American Conference Institute (ACI) will be holding its 2nd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA as a VIRTUAL conference from October 11-27, 2022.
The conference will present different aspects of Hatch-Waxman and BPCIA each day having the following agenda (all times Eastern Standard Time):
October 11th, 1:00 pm to 4:15 pm: Agency Overview, including jurisdiction and roles of FDA and PTO in patenting drugs and biologics, and pre-commercialization concerns
October 12th, 1:00 pm to 5:00 pm: Links between patenting and FDA approval, patenting and other IP-related protections and mechanisms, and the Orange Book
October 18th, 1:00 pm to 5:00 pm: The Hatch-Waxman Landscape, including ANDA and exclusivities, Paragraph IV Disputes and Litigation
October 20th, 1:00 pm to 4:45 pm: Biosimilars and Overview of aBLAs, the "patent dance" and pros and cons of participating, and the Purple Book
October 25th, 1:00 pm to 5:00 pm: Bioequivalence and interchangeability standards, 180-day exclusivity, and the intricacies of regulatory (non-patent) exclusivities
October 27th, 1:00 pm to 4:45 pm: Safe Harbor and patent protection, patent term adjustment (PTA) and patent term extension (PTE)
The agenda for the conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $1,795 if registered and paid by September 23rd, and $1,895 for registration and payment by October 11th. Patent Docs readers who reference the discount code "D10-999-PATENTDOCS" will receive a 10% discount. Those interested in registering for the conference can do so here, by e-mailing [email protected], by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of the Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA.
Comments