Bill > HR6485

This bill amends Title 35 of the United States Code to create a "safe harbor" provision for generic drug and biological product manufacturers, allowing them to seek FDA approval and market their products without infringing on method of use patents under certain conditions. Specifically, the bill permits generic drug and biological product manufacturers to submit applications, seek approval, and commercially market their products without being considered as infringing on a method of use patent, provided that their labeling and promotional materials do not reference the specific patented conditions of use. The legislation applies to both pharmaceutical drugs (under the Federal Food, Drug, and Cosmetic Act) and biological products (under the Public Health Service Act). This safe harbor means that generic manufacturers can develop and seek approval for their products without being sued for patent infringement, as long as they carefully avoid referencing the patented uses in their marketing and labeling. The bill is retroactive, applying to conduct that occurred before, on, or after the date of enactment, and to all pending legal proceedings, which could potentially provide relief for manufacturers currently involved in patent disputes.

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https://www.congress.gov/bill/119th-congress/house-bill/6485/all-info