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
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
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
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
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
Quarterly Post-Grant and Patent Litigation Update -
Welcome to our ongoing updates relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. We hope you find...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
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products.
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more