The Biologics Price Competition and Innovation Act (BPCIA) has been considered overly complex and unclear as to many of its procedural requirements. The US Supreme Court is now considering the Federal Circuit Court’s decision in Amgen v Sandoz, which held that a biosimilar applicant could choose to opt out of the so-called patent dance and that the biosimilar’s notice of commercial launch may only be given after the FDA approves the biosimilar’s application. The Supreme Court’s decision in the case, expected by July, could set a precedent on whether the patent-dance exchange of patent and manufacturing information before FDA approval is necessary and whether biosimilar manufacturers must obey the provision specifying notice of commercial marketing, which effectively adds 6 months to the wait to market the drug after FDA approval.
One of the big questions biosimilar applicants have had to decide upon is whether to engage in the patent dance at all, and if so, for how long. The procedure takes approximately 6 months to complete, representing a significant delay in commercial launch. Another issue has been when to give the reference drug sponsor (RDS) the 180-day notice of commercial launch required by the BPCIA, which represents another 6 months of delay (and is the reason applicants have been trying different ways to give notice as soon as possible; see Amgen v Apotex below). RDSs have also been uncertain about these steps and whether they have the right to seek legal means of forcing biosimilar applicants to comply with the steps.
To date, companies have used 3 main strategies to address the patent dance, according to an analysis in Bloomberg Law Life Sciences Law & Industry Report.
There are still many open questions in the area of biosimilars litigation that the Supreme Court and Federal Circuit Court will continue to weigh in on, and the answers they provide will have significant impact for biosimilar applicants going forward.