No Rehearing of Federal Circuit Biosimilar Ruling

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By John T. Aquino

Oct. 16 — A federal appeals court Oct. 16 denied Amgen and Sandoz a full court rehearing of the first court interpretation of the biosimilar statute, leaving the panel ruling in place, absent Supreme Court review.

A three-judge panel of the U.S. Court of Appeals for the Federal Circuit on July 21 gave the parties in Amgen v. Sandoz basically a split decision.

The panel agreed with Sandoz that the information exchanges in the Biologics Price Competition and Innovation Act (BPCIA) are optional. It also agreed with Amgen that Sandoz couldn't notify Amgen that it was preparing to market Zarxio, its biosimilar of Amgen's cancer treatment, Neupogen, until the Food and Drug Administration approved the biosimilar.

The latter ruling meant that Sandoz couldn't release Zarxio, the first biosimilar approved under the BPCIA, for 180 days after FDA approval, delaying the release until Sept. 2.

Additional Exclusivity Still Rule

S. Maurice Valla of Baker Hostetler, Philadelphia, told Bloomberg BNA in a phone interview on July 27 about the panel's decision, “Sandoz took the position that the FDA's approval and the issue of exclusivity double track, and it lost on that. Reference product sponsors [RPSs] do get six additional months of exclusivity.”

Both parties asked the Federal Circuit for a rehearing by another panel or a full (en banc) rehearing. The Federal Circuit's denial of the parties' petitions leaves them with Supreme Court review as their only appeal option.

As to any plans for petitioning the Supreme Court for review, an Amgen spokeswoman declined comment and Sandoz didn't respond to Bloomberg BNA's e-mail request for comment.

Nicholas K. Mitrokostas of Goodwin Procter LLP, Boston, told Bloomberg BNA in an Oct. 16 e-mail that he thinks the chances the Supreme Court will agree to review the case are relatively low.

A biosimilar is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic product, known as a reference product.

Panel Affirmed, Reversed Lower Court

According to court records, Sandoz notified Amgen in July 2014 that it had filed a biosimilar application referencing Neupogen but didn't provide Amgen with confidential access to the application and manufacturing and patent information as specified in 42 U.S.C. §262(l). That section also provides that the applicant give 180 days notice of commercial marketing to the biologic RPS, which was intended to give the RPS time to seek a preliminary injunction based on patents that the parties identified during the information exchange but that didn't immediately result in patent infringement litigation.

Amgen sued Sandoz in the U.S. District Court for the Northern District of California and asked the court to order Sandoz to delay the release of Zarxio until Sandoz complied with the BPCIA. The district court found in favor of Sandoz, concluding that the information exchange isn't mandatory and that Sandoz could give notice of commercial marketing before the FDA approved the biosimilar.

The Federal Circuit panel affirmed on the first issue and reversed on the second.

Next Steps, If Any?

Valla told Bloomberg BNA, “[The Federal Circuit made clear] that there are pros and cons in this law that balance things out. There is a risk to any applicant who doesn't engage in the manufacturing and patent information exchange. The RPS may immediately file a declaratory judgment for infringement and ask for an injunction and, if it doesn't sue right away, then the biosimilar applicant's product has the risk of an infringement action hanging over it.”

Mitrokostas said that either Amgen or Sandoz could now file a petition for certiorari to the Supreme Court, which would be due in 90 days. “They could also seek to stay the mandate of the Federal Circuit until their petition for certiorari, should they file one, is decided. But it is hard to see what irreparable harm either party would argue could come without a stay of the mandate, since Sandoz has already launched its product.”

Given that the issues between Sandoz and Amgen are essentially moot, the injunction against Sandoz has expired and Amgen lost in the Federal Circuit, there's relatively little chance that the Supreme Court would want to step in at this point and address these issues, Mitrokostas said.

He added that a number of BPCIA interpretation issues remain open and unanswered, including whether notice of commercial marketing is mandatory for biosimilar applicants that have engaged in the information exchanges.

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Randy Kubetin at

The order denying rehearing or en banc review is at


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