Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant

Streszczenie

The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a "subsection (k) applicant") notified FDA that an action for patent infringement was filed in connection with the applicant's BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of Health and Human Services (HHS) with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register.