugs (under the Federal Food, Drug, and Cosmetic Act) and biological products (under the Public Health Service Act). For generic drugs, manufacturers can submit applications and market their products as generic equivalents, and for biological products, they can describe their product as biosimilar or interchangeable, as long as their labeling and promotional materials do not mention the patented use conditions. The bill's provisions apply retroactively to conduct occurring before, on, or after the date of enactment and to all pending judicial proceedings, effectively providing broader legal protection for generic and biosimilar drug manufacturers.

Justice

https://www.congress.gov/bill/119th-congress/senate-bill/43/all-info