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.
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 Development: Part 1: Shall We (Patent) Dance? — Key Considerations For Biosimilar Applicants; Part 2: The Biosimilar Patent Dance: What Can We Learn From Recent BPCIA Litigation?
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 Numbers Indicate the Russian Olympic Ban Was Too Harsh,” Sports Law360, December 5, 2017, https://www.gcalaw.com/wp-content/uploads/2017/12/the_numbers_indicate.pdf.
“Australian Football Transgender Ban Is Discriminatory,” Sports Law 360, October 16, 2017,
“Would Spock Kneel for the Anthem,” Texas Tribune, October 10, 2017, https://www.tribtalk.org/2017/10/10/would-spock-kneel-for-the-anthem/
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.
“Pepperdine Gay Bias Case—A Loss and a Win for Plaintiffs, Law 360, August 14, 2017, https://www.gcalaw.com/wp-content/uploads/2017/08/SBRM.pdf.