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07/10/2025 23/10/2025 America/Toronto Hatch-Waxman and BPCIA Hatch-Waxman and BPCIA
October 7 – 23, 2025
, Virtual Series
Please visit https://www.americanconference.com/hatch-waxman/ for more information and updates. , Virtual Series true DD/MM/YYYY 1440 use-title -
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07/10/2025 23/10/2025 America/Toronto Hatch-Waxman and BPCIA Hatch-Waxman and BPCIA
October 7 – 23, 2025
, Virtual Series
Please visit https://www.americanconference.com/hatch-waxman/ for more information and updates. , Virtual Series true DD/MM/YYYY 1440 use-title -
Master Hatch-Waxman and BPCIA Essentials for Legal and Business Professionals in the Biopharma Arena
Unlock a critical skillset tailored for legal professionals in the biopharmaceutical sector. ACI’s Hatch-Waxman and BPCIA Proficiency Series is a virtual, three-week intensive program designed to equip new life sciences lawyers and executives with the expertise needed to navigate Hatch-Waxman and BPCIA litigation and regulation.
In today’s complex biopharmaceutical landscape, understanding the regulatory and IP nuances is essential for securing and defending patents. This series delivers a thorough examination of Hatch-Waxman and the BPCIA, alongside foundational IP insights for both small molecules and biologics, empowering you to strategically manage patent lifecycles and guide business development decisions effectively.
Join us on our state-of-the-art interactive platform to gain the essential knowledge and tools that underpin success in the life sciences legal field.
Week One
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Week Two
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Week Three
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Practical Benefits to Attending
UNDERSTAND the interplay of the PTO and FDA in the patenting of drugs and biologics
LEARN about the approval process for drugs and biologics and their connection to the patent process
COMPREHEND the framework of Hatch-Waxman Paragraph IV litigation and BPCIA patent dance
MAKE SENSE of the relationship between patent and non-patent exclusivity
EXAMINE patent extensions including restorations and adjustments
NAVIGATE the rules and exceptions of the safe harbor
DEVELOP an in-depth and practical knowledge of Hatch-Waxman protocols, including:
- Differences between NDAs, ANDAs, BLAs, aBLAs
- The Orange Book vs. The Purple Book
- 180 Exclusivity
- Bioequivalency
- The Safe Harbor
Who Should Attend
The Hatch-Waxman and BPCIA Proficiency Series is designed for new associates, junior partners, and professionals in the life sciences industry.
Law Firms with Practice Groups
- Life Sciences, Pharmaceuticals and Biopharmaceuticals
- Follow-on Biologics and Biosimilars
- Intellectual Property and Patent Prosecution
- Patent and IP Litigation
- Hatch-Waxman and BPCIA Litigation
- Regulatory and Commercialization
- Trademark & Copyright
- Life Sciences IP Antitrust
Pharma and Biopharmeutical Companies
- C-Suite Executives and Associate Executives
- In-House Counsel (IP, Regulatory, Corporate, Litigation)
- Business Development Executives
Accreditation
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
“Legal and business professionals who work in the life sciences industry must be well versed in the regulatory components and IP issues that play an integral role in the protection of companies’ products. This immersive series explores a variety of patent and regulatory issues, including essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. The Series is so comprehensive, it truly stands apart as the best option to train newer lawyers and in-house counsel.”
—Fangli Chen, Ph.D., Partner
Proskauer Rose LLP (2024 Conference Co-Chair)
“Patent litigation continues to generate numerous consequential precedents that impact the strength and scope of patent rights covering pharmaceutical and biopharmaceutical innovations. Further, legislators and regulators continue to increase their oversight of the pharmaceutical and biopharmaceutical industries. This Series covers the essentials of the litigation, regulatory, and business landscape relating to these industries to give attendees a proficiency with the fundamentals of patent prosecution, exclusivities, patent litigation, commercialization, and more. This comprehensive Series is important especially at a time when all attorneys increasingly need to have a holistic and multifaceted understanding of the legal and business aspects of these complex industries.”
—Jason Murata, Partner
Axinn, Veltrop & Harkrider (2024 Conference Co-Chair)
Sponsor Opportunities
With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, the Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.
For more information please contact:
Aaron Goldstein
Senior Business Development Manager
Phone: 201-282-7274 | Email
