FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision alters patent term adjustment

Two recent developments will affect the listing of patent information with pharmaceutical products approved by the US Food and Drug Administration (FDA).

First, the FDA has revised the forms on which such information is submitted. The revised forms may alter the manner in which sponsors describe patent claims covering methods of using their FDA-approved drug products.

Second, the Federal Circuit recently held that the US Patent and Trademark Office (PTO) has incorrectly interpreted a statutory patent term adjustment under 35 USC 154 for certain patents whose prosecution included a request for continued examination. Although this decision is not limited to pharmaceutical patents, any changes to patent expiration dates for FDA-approved drug products must be promptly submitted to the FDA on the revised forms…

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