In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
4/8/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
Drug Approvals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
This post reviews developments from the Northern, Southern, Eastern, and Western Districts of Texas in December 2023. ...more
2/7/2024
/ Inter Partes Review (IPR) Proceeding ,
Markman Hearing ,
Motion To Stay ,
Multidistrict Litigation ,
Noninfringement ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Willful Infringement
On December 7, the Biden administration announced a proposed framework for determining whether the government may exercise its march-in rights to license pharmaceutical patents to third parties if it determines that the price...more
This post reviews three July 2022 opinions from the Western and Eastern Districts of Texas resolving motions to stay. The first case involves the denial of a stay pending reexamination proceedings issued by the...more
This post reviews two April 2021 opinions from the Eastern District of Texas deciding post-trial motions. The first case involves the denial of enhanced damages by the Honorable Amos L. Mazzant, III. In the second case, the...more
This post analyzes three March 2020 opinions from the Eastern District of Texas deciding motions to stay pending: (1) an IPR filed by a third party; (2) a declaratory judgment action pursuant to the customer-suit exception;...more
A Tale of Two ANDAs: Jurisdiction and Venue in a Non-Traditional Sense -
Judge Gilstrap’s recent opinion in Apicore US LLC v. Beloteca, Inc., No. 2:19-CV-00077-JRG, 2019 WL 1746079 (E.D. Tex. Apr. 18, 2019), highlights...more
This post is our latest review of noteworthy case developments in the Eastern and Northern Districts of Texas for the month of April 2018. Two subjects stand out this month from the Eastern District: (1) testimony of damages...more