Biosimilars & Innovator Biologics

June 22 – 23, 2021 (Eastern Daylight Time)

Agenda (Eastern Daylight Time)

Conference Program
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Day 1 - Tuesday, June 22, 2021

9:50	Opening Remarks from the Conference Co-Chairs
10:00	Year in Review: Regulatory and Legislative Developments Impacting the Biopharmaceutical Industry
11:00	FDA KEYNOTE Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation
11:45	1:1 Networking
11:55	Morning Break
12:15	Amgen v. Sanofi: Analyzing the Impact of the Antibody Enablement Ruling on In-House Strategies
1:00	Skinny Labeling Post-GSK v. Teva: How the Decision Will Inform Biosimilar Carve-Outs
2:15	Networking Luncheon
3:00	GLOBAL STRATEGIES Spotlight on Europe and China: From Patent Protection to Cost and Market Access
4:00	Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum
5:00	EQUITY DIVERSITY & INCLUSION Advocating for Diversity in IP: Practical Ideas for Implementing Change
6:30	Day One Adjourns

Day 2 - Wednesday, June 23, 2021

9:55	Co-Chairs’ Recap of Day One and Opening Remarks
10:00	The APJs Speak on Practice, Policy and Procedure
11:00	FTC KEYNOTE Antitrust Developments Impacting Biosimilars and Innovators
11:30	1:1 Networking
11:40	Morning Break
12:00	Think Tank on State and Federal Antitrust Initiatives: Commercial Considerations for Patent Settlements, Reverse Payments, and Emerging Legislation
1:00	Lunch Break
1:45	The Future of Patent Thickets: Balancing Innovation and Competition in the Biologic Ecosystem
2:45	Naming, Labeling, Interchangeability, and Promotion: Regulatory Considerations for the growing U.S. Marketplace for Biosimilars
3:45	The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies
4:45	INTERACTIVE ETHICS DRILLS New Developments Impacting Professional Responsibility in the Biologic Arena
5:45	Conference Concludes

Day 1 - Tuesday, June 22, 2021

9:50	Opening Remarks from the Conference Co-Chairs Huong Nguyen General Counsel Fosun Pharma USA Inc. Katie Nolan-Stevaux Specialist, Assistant General Counsel Genentech
10:00	Year in Review: Regulatory and Legislative Developments Impacting the Biopharmaceutical Industry Hans Sauer Deputy General Counsel VP of IP BIO Karin A. Hessler Assistant General Counsel Association for Accessible Medicines (AAM) David E. Korn Vice President, IP and Law PhRMA Moderator: Irena Royzman Partner Kramer Levin Neftalis & Frankel LLP
11:00	FDA KEYNOTE Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation Jessica Greenbaum Regulatory Counsel, Therapeutic Biologics and Biosimilars Staff U.S. FDA
11:45	1:1 Networking Take advantage of this networking break and see how many people you meet. Your next legal team, business partner or client could be right in our virtual networking room – it is up to you to find them! To maximize your connections, benefit from virtual business card exchange opportunities.
11:55	Morning Break
12:15	Amgen v. Sanofi: Analyzing the Impact of the Antibody Enablement Ruling on In-House Strategies Maureen A. Bresnahan Assistant General Counsel Eisai US Gerald Flattmann Partner King & Spalding Alicia A. Russo Partner Venable LLP Siegmund Y. Gutman Partner Proskauer Rose LLP Jeanna Wacker Partner Kirkland & Ellis LLP The Federal Circuit’s decision in Amgen Inc. v. Sanofi, No. 20-1074 (Fed. Cir. 2021) is one of the most important patent stories of the year. In this case which concerns the validity of antibody epitome claims, the Federal Circuit held that “a genus of antibodies claimed only by specific functional properties are invalid for lack of enablement.” The court went on to invalidate all claims for lack of enablement, holding that “the binding limitation itself was sufficient for the claims to require undue experimentation.” In view of this precedential decision, this panel will offer practical patenting strategies for the critical stages of the lifecycle, including: Patent preparation and prosecution Licensing Transactional IP due diligence Enforcement
1:00	Skinny Labeling Post-GSK v. Teva: How the Decision Will Inform Biosimilar Carve-Outs Steven D. Maslowski Partner Akin Gump Strauss Hauer & Feld LLP Brian McCormick Vice President - Chief Regulatory Counsel, Head of Global Regulatory Policy Teva Pharmaceuticals W. Blake Coblentz Chair, Hatch-Waxman & Biologics Litigation Cozen O’Connor Vanessa Yen Partner King & Spalding LLP Moderator: Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP At the time of press, the Federal Circuit vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. In GSK v. Teva (Fed. Cir. Feb. 9, 2021), the Federal Circuit vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. As we await a final decision, this panel will provide strategies and tactics in view of the decision, including: Reevaluating claim and label language for optimal drafting Analyzing what types of evidence should be used to prove infringement Understanding second medical use patents and carve-out strategies Clarifying the patentability of further medical use inventions Outlining the implications of the Federal Circuit decision striking down labeling carve-outs Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use Balancing competing interests in promoting innovation v. permitting generic drugs
2:15	Networking Luncheon
3:00	GLOBAL STRATEGIES Spotlight on Europe and China: From Patent Protection to Cost and Market Access Tara Rahemba Executive Director, Intellectual Property Alexion Pharmaceuticals, Inc. Amy Feng Partner Wu, Feng & Zhang Biosimilar and innovator biologic markets and their governing regulations have steadily evolved in Europe and the United States. The European biosimilar marketplace – nearly a decade ahead of the U.S. has experienced 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. Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region Understanding the economics and market influences Considerations for market access, sustainable pricing and reimbursement policies. Market uptake of biosimilar products. Biosimilar v. biosimilar litigation in a crowded market
4:00	Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum John J. Molenda Partner Steptoe & Johnson LLP Gregory A. Morris Partner Honigman LLP Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP Linnea P. Cipriano Partner Goodwin Procter LLP Eric R. Hunt Partner Rakoczy Molino Mazzochi Siwik LLP 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: Reducing risk by challenging patents in advance of launching biosimilars at risk Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars Anticipating an answer to the unresolved question as to how much investment is required in the biosimilar context under Article III in order to establish standing Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation Assessing concerns surrounding multiple filer petitions and relevant timing considerations Analyzing biosimilars IPR filings and recent PTAB decisions
5:00	EQUITY DIVERSITY & INCLUSION Advocating for Diversity in IP: Practical Ideas for Implementing Change Huong Nguyen General Counsel Fosun Pharma USA Inc. Katie Nolan-Stevaux Specialist, Assistant General Counsel Genentech Wanda D. French-Brown Partner Loeb & Loeb LLP Stacie L. Ropka Partner Axinn, Veltron & Harkrider LLP Young J. Park Partner, Litigation Department Paul Hastings LLP Valencia Martin-Wallace Deputy Commissioner for Patents USPTO 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: Growing the awareness of the pharmaceutical IP practitioners among underrepresented racial and ethnic groups Championing their representation in the pharmaceutical IP work force Advocating for diverse and young attorneys appearing in the court room Reviewing data showing the benefits of a diverse workforce Accelerating the advancement of a more diverse pharmaceutical IP community via mentoring and networking Understanding what specific evidence of diversity pharmaceutical companies, and IP departments, are seeking from their law firm counterparts Implementing organizational changes that promote diversity How clients can seek out partnerships with firms that promote: Utilizing NAMWOLF lists Abiding by the Mansfield Declaration Using a DuPont Legal Model Identifying best practices for evaluating your outside firm’s efforts in promoting diversity Reviewing firm statistics on women, minorities, sexual orientation, etc. Sharing data-driven strategies to address current diversity challenges in STEM Remove term: EQUITY DIVERSITY & INCLUSION EQUITY DIVERSITY & INCLUSION
6:30	Day One Adjourns

Day 2 - Wednesday, June 23, 2021

9:55	Co-Chairs’ Recap of Day One and Opening Remarks Huong Nguyen General Counsel Fosun Pharma USA Inc. Katie Nolan-Stevaux Specialist, Assistant General Counsel Genentech
10:00	The APJs Speak on Practice, Policy and Procedure Hon. Jacqueline Wright Bonilla Deputy Chief Judge PTAB USPTO Hon. Michelle Ankenbrand Lead Administrative Patent Judge PTAB USPTO Honorable Kristi Rupert Sawert Administrative Patent Judge PTAB USPTO Moderator: Elizabeth S. Weiswasser Partner Weil, Gotshal & Manges LLP
11:00	FTC KEYNOTE Antitrust Developments Impacting Biosimilars and Innovators Markus H. Meier Assistant Director, Health Care Division Bureau of Competition U.S. FTC
11:30	1:1 Networking Take advantage of this networking break and see how many people you meet. Your next legal team, business partner or client could be right in our virtual networking room – it is up to you to find them! To maximize your connections, benefit from virtual business card exchange opportunities.
11:40	Morning Break
12:00	Think Tank on State and Federal Antitrust Initiatives: Commercial Considerations for Patent Settlements, Reverse Payments, and Emerging Legislation Evan Diamond Partner King & Spalding LLP Celeste C. Saravia Vice President Cornerstone Research Gwendolyn J. Lindsay Cooley Assistant Attorney General Wisconsin Department of Justice Antitrust enforcement is routinely triggered via the approval of a biosimilar. This session will consider the economic implications of biosimilar reverse payment litigation, the competitive effects, and economic damages. Topics of discussion will include: Understanding settlement strategies between innovator biologic companies and biosimilar applicants Highlighting the state legislation directly addressing “reverse payment” patent settlements When biologic manufacturers should expect antitrust scrutiny Reviewing the proper standards of antitrust review and the rising call for a legislative response Analyzing the current legislative and regulatory framework Mergers, acquisitions and exclusive licenses Anticompetitive agreements Abuse of dominance Life cycle management and contracting Pricing strategies Avoiding costly litigation and associated penalties by effectively complying with the law
1:00	Lunch Break
1:45	The Future of Patent Thickets: Balancing Innovation and Competition in the Biologic Ecosystem Ivan M. Poullaos Partner Winston & Strawn LLP Nicholas P. Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Steven R. Trybus Partner Locke Lord LLP Christopher E. Ondeck Partner Proskauer Rose LLP In recent years, there have been bipartisan efforts to curb illegal product hopping and patent thickets. In March 2019, a group of indirect payers for Humira filed suit against AbbVie, alleging antitrust activity in violation of Sections 1 and 2 of the Sherman Antitrust Act. The antitrust challenge is centered on AbbVie’s alleged patent thicket involving Humira and the settlements reached with six biosimilar companies to keep them off market until 2023. This session will consider the impact of the decision on the IP landscape for biologic drugs. Topics of discussion will include: Whether developing a patent thicket is an antitrust violation o UFCW Local 1500 Welfare Fund v. AbbVie Inc.(7th Cir. Dec. 28, 2020) Reviewing what is deemed “anti-competitive activities” Whether you need to prove that all the patents in the ‘thicket’ around a drug are invalid
2:45	Naming, Labeling, Interchangeability, and Promotion: Regulatory Considerations for the growing U.S. Marketplace for Biosimilars Laura Sim Sr. Counsel Development, Regulatory, Operations, & Contracting Law Amgen Kevin E. Noonan Partner McConnell Boehnen Hulbert & Berghoff LLP Use of biosimilars in the United States is gaining ground and promoting competition. FDA’s naming convention for biologics, guidance on biosimilar labeling, approach toward interchangeability, and guidance on advertising and promotion are helping shape the landscape for marketing and use of biosimilars. This session will outline the central components of naming, labeling, interchangeability, and marketing considerations for biosimilars. Points of discussion will include: Analyzing the Latest developments concerning interchangeability designations and exclusivity and state substitution laws Assessing FDA’s published Guidance for Industry on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Evaluating the benefits and challenges of a naming system that allows biosimilars to be differentiated and traced to promote pharmacovigilance Understanding how best manufacturers can communicate the clinical and economic benefits of a drug
3:45	The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies Ali I. Ahmed Senior Vice President, Biosimilars Fresenius Kabi USA Evaluating the clinical pipeline by company, indication and phase Considering the implications of insurers placing biosimilars on “primary tiers” and what that means for the future Reviewing the implications of the House passed Lower Drug Costs Now Act Understanding the implications of empowering the government to negotiate directly with manufacturers
4:45	INTERACTIVE ETHICS DRILLS New Developments Impacting Professional Responsibility in the Biologic Arena Vishal C. Gupta Partner Steptoe & Johnson LLP Ryan Hagglund Partner Loeb & Loeb LLP Chad J. Peterman Partner, Litigation Department Paul Hastings, LLP Establishing standards for determining when attorneys and/or firms should be disqualified Determining who is a client based on actual representation
5:45	Conference Concludes

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