https://www.law.com/njlawjournal/2024/07/02/hatch-waxman-litigation-and-improper-orange-book-patent-listings-whats-next/
COMMENTARY
“Innovator companies should expect Orange Book patent listing challenges to emerge as an additional and simpler tool for overcoming ANDA litigation,” write Peter J. Butch III and Howard S. Suh.
July 02, 2024 at 10:00 AM
7 minute read
By Peter J. Butch III and Howard S. Suh |
July 02, 2024 at 10:00 AM
A recent ruling in the U.S. District Court for the District of New Jersey could have far reaching implications on the development and sale of generic drug products.
While the judge’s decision is currently on appeal, it is clear pharmaceutical companies that innovate new drugs should expect more challenges to U.S. Food and Drug Administration’s Orange Book patent listings. They also should expect the U.S. Federal Trade Commission (FTC) to insert itself early into more Orange Book listing challenges in support of generic drug companies.
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