In a decision that will speed the U.S. launch of biosimilars, the Supreme Court Monday resolved a few questions about the Biologics Price Competition and Innovation Act (BPCIA) – and raised a few more uncertainties in the process.

The court's unanimous decision in Sandoz Inc. v. Amgen Inc. held that the 180-day notice of commercial marketing required by the BPCIA can be sent before a biosimilar is licensed, reversing a fractured Federal Circuit panel that had ruled that the notice had to be sent after the FDA approved a biosimilar. In challenging the Federal Circuit ruling, Sandoz Inc. claimed that it gave an innovator six additional months of exclusivity. (See BioWorld Today, July 22, 2015.)

The two biosimilars that have launched in the U.S. – Sandoz's Zarxio, referencing Amgen's Neupogen (filgrastim), and Pfizer Inc.'s Inflectra, referencing Janssen Biotech Inc.'s Remicade (infliximab) – waited the additional six months after being licensed, but going forward, a biosimilar conceivably could be launched as soon as it gets the FDA green light.

Samsung Bioepis didn't respond to a request for comment on whether the decision would change its launch plans for Renflexis, a Remicade biosimilar approved in April, but both Sandoz and Pfizer welcomed the news. "The justices' unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments," said Carol Lynch, global head of biopharmaceuticals at Sandoz. (See BioWorld Today, April 25, 2017.)

Pfizer spokeswoman Allyanna Anglim said, "The court's decision reinforces the important role of biosimilars in the U.S. and benefits biosimilar manufacturers by helping to facilitate a more timely delivery . . . following FDA approval."

With several of its biologics facing biosimilar competition, Amgen wasn't so pleased – even though its own biosimilar pipeline could benefit from the decision. "While we are disappointed in the court's decision on the notice of commercial marketing, we will continue to seek to enforce our intellectual property against those parties that infringe upon our rights," Amgen spokeswoman Kelley Davenport said.

Skirting the dance

While both innovators and biosimilar sponsors seem focused on the court's answer to the timing of the commercial notice, patent attorney Sanya Sukduang told BioWorld the biggest surprise in Monday's ruling has to do with whether the BCPIA's so-called patent dance is optional. "The way they went about it here really skirted the issue," said Sukduang, a partner with Finnegan, Henderson, Farabow, Garrett & Dunner LLP.

Although the Supreme Court agreed with the Federal Circuit that a federal injunction couldn't be used to force a biosimilar sponsor to follow the patent exchange laid out in the BPCIA, the justices declined to go along with the lower court in declaring the patent dance optional.

"The BPCIA, standing alone, does not require a court to decide whether [the exchange] is mandatory or conditional; the court need only determine whether the applicant supplied the sponsor with the information required," Justice Clarence Thomas wrote in the opinion.

If a biosimilar applicant fails to provide the information required under the BPCIA, then the innovator can bring an immediate declaratory judgment action against the applicant, the court said, noting, however, that failure to dance the BPCIA steps is not an act of infringement. But it could violate state laws dealing with unfair competition.

The Supreme Court remanded that part of the decision to the Federal Circuit, instructing it to determine whether California law – the case was originally filed in federal district court in California – would treat Sandoz's failure to comply with the BPCIA patent dance as "unlawful." The Federal Circuit also is asked to determine whether the BPCIA preempts additional remedies that may be available under state law, such as a state-ordered injunction, and whether Sandoz forfeited a preemption defense.

So far, Sandoz is the only biosimilar applicant that hasn't engaged, at least partially, in the BPCIA patent exchange. Both innovators and biosimilar applicants were looking to the court to provide certainty on whether the dance was mandatory, Sukduang said, adding, "I'm not sure the Supreme Court decision provides that certainty." Instead, it could raise a myriad of state issues.

The decision also means that it's likely not the last word in the case. Sukduang said he wouldn't be surprised if the Federal Circuit kicked it down to the state court.

Good news for biosimilars

Certainty or not, the Supreme Court's decision "is better news for a biosimilar applicant in that they can perhaps speed things along," Sukduang said.

Courtenay Brinckerhoff, a partner at Foley & Lardner LLP, agreed, saying the decision "gives biosimilar applicants control over how – and when – patent disputes are addressed." A biosimilar applicant that wants to resolve the patent issues early to clear the way for a launch upon approval could share its application at the outset to force the innovator "to bring suit based on the information in the application or face the limitations on remedies set forth in [the BPCIA]," Brinckerhoff said. Otherwise, the innovator could postpone patent litigation until the biosimilar candidate is closer to approval, thus delaying the launch.

"The court's decision on the premarketing notice issue will mean that biosimilar products can be marketed as soon as they are approved, as long as there are no preliminary injunctions stemming from any still-pending patent litigation," Brinckerhoff said. "That possibility might encourage biosimilar applicants to participate in the patent dance to increase the likelihood that all patent disputes will be resolved by the time the product is approved."

IPR challenge

In other action Monday, the Supreme Court agreed to hear Oil States Energy Services v. Greene's Energy Group in its next term. The case raises the question of the constitutionality of inter partes review (IPR) proceedings to invalidate patents, since they extinguish private property rights through a non-Article III forum without a jury.

The court's decision on the issue could have a bearing on how biosimilar applicants clear the path for their products in the future. As things stand now, Brinckerhoff noted that applicants may try to defer costly patent litigation while challenging the innovator's patents in an IPR or post-grant review proceeding, which have a lower burden of proof for invalidity.