Life Sciences Litigation: 505(b)(2) Applications and Beyond: Prosecution and Litigation Strategies for Filing and Defending Against 505(b)(2) NDAs
Event summary
Cooley Rx is a virtual series focused on the life sciences and healthcare sectors. Join us as we discuss the top issues and trends in these industries – and provide decision-makers with information they can use to strengthen their organizations.
Life Sciences Litigation: 505(b)(2) Applications and Beyond: Prosecution and Litigation Strategies for Filing and Defending Against 505(b)(2) NDAs
New Drug Applications (NDAs) filed under § 505(b)(2) are on the rise from traditional innovative pharma and specialty pharma companies. Because of their unique nature, different prosecution and litigation strategies need to be employed by companies looking to file a 505(b)(2) NDA and those who will assert their Orange Book listed patents against such filers. Cooley attorneys Sanya Sukduang, Jon Cousin and Jason Valentine will explore strategies from a prosecution and litigation perspective, providing insight on how to:
- Evaluate freedom to operate for a 505(b)(2) product.
- Develop a patent portfolio and exclusivity strategy for 505(b)(2) products that protects against generics and subsequent 505(b)(2) filers.
- Create successful litigation strategies as the NDA holder and as the 505(b)(2) filer.
- Develop litigation strategies to defend 505(b)(2) products against generic challenges and subsequent 505(b)(2) filers.
Credits
- Attendees may earn up to 1.0 continuing legal education (CLE) credit for participating in this live webinar. Credit will not be granted for on-demand viewing.
- Cooley LLP is an approved provider and will provide credit in CA, CO, IL, NY, PA and TX.
- Cooley LLP is a sponsor and will apply for credit in FL, OH, VA and WA.
- Credit in other jurisdictions may be available via reciprocity.
- If you have specific CLE credit questions, please contact Cooley’s licensing and compliance team.
For more information, please email Megan Senerchia.
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