Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...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
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. Pursuant to a law enacted in late...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
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...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
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
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...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
On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or...more