On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user.
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology.
China Patent Linkage System | Wilson Sonsini Goodrich & Rosati jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
New legislation requires certain patent information to be published in FDA Purple Book internationallawoffice.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from internationallawoffice.com Daily Mail and Mail on Sunday newspapers.
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: