This bill establishes a safe harbor from patent infringement for companies developing generic drugs and biological products, specifically concerning method-of-use patents. It amends section 271 of title 35, United States Code, to clarify that certain actions will not constitute infringement. These protected actions include submitting or seeking approval for generic drug applications (under sections 505(j) or 505(b)(2) of the Federal Food, Drug, and Cosmetic Act) or biosimilar applications (under section 351(k) of the Public Health Service Act), as well as promoting or commercially marketing these products. The safe harbor is strictly conditional: it applies only if the labeling, promotion, or commercial marketing of the generic or biosimilar product does not reference the specific condition or conditions of use claimed in the patent . For generic drugs, this means the application must include a statement for the method-of-use claims, and the product's labeling must avoid the patented use. Similarly, for biosimilars, the product must not be approved for the patented condition, and its labeling must omit reference to that use. The Act's provisions apply retroactively to conduct occurring before, on, or after its enactment date, and to all pending legal proceedings.