2022 Agenda
- Jump to:
- At a Glance
- Day 1
- Day 2
- Print-friendly Format
Day 1 - Tuesday, June 28, 2022
Day 2 - Wednesday, June 29, 2022
7:15 |
Registration and Breakfast |
8:00 |
Co-Chairs Recap of Day One and Opening Remarks |
8:15 |
THE PTAB LIVE!The APJs Speak on Practice, Policy and Procedure |
9:15 |
SPOTLIGHT ON ANTI-TRUSTAntitrust Developments Impacting Biosimilars and Innovators |
9:45 |
Morning Break |
10:30 |
Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements |
11:30 |
COMMERCIAL STRATEGIES FOR THE INNOVATOR AND BIOSIMILARS MARKETPLACEGLOBAL STRATEGIES: From Patent Protection to Cost and Market Access |
12:30 |
Luncheon Break |
2:00 |
The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies |
3:15 |
Preparing for the Future: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies |
4:00 |
Afternoon Break |
4:30 |
EQUITY DIVERSITY & INCLUSIONAdvocating for Diversity in IP: Practical Ideas for Implementing Change |
5:30 |
Conference Concludes |
Day 1 - Tuesday, June 28, 2022
7:00 |
Registration and Breakfast |
8:00 |
Opening Remarks from the Conference Co-Chairs![]() Charles K. Sholtz, PhD, JD ![]() Gillian Woollett |
8:15 |
THE POLITICS AND POLICIES OF BLAs AND aBLAsLegislative and Regulatory Developments Impacting the Biopharmaceutical Industry![]() Hans Sauer ![]() Karin A. Hessler ![]() David E. Korn Moderator:![]() Susan Krumplitsch |
9:30 |
FDA KEYNOTEBiosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation![]() M. Stacey Ricci Interviewed by:![]() Eva A. Temkin |
10:15 |
Morning Break |
10:45 |
BPCIA TRIAL TRACKER: New Developments at the Federal Circuit District Courts and the PTABSatisfying the Statutory Requirements for Enablement and Written Description: §112(a) and the Future of Genus Claims![]() Maureen A. Bresnahan ![]() Rachel Elsby ![]() Nicholas P. Groombridge ![]() Ryan Hagglund Two recent Federal Circuit decisions, Amgen Inc. v. Sanofi and Juno Therapeutics, Inc. v. Kite Pharma, Inc., confirmed biopharma patents claiming a genus of antibodies may be especially susceptible to invalidation for lack of enablement or insufficient written description under 35 U.S.C. §112(a). Given that the scope of appropriate claims for antibodies is tightening, biopharmaceutical patent attorneys will need to consider:
|
11:45 |
The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies![]() Jenny Johnson ![]() W. Blake Coblentz ![]() Nicholas Mitrokostas Moderator:![]() Vishal Gupta Subsequent to the Federal Circuit’s skinny label ruling in GSK v. Teva, the District of Delaware in Amarin v. Hikma (D. Del. 2022) embraced a narrower approach in dismissing an induced infringement claim based on an allegedly inadequate skinny label carve out. The Delaware court also examined the novel question of whether a health insurer’s formulary placement of the drug in question induced infringement of method-of-use patents. Further, confirming that without any bright line rules, and absent a decision from the U.S. Supreme Court or legislation, the fate of the skinny label remains in the balance.
|
12:45 |
Networking Luncheon |
2:00 |
Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum![]() Whitney Meier Howard ![]() Siegmund Y. Gutman ![]() Gregory A. Morris ![]() Maureen L. Rurka Moderator:![]() John J. Molenda IPRs offer biosimilar and generic drug manufactures the benefit of challenging innovator patents with comparative haste and efficiency. While IPRs continue to provide an alternative forum for biosimilar manufactures who seek a faster alternative to BPCIA litigation, successful IPRs of biologics patents remains a challenge. During this interactive session, points of discussion will include:
|
3:15 |
Examining the Role of the ITC in Biotech Litigation: Investigations, IP Infringement and Trade Secrets![]() Tasha Francis Gerasimow ![]() Elizabeth S. Weiswasser ![]() Irena Royzman While investigations relating to IP infringement allegations at the ITC have been increasing, years, the ITC remains a relatively uncommon forum for cases involving pharmaceutical and biotech products. In March of 2021, AbbVie filed a trade secret complaint against Alvotech, followed by similar allegations asserted in an additional ITC action in December of 2021. The complaint alleges misappropriation of trade secrets and tortious interference with contractual relations. In this session, our panelists will consider:
|
4:00 |
Afternoon Break |
4:15 |
INTERACTIVE ETHICS DRILLSEthical Considerations in Biologics and Biosimilars Litigation![]() Young J. Park ![]() Robert Cerwinski ![]() Mike Cottler
|
5:15 |
Day One Adjourns |
Day 2 - Wednesday, June 29, 2022
7:15 |
Registration and Breakfast |
8:00 |
Co-Chairs Recap of Day One and Opening Remarks |
8:15 |
THE PTAB LIVE!The APJs Speak on Practice, Policy and Procedure![]() Hon. Michelle Ankenbrand Moderator:![]() Eric R. Hunt |
9:15 |
SPOTLIGHT ON ANTI-TRUSTAntitrust Developments Impacting Biosimilars and Innovators![]() Beckey Egeland |
9:45 |
Morning Break |
10:30 |
Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements![]() Sarah Abraham ![]() Orion Armon ![]() Evan Diamond ![]() Steven R. Trybus Antitrust enforcement is routinely triggered via the approval of a biosimilar. Many believe that anti-competitive behavior exhibited by reference products represents the most formidable barrier to entry. In response, FDA and FTC recently issued a joint statement regarding a collaboration to advance competition in the biologic marketplace. Complicating matters further, several states have enacted laws meant to curb reverse-payment patent settlements – with no comparable statute at the federal level. This session will consider the economic implications of biosimilar reverse payment litigation, the competitive effects, and economic damages. Topics of discussion will include:
|
11:30 |
COMMERCIAL STRATEGIES FOR THE INNOVATOR AND BIOSIMILARS MARKETPLACEGLOBAL STRATEGIES: From Patent Protection to Cost and Market Access![]() Otto Licks ![]() Huiya Wu ![]() Honorable Teresa Rea Biosimilars and innovator biologic markets and their regulation have steadily evolved in Europe and the United States, with the European marketplace experiencing the most commercial success. As pharmaceutical drug pricing continues to attract global scrutiny and political pressure, a growing number of potentially cost-saving drugs are in the pipeline. Not far behind, and thanks to a favorable regulatory environment, the Chinese biosimilar marketplace is booming. Although the regulatory approaches are similar in general scientific content, certain key differences have amplified acceptance and market growth in China relative to the United States and Europe. This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like China.
|
12:30 |
Luncheon Break |
2:00 |
The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies![]() Sonia Oskouei ![]() Chad A. Landmon ![]() Juliana “Julie” Reed ![]() Mandy C. Leonard Moderator:![]() Ali I. Ahmed
|
3:15 |
Preparing for the Future: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies![]() Tara Rahemba ![]() Alicia A. Russo ![]() Chad J. Peterman
|
4:00 |
Afternoon Break |
4:30 |
EQUITY DIVERSITY & INCLUSIONAdvocating for Diversity in IP: Practical Ideas for Implementing Change![]() Jason Murata ![]() Eldora L. Ellison, Ph.D. ![]() K. Nicole Clouse ![]() Sarah Chapin Columbia ![]() Hannah Lee Moderator:![]() Melanie K. Sharp The Director of the National Institute of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science”. The growing call to action seems clear: the pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. In this interactive session, points of discussion will include:
|
5:30 |
Conference Concludes |