Biosimilars & Innovator Biologics

Registration and Breakfast

Opening Remarks from the Conference Co-Chairs

Charles K. Sholtz, PhD, JD
Director and AGC, Manufacturing IP Lead
Intellectual Property
Genentech | A Member of the Roche Group

Gillian Woollett
VP, Head Regulatory Strategy and Policy
Samsung Bioepis

THE POLITICS AND POLICIES OF BLAs AND aBLAs

Legislative and Regulatory 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:

Susan Krumplitsch
Partner
DLA Piper

FDA KEYNOTE

Biosimilars and Interchangeable Products: Insights into FDA’s Perspective on Implementation

M. Stacey Ricci
Director, Scientific Review Staff Office of Therapeutic Biologics and Biosimilars
U.S. Food and Drug Administration

Interviewed by:

Eva A. Temkin
Partner
King & Spalding LLP

Morning Break

BPCIA TRIAL TRACKER: New Developments at the Federal Circuit District Courts and the PTAB

Satisfying the Statutory Requirements for Enablement and Written Description: §112(a) and the Future of Genus Claims

Maureen A. Bresnahan
Assistant General Counsel, Legal Department
Eisai Inc.

Rachel Elsby
Partner
Akin Gump Strauss Hauer & Feld LLP

Nicholas P. Groombridge
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP

Ryan Hagglund
Partner
Loeb & Loeb LLP

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:

• Devising alternate strategies for drafting enforceable claims
• Protecting newly-developed biopharma IP
• Analyzing how these decisions (including further appeals to the U.S. Supreme Court) impact the enforcement of existing claims
• Reconciling whether written description is met when the specification discloses formulas

The Current State of the Skinny Label Regime: Press Release Language, Marketing Materials, and the Liability for Insurance Companies

Jenny Johnson
VP, IP
Endo Pharmaceuticals

W. Blake Coblentz
Co-Chair Hatch-Waxman and Biologics Litigation Group
Cozen O’Connor

Nicholas Mitrokostas
Partner
Allen & Overy LLP

Moderator:

Vishal Gupta
Partner
Co-Chair, Healthcare & Life Sciences Practice
Steptoe & Johnson LLP

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.

• Considering whether the language of press releases, web pages and other marketing materials require more scrutiny
• Analyzing potential liability faced by insurers for placement of skinny label on formularies
• Does liability exist for induced infringement by listing a skinny label on a formulary
• Taking stock of the potential impact to patients
• Understanding when information can put you at risk for infringement claims regardless of labeling revisions have been approved by FDA as part of a skinny label

Networking Luncheon

Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum

Whitney Meier Howard
Partner
Venable LLP

Siegmund Y. Gutman
Partner
Proskauer Rose LLP

Gregory A. Morris
Partner
Honigman LLP

Maureen L. Rurka
Partner
Winston & Strawn LLP

Moderator:

John J. Molenda
Partner
Co-Chair, Healthcare & Life Sciences Practice
Steptoe & Johnson 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 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

Examining the Role of the ITC in Biotech Litigation: Investigations, IP Infringement and Trade Secrets

Tasha Francis Gerasimow
Partner
Kirkland & Ellis LLP

Elizabeth S. Weiswasser
Partner
Weil, Gotshal & Manges LLP

Irena Royzman
Partner
Kramer Levin Neftalis & Frankel LLP

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:

• Reviewing recent cases with trade secret allegations
• Anticipating when reference product sponsors may seek to bring these claims
• Protecting against misappropriation claims
• Developing robust policies against the use of another party’s confidential information
• Ensuring compliance with strong internal policies

Afternoon Break

INTERACTIVE ETHICS DRILLS

Ethical Considerations in Biologics and Biosimilars Litigation

Young J. Park
Partner
Paul Hastings LLP

Robert Cerwinski
Managing Partner
Gemini Law LLP

Mike Cottler
Global Head of Litigation
Alvotech

• Understanding conflicts of interest leading to possible disqualifications
• Establishing standards for determining when attorneys and/or firms should be disqualified
• Determining who is a client based on actual representation
• Appreciating duties to former clients
• Assessing concurrent conflicts via hypothetical scenarios

Day One Adjourns

Registration and Breakfast

Co-Chairs Recap of Day One and Opening Remarks

THE PTAB LIVE!

The APJs Speak on Practice, Policy and Procedure

Hon. Michelle Ankenbrand
Senior Lead Administrative Patent Judge, PTAB
USPTO

Moderator:

Eric R. Hunt
Partner
Rakoczy Molino Mazzochi Siwik LLP

SPOTLIGHT ON ANTI-TRUST

Antitrust Developments Impacting Biosimilars and Innovators

Beckey Egeland
Attorney, Bureau of Competition
U.S. FTC

Morning Break

Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements

Sarah Abraham
Manager
Cornerstone Research

Orion Armon
Partner
Cooley LLP

Evan Diamond
Partner
King & Spalding LLP

Steven R. Trybus
Partner
Locke Lord LLP

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:

• Assessing whether developing a patent thicket is an antitrust violation
• UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020)
• Reviewing what is deemed “anti-competitive activities”
• Do you need to prove that all the patents in the ‘thicket’ around a drug are invalid?
• 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

COMMERCIAL STRATEGIES FOR THE INNOVATOR AND BIOSIMILARS MARKETPLACE

GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access

Otto Licks
Partner
Licks Attorneys

Huiya Wu
Partner
Goodwin Procter LLP

Honorable Teresa Rea
Partner
Crowell & Moring LLP
(Former Acting Director of the United States Patent and Trademark Office)

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.

• 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

Luncheon Break

The Economics of Biosimilars: Improving Market Access, Sustainable Pricing and Reimbursement Policies

Sonia Oskouei
Vice President, Biosimilars
Cardinal Health

Chad A. Landmon
Partner
Axinn, Veltrop & Harkrider LLP

Juliana “Julie” Reed
Executive Director
The Biosimilars Forum

Mandy C. Leonard
Senior Director, Drug Use Policy and Formulary Management
Cleveland Clinic

Moderator:

Ali I. Ahmed
Senior Vice President, Biosimilars
Fresenius Kabi USA

• Evaluating the clinical pipeline by company, indication and phase
• Analyzing the market share for biosimilars in the United States
• Target drugs with highest spending
• Current market dynamics and considerations for biosimilar adoption
• Comparing the European Union biosimilar experience
• 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

Preparing for the Future: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies

Tara Rahemba
Executive Director, IP Counsel
Alexion, AstraZeneca Rare Disease

Alicia A. Russo
Partner
Venable LLP

Chad J. Peterman
Partner, Litigation Department
Paul Hastings, LLP

• Calling attention to the products coming off-patent
• Analyzing approved and marketed biosimilars while looking ahead and considering clinical insights, pricing and dosages
• Predicting what problems future competitors may run into with respect to their IP profiles
• Forecasting which segments or regions will drive market growth
• Reviewing key sustainability tactics adopted by leading market players
• Evaluating the impact of off-patent drugs on competition and growth strategies
• Developing techniques for an accurate assessment of the current value of your portfolio while devising forward-thinking product strategies

Afternoon Break

EQUITY DIVERSITY & INCLUSION

Advocating for Diversity in IP: Practical Ideas for Implementing Change

Jason Murata
Partner, Chair, Diversity, Equity & Inclusion Committee
Axinn, Veltrop & Harkrider LLP

Eldora L. Ellison, Ph.D.
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.

K. Nicole Clouse
IP Counsel
Biogen

Sarah Chapin Columbia
Partner
McDermott Will & Emery

Hannah Lee
Partner
Kramer Levin Naftalis & Frankel LLP

Moderator:

Melanie K. Sharp
Partner
Young Conaway Stargatt & Taylor, LLP

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

Conference Concludes