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This bill amends federal patent law to create a safe harbor from patent infringement for generic drug manufacturers and biosimilar manufacturers when they submit applications for FDA approval and market their products with labeling that does not reference patented methods of use. The safe harbor applies to generic drugs, authorized generics, and biosimilar biological products, provided the approved labeling does not promote or describe uses covered by method-of-use patents listed with the FDA. The bill's provisions apply retroactively to all pending proceedings.
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