FDA Law Blog: Biosimilars
JUNE 13, 2024
Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. And on X (R.I.P.
Collaborative Drug
OCTOBER 7, 2024
So just like a library needs to keep track of its books, you need to organize and track your compounds: You need to know if multiple lots exist in order to average biological responses from multiple assays. You need to know if you are registering the same compound with a different salt, or simply just a new lot of the same compound.
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Drug Target Review
JANUARY 14, 2025
Drug discovery scientists spend their days developing and testing complex hypotheses, leveraging data and expertise through workflows that utilise available tools. Defining the research question A well-defined research question is the cornerstone of an effective scientific workflow in drug discovery. provide more general information.
Drug Patent Watch
APRIL 23, 2024
Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs. This book chapter provides a… Source
FDA Law Blog: Biosimilars
MARCH 26, 2024
Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed. For the second time in recent years, the FTC has filed an Amicus Brief explaining exactly which patents should not be in the Orange Book.
FDA Law Blog: Biosimilars
SEPTEMBER 25, 2024
But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments. He originated the idea of patent certifications, new drug exclusivity, and the Bolar exemption. (And
FDA Law Blog: Biosimilars
SEPTEMBER 19, 2023
Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.
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