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Key Trends in PTAB’s 2021 Orange Book and Biologic Patent Study

LexBlog IP

The first study covering these topics was released on March 13, 2018, and the second on July 18, 2019. This is the third report providing data on post-grant petitions filed against Orange Book and biologic patents released by the PTAB, and it covers AIA petitions filed between September 16, 2012 and June 30, 2021. Trends Over Time.

Patent 52
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Patent Case Management Goes Cross-Institutional and Global

Patently-O

s distinctive approaches to dealing with border control (the ITC’s Section 337 authority) and pharmaceutical patents (Hatch Waxman and the BPCIA). SELECTED TOPICS. It was time to integrate PTAB case management into U.S. patent case management. The project illuminated the U.S.’s PATENT INFRINGEMENT. THREATS ACTIONS. ENFORCEMENT.

Patent 67
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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

Litigation under the Biologics Price Competition and Innovation Act (BPCIA) in the district courts also decreased. BPCIA Litigation. BI had asked FDA to change its interpretation of the term “strength” as used in the BPCIA for parenteral solutions to mean “total drug content” without regard to concentration. BPCIA Litigation.