Pediatric Exclusivity for Biologics

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At the …›

Casting a New Light on Diagnostic Patents: “Methods of Preparation” Patent-Eligible

The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as …›

Patent Offices Extend Certain Deadlines, but Proceed With Caution

Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. For example, the U.S. Patent Office has extended various patent deadlines until June 1, 2020 and the European Patent Office …›