Supreme Court Jumps Into Biosimilars Battle Over Launch Notification, Patent Dance

Following advice of Solicitor General, high court grants both Sandoz and Amgen Zarxio petitions challenging Federal Circuit’s interpretation of the biosimilars statute.

The rules of the biosimilars pathway could change now that the Supreme Court has agreed to hear Amgen Inc. and Sandoz Inc. petitions challenging the Federal Circuit’s interpretation of the statute. At stake is whether biosimilar sponsors must wait 180 days after approval to notify the brand-name company of intent to launch and whether the exchange of patent information is optional.

In orders issued Jan. 13, the court granted both Sandoz’s petition on launch notification and Amgen’s conditional cross-petition on the so-called patent dance provisions of the Biologics Price Competition and Innovation Act (BPCIA). The court consolidated the two cases, which involve Sandoz’s Zarxio (filgrastim-sndz), a biosimilar to Amgen’s Neupogen (filgrastim), and allotted one hour for oral argument.

Sandoz and Amgen both issued statements saying they were pleased the court decided to hear their petitions and reiterating their interpretation of the statute.

Irena Royzman, a partner at Patterson Belknap Webb & Tyler, said the court recognizes that the case is very important to biosimilar sponsors and innovators. She said the question raised by Amgen is the more fundamental as it addresses whether the biosimilar sponsor can obtain the benefit of the biosimilar pathway and bypass the dispute resolution procedure.

The statute states that the biosimilar applicant “shall provide” its application and manufacturing process information to the reference product sponsor within 20 days after FDA’s acceptance of its application for review. The US Court of Appeals for the Federal Circuit concluded that this did not mean the disclosure was mandatory since the statute provided consequences if the biosimilar sponsor failed to do so. (Also see "Biosimilar Sponsors Can Avoid Patent Dance, But Innovators Win Extra Exclusivity" - Pink Sheet, 21 Jul, 2015.)

“Does ‘shall’ mean ‘shall’ is an attractive question for the court,” Royzman said. “How it plays out is hard to know.”

Royzman represents Janssen Biotech Inc. in litigation against Celltrion Inc. and Pfizer Inc. over their biosimilar to Janssen’s Remicade (infliximab), Inflectra (infliximab-dyyb). She noted that it is also uncertain what the views of the new administration will be.

Decision Is Likely By June

The Solicitor General had advised the court to take up both petitions and sided with Sandoz on both the notification and patent dance questions. (Also see "Biosimilar Launch Notification: Solicitor General Backs Pre-FDA Approval Notice" - Pink Sheet, 9 Dec, 2016.)

Acting Solicitor General Ian Gershengorn said the BPCIA requires the biosimilar sponsor to provide launch notice no later than 180 days before the date of the first commercial marketing but did not additionally restrict how soon the applicant may provide notice after submitting its abbreviated biologics license application to FDA. On the patent dance provision, he said the reference product sponsor could bring a declaratory judgement action against the biosimilar sponsor and obtain the information in discovery.

Goodwin Procter partners Robert Cerwinski and William Jay said the Supreme Court’s decision to address questions about the statute will provide certainty about its application going forward.

“In this early stage of the biosimilars market it is something everyone is trying to figure out,” Cerwinski said. “Given the dollars being invested in biosimilars it’s important that industry gets certainty around these questions.”

As for the timing of the case, Jay said the petitions were granted in time to be heard in April and the court will most likely issue an opinion by the end of the term in June.

Court May Address Apotex’s Argument

The case arose when Amgen filed suit against Sandoz, a unit of Novartis AG, for failing to follow the information exchange and notification provisions of the BPCIA, which provides a pathway for approval of biosimilars. Sandoz had not provided its BLA or manufacturing process information to Amgen and provided notification of its intent to launch Zarxio prior to approval.

In July 2015, a three-judge panel of the Federal Circuit ruled that the patent dance provisions of the BPCIA are optional and that Sandoz had to wait until FDA approval of Zarxio to notify Amgen of its intent to launch. However, the panel was divided as one judge dissented from the entire opinion and another dissented on the ruling regarding commercial notification. The Federal Circuit denied petitions by both parties to rehear the case en banc.

In its petition to the Supreme Court, Sandoz argued that if the ruling is not reversed it will delay patient access to all biosimilars for six months longer than Congress intended.

Amgen opposed Sandoz’s petition but asked the court to review the patent information exchange provisions of the BPCIA if it agreed to Sandoz’s request.

Last month, the Supreme Court denied a petition by Apotex Inc., which also challenged the Federal Circuit’s ruling on launch notification. Apotex argued that its case was different from that of Sandoz since it had provided Amgen with its application and manufacturing process information for a biosimilar to Neulasta (pegfilgrastim). (Also see "Biosimilar Launch Notification May Head Back To Court" - Pink Sheet, 10 Sep, 2016.)

In its Jan. 13 orders, the court granted Apotex’s motion to file a brief in the Zarxio litigation.

Royzman said she thinks the court will answer the questions in the case more broadly, in a way that encapsulates Apotex’s argument based on its interpretation of Amgen v. Sandoz. “I would be surprised if the court didn’t address these issues more holistically,” she said.