Archive for category: Publications

How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (also known as MMA, the Medicare Modernization Act) to require that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the Federal Trade Commission (FTC) and the Department of Justice (DOJ). In this article, published in Biosimilar Development, Limin Zheng summarizes the key provisions of the new law, discusses its limitations, and takes a look at FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and how similar analyses may be applied to biosimilar settlements.

A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

How does the Biologics Price Competition and Innovation Act of 2009 (BPCIA) impact a biosimilar maker’s right to declaratory relief?  In this article, published in Biosimilar Development, Limin Zheng explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

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.