The document discusses the role of formulations in extending patent protection for biologics through patent life cycle management strategies. It provides insights from the pharmaceutical industry on how they obtain additional patents beyond the original patents covering the biologic itself. Novel formulations are extremely valuable for patent life cycle management as they can potentially obtain formulation patents with later filing dates than the original biologic patent. The document examines case studies of patents obtained for erythropoietin and growth hormone to extend market exclusivity through formulation improvements.

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