The FDA sought comments as part of its wide effort to modernize the Orange Book in Docket FDA-2020-N-1127 regarding the types of patent information listed in the Orange Book. Specifically, the FDA sought input for specific questions regarding:
In addition, the FDA also asked for general comments regarding potential improvements to the Orange Book patent listing process.
The IPO Pharmaceutical and Biotechnology Issues Committee formed a subcommittee to draft a response to the FDA. Finnegan's Tom Irving and Stacy Lewis, members of the IPO Pharmaceutical and Biotechnology Issues Committee, joined the subcommittee and, with the help of Finnegan's Jill MacAlpine, drafted detailed recommendations for changes to the Orange Book Listing Form 3542, found in the Appendix to the IPO response. Tom Irving and Stacy Lewis also participated in the subcommittee's drafting of substantive responses to the FDA's request for comments and specific questions.
October 13, 2022
October 11-27, 2022
October 10-12, 2022
September 27, 2022
September 18-20, 2022
September 1, 2022
August 24, 2022
If you have European patents, you need to know about the Unified Patent Court (UPC).