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Patent Transparency For Biologics Biosimilars The Revamped Purple Book

Patent Transparency For Biologics Biosimilars The Revamped Purple Book
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Taking Advantage of the New Purple Book Patent Requirements for Biologics | Morgan Lewis

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New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to list these patents in the Purple Book. Small and medium-sized enterprises (SMEs) and others in the industry can take advantage of this new source of information by using it to identify (i) potential partnerships for licensing of existing IP; (ii) targets for IPRs; or (iii) design around opportunities for the development of new technology. ....

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"Purple Book" Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect? | King & Spalding

The Biological Product Patent Transparency Act (“BPPT”)
1 – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the first-ever provision requiring public listing in the FDA’s “Purple Book” of certain patents associated with biologic drug products (
e.g., monoclonal antibody products and other protein drug products). See the text of the BPPT here.
The BPPT sidestepped some of the more controversial approaches to biologics patent listing, by piggybacking off of the patent lists that reference product sponsors (
i.e., biologics innovators) are already required to exchange with biosimilar applicants ....

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Biological patent transparency

The Consolidated Appropriations Act, which was enacted on 27 December 2020, requires drug manufacturers and licence holders to market biologic drugs and disclose all patents that cover their products to the Food and Drug Administration. By increasing transparency, the act aims to force manufacturers to conform to rules which have proven successful in promoting the development and use of small-molecule generic drugs. ....

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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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