Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
In the recent decision Ex parte Chamberlain, Appeal 22-1944 (Xencor), the United States Patent and Trademark Office’s new Appeals Review Panel provided clarity regarding its stance on means-plus-function claims. Its decision...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
5/13/2024
/ Biologics ,
Biosimilars ,
FDA Approval ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
The US Court of Appeals for the Federal Circuit in Purdue Pharma L.P. v. Collegium Pharm. Inc. addressed a unique situation in November 2023 whereby the Patent Trial and Appeal Board failed to issue its Final Written Decision...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.
Since the enactment of the Biologics Price Competition and Innovation...more
12/30/2022
/ Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Litigation Strategies ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
10/19/2022
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Strategies ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
7/12/2022
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
4/5/2022
/ Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.
Since the enactment of the BPCIA, 29 biosimilars have been approved, 16...more
8/30/2021
/ Biologics ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
USPTO
The US Supreme Court issued its highly anticipated decision on June 21 in United States v. Arthrex, Inc., addressing whether the authority of administrative patent judges (APJs) of the Patent Trial and Appeal Board (PTAB) to...more
6/24/2021
/ Administrative Patent Judges ,
Appointments Clause ,
Constitutional Challenges ,
Director of the USPTO ,
Inferior Officers ,
Patent Trial and Appeal Board ,
Patents ,
Principle Officers ,
PTAB Precedential Opinion Panel (POP) ,
SCOTUS ,
United States v Arthrex Inc
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. This past quarter as COVID spread across the globe, challenges to patents...more
As of 2020, post grant proceedings have been in use for eight years. Designed as an alternative to district court litigation post grant proceedings have offered litigants a faster and more cost effective forum for resolving...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. This past quarter as COVID spread across the globe, challenges to patents...more
The US Supreme Court has granted certiorari in three cases relating to the US Court of Appeals for the Federal Circuit’s controversial October 2019 decision in Arthrex, Inc. v. Smith & Nephew, Inc. In Arthrex, the Federal...more
10/19/2020
/ 5 U.S.C. § 7513(a) ,
Administrative Patent Judges ,
Appointments Clause ,
Arthrex Inc v Smith & Nephew Inc ,
Constitutional Challenges ,
Director of the USPTO ,
Inferior Officers ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Polaris Innovations Ltd v Kingston Technology Co ,
Principle Officers ,
SCOTUS ,
Severability Doctrine ,
Tenure ,
United States v Arthrex Inc
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.
The BPCIA celebrated its 10-year anniversary on March 23, 2020. During...more
Welcome to our 1Q 2020 update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics.
Notably, the BPCIA celebrated its 10-year anniversary on March 23, 2020....more
The US Court of Appeals for the Federal Circuit held that data obtained after an asserted patent’s priority date may be used to demonstrate what is “necessarily present” in a prior art embodiment. Although the district court...more
In one of its first precedential opinions of the new year, the US Court of Appeals for the Federal Circuit held that a claim using “comprising” as a transition phrase followed by a limitation requiring a component that...more
The US Court of Appeals for the Federal Circuit recently upheld the district court’s denial of a judgment as a matter of law (JMOL) or, alternatively, motion for a new trial, reinforcing the fine line that exists between...more
Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...more
As of 2019, post-grant proceedings have been in use for seven years. Designed as an alternative to district court litigation, post-grant proceedings have offered litigants a faster and more cost-effective forum for resolving...more