Unique among leading global law firms, Goodwin’s Late Stage Drug Development practice focuses on obtaining and enforcing patent protection that extends patent term on late stage products.
Our team has created a series of webinars to provide a working understanding of the following legal services and best practices when navigating critical intellectual property lifecycle steps:
- Patent product strategy and procurement to extend patent term
- Regulatory exclusivity
- Minimizing risk related to third party-patents
- FDA compliance, including marketing and promotion compliance
- Trademark and trade dress
- IP litigation
- FDA litigation
Tune in below!
Please note that our webinar and event recordings are for informational purposes only; CLE credit is only available for our guests attending live webinars and other events.
FDA Readiness: Strategic Considerations for a Successful Marketing Application Review Cycle and Product Launch
October 26, 2023
Once pivotal clinical trials have been completed and an NDA or BLA has been submitted to FDA, sponsors must navigate ongoing FDA interactions while preparing for a potential product launch. During this time period, a coordinated, proactive plan within the company is key. In this session, FDA Litigation co-chair Alexander Varond and Life Sciences Regulatory & Compliance associate Elizabeth Mulkey discussed areas where strategic planning and action can help a sponsor successfully engage with FDA and position the company for the next phase of the program’s lifecycle, including negotiating post-marketing commitments, preparing for a REMS, labeling discussions with FDA, payor engagement, and establishing an internal review process for product promotional materials.
Speakers
Alexander Varond
Elizabeth Mulkey
Contracting Away Your IP Rights: Pitfalls to Avoid With Third-Party Partners During Drug Development
December 12, 2023
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. Late Stage Drug Development co-chair Olivia Uitto and Intellectual Property Litigation partner Eric Romeo provided 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.
Speakers
Eric Romeo
Olivia Uitto
Contacts
- /en/people/r/romeo-eric
Eric T. Romeo
Partner - /en/people/u/uitto-olivia
Olivia D. Uitto
Partner - /en/people/m/mulkey-elizabeth
Elizabeth Mulkey
Associate
