Fall 2020-Spring 2021
NOTE: Session 4 – Drug Pricing POSTPONED; new date TBA
Full Series: $300
BCLT Sponsor Full Series (50% discount): $150
Single Session: $75
This 5 part webinar series will explore recent developments in regulatory law and intellectual property issues affecting innovation in the life sciences. The first two webinars in the series are set: One on the new patent law in China and its implications for the life sciences and one on regulatory developments at the FDA. Other webinars in the series are planned around innovative foods (genetically engineered, processed, and medical foods); drug pricing, licensing and antitrust issues; and questions associated with human genetics data (privacy, data sharing and national efforts to limit cross-border flows of data).
Who Will Benefit from This Series
This series is intended for in-house counsel and law firm attorneys representing innovators in the life sciences, including but not limited to pharmaceutical companies. Whether you have been working in the fields of bio-tech and the life sciences for a long time, or are newly focused on this growing field, this series will get you up to speed on key developments in the law.
Participate in Real Time or View the Series at Your Convenience
Each one-hour session in the series will be presented in real-time, with audience Q&A. In addition, a recording of each session will be made available exclusively to registrants. So even if you subscribe to the series after it begins, you can go back at your convenience and watch the recorded sessions. CLE credit will be offered to subscribers for live or recorded viewing.
Session 4 – Drug Pricing POSTPONED, TBA
This session will examine a range of issues associated with drug pricing and licensing, including reverse settlement agreements and the relationship between intellectual property and antitrust. Looking ahead to possible Congressional action, it will consider the possible relationship between patent legislation and drug pricing/access issues.
Talha Syed, Berkeley Law
Session 1 – November 17, 2020: China’s Emerging Regime for IP and Life Sciences
4:30-6:00 P.M. (PT)
The recording for this session, focused on the new patent law in China and its implications for the life sciences, is available to all series registrants. Topics included the Phase 1 Trade Agreement and its impact on pharma IP in China, the impact of China’s recent patent law reforms, new judicial interpretation and agency rules on patent linkage, outstanding issues in the proposed legislative scheme such as what implementing regulations to the patent law might include, the current scope of China’s Bolar exemption, timeframes for linkage challenges, the lack of “artificial infringement” in the current scheme, and timeframes for implementation. Panelists also discussed the relationship of new reforms to existing IP laws, the respective role of the courts and administrative agencies, the latest developments in pharma patent prosecution, including post-filing supplementation of data, regulatory data protection and patent term restoration, China’s evolving “Orange Book,” the impact of actual and proposed changes on patent and regulatory approval strategies for foreign companies, and how these changes compare to the US system. A full set of background materials is available for registrants.
Dr. CUI Can, Morrison & Foerster LLP
Dr. Karen Guo, Novo Nordisk (Beijing)
He Jing, GEN law firm
Chief Judge Randall R. Rader (CAFC, ret.)
Hu Xuejiao, Beigene
Moderator: Mark Cohen, BCLT, Berkeley Law
Session 2 – December 3, 2020: Intellectual Property and FDA Innovation
12:00 – 1:00 P.M. (PT)
This session will examine how the FDA itself is innovating, considering both pandemic-related issues as well as longer term trends in the life sciences that have prompted innovation at the FDA. Topics will include the latest agency practices around Emergency Use Authorizations, fast track trials, post-approval tracking, and developments with respect to Hatch-Waxman and the intersection of FDA and PTO authorities.
Sally Allain, Johnson and Johnson Innovation
Charles Andres, Wilson Sonsini
Rick Geoffrion, Cyrano Therapeutics
Dr. Michelle McMurry-Heath, CEO of BIO
Jim Dempsey, BCLT
Vern Norviel, Wilson Sonsini
Session 3 – January 28, 2021: Food Innovation
12:00 – 1:00 P.M. (PT)
This session will address the wide range of regulatory issues posed by exciting developments in the production of food (what some are calling the “age of innovation” in protein), including gene-edited and genetically engineered foods, cellular agriculture, microbial fermentation, and medical foods, looking at how to navigate regulatory requirements managed by the FDA and the USDA.
Brian Sylvester, Covington
Deepti Kulkarni, Sidley
Vincent Sewalt, DuPont Nutrition & Biosciences
Moderator: Molly Van Houweling, BCLT, Berkeley Law
Session 5 – March 4, 2021: Sharing Data for Research and Development
12:00 – 1:00 P.M. (PT)
This session will examine legal and regulatory issues around the sharing and use of data, including human genetics data. It will explore the interface of privacy laws and national efforts to limit cross-border flows of data based on national trade considerations and the impact of those restrictions on collaboration and innovation.
Cynthia Cole, Baker Botts
Behnam Dayanim, Paul Hastings
Lothar Determann, Baker McKenzie
Monica He, Amgen
Moderator: Jim Dempsey, BCLT/Berkeley Law
If you require an accommodation for effective communication (ASL interpreting/CART captioning, alternative media formats, etc.) to fully participate in this event, please contact Nathalie Coletta at firstname.lastname@example.org or 510-643-5518 with as much advance notice as possible and at least 7-10 business days in advance of the event.