SCOTUS to hear biosimilar clash between Amgen and Sandoz

The US Supreme Court will hear oral arguments from Sandoz and Amgen tomorrow, when the battle over a biosimilar of Amgen’s Neupogen (filgrastim) will resume.

The case between the two parties arose after Amgen and Sandoz disagreed over the interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

Amgen and Sandoz claim different interpretations of the statute, which states that a biosimilar applicant “shall” provide its application and manufacturing information to the reference product sponsor within 20 days of filing its biosimilar drug application.

Sandoz claimed that the wording “shall” means that providing the information is optional, as opposed to Amgen, which interpreted the meaning as mandatory.

The US Court of Appeals for the Federal Circuit affirmed the district court’s holding that Sandoz did not violate the BPCIA by failing to disclose its application and manufacturing process to Amgen.

Also at issue is whether a 180-day notice of commercial marketing must be given after the biosimilar product is licensed by the Food and Drug Administration (FDA). The Federal Circuit held that a biosimilar applicant must give 180 days’ notice.

Amgen has asked the Supreme Court to clarify whether a biosimilar applicant has to provide the information and, if it does not, whether the reference product sponsor’s (RPS) only option is to launch a declaratory judgment and/or a patent infringement action.

Amgen’s Neupogen (filgrastim) had been marketed since 1991 but, in May 2014, Sandoz filed an application at the FDA for approval of a biosimilar under the brand name Zarxio.

The Supreme Court agreed to hear the cases in January this year after accepting Sandoz’s and Amgen’s writs of certiorari.

According to Brendan O’Malley, partner at Fitzpatrick, Cella, Harper & Scinto, there is a lot at stake for both parties.

If the Supreme Court backs Amgen, finding that a biosimilar applicant must wait until its product is approved by the FDA before giving notice, the parties will have a six-month window to resolve remaining patent disputes through a declaratory judgment action and to apply for injunctive relief if necessary, explained O’Malley.

RPS companies believe that a reversal on the question would “lead to chaos”, he added.

This is because it could make it difficult to predict when a launch might be imminent, he said, making it hard to obtain a preliminary injunction before the biosimilar enters the market.

O’Malley added that if the Supreme Court affirms that providing the information is optional, this could mean that a declaratory judgment action might be the RPS’s sole mechanism for patent enforcement if the biosimilar applicant declines to engage in the ‘patent dance’.

“A reversal on this question could help to restore reference product sponsors’ expectations that an early and orderly pathway would exist for enforcing their patent rights,” he said.

Sandoz said in a webinar held on Thursday, April 20 that if the Supreme Court rules in its favour, it will result in patients having earlier access to medicines.

Sandoz added that it would also potentially give additional time for biosimilars to increase competition and decrease cost of treatments.

The SCOTUS ruling is expected by July this year.