Amgen Inc., et al. v. Hospira, Inc., C.A. No. 15-839 - RGA, August 5, 2016.
Andrews, J. Defendant’s motion to dismiss Count I of the amended complaint is denied. Oral argument took place on February 17, 2016.
42 U.S.C. section 262(1)(8)(A) requires notice to a subsection (k) applicant 180 days before commercial marketing. Plaintiff contends that the Federal Circuit has held that such notice is not effective until after the FDA has licensed the product. The court finds that declaratory judgment relief is available for injunctive relief for violations of (8)(A) and therefore declines to dismiss Count I.