federal_register: 2018-19811

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2018-19811 Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant Notice The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register. 2018-09-12 2018 9 https://www.federalregister.gov/documents/2018/09/12/2018-19811/receipt-of-notice-that-a-patent-infringement-complaint-was-filed-against-a-biosimilar-applicant https://www.govinfo.gov/content/pkg/FR-2018-09-12/pdf/2018-19811.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the...  

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