Do a little patent dance

Will the US Supreme Court wade into the first BPCIA dispute?

The US Supreme Court could be asked to issue guidance over the Biologics Price Competition and Innovation Act (BPCIA) dispute between Amgen and Sandoz, after the Court of Appeals for the Federal Circuit chose not to address both parties’ petitions for an en banc rehearing.

In October, plaintiff Amgen and defendant Sandoz asked the Federal Circuit to rehear the case after it previously upheld a lower court’s finding and issued a split decision in July, holding that a biosimilar applicant is not required to inform the patent owner of its intentions to produce a biosimilar within the mandated timeframe.

Under the BPCIA, it was thought that a biosimilar applicant is required to notify the patent owner of its intention to produce a biosimilar, but the Federal Circuit dismissed that interpretation in the first ruling on the act.

The BPCIA seeks to create an expedited pathway for the approval of biosimilar drugs. It was enacted as part of the Affordable Care Act, which was signed into law in 2010, a controversial piece of legislation in its own right.

Sandoz was the first applicant to receive approval in the US for a biosimilar under the BPCIA since its inception. Zarxio (filgrastim-sndz) is similar to Amgen’s Neupogen cancer drug. Amgen claimed that Sandoz did not inform it of the biosimilar by the required date, in violation of the approval pathway laid down in the BPCIA.

Under the BPCIA, it was thought that the biosimilar applicant had to comply with provisions on information exchange, also known as the ‘patent dance’, and a 180-day notice for commercial marketing.

Sandoz filed an abbreviated biologics licence application (aBLA) in May 2014 seeking approval of its biosimilar version of Amgen’s filgrastim product Neupogen. But it failed to provide a copy of the aBLA and manufacturing information to the patent owner, which Amgen argued was mandatory under the BPCIA.

In July, the Federal Circuit issued its split decision that held a biosimilar applicant does not have to comply with the optional information exchange and patent dance procedures. The requirement to provide 180 days of notice before engaging in commercial marketing, however, is mandatory and effective once the Food and Drug Administration (FDA) approves an aBLA.

The Federal Circuit rejected Amgen’s request for a rehearing of the information exchange and patent dance rulings, while Sandoz wanted a redo of the decision on the 180-day notice requirement.

Amgen and Sandoz have until 14 January 2016 to petition the Supreme Court to hear any appeals.

Rob Cerwinski, partner at Goodwin Procter, explains what is likely to happen next in this biosimilar saga.

What comes next for Amgen and Sandoz?

The Federal Circuit’s denial means that its July decision remains intact. The pre-suit exchange of information is optional, and in a case where the biosimilar applicant refuses to engage in the exchange, it must give the reference product sponsor 180 days’ notice before it may commence commercial marketing of the biosimilar. Moreover, this notice is effective only when it is given after the FDA has licensed the biosimilar product.

In denying the en banc petitions, the Federal Circuit stated: “The mandate of the court will issue on 23 October 2015.” This means that the Federal Circuit is done with the appeal and its July ruling must now be implemented.

This also means that questions left open by the Federal Circuit’s July decision will remain unanswered for now.

Is it likely that the Supreme Court will hear any appeal?

Even if the parties were to petition the Supreme Court for review of the Federal Circuit’s July decision, it is highly unlikely that the Supreme Court would grant such review. Although the Federal Circuit’s ruling was a split decision, the issues raised by Sandoz are essentially moot. The injunction against Sandoz (imposed as a result of the Federal Circuit’s holding that Sandoz’s pre-approval notice of commercial marketing was not legally effective under the BPCIA) has already expired. As for Amgen, its case is in an interlocutory posture, since it still has its patent claims at the district court level. The Supreme Court often prefers not to take cases in which the petitioner could still win on other pending arguments.

This is also the first time that the Federal Circuit has had a chance to construe the BPCIA, and the Supreme Court is unlikely to step in until the Federal Circuit and lower courts have had more opportunity to construe the statute.

Does the split decision indicate that the Federal Circuit may just issue another ruling?

The Federal Circuit would not overrule the holdings of the three-judge panel in Amgen v Sandoz except by en banc review. Thus, any future three-judge panel may not issue a contrary ruling on the same issues. However, the holdings in the July decision are quite limited in scope, and many questions about how to interpret the BPCIA remain open.

One open question, for example, is whether the 180-day notice of commercial marketing is required in a case where the applicant does engage in at least part of the ‘patent dance’.

This issue has been raised in two other pending litigations brought under the BPCIA.

In Janssen v Celltrion, Celltrion and Hospira have argued that notice of commercial marketing is not required because they have engaged in the patent dance.

In Amgen v. Hospira, Hospira has made a similar argument in support of its motion to dismiss Amgen’s BPCIA claims.

Should either district court issue a decision on this, it is likely that the losing party will appeal to the Federal Circuit. A new three-judge panel—perhaps consisting of different judges—will then decide this related question. IPPro

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