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22 July 2015Americas

Federal Circuit says ‘patent dance’ is optional

The US Court of Appeals for the Federal Circuit has ruled that biosimilar applicants can opt out of the so-called patent dance, paving the way for Sandoz to sell a biosimilar version of an Amgen drug.

In a ruling handed down yesterday, July 21, the court said that Sandoz is free to launch its Zarxio drug, which is similar to Amgen’s Neupogen (filgrastim), on September 2.

Biosimilar applicants must give the original drug maker 180 days’ notice of their intent to sell their biosimilar product after it has been approved, the court said.

The dispute, which has made its way up from the US District Court for the Northern District of California, centres on provisions of the Biologics Price Competition and Innovation Act (BPCIA).

The BPCIA provides both a shortened regulatory pathway for biosimilar drugs and a mechanism, known as the ‘patent dance’, which allows parties to address any patent claims while the drug is being approved.

In July last year Sandoz notified Amgen that it had filed an application with the US Food and Drug Administration (FDA) to sell Zarxio. It added that it intended to sell Zarxio upon FDA approval.

The application was granted on March 6, making Zarxio the first biosimilar to be approved in the US.

The companies were arguing about whether Sandoz should have provided a copy of the application submitted to the FDA or any other information that described the process or processes used to manufacture Zarxio, as required by the BPCIA.

Sandoz, a subsidiary of Novartis, did not provide this information because it argued that it was not mandatory to do so.

Amgen, which had been prevented from initiating the patent dance, then sued Sandoz at the California district court last October, accusing it of unlawfully refusing to engage in the practice.

Both the California district court, in March this year, and the federal circuit ruled that the patent dance is optional.

But opting out could subject biosimilar makers to an immediate declaratory judgment of patent infringement by the branded drug owner, the court added.

The federal circuit’s ruling was passed in a 3-0 majority by Judges Alan Lourie, Raymond Chen and Pauline Newman, though both Chen and Newman dissented in part.

For example, Chen said the decision not to allow Sandoz to enter the market until September 2 gives Amgen an “exclusivity windfall”.

Courtenay Brinckerhoff, partner at law firm Foley & Lardner, said: “Because the federal circuit panel was so divided, it would not be surprising if the court agrees to re-hear the case en banc.

“Because the BPCIA does not include any other provisions requiring biosimilar applicants or the FDA to notify the reference product sponsor when a biosimilar application is filed, companies with original biologic products may need to monitor press releases and news reports to identify potential biosimilar products before they are approved.

“Such companies probably are wondering if this really is the ‘balance’ of ‘innovation and price competition’ they bargained for when the complicated scheme of the BPCIA was being crafted in Congress.”

Carol Lynch, global head of Sandoz Biopharmaceuticals & Oncology Injectables, said: “We welcome the federal circuit’s finding that the BPCIA’s patent dance is optional.

“We look forward to launching Zarxio after September 2 as the first US biosimilar.”

A spokesperson for Amgen said: “While the court did not rule in our favour on all issues, the court found that product approval is required before the biosimilar can give 180 days' notice of first commercial marketing.

“The appellate court extended the injunction which prohibits Sandoz's commercial launch of its biosimilar filgrastim product until September 2.”


More on this story

Americas
4 September 2015   Drug maker Sandoz has officially launched its Zarxio biosimilar after a US appeals court declined to issue an injunction that would have prevented it from being sold.
Americas
19 October 2015   The US Court of Appeals for the Federal Circuit has declined to hear the Amgen v Sandoz ‘patent dance’ dispute en banc.
Americas
17 February 2016   Sandoz has petitioned the US Supreme Court to review the US Court of Appeals for the Federal Circuit’s ruling in the ‘patent dance’ dispute.

More on this story

Americas
4 September 2015   Drug maker Sandoz has officially launched its Zarxio biosimilar after a US appeals court declined to issue an injunction that would have prevented it from being sold.
Americas
19 October 2015   The US Court of Appeals for the Federal Circuit has declined to hear the Amgen v Sandoz ‘patent dance’ dispute en banc.
Americas
17 February 2016   Sandoz has petitioned the US Supreme Court to review the US Court of Appeals for the Federal Circuit’s ruling in the ‘patent dance’ dispute.