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Big Molecule Watch
April 14, 2017

Genentech Will Not File Amended Complaint in Case Against Amgen

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding in Amgen v. Sandoz.  The court granted the motion with leave for Genentech to amend its complaint within 45 days of the court’s order to assert claims of patent infringement.

Today, Genentech filed a letter with the court indicating that it would not be amending its complaint.  In the letter, Genentech states that “it is more efficient for the Court and the parties to address both the patent merits and Amgen’s continued noncompliance with its statutory production obligations . . . after the Supreme Court’s expected decision in June in Amgen v. Sandoz.”  Genentech notes that in the pending appeal Amgen is the “innovator company” and “has argued that a wide range of equitable remedies is available to enforce compliance with § 262(l)(2).”  Genentech further states that the Supreme Court’s resolution of issues regarding both the available remedy for alleged noncompliance with § 262(l)(2) as well as the permissible timing of notice of commercial marketing “may significantly impact the timing and scope of patent litigation between the parties.”  Genentech closes by requesting that the court enter an order dismissing the action without prejudice.