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
On October 6, the United States Patent and Trademark Office issued a Notice of Proposed Rulemaking regarding pre-issuance internal circulation and review of decisions of the Patent Trial and Appeal Board. The Office also...more
2022 was a milestone year for the Patent Trial and Appeal Board. In April, Kathi Vidal began her tenure as Director of the United States Patent and Trademark Office with an early focus on promoting increased efficiency at the...more
Earlier today, USPTO Director Kathi Vidal issued interim guidance regarding the application of the factors the PTAB considers in determining whether to institute an AIA post-grant proceeding where there is parallel district...more
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
In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more
3/8/2021
/ Appeals ,
Biologics ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
USPTO
U.S. Pat. No. 6,331,415, commonly referred to as “Cabilly II,” has been called one of the most-litigated patents of all time, having been challenged multiple times in both the district court and at the U.S. Patent and...more