Disagreement on outcome of SCOTUS Amgen v Sandoz ruling
The US Supreme Court’s decision in the Amgen and Sandoz clash, which was handed down yesterday, has sparked disagreement between lawyers on the consequences of the ruling.
The first issue in dispute was whether a 180-day notice of commercial marketing must be given to the reference product sponsor (RPS) after the biosimilar product is licensed by the Food and Drug Administration (FDA).
Amgen claimed that a biosimilar applicant must wait until its product is approved by the FDA before giving notice, while Sandoz argued that notice may be given before approval.
Siding with Sandoz, the Supreme Court said that an applicant may provide notice before obtaining a licence.
The Supreme Court also said that no injunction is available under federal law to force compliance with the ‘patent dance’, but the court remanded the issue for the US Court of Appeals for the Federal Circuit to determine whether a state law injunction is available.
According to Courtenay Brinckerhoff, partner at Foley & Lardner, biosimilar applicants might be encouraged by the decision to participate in the ‘patent dance’, to increase the chance that all disputes are resolved by the time a product is approved.
Christopher Loh, partner at Fitzpatrick, Cella, Harper & Scinto, disagreed with Brinckerhoff, explaining that the practical effect of the ruling will be to permit biosimilar applicants to bypass the requirements of the dance.
“I think one of the functions of the patent dance was to get the parties talking about patents early and potentially settling certain patent issues, before the start of any litigation.
“The Sandoz decision has the potential to circumvent that process,” he said.
Brinckerhoff added: “The court’s decision on both issues gives a biosimilar applicant control over how, and when, patent disputes are addressed.”
She explained that a biosimilar applicant who wants to resolve disputes early could share its application at the outset, to force the RPS to bring a suit based on the information in the application or face the limitations on remedies set forth in 35 USC, section 271(e)(6)(B).”
The section covers patent infringement and states that the sole and exclusive remedy that may be granted by a court—upon a finding that the making, using, offering to sell, selling, or importation into the US of the biological product that is the subject of the action infringed the patent—shall be a reasonable royalty, she added.
On the other hand, “a biosimilar applicant who wants to defer the patent issues could decide not to share its application and even wait for FDA approval before giving pre-marketing notice”.
Brinckerhoff added that a biosimilar applicant could also try to defer litigation while challenging the patents in an inter partes review or post-grant review proceeding at the Patent Trial and Appeal Board, where it could take advantage of the lower burden of proof for invalidity.
Kevin Noonan, partner at McDonnell Boehnen Hulbert & Berghoff, said that the court did not address the fundamental question of the patent dance.
He added: “The court focused on the issue of whether the court had a remedy to grant injunction. It sounded like the court didn't have one and sent it back to the Federal Circuit to determine.
“The court seems to dodge the fundamental question of whether or not disclosing the biosimilar application was mandatory—it didn't even really address it.”
Carol Lynch, global head of biopharmaceuticals at Sandoz, said that the Supreme Court’s unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments.
She added: “We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward.”
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