Archive for category: Publications

Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know

The U.S. Supreme Court recently issued two decisions related to inter partes review. This article by Limin Zheng will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.

The Biosimilar Patent Dance

A biosimilar applicant has sole control over whether to initiate the “patent dance” under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and how far to take it.  The question for the biosimilar applicant is how to most effectively leverage that control.  Limin Zheng explores the question in her two-part article published in Biosimilar DevelopmentPart 1: Shall We (Patent) Dance? — Key Considerations For Biosimilar Applicants; Part 2: The Biosimilar Patent Dance: What Can We Learn From Recent BPCIA Litigation?

The Post-Mayo World Of Life Sciences Patents

In this three-part series, we will look at how the U.S. Supreme Court’s jurisprudence on patent eligibility has evolved, examine the impact of its March 2012 decision in Mayo Collaborative Services v. Prometheus Labs, Inc. on life sciences patent litigation in lower courts, and discuss what it means for patent eligibility of biologic and biosimilar patents. Read Limin Zheng’s article published in Biosimilar Development: Part 1; Part 2; Part 3.


The Biosimilar Patent Dance: When in Doubt, List It

In Amgen v. Hospira, issued August 10, the Federal Circuit provided its latest take on the “patent dance” under the Biologics Price Competition and Innovation Act (“BPCIA”).  The Federal Circuit sets a low bar for what constitutes “a claim of patent infringement could reasonably be asserted” under BPCIA and allows a reference product sponsor to potentially identify a lot more patents at the beginning of the dance than what it can reasonably assert at the end of the dance, after receiving additional information from the biosimilar applicant.  Read Limin Zheng’s article published in Daily Journal here.