Biotechnology

Despite mixed results, biosimilar makers continue to turn to inter partes review (IPR) proceedings in order to challenge innovator patents protecting some of the most important biologics. IPRs have been attractive to biosimilar makers, not only because of the procedural and substantive advantages that IPRs currently provide, but because they allow litigation at a point in time before the biosimilar makers can challenge the validity of the patents in district court under the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Biosimilar makers have filed 13 IPR petitions in the last 16 months and hedge fund owner Kyle Bass also filed an IPR petition to challenge a patent protecting an innovator biologic. The Patent Trial and Appeal Board’s (PTAB) instituted three of the 14 IPRs at least as to some of the challenged claims and denied four in their entirety. This article reviews these recent challenges to patents that would normally be litigated in district court under the intricate patent litigation framework set forth in the BPCIA.

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