The Issue with Reissue: PTE Edition
FDA Law Blog: Biosimilars
MARCH 18, 2025
Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. The plain text of 35 U.S.C. The Court thus explained that interpreting the patent in 35 U.S.C.
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