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ARTICLE · 25 JANUARY 2021

Orange Book Transparency Act Creates Some New Obligations

Cooley LLP
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The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing...

United StatesIntellectual Property
Orion Armon
Orion Armon
Jonathan Davies
Jonathan Davies
Daniel Knauss
Daniel Knauss
Michelle Rhyu
Michelle Rhyu
Sanya Sukduang
Sanya Sukduang
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The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations. It also requires that the FDA provide a list of exclusivities and a report related to certain types of device-related patents.

The act does not significantly impact the form or function of the Orange Book, but several aspects are worth noting.

  • While the FDA is currently considering comments regarding the scope of listable patents, the act provides essentially the same identification of listable patents as the existing related regulations – i.e., "drug substance (active ingredient)," "drug product (formulation or composition)" and "method of using such drug for which approval is sought or has been granted."

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