Keyword Analysis & Research: orange book listed patent


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Frequently Asked Questions

Why are not all FDA-approved patented drugs listed in the Orange Book?

However, not all FDA-approved patented drugs are listed in the Orange Book, and that could be for two reasons: The patent is a process patent and not a patent on the actual medication. The patent holder failed to ask the FDA to include it in the Orange Book.

What is the Orange Book and why is it important?

The Orange Book makes it easier for drug makers to monitor for new generic drugs that come on the market and infringe on their own patents. Therefore, such businesses holding patents on FDA-approved drugs will very easily know if new generic versions are being manufactured and sold.

What happens if a generic drug is found in the Orange Book?

If a drug maker finds the new generic version in the Orange Book, it can notify the new creator of possible infringement and can subsequently file a patent infringement suit (without having to see the generic drug that was created).

Can a district court infringe a non-Orange Book patent?

The Federal Circuit also has not addressed “whether district courts may exercise jurisdiction over a claim asserting future infringement of a non-Orange Book patent under the Declaratory Judgment Act when such a claim is based solely on the filing of an ANDA by a generic manufacturer. ” Takeda Pharm. Co. v. Mylan Inc ., 62 F. Supp.


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