What is Patent Dance?

In the fast-growing biosimilar industry, success is not just about creating cost-effective alternatives to biologics. It’s also about navigating the intricate legal and regulatory framework laid out by the Biologics Price Competition and Innovation Act (BPCIA). At the heart of this framework lies the “patent dance”—a critical pre-litigation process that determines how biosimilars can enter the market while respecting intellectual property (IP) rights.

The patent dance is a formal, step-by-step process established under the Biologics Price Competition and Innovation Act (BPCIA) to manage patent disputes between biosimilar developers (applicants) and the manufacturers of original biologic products (reference product sponsors or RPS). It is designed to facilitate the exchange of information, identify relevant patents, and resolve intellectual property (IP) issues before a biosimilar product enters the market.

Purpose of the Patent Dance

The patent dance helps:

• Streamline Dispute Resolution: It avoids unnecessary legal battles by resolving disputes early.
• Ensure Regulatory Compliance: It aligns with the BPCIA’s requirements for biosimilar approval.
• Facilitate Market Access: By addressing patent issues upfront, biosimilar developers can enter the market faster.
• Balance Interests: It protects the IP rights of the RPS while enabling biosimilar competition.

The process begins when the biosimilar applicant submits their abbreviated Biologics License Application (aBLA) to the FDA. The applicant is required to provide the RPS with a copy of their application and information about the manufacturing process.