The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
2/13/2025
/ Artificial Intelligence ,
Compliance ,
Corporate Counsel ,
Data Integrity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more
1/31/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Marketing ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Preliminary Injunctions
The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more
1/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents