The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more
1/20/2025
/ Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Data Protection ,
Innovation ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Machine Learning ,
Mergers ,
Patents ,
Pharmaceutical Industry ,
Popular
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
11/21/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more
7/9/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
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 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
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
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
The Patent Trial and Appeal Board issued a decision on February 28 awarding priority of invention of foundational CRISPR gene editing patents to the Broad Institute, Massachusetts Institute of Technology, and Harvard...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 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
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance). This update is FDA’s...more
Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act.
Shortly after Amgen received US Food and Drug Administration (FDA)...more