Sandoz v. Amgen: Why the Biologics Price Competition and Innovation Act of 2009 Allows Biosimilar Makers to Pursue Pre-Application Declaratory Judgment Actions and Will Enhance Competition

Abstract

The generic drug industry is shifting towards biosimilars. In the coming years, first-generation blockbuster biologic drugs will come off patent protection. However, unlike the small-molecule chemical drug market where exact generic copies can be produced, the complexity of large-molecule biologic drugs makes exact replicates impossible. As a result, biologic copies aim to be as similar as possible to their blockbuster counterparts – thus, the name: biosimilars. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates biosimilar approval.Submarine patents threaten the development of biosimilars. These types of patents are a product of manipulative continuation practices by the applicant, and can result in patent issuance more than a decade after the filing date. Submarine patents are meant to surprise an industry and preclude competition. While some believe submarine patents are a thing of the past, a pending case before the Federal Circuit shows they are not. In Sandoz v. Amgen, the Federal Circuit’s interpretation of the BPCIA will determine what litigation strategies are available to biosimilar makers to combat submarine patents. This is the first case to arise in the biosimilar industry. The issue is one of pure statutory interpretation: does the BPCIA bar a biosimilar maker from filing a declaratory judgment (DJ) action before submitting an application for approval.This article argues that the BPCIA does not preclude pre-application DJ actions. In addition, the article posits that pre-application DJ actions are an important tool in the fight against submarine patents and will enhance competition. The biosimilar industry is fast approaching and the legal community must take notice. This article seeks to further that conversation.