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
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
1/12/2022
/ America Invents Act ,
Antitrust Provisions ,
Biden Administration ,
Biologics ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
New Guidance ,
New Legislation ,
Orange Book ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements ,
USPTO
As discussed in our prior piece on Patent Law, the United States patent system is built on a “carefully crafted bargain” between inventors and the public. Issuance of a patent allows the owner of that patent to prevent others...more
9/14/2020
/ Covered Business Method Patents ,
Inter Partes Review (IPR) Proceeding ,
International Trade Commission (ITC) ,
Inventions ,
Inventors ,
MPEP ,
Patent Infringement ,
Patent Registration ,
Patents ,
Post-Grant Review ,
Trademark Registration ,
Trademarks ,
USPTO
This post is a part of a monthly series summarizing notable activity in patent litigation in the District of Massachusetts, including short summaries of substantive orders....more