Sandoz: Don't Block Zarxio Under Amgen-Created 'Emergency'

Declaring that if its biosimilar Zarxio (filgrastim-sndz) was further withheld from the US market, cancer patients and purchasers of the biosimilar, including taxpayers, would be harmed, Novartis unit Sandoz on Aug. 31 asked the U.S. Court of Appeals for the Federal Circuit to reject a "perfunctory" emergency motion filed late last week by Amgen, which seeks to block the Sept. 2 launch of the medicine.

Sandoz insisted Amgen had failed to demonstrate the likelihood it would succeed in its petition for a rehearing before the full Federal Circuit, or en banc, and a reversal of the July 21 decision by a three-judge panel that the so-called "patent dance" is optional.

Moreover, the Swiss firm argued Amgen's "emergency" was entirely its "own making," since the Federal Circuit panel handed down its ruling over a month ago, at which time it extended Zarxio's launch to Sept. 2 to allow the California biotech giant a "period of time to assess and act upon its patent rights."

But, Sandoz said, even though Amgen has had Zarxio's application in its possession since Feb. 9, the firm has "not sought an injunction from any court based on any alleged patent rights."

"Amgen's own delay precludes the equitable relief it seeks," Sandoz contended.

The biosimilar maker insisted that if Amgen's motion is granted, it should be conditioned on the posting of a "substantial bond" – something Sandoz had earlier urged the court to impose.

Sandoz is seeking a bond of $460,000 per day for the period of the injunction – an amount it said Amgen is perfectly capable of handling, since it has $27bn in cash and marketable securities.

Amgen, whose human granulocyte colony-stimulating factor Neupogen (filgrastim) is the product on which Zarxio was referenced, filed its emergency motion on Aug. 27 a week after the company and Sandoz each filed separate petitions calling for an en banc review of the July decision, in which both sides gained a win, but also experienced a loss.

The dispute started in October 2014 when Amgen filed a lawsuit in the US District Court for the Northern District of California claiming Sandoz had violated the disclosure and negotiation procedures outlined in the Biologics Price Competition and Innovation Act (BPCIA), known as the patent dance, when it withheld its 351(k) biosimilars application and manufacturing information.

Amgen also asserted that Sandoz failed to provide proper notice that the biosimilar maker planned to launch its product as soon as it won FDA approval of Zarxio – a decision that came from the drug agency on March 6.

The biosimilar – the first ever approved in the US – in indicated to treat patients with cancer receiving myelosuppressive chemotherapy; those with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; people eundergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

District Judge Richard Seeborg in late March ruled that Sandoz did nothing wrong by not engaging in the disclosure and dispute resolution process, declaring the firm's actions were within its rights.

The judge refused to grant an injunction to stop Sandoz from launching Zarxio.

But Amgen appealed to the Federal Circuit, which granted the motion for the injunction in May, prohibiting Sandoz from marketing its biosimilar until the court had ruled on the case.

In July, the Federal Circuit panel, which heard oral arguments in June, ruled 2-1 that Sandoz and other biosimilar makers could opt out of the patent dance and would not have to disclose their applications and manufacturing details if they chose to do so.

But in a 2-1 decision, the panel ruled in Amgen's favor, declaring that when a firm opts out of the patent dance, BPCIA's 180-day notice of commercial marketing is mandatory and can only be given after FDA approval – telling Sandoz it could not market Zarxio until Sept. 2.

So both sides are seeking to get their respective losses overturned by the full Federal Circuit.

But Sandoz insisted that waiting almost right up until Zarxio's launch to file the emergency motion was "unfair," said New York lawyer Robert Cerwinski, a partner in the intellectual property litigation group at Goodwin Procter

"That Amgen waited so longs to protect unspecified 'unique interests that go beyond its patents' also shows, in Sandoz's view, that even Amgen does not believe it will suffer 'irreparable' harm should the Federal Circuit fail to extend the injunction," Cerwinski told Scrip.

He noted that Sandoz also is insisting the remedy for which Amgen was entitled to under the BPCIA was a patent suit, not an emergency injunction from the Federal Circuit arising out of the latter firm's state law claims of unfair competition.

"Sandoz points out that if Amgen believed it had a strong case of patent infringement, it could have, and should have sought an injunction in the district court on that ground," Cerwinski said.

But because Amgen has not done so, Sandoz is arguing the California firm does not have a strong patent case, and thus any further delay in the launch of Zarxio is unwarranted, he explained.

"It will be interesting to see whether the Federal Circuit freezes the status quo to give itself time to consider Amgen's motion," given the current injunction expires on Sept. 2, Cerwinski said.

"If it does not, that may indicate that there are not enough votes among the Federal Circuit judges for en banc review, and thus little point in extending the injunction," he said.