December 12, 2023 | 1:00 PM - 2:00 PM ET

SUMMARY

For many innovative drug companies, advancing a candidate through late-stage development means contracting with third-party service providers. These relationships can involve a wide range of services—e.g., bioassay development, manufacturing, clinical trial administration, product distribution, marketing, etc.—depending on the innovator's size, technical capabilities, and business objectives. However, third party agreements can pose significant risks to an innovator's ability to obtain (and maintain) patent protection on their drug products. Problems in this context most often arise when a third-party relationship triggers the "on-sale bar" and/or "public use bar" under 35 U.S.C. § 102. This training will provide attendees with a working overview of how the on-sale and public use bars work as well as best practices for contracting with third parties during drug development. Topics covered include: (1) the current state of the law related to the on-sale and public use bars; (2) real-life examples of how third-party contracts can create patent issues under § 102; (3) practical strategies to consider when dealing with third-party contract partners, both inside and outside the United States; and (4) tips for designing an effective IP strategy that aligns with a company's business needs and strategic objectives.