Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Venable’s BiologicsHQ Monthly Injection – June 2024...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list...more
In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted...more
The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more
As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent...more
The Purple Book—a database containing information about all licensed biological products—is set for a revamping that offers more patent transparency regarding reference biologics. The Purple Book, which was first published in...more
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...more
On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more
The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food...more
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory,...more
Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more
As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and more user-friendly search functionality for the biological product...more
Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more
The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved...more
This past week, the Food and Drug Administration (FDA) announced the creation of the “Purple Book,” which will list all biological products, including any biosimilar and interchangeable biological products, licensed by the...more