American Conference Institute (ACI) will be holding its Hatch-Waxman and BPCIA Virtual Proficiency Series, a 3-week primer on IP basics and regulatory fundamentals on small molecule and biologic drugs and their generic and biosimilar equivalents, from October 5-21, 2021.
In Week One, meeting on October 5th and 7th, the regulatory framework will be discussed, including:
• The interplay between the PTO and FDA
• Pre-commercialization concerns
• Links between the FDA approval process and the patent process
• The Orange Book
Week Two, meeting on October 12th and 14th, will cover the Hatch-Waxman and BPCIA framework, including:
• The Hatch-Waxman landscape
• Paragraph IV disputes and litigation
• Biosimilars, the BCIA and aBLA overview
• Participating in the "patent dance"
• The Purple Book
Finally, in Week Three, the focus will be on bioequivalence, exclusivity, extensions, and exceptions, including:
• Bioequivalence and interchangeability
• 180-day exclusivity
• Non-patent/regulatory exclusivity
• Exploring the safe harbor
• Examining patent term extensions
The sessions will meet from:
• 1:00 pm - 4:15 pm EST on October 5th,
• 1:00 pm - 5:00 pm EST on October 7th,
• 1:00 pm - 5:00 pm EST on October 12th,
• 1:00 pm - 4:45 pm EST on October 14th,
• 1:00 pm - 5:00 pm EST on October 19th, and
• 1:00 pm - 4:45 pm EST on October 21st.
An agenda for the conference can be found here.
The all-inclusive registration fee for the conference is $1,695 if registered and paid by September 17th and $1,795 if registered and paid by October 4th. Patent Docs readers are entitled to a 10% discount off of registration using discount code D10-130-130AX01. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's Hatch-Waxman and BPCIA Virtual Proficiency Series.
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