Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
4/18/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
9/27/2023
/ Biologics ,
BPCIA ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Motion To Stay ,
Parallel Proceedings ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Webinars
The Act’s Objectives -
USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged...more
As of July 24, 2023, the United States Patent and Trademark Office (USPTO) revised the interim Director Review process and replaced the Precedential Opinion Panel (POP) with the Appeals Review Panel process, which will review...more
On June 22, 2023, Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) announced the reintroduction of legislation to reform the patent eligibility requirements under 35 U.S.C. § 101....more
Earlier today, the Supreme Court issued a unanimous decision in Amgen v. Sanofi, construing the statutory enablement requirement.
The case concerns antibodies that help reduce levels of LDL cholesterol....more
It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more