United States:
FDA Publishes Notice Of Patent Infringement Complaint Filed Against A Biosimilar Applicant
15 September 2015
Jones Day
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In the August 24, 2015, Federal
Register, FDA announced that an applicant for a
proposed biosimilar product had notified FDA that a patent
infringement action has been filed in connection with the
applicant's BLA. FDA received notice of the following
complaint: Janssen Biotech, Inc., et. al. v. Celltrion
Healthcare Co., Ltd., et al., 15–cv–10698 (D.
Mass., filed March 6, 2015).
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