‘Patent dance’ ruling leaves lawyers in a spin
The US Court of Appeals for the Federal Circuit’s decision in Amgen v Sandoz is what the biosimilar industry would have been hoping for but clarity is lacking in several areas, lawyers have told LSIPR.
Reacting to the ruling from Tuesday, July 21, lawyers said the biosimilar industry will be relieved but explained that there are still questions that need to be answered.
In its judgment, the federal circuit ruled that biosimilar applicants can opt out of the so-called patent dance and that Sandoz is free to launch its Zarxio drug, a biosimilar of 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 added.
MaryAnne Armstrong, partner at law firm Birch Stewart Kolasch & Birch, said that although she believed the court’s ruling was the “interpretation that the biosimilar industry was hoping for”, there is a lack of clarity over the 180-day rule.
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’ dispute centred on whether Sandoz should have provided Amgen with 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.
Both the California district court, in March this year, and the federal circuit, in this week’s judgment, ruled that the patent dance is optional.
“An expectation that an applicant will proactively turn all their confidential documents over to the reference product sponsor created grave concern in the industry,” Armstrong said.
But Armstrong expressed concern over the exact rules surrounding the 180-day notice period.
“What is the penalty if the applicant does not provide the reference product sponsor with the required 180-day notice?” Armstrong asked.
“This question was not answered in the dispute because Sandoz provided notice after they received approval. But what would be Amgen’s recourse if Sandoz did not provide notice and simply launched their product?” she added.
Terry Mahn, principal at law firm Fish & Richardson, said questions concerning amendments to biosimilar applications also remained.
“The statute says nothing about amendments. What is to restrict a biosimilar applicant from disclosing a non-infringing application, side step the first wave of patent litigation and thus avoid having to disclose what it really intends to market in a later-filed amendment until after the biosimilar is on the market?”
Thomas Wintner, member of law firm Mintz Levin Cohn Ferris Glovsky and Popeo, added that as the court’s opinion was “fractured on several fronts”, there is a pretty good chance that the case will be revisited en banc by the federal circuit.
