
IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy. Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015. Mylan, Celltrion, and Pfizer, all with competing biosimilar candidates, have filed IPR petitions challenging patents reportedly covering trastuzumab. Recently, the PTAB granted a petition filed by Hospira (subsidiary of Pfizer) to institute IPR of U.S. Patent No 7,807,799 (“the ’799 patent”), directed to protein A affinity chromatography. Hospira, Inc. v. Genentech, Inc., IPR2016-01837, Paper No. 19 (April 7, 2017).
Continue Reading PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent
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