Biologics and Biosimilars

Biography

Biography: Laura Burson,

Abstract

In Amgen v. Sandoz, the Federal Circuit held that biosimilar applicants are not required to provide their Biologics License Application (BLA) or engage in the patent dance – the process under the BPCIA in which the parties identify which patents the parties believe should be litigated.  However, the court held that an applicant who fails to provide its BLA must provide the brand with 180-days’ notice of launch.  In Amgen v. Apotex, the Federal Circuit held that a biosimilar applicant must always provide the brand with 180-days’ notice before launch, regardless of whether the applicant provided its BLA or engaged in the patent dance.  The result of these decisions may be that few biosimilars applicants engage in the patent dance. 

Rather than litigating biologics patents under the BPCIA, biosimilars applicants may challenge biologics patents by filing IPRs.  We will review IPRs that have been filed in the biologics area, analyze key institution decisions, and provide takeaways from the institution decisions and our views on lessons that should be learned from these decisions.