Biotechnology

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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