Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have launched in the U.S. market....more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
1/23/2023
/ Antitrust Provisions ,
Biosimilars ,
BPCIA ,
Competition ,
FDA Approval ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements
Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more
2/5/2021
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
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
The United States patent system is built on a “carefully crafted bargain” between inventors and the public. In exchange for a disclosure teaching the public how to make and use an invention, the federal government grants the...more
Introduction -
In many ways, 2019 was a notable year for biosimilars in the U.S. FDA approved the 26th biosimilar product and the 13th biosimilar product was launched in the U.S. market. These developments were...more
2/3/2020
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
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
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
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.
Enovate Medical, LLC v. Definitive Technology...more