ARTICLE
15 September 2015

FDA Publishes Notice Of Patent Infringement Complaint Filed Against A Biosimilar Applicant

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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.
United States Food, Drugs, Healthcare, Life Sciences

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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