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Drug patent listing and exclusivity clarified in new US bill

drug tablets
January 12, 2021

The Orange Book Transparency Act of 2020 (H.R. 1503) was signed into law last January 5, 2021. The Act updates regulations of the US Food and Drug Administration concerning the Approved Drug Products with Therapeutic Equivalence Evaluations (more commonly known as the Orange Book) which contains publicly available patent and exclusivity information, particularly on approved and available generic drugs.

The newly signed bill clarifies information regarding patent listing and exclusivity information that should be listed on the FDA’s Orange Book. 

It requires new drug applicant (NDA) holders, such as brand manufacturers, to provide the FDA the patent number and expiration date within 30 days after approval, provided that the approved drug has patented claims related to the drug substance (active ingredient); the drug product such as formulation or composition; or a method of use included in the application. All other patent information not related to what is required by the bill should not be submitted under the new law.

The amended Act also requires invalid patents to be removed from the Orange Book within 14 days of a final decision by a court or by the Patent Trial and Appeal Board. NDA holders must notify the FDA and the FDA is likewise required to remove or update the patent information in the Orange Book with the resulting decision. However, it will not be removed or amended until the 180-day exclusivity period relying on paragraph IV certification has expired. 

The FDA must also specify any applicable exclusivity period for a listed drug. This includes the 180-day exclusivity period for generic applications who have filed first under paragraph V. The provision will likely lead to increased transparency for new generic drug applicants.

The amendments come after changes to intellectual property law were enacted in the Omnibus Appropriations Bill in late December 2020. Those changes include disclosure concerning patent information related to biological products which affect the FDA’s Purple Book. The legislative changes suggest a push for greater transparency in the patent landscape for drugs, which could potentially impact the pharmaceutical industry.

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