A Dive Into BPCIA Confidential Info Disclosure Requirements

Law360, New York (March 15, 2017, 12:13 PM EDT) -- Will Orlady

Tasha M. Francis The Biologics Price Competition and Innovation Act balances interests in competition and innovation. To do so, the BPCIA provides biosimilar manufacturers (subsection (k) applicants) with an abbreviated pathway for regulatory approval. The counterweight to this abbreviated pathway is the BPCIA’s amendment to the Patent Act creating an artificial act of infringement, allowing reference product sponsors (RPSs) to bring infringement suits based on the filing of biosimilar applications. To facilitate these infringement suits, the BPCIA also provides for a complex set of information...
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