With the enactment of health care reform legislation, Congress for the first time authorized the FDA to approve biological products through an abbreviated regulatory pathway that does not require full clinical testing. Although generic drugs have been permitted under the Hatch-Waxman Amendments since 1984, Congress had not previously established an analogous scheme allowing for approval of so-called "follow-on biologics" or "biosimilars." In addition to establishing a new abbreviated approval process, the new law imposes a scheme for patent litigation that is very complex and completely different from Hatch-Waxman.
Seminar topics will include:
- What are the similarities and differences between the new law and Hatch-Waxman?
- How does the legislation impact product exclusivity, including: data exclusivity for reference products and interchangeable biosimilars, patent litigation provisions, and penalties for mistakes?
- How does the new law impact patent license agreements in the biologics area?
Who should attend?
- In-house business development officers
- In-house regulatory, IP and transactional lawyers
- Private equity and venture capitalists contemplating an investment in a biotech company
- Alan Bennett, Partner, FDA Regulatory, D.C.
- Bruce Manheim, Partner, Life Sciences Litigation and Regulatory, D.C.
- David McIntosh, Partner, Life Sciences IP Transactions, Boston
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