In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe harbor” provisions for certain clinical trials and regulatory filings. Although the case
Summary of the Budapest Treaty for Biological Deposits
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 biological material to meet patent disclosure requirements. The agreement was first ratified in 1977, and