Developing IP Strategy for FDA-Regulated Drug Products Requires Special Considerations
More Than Your Mark
FEBRUARY 11, 2019
The complex calculation to determine the term of a patent is discussed in detail in my earlier blog posts here and here. One factor that contributes to patent term is Patent Term Extension (PTE) available under 35 U.S.C. Orange Book – NDA sponsors to identify patents it believes cover its drug, which the FDA lists in the Orange Book.
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