The Future Of US Biosimilars Litigation: Method-Of-Use Patents And ‘Dance’ Obligations
Expect plenty of litigation over what constitutes infringement of a method-of-use patent even when the protected indication is not found on a biosimilar’s labeling, a panel of legal experts said at the recent BIO meeting; another area of unsettled law is the extent to which a biosimilar sponsor has satisfied the information-exchange provisions of the BPCIA ‘patent dance.’
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BIO 2019 Notebook: Merck On Finding The Right Balance, NORD On Patient Engagement, Sandoz On The Next Wave Of Biosimilars
News and views from day three of the BIO International Convention: Merck’s Frazier champions both social justice and capitalism; National Organization for Rare Disorders’ Salstonstall sees impact from FDA reviewers talking to patients; Sandoz’s Pike thinks refinement of clinical data requirements will encourage biosimilar sponsors to target more moderate-selling biologics.
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.
Biosimilar Labeling Carve-Out Turned Erelzi's Psoriatic Arthritis, Plaque Psoriasis Uses Into 'Another Indication'
US FDA review documents for first-ever carve-out labeling supplement of a biosimilar reveal how references to Erelzi's deleted uses were replaced with 'another indication(s)' when data could not be separated or was needed to convey safety information.