WASHINGTON (Legal Newsline) – The U.S. Supreme Court has asked for consideration from Solicitor General
Ian Heath Gershengorn in a case involving biologics.
In the case Amgen v. Sandoz, the court has deferred its decision, instead asking Gershengorn to comment on petitions filed by both parties involved in the case. Sandoz asked for a review of the only interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The case examines when a biosimilar applicant can provide notice of commercial marketing. Under the BPCIA, this must be issued at least 180 days before the biological product enters the market, but the federal court has held that the manufacturer can only give effective notice after the FDA has licensed the product.
Sandoz argues that a federal court extended the statutory period beyond what Congress intended with the BPCIA and has unfairly awarded Amgen an injunction. In its cross-petition, Amgen is alleging that biosimilar applicants should participate in the “patent dance”
The patent dance is the process that biological applicants and the reference product sponsor exchange patent information before the biological product can be allowed to enter the market. In this case. Sandoz prevailed regarding whether the procedure for the “patent dance” is mandatory or optional.
The Supreme Court’s decision to ask the solicitor general to weigh in on the case is a rare occurrence, as Aron Fischer, partner at Patterson Belknap, told Legal Newsline.
“It occurs, but it’s not on a routine basis," he said. "The large majority of petitions will be denied without input from the solicitor general so this is quite unusual. When there’s a relatively serious issue about federal statutes, they often ask interpretation of the federal statutes.
"I think they think the petition requires additional consideration and also because there’s a federal statute, so they want to know what the United States views on this statute.”
Amgen didn’t file a petition on the patent dance until Sandoz filed its. The U.S. Court of Appeals for the Federal Circuit held that a patent infringement suit is the only remedy for not participating in the “patent dance.”
Both parties' petitions were given separate docket numbers and the Supreme Court’s order to the solicitor general asks him to examine both petitions.
As for what the solicitor general’s comments will be, Fischer said, “I wouldn’t want to venture a predication. There’s two complicated issues. It’s hard to say.
"The case has already been decided by the federal circuit and had an impact. If the Supreme Court takes the case it will resolve that issue. It shows that it's doing more consideration, but until the solicitor general's brief and the Supreme Court decision, it's just speculation on what’s going to happen next.”
No deadline has been set for the solicitor general to comment on both parties' petitions, but it is expected that it will provide its considerations in August at the beginning of next term.