Agenda

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Day 1 - Thursday, December 1, 2022
Day 2 - Friday, December 2, 2022
8:45 |
Co-Chair’s Recap of Day One and Opening Remarks |
9:00 |
THE IMPACT OF BIOSIMILAR COMPETITION IN EUROPESpecial Keynote: Tracking Changes in Competition Law |
10:00 |
Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements |
11:00 |
Morning Networking Break |
11:30 |
COMMERCIAL STRATEGIES FOR THE ORIGINATOR AND BIOSIMILARS MARKETPLACEThe Economics of Biosimilars: Improving Market Access and Sustainable Pricing Across Europe |
12:30 |
Networking Luncheon |
2:00 |
GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access in The U.S., the EU, and Asia |
3:00 |
The Business of Biologics: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies for Maximizing Global Success |
4:00 |
Artificial Intelligence, Data and Drug Development: Accelerating Biopharmaceutical Discovery and Development |
5:00 |
Conference Concludes |
Day 1 - Thursday, December 1, 2022
7:00 |
Registration and Breakfast |
7:45 |
Opening Remarks from the Conference Co-Chairs |
8:00 |
The Unitary Patent and the Unified Patent Court: A Guide to Ratification, Implementation, and Strategies for Biosimilars and Originator BiologicsThe Unitary Patent and the Unitary Patent Court were designed to achieve a simpler, cost-effective means of protecting and enforcing patents in Europe. While it is certain that the UPC’s decisions will have pan-European effect, it is less clear how the UPC could impact biosimilar medicines. This session will analyze the changes under the UPC and UP and provide attendees with a handbook for the future. Topics of discussion will include:
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9:00 |
THE INTERNATIONAREGULATORY THINK TANKPart I: Anticipating the Impact of EU Regulatory Change on Life Sciences CompaniesRecent and ongoing European regulatory changes will affect every originator and biosimilar company that currently sells or sponsors products in the European Union and the UK. The regulatory landscape is transforming so rapidly that that companies must track and monitor these developments or risk the license-to-operate. While timelines continue to waver, manufacturers, distributors, providers, and counsel must consider the implications of these regulations and take a proactive approach to dealing with regulatory change. Topics of discussion will help you:
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10:00 |
Morning Networking Break |
10:15 |
Part II: Comparing Global Biosimilar Regulation, the EMA, FDA and Their Approval ProcessesThere are fundamental differences in both the regulatory processes and the market dynamics of the U.S. and the EU that account for much of the discrepancy in the uptake of biosimilars. This session will dissect the BPCIA, compare it with the European approach, and consider near and medium scenarios for biosimilars in the United States. Topics of discussion will include:
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11:15 |
European Supplementary Protection Certificates: What Every Regulatory and IP Attorney Needs to Know About the Evolving Framework Governing SPCsThe introduction of the SPC manufacturing waiver which went into effect on 2 July 2022 addressed a significant disadvantage that European producers of biosimilars had compared to non- European rivals. Under the new system, the UPC will have jurisdiction over SPCs unless the opt-out provision is invoked or if they originate from an already opted out European patent. This session will detail the rights conferred by the SPC. Topics of discussion will include:
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12:15 |
Medical Uses of Known Biological Products and Drug Repurposing: Reconciling Infringement and EnforcementAs originators become more active in the business of biosimilars, and biosimilar manufacturers have entered the arena of creating their own new biologics, the importance of second medical uses for individual companies as well as the global industry is of growing importance. Topics of discussion will include:
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1:15 |
Networking Luncheon |
2:30 |
Plausibility, Sufficiency, and Inventive Step: Deliberations for Formulation and Combination PatentsPlausibility in the context of the inventive step and sufficiency requirements can be a contentious issue. To discern whether an invention is purely speculative, the Boards of Appeal of the EPO developed the doctrine of plausibility in the context of sufficiency of disclosure as well as inventive step. As we await the Board of Appeal to issue the written decision, this session will consider in what situations post-published evidence can be considered to support the effect of the invention. Topics of discussion will include:
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3:30 |
Proportionality, Preliminary Injunctions & Damages: The Ability to Deny, Grant or Tailor Injunctive Relief
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4:30 |
Alternative Dispute Resolution: The Shift from Ordinary Proceedings Towards ADR
|
5:30 |
Day One Adjourns |
Day 2 - Friday, December 2, 2022
8:45 |
Co-Chair’s Recap of Day One and Opening Remarks |
9:00 |
THE IMPACT OF BIOSIMILAR COMPETITION IN EUROPESpecial Keynote: Tracking Changes in Competition Law |
10:00 |
Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for SettlementsThis session will consider the economic implications of biosimilar reverse payment litigation globally, the competitive effects, and economic damages. Topics of discussion will include:
|
11:00 |
Morning Networking Break |
11:30 |
COMMERCIAL STRATEGIES FOR THE ORIGINATOR AND BIOSIMILARS MARKETPLACEThe Economics of Biosimilars: Improving Market Access and Sustainable Pricing Across Europe
|
12:30 |
Networking Luncheon |
2:00 |
GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access in The U.S., the EU, and AsiaOur panelists of global thought leaders will contemplate where the EU fits in the global biosimilars
|
3:00 |
The Business of Biologics: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies for Maximizing Global Success
|
4:00 |
Artificial Intelligence, Data and Drug Development: Accelerating Biopharmaceutical Discovery and Development
|
5:00 |
Conference Concludes |