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This Viewpoint discusses a current Supreme Court lawsuit, Amgen v Sanofi, involving Amgen’s broad patents on PCSK9 that could effectively prevent other manufacturers from producing similar or even clinically superior antibodies, with important negative consequences for patients.

This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.

This Viewpoint discusses 3 bills introduced recently in Congress that focus on patent eligibility, fraud, and quality and that have major implications for clinical medicine and pharmaceutical development.

This cohort study assesses the frequency of approval and marketing of skinny-label biosimilars and their savings to Medicare.