Amgen to High Court:Review Both Parts of Biosimilar Ruling

By John T. Aquino

March 24 — Amgen Inc. has asked the Supreme Court to either review both portions of the Federal Circuit's interpretation of the biosimilars statute, or neither part of that ruling.

Amgen's filing March 21 of both an opposition to review and a cross-petition came in response to Sandoz's petition for the Supreme Court's review of the decision.

If the high court were to deny Sandoz's petition, then Amgen asks the court to deny its cross-petition as well. If the court grants Sandoz's petition, then Amgen asks that the court to grant its cross-appeal and to review both portions of what had basically been a split decision, favoring each party on one of the two issues in dispute: the timing of notification before a biosimilar launch, and the exchange of patent-related information.

The dispute concerns interpretations of the law that created a pathway for Food and Drug Administration approval of biosimilars, which are similar and less expensive versions of biologic drugs. The focus is on the first biosimilar approved by the FDA, Sandoz's Zarxio (filgrastim-sndz), a biosimilar of Amgen's biologic cancer treatment Neupogen (filgrastim). Zarxio was approved in March 2015 , and Sandoz (part of Novartis) first marketed the drug half a year later .

The U.S. Court of Appeals for the Federal Circuit's decision concerning Zarxio was that court's first interpretation of the 2010 biosimilars law, part of the Affordable Care Act . If the Supreme Court agrees to review the decision, it would be the Supreme Court's first analysis of the law as well.

Sandoz Wants 180-Day Ruling Reversed

Sandoz Feb. 16 filed a petition for the high court to review and to reverse the Federal Circuit's holding on the provision of the Biologics Price Competition and Innovation Act's (BPCIA) 180-day notice of commercial marketing that the biosimilar applicant—in this case Sandoz—must give the reference product sponsor (RPS) of the biologic—in this case, Amgen .

The Federal Circuit held that the 180-day period begins after the FDA approves the commercialization of the biosimilar for market and not, as Sandoz wanted, when the FDA first agrees to review the biosimilar application.

The appeals court ruled in Sandoz's favor on the other issue in dispute—that the exchange of patent information between the RPS and the biologic, sometimes referred to as the “patent dance,” is optional, and not mandatory, as Amgen had argued.

The court's ruling makes patent infringement litigation the only legal remedy an RPS has if an applicant doesn't provided the patent information. But Amgen had contended that without the exchange of patent information as outlined in the BPCIA, it couldn't know which of its patents, if any, the not-yet-released biosimilar had infringed.

Amgen's Opposition and Cross-Petition

Sandoz filed its petition for certiorari (review) by the deadline for the court to review the 180-days notice part of the Federal Circuit's decision. Amgen didn't petition for a review of the “patent dance” provision. Some speculated that Amgen didn't wish to overturn the “patent dance” portion of the decision because it is a biosimilar applicant itself.

But on March 21, Amgen announced that it had filed an opposition to Sandoz's petition for review and, in doing so, also filed a cross-petition for the Supreme Court to review the “patent dance” portion of the Federal Circuit's decision.

Amgen's announcement suggested that its filing a cross-petition as well as its opposition to Sandoz's petition was strategic.

Amgen's Argument

Amgen said that in its opposition filing it asked the court to deny Sandoz’s petition, noting that the Federal Circuit’s holding on the 180-days notice provision was unanimous.

“In holding that the notice called for by [the BPCIA] is effective only if given after FDA approval, the Federal Circuit faithfully applied this Court’s statutory-interpretation precedents, faithfully applied the text of the BPCIA, and did so consistently with the statutory context. There is no reason for this Court to grant a writ of certiorari to review that decision,” Amgen wrote.

Amgen also noted that in its petition, Sandoz addressed the existence of a private right of action and the availability of injunctive relief. Amgen argued these issues have no relation to the facts of the case.

“Moreover, to the extent that those issues might be worthy of this Court’s review at some point, they are currently being litigated in the lower courts,” Amgen wrote, noting the seven cases pending in lower courts concerning biosimilar applications, including , for which the Federal Circuit will hear oral arguments on April 4. “One of those cases might someday be an appropriate vehicle for this Court’s review; this case is not such a vehicle,” Amgen wrote.

Amgen’s cross-petition asked the court to review the appellate court’s holding that when an applicant doesn't provide the disclosures required by Section 262(l)(2)(A) of the BPCIA, the RPS’s sole recourse is to begin a declaratory-judgment or patent-infringement action.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com