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Fed. Circ. Case May Change Biosimilar IPR Strategy

Law360 (April 12, 2018, 12:35 PM EDT) -- Biosimilar developers have been aggressive in filing petitions for inter partes reviews of biologics patents before the Patent Trial and Appeal Board, many of them preceding the filing of a marketing application. Such early IPRs are attractive to biosimilar makers, because they provide a chance to challenge innovator patents years before the biosimilar maker files a marketing application with the U.S. Food and Drug Administration. Since a petitioner need not have Article III case-or-controversy standing to bring an IPR, the remoteness and uncertainty of future infringement...
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