Will Amgen, Sandoz Tango Across Old Ground?
This article was originally published in Scrip
Amgen and Novartis unit Sandoz are expected to soon know whether the full U.S. Court of Appeals for the Federal Circuit will rehear their arguments involving the latter firm's biosimilar Zarxio (filgrastim-sndz), which is referenced on the former company's human granulocyte colony-stimulating factor Neupogen (filgrastim).
Both drug makers last week submitted responses to each other's petitions for the en banc review of the July 21 decision by a three-judge panel in Amgen v. Sandoz, in which the companies each gained a win, but also experienced a loss.
The fight between the two manufacturers, which has been ongoing since last October, has broad implications for the interpretation of the Biologics Price Competition and Innovation Act (BPCIA) – the law that created the regulatory pathway for the FDA to approve biosimilars.
In July, the Federal Circuit panel, in a 2-1 ruling, said Sandoz and other biosimilar makers could opt out of BPCIA's disclosure and negotiation procedures – commonly called 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 also ruled that when a firm opts out of the patent dance, the 180-day notice of commercial marketing under the BPCIA is mandatory and can only be given after FDA approval, telling Sandoz it could not market Zarxio until after Sept. 2.
Amgen was unsuccessful in trying to get the Federal Circuit panel to extend its injunction beyond that date, so Sandoz was free to launch Zarxio, which it did on Sept. 3 – pricing the drug, which was approved on March 6 as the first biosmilar in the U.S., at a 15% discount to Neupogen.
Nonetheless, Amgen and Sandoz each had filed petitions on Aug. 20 seeking a rehearing by the full Federal Circuit trying to get the decisions reversed for which the firms had respectively lost.
In its response to Sandoz' petition, Amgen argued that Congress had anticipated the "increased burden and disruption" the new statutory scheme under the BPCIA would create for the courts, so lawmakers established a "defined statutory window" of no less than 180 days after FDA licensure and before commercial marketing, during which the court and the parties could fairly assess the companies' rights prior to the launch of the biosimilar product.
By providing that period of time, there could be an orderly resolution of the disputes, which could avoid forcing the innovator company from having to seek a temporary restraining order to prevent a biosimilar's imminent launch, Amgen said.
New York lawyer Robert Cerwinski, a partner in the intellectual property litigation group at Goodwin Procter, noted that Amgen had directly compared BPCIA's 180-day period with the 30-month stay in the litigation process established for generics under the Hatch-Waxman Act, and asserts that both are intended to give the courts time to decide whether to maintain the status quo during litigation with a preliminary injunction.
"This is an interesting argument, but begs the question of why, if Amgen is right, Congress didn't include a 30-month stay in the BPCIA," Cerwinski said.
In its argument, he noted that Sandoz points out that even if it had decided to engage in the "dance," "the process would ultimately have resulted in the parties being where they are right now – with Amgen having filed suit and having a copy of Sandoz's biosimilar application."
"This underscores one issue we've been scratching our heads over, which is what will happen on remand if the Federal Circuit decides the dance is mandatory," Cerwinski told Scrip.
"Making the parties retread ground they've already danced over would seem to serve no purpose," he said.
On Sept. 3, Hospira and Celltrion, which are engaged in their own legal battle with Johnson & Johnson unit Janssen involving a biosimilar of the latter company's Remicade (infliximab), pleaded in a brief to the court not to let the questions about the commercial marketing provision in the BPCIA raised in Amgen v. Sandoz "percolate" – insisting that to do so would not advance the law, but settling the issues would spur competition.