Fed. Circ. Case May Change Biosimilar IPR Strategy

April 13, 2018

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 in such circumstances does not preclude these early IPRs. Under settled precedent, however, a biosimilar maker must have Article III standing to seek a Federal Circuit appeal if the PTAB issues a final decision upholding the challenged patent. A decision expected from the Federal Circuit this quarter in Momenta Pharmaceuticals Inc. v. Bristol-Myers Squibb Co.[1] will address how and when a biosimilar maker can establish that standing.

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