16th Annual ACI Paragraph IV Disputes Conference
November 9-10, 2021
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Alyson Wooten participated in the “Understanding the Importance of Aligning Legal and Business Functions for Patent Litigation Planning” panel on November 9.
Panelists discussed:
- Utilizing business functions such as operations, business development, and life cycle management to advance product portfolio acquisitions and intellectual property (IP) protections
- Understanding the importance of global portfolio planning from the get-go
- Responding in kind to continued growth on a global scale by building a team structure that is sustainable on a long-term basis to address IP litigation around the world
- Assessing common international business scenarios encountered by both brand name and generic manufacturers that may lead to patent and/or exclusivity loss
- Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers
- Considering FDA warning letters relative to foreign manufacturing sites and reviewing related manufacturer liability
- 180-day exclusivity forfeiture
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