By Kevin E. Noonan --
The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO® biosimilar product until [the] Court resolves the appeal." The Order also sets a date of no later than seven days from today for Sandoz to propose an amount of the bond (for damages accruing daily) the Court should order, with Amgen being given seven days thereafter for responding.
The Court’s Order thus maintains the status quo ante between the parties, who are involved in a declaratory judgment action brought by Amgen in the Northern District of California before Judge Seeborg. Last month, the District Court denied Amgen’s motion for an injunction (see "Gotta Dance? Apparently Not -- A Biosimilar Update"), based in part on the court’s opinion that Sandoz correctly interpreted the "patent dance" provisions of Biologics Price Competition and Innovation Act of 2009 (BPCIA) to permit Sandoz to refuse to disclose to Amgen its biosimilar application and "such other information that describes the process or processes used to manufacture the biological product that is the subject of such application" as apparently mandated by the Act ("Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant—(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application") (see "The Tyranny of the Judiciary"). Thus, the first biosimilar product approved by the FDA (see "FDA Approves Sandoz Filgrastim Biosimilar") will remain off the market in the U.S. at least until the Federal Circuit decides whether Sandoz’s creative construction of the statutory language comports with Congressional intent in enacting this portion of the omnibus health care reform legislation.
Oral argument is scheduled for June 3rd.