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
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
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
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
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
A split Federal Circuit panel recently upheld the district court’s judgment of invalidity and noninfringement because the phrase “consisting essentially of” rendered the asserted claims indefinite and the proposed ANDA label...more
There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more
12/8/2017
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Hatch-Waxman ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patents ,
Principal Place of Business ,
TC Heartland LLC v Kraft Foods ,
Teva Pharmaceuticals ,
Venue
AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success.
The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
7/6/2016
/ Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions