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Legislative Changes to FDA's Orange Book and Purple Book Listing Requirements | Arent Fox


Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.
 
Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the Orange Book Transparency Act of 2020 (the “Orange Book Act”) and the so-called Purple Book Continuing Act (the “Purple Book Act”) were both signed into law with relatively little public fanfare. Both of these bills largely codify in statute the patent-listing and related requirements currently incorporated in FDA’s regulations and guidance. Nevertheless, the recent codification provides additional regulatory clarification and certainty, and, more notably, includes additional substantive requirements. Each of these Acts is summarized below. ....

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IP Implications of the Consolidated Appropriations Act, 2021 | McDermott Will & Emery


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On December 27, 2020, Congress signed the Consolidated Appropriations Act, 2021, into law. The omnibus act includes new legislation affecting patent, copyright and trademark law. A brief summary of key provisions is provided below.
Patents – Section 325 Biological Product Patent Transparency
42 USC § 262(k) was amended to require that the US Food and Drug Administration (FDA) provide the public with more information about patented biological products. Within six months, the FDA must make the following information available to the public on its Database of Licensed Biological Products or “Purple Book,” and it must update the list every 30 days: ....

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IP Implications of the Consolidated Appropriations Act, 2021


IP Implications of the Consolidated Appropriations Act, 2021
Thursday, January 14, 2021
On December 27, 2020, Congress signed the Consolidated Appropriations Act, 2021, into law. The omnibus act includes new legislation affecting patent, copyright and trademark law. A brief summary of key provisions is provided below.
Patents – Section 325 Biological Product Patent Transparency
42 USC § 262(k) was amended to require that the US Food and Drug Administration (FDA) provide the public with more information about patented biological products. Within six months, the FDA must make the following information available to the public on its Database of Licensed Biological Products or “Purple Book,” and it must update the list every 30 days: ....

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