20th Anniversary Paragraph IV Disputes - WEB

Judicial Insights:

2024 Chairs: What’s NEW for 2024:

Andrei Iancu Partner Sullivan & Cromwell LLP (Former Director of the USPTO)

Brian Malkin Associate General Counsel Teva Pharmaceuticals

Mira Mulvaney Assistant General Patent Counsel IP Litigation

Eli Lilly & Company

Hon. Pauline Newman Circuit Judge U.S. Court of Appeals for the Federal Circuit

Hon. Randall R. Rader (ret.) Former Chief Judge U.S. Court of Appeals for the Federal Circuit

Hon. Sherry R. Fallon Magistrate Judge United States District Court, District of Delaware

Hon. Douglas E. Arpert Magistrate Judge United States District Court, District of New Jersey

Hon. Tonianne J. Bongiovanni Magistrate Judge United States District Court, District of New Jersey

Honorable Stanley R. Chesler District Judge United States District Court, District of New Jersey

Honorable Rian Kalden

Legally Qualified Judge Second Chamber of the Court of Appeal Unified Patent Court

and Trademark Office

Honorable Linda Horner Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Government Representatives from

Angle-Right Hatch-Waxman at 40: Navigating the Evolution and Future of Life Sciences IP

» Celebrate 40 years of the Hatch-Waxman Act and 20 impactful years of ACI’s PIV Disputes while exploring future trends in pharmaceutical IP litigation

Angle-Right Policy Shifts in Pharma IP: Adapting to Regulatory and Economic Changes

» Learn how the impact of new policies under the IRA, the push for march-in rights, and the FTC’s new stance on Orange Book patents will reshape Hatch-Waxman strategies - including Paragraph IV litigation - as well as the economics of pharmaceutical IP

Angle-Right Judicial Insights in Hatch-Waxman Litigation: Analyzing Key Court Decisions

» Anticipate how appellate activity on §112 and ODP will play out at the Federal Circuit and Supreme Court to create new Hatch-Waxman jurisprudence and re-write the pharmaceutical patent management playbook

ACI’s

HatchWaxman SERIES

Celebrate Two Important Milestone with Us: The 20th Edition of ACI's Paragraph IV Disputes Conference and the 40th Anniversary of the Hatch-Waxman Act

Since our inaugural conference in 2006, American Conference Institute’s Paragraph IV Disputes conference has been the premier forum where the "who's who" of Hatch-Waxman litigators set the standards for ANDA practice. This year, we mark not only the 20th iteration of this pivotal program but also commemorate the 40th anniversary of the Hatch-Waxman Act — the statute that has been at the heart of pharmaceutical patent disputes for four decades.

Join us as we take a retrospective look at the impactful court cases, pivotal legislation, and industry shifts that have defined the patent endgame and the pursuit of profits. As we cast our gaze forward and consider the future of Paragraph IV litigation in an evolving legal and regulatory landscape, we also reflect on the journey thus far. Now is the time to strategize for the road ahead, ensuring that every pharmaceutical IP attorney is equipped for the changes to come.

Leaders from brand-name and generic drug companies alike acknowledge the unmatched value of our conference — the only event that caters to all sides of the industry with critical legal insights and strategic economic takeaways. We cover the most pressing matters - but also contextualize them within the entire patent lifecycle under Hatch-Waxman, from pre-suit considerations to case filings and final adjudication.

Esteemed Judges from the federal judiciary and the USPTO's PTAB, alongside representatives from the FTC and FDA, have graced our forums and will be present at this anniversary event providing invaluable perspectives that bridge the gap between legal theory and business realities.

As we celebrate these significant anniversaries, we invite you to be part of a forward-thinking dialogue at our flagship event. Catch up on the latest legal developments and learn how your peers — and competitors — are adapting to and navigating the ever-changing Hatch-Waxman terrain.

ACI’s Hatch-Waxman Series Advisory Board

American Conference Institute’s Hatch-Waxman Series Advisory board was created as a part of ACI’s ongoing effort to provide industry leading content and a world renowned speaker faculty. The board is composed of a selection of all-in-house advisers, including Chief IP and very senior IP/Patent counsel from the leading brand name and generic pharmaceutical companies in the country and in some cases the world. This ‘inner circle’ counsels ACI on the impact of litigation trends and emerging topics. HatchWaxman SERIES ACI’s

Ryan M. Daniel AGC, Corporate and Business Transactions

Fresenius Kabi USA, LLC

Stephanie Donahue Head of Global Patent Litigation, Global Intellectual Property Department, Legal, Ethics & Business Integrity

Sanofi

Serena Farquharson Torres Executive Director, Assistant General Counsel Bristol Myers Squibb

Linda Friedlieb Division Counsel AbbVie

Colin Heitzmann Vice President, IP and Business Development

Daiichi Sankyo, Inc.

Jenny Johnson Vice President, IP Endo Pharmaceuticals

Staci Julie SVP and Chief IP Counsel Teva Pharmaceuticals

Neema Kumar Vice President, IP, North America Sandoz

James P. Leeds Assistant General Patent Counsel

Eli Lilly & Company

Mary Morry Counsel, IP Litigation Merck & Company

Jeffrey N. Myers, Ph.D. Vice President & Assistant General Counsel Pfizer Inc

Aaron Pereira Senior Director of Patents Ferring Pharmaceuticals

Pearl T. L. Siew Senior Vice President and Head of IP Design Therapeutics

EMERITUS MEMBERS

Stephen R. Auten

Partner, Chair of Pharmaceutical & Life Sciences Litigation

Taft Stettinius & Hollister LLP

(Former Vice President, IP, Sandoz, Inc.)

Guy Donatiello Former SVP of IP Endo Pharmaceuticals

George W. Johnston Counsel

Gibbons P.C. (Newark, NJ)

(Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Honorable Kathleen M. O’Malley (Ret.) Of Counsel

Sullivan & Cromwell LLP

(Former United States Circuit Judge U.S. Court of Appeals for the Federal Circuit)

Honorable Teresa Rea Consultant

Rea Consulting LLC

(Former Acting Director of the USPTO)

Brian Stone Associate General Counsel Global Legal-Regulatory Viatris

Lars Taavola VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals

Andrea D. Tiglio Executive Director, Assistant General Counsel, Intellectual Property Jazz Pharmaceuticals

Serena Farquharson Torres Executive Director, Assistant General Counsel Bristol Myers Squibb

Maryll Toufanian

Senior Vice President, Regulatory Strategy and Government Affairs Amneal Pharmaceuticals

Kevin Zive

Vice President - General Counsel, and Head of Global Intellectual Property Apotex Inc.

Shashank Upadhye Partner

Upadhye Tang LLP

(Former Vice President – Global Intellectual Property, Apotex, Inc.)

Peter Waibel Former Head, US Patent Litigation Novartis Pharmaceuticals Corporation

From the Hatch-Waxman Act's inception in 1984, which revolutionized drug patenting and approvals, to landmark Supreme Court decisions and regulatory evolutions, this timeline chronicles the critical junctures and legal precedents that have defined and redefined the contours of Hatch-Waxman litigation.

Passage of the Hatch-Waxman Act (1984)

Officially known as the Drug Price Competition and Patent Term Restoration Act, this legislation was enacted to balance the need for innovator pharmaceutical companies to be rewarded for their investment in new drugs and the necessity to provide affordable generic drugs to the public.

1980s -1990s

Roche Products, Inc. v. Bolar Pharmaceuticals Co. Inc. (1984)

The decision meant that generic manufacturers would potentially have to wait until the expiration of a patent to even begin the process of seeking FDA approval, which could significantly delay the entry of generic drugs into the market.

KSR v. Teleflex (2007)

Changed the standard of obviousness, impacting how patents are challenged and defended.

Medicare Modernization Act (2003)

Introduced changes to the Hatch-Waxman Act, particularly affecting the 180-day exclusivity period for the first generic applicant and addressing some of the issues related to “parking” of exclusivity.

Merck KGaA v. Integra Lifesciences I, Ltd. (2005)

Expanded the scope of the “safe harbor” provision to include preclinical research.

2010s

Caraco Pharmaceutical Laboratories v. Novo Nordisk (2012)

Addressed the ability of generic companies to challenge the accuracy of brand-name labels.

The America Invents Act (AIA) (2011)

Introduced Inter Partes Review (IPR), providing a new avenue for challenging patents outside of traditional litigation.

Eli Lilly v. Medtronic (1990)

The Supreme Court allowed for broader use of the “safe harbor” provision under 35 U.S.C. § 271(e)(1).

2000s

Mylan Pharmaceuticals Inc. v. Thompson (2001)

Addressed issues related to the 180-day exclusivity forfeiture provisions.

American Conference Institute launches the first ever Maximizing Patent Life Cycles (Now known as PIV Disputes) (2002)

Sandoz v. Amgen (2015)

Clarified aspects of the Biologics Price Competition and Innovation Act (BPCIA), impacting biosimilars.

FTC v. Actavis, Inc. (2013)

The Supreme Court ruled on the legality of “pay-for-delay” settlements.

Amgen Inc. v. Sanofi (2023)

SCOTUS held that Amgen’s patents failed the enablement requirement of the Patent Act due to their overly broad claims compared to the actual invention described, could have significant implications for Hatch-Waxman litigation by potentially raising the bar for the specificity required in biopharmaceutical patents.

Vidal v. Hirshfeld

Ongoing case as of 2023, with potential implications for the discretion of the USPTO in reviewing patents post-grant.

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. (2019)

The Supreme Court clarified the “on sale” bar under the AIA.

COVID-19 Pandemic (2020)

Accelerated discussions about patent rights versus public health needs.

United States v. Arthrex, Inc. (2021)

Supreme Court case affecting the authority of Patent Trial and Appeal Board (PTAB) judges.

2020s

HatchWaxman SERIES ACI’s

DAY ONE

Thursday, April 25, 2024

7:00 Breakfast and Registration

8:00

Opening Remarks from the Chairs

microphone-alt Andrei Iancu, Partner, Sullivan & Cromwell LLP (Former Director of the USPTO)

Brian Malkin, Associate General Counsel, Teva Pharmaceuticals

Mira Mulvaney, Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company

8:15

The Hatch-Waxman Act at 40: Reflections on Past, Present, and Future

microphone-alt Hon. Pauline Newman, Circuit Judge, U.S. Court of Appeals for the Federal Circuit

Hon. Randall R. Rader (ret.), Former Chief Judge, U.S. Court of Appeals for the Federal Circuit

Moderator: Andrei Iancu, Partner, Sullivan & Cromwell LLP (Former Director of the USPTO)

ACI is honored to have this panel of distinguished jurists who were actively involved in Paragraph IV cases from the start to provide a retrospective look at the Hatch-Waxman Act. Join us as these legends detail the law’s original intents, pivotal milestones, and future trajectories. They will outline how this landmark legislation has shaped the pharmaceutical industry and patent litigation for brands and generics.

9:15

The Hatch-Waxman Year in Review: Pivotal Moments and Policy Shifts for Small Molecule Patents

microphone-alt Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP

Dan Troy, Managing Director, Berkeley Research Group

Gerald J. Flattman Jr., Partner, Cahill Gordon & Reindel LLP

Ashley Ross, Partner, Kirkland & Ellis LLP

Moderator: Emer Simic, Partner, Neal, Gerber & Eisenberg LLP

Join us for a look back at the past year’s most important developments impacting small molecule drugs, including groundbreaking court decisions, pivotal regulatory and policy changes, and major industry shifts.

Session leaders will offer insights how these developments are changing the practice of Hatch-Waxman Litigation. Topics of discussion will include:

• The Biden Administration’s new stance on drug pricing and march-in rights

» Analyzing recent actions to control prescription drug prices in the U.S., including the potential impact of using march-in rights under the Bayh-Dole Act

• FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay

» Exploring the intensified scrutiny and investigations

» Examining recent listing and relisting of drugs in the Orange Book

» Understanding how this is influencing the dynamics of drug patenting and market exclusivity

• The evolution of USPTO-FDA Collaboration

» Taking stock of the evolving partnership and understanding the impact on patent prosecution and regulatory approvals

• §101 legislation and the impact on patent eligibility

» Assessing the latest legislative proposals regarding §101, focusing on the potential effects on the patentability of small molecules

• Global policy shifts

» Understanding the implications of the new TRIPS waiver and the WIPO’s disclosure proposals on international pharmaceutical patent protection and licensing

• Implications of GSK v. Teva on section viii carve-outs for small molecules

» Examining the current landscape for small molecule patent strategies and litigation

10:30 Morning Break

10:45

The Economics

of

Pharmaceutical Patents in 2024: Understanding How the Next Ledge of the Patent

Cliff Will Reshape PIV Strategy

microphone-alt John Christopher “J.C.” Rozendaal, Director, Sterne Kessler

Alex Brill, Senior Fellow, American Enterprise Institute

Eric Alan Stone, Partner, Groombridge Wu Baughman & Stone

Moderator: Brian Malkin, Associate General Counsel, Teva Pharmaceuticals

By 2026, nearly 400 small molecule drugs – including at least a half dozen of blockbuster status and blockbuster revenue are set to go off patent.

This panel will explore the seismic economic implications of this latest patent cliff statistic as well as its effects on Hatch-Waxman litigation. Join us as we examine the current challenges and opportunities relative to the complexities of the looming patent cliff, pipeline replenishment, and the strategies brands and generics are employing to navigate these challenges. Points of discussion will include:

• It’s not 1984 anymore…

» Understanding why this latest patent cliff is different than others

• The economic impact of the patent cliff

» Potential revenue loss and market share shifts

• Strategies for scaling today’s patent cliff

» Extending patent life, managing patent portfolios, and navigating legal challenges in a competitive market

• Assessing the impact of the cliff on Paragraph IV practice: to sue or not to sue?

• The role of AI, automation, and digital transformation in creating new opportunities considering patent cliff challenges

• Understanding the influence of new and evolving regulation on pharma patenting strategies and the broader implications for access and pricing

• Predicting long-term shifts in pharma IP management based on cliff dynamics

• The evolving landscape of pharmaceutical innovation: recent trends and breakthroughs in research, advancements in obesity treatment and discoveries in Alzherimer’s disease

11:45

The Inflation Reduction Act’s Transformative Impact: Pharmaceutical Patent Dynamics, Drug Valuation and Pricing, ANDA Litigation and Settlements

microphone-alt

David Korn, Vice President, IP and Law, PhRMA

Jason Leonard, Partner, McDermott Will & Emery

Adam Perlman, Partner, Latham & Watkins

Moderator: Steven Maslowski, Partner, Akin Gump Strauss Hauer & Feld LLP

The IRA has far-reaching effects on big pharma. This session will detail the ripple effect of drug pricing reforms patent portfolio management, life cycle management and litigation

• Evaluating the potential impact of the IRA on pharmaceutical patent litigation

• Examining possible patent perils during IRA price negotiation

» What happens when a patent holder’s product is selected for negotiation before or during litigation?

» What is the impact on recoverable damages in an at-risk launch scenario?

» Assessing the impact on coordination and discovery

• Exploring how the IRA can encourage settlement of infringement litigation

• Practical strategies for safeguarding IP value when your drug is selected for negotiation

12:45

Networking Luncheon

Sponsored by

1:45

§112 Before the Supreme Court and Federal Circuit: Navigating Genus Claims and MPF Strategies Post Amgen and Xencor

microphone-alt

Matthew J. Becker, Partner, Axinn, Veltrop & Harkrider LLP

Ryan Hagglund, Partner, Loeb & Loeb LLP

Colleen Tracy James, Partner, Cahill Gordon & Reindel LLP

Moderator: Aaron Pereira, Senior Director, Patents, Global IP, Ferring Pharmaceuticals

This session will outline the evolving landscape of §112 in Hatch-Waxman litigation, illustrated by the Supreme Court’s decision in Amgen v. Sanofi, and the Federal Circuit’s pending decision in In re: Xencor. Session leaders will detail how these cases are shaping the future of patent drafting and Paragraph IV litigation strategies, particularly broad genus claims and mean-plus-function claims in.

• Analyzing the impact of the Supreme Court’s decision in Amgen on the enablement requirement for broad genus claims and the resulting impact to patent portfolios

• Discussing potential outcomes of the Xencor case and how it could reshape the use and viability of MPF claims on antibody patents

• Exploring best practices in claim drafting relative to Amgen and Xencor

» Broad protection v. sufficient disclosure

• Assessing how these cases influence Hatch-Waxman strategies, especially for ANDA filers

2:45 Afternoon Break

3:00

Closed Door Executive Meeting with ACI’s Hatch-Waxman Advisory Board

microphone-alt Stephanie Donahue, Head of Global Patent Litigation, Global Intellectual Property Department, Legal, Ethics & Business Integrity, Sanofi

Neema Kumar, VP, IP, North America, Sandoz

Lars Taavola, General Counsel, Brands, Mallinckrodt Pharmaceuticals

Mary Morry, Counsel, Merck Sharp & Dohme LLC

Serena Farquharson Torres, Executive Director, Assistant General Counsel, Bristol Myers Squibb

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, CustomerCentric, Conscientious, and Committed.

Looking back on 40 years, we are grateful for our achievements— hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

Colin Heitzmann, Vice President, IP and Business Development, Daiichi Sankyo, Inc.

Limited to 25 attendees, this unique, interactive discussion will provide an exclusive and intimate networking and benchmarking opportunity that will shed light on the expectations of in-house counsel from their law firm partners

It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with those of the Advisory Board.

Contact Joe Gallagher to reserve your spot at this rare opportunity. Email: j.gallagher@americanconference.com

• “Cost”, will offer insights on the monitoring of legal spend and balancing a budget

• “Competency”, will provide best practices for overcoming talent limitations with demonstrable advice

• “Communication”, will engage attendees in the art of communicating value and fostering collaboration between corporate legal counsel and outside

BREAKOUT TRACKS

TRACK 1 The Business of PIV Disputes

3:00

Communicating Value and Collaboration Between Corporate Legal and Outside Counsel

microphone-alt Donna Meuth, Associate General Counsel, IP, Eisai

Melanie Rupert, Partner, Litigation Department, Paul Hastings LLP

David M. Knapp, Attorney, Locke Lord LLP

This session will enhance the synergy between in-house legal teams and their law firm counterparts. Session leaders will explore effective communication strategies, share best practices for aligning business goals, and provide you with actionable insights into building stronger partnerships, managing expectations, and fostering a collaborative environment that supports the unique legal needs of Hatch-Waxman practitioners.

TRACK 1 The Business of PIV Disputes

3:45

Optimizing Patent Portfolio Management

microphone-alt Gloria Fuentes, Vice President & Assistant General Counsel, Bristol Myers Squibb

Colman Ragan, VP & General Counsel, North America IP Litigation, Teva Pharmaceuticals

Jennifer Nock, Partner, Rothwell Figg

This session will provide you with effective strategies for managing and maximizing the value of your patent portfolio. Session leaders will provide insights into winning techniques for strategic patent management. Whether navigating patent lifecycles or exploring innovative expansion to your portfolio, you will be empowered with the tools required for successful portfolio optimization.

4:30 Refreshment Break and 20/40 Toast

4:45

TRACK 2

3:00

The Practice of PIV Disputes

AI in Pharma: Transforming Life Sciences IP and Reshaping the Hatch Waxman Litigation Landscape

microphone-alt Rama G. Elluru, Senior Director, Special Competitive Studies Project – SCSP

Erin Austin, Partner, Venable LLP

• Detailing the impact of AI on life sciences IP and Hatch-Waxman litigation

» Discovering how AI is revolutionizing drug discovery and development

» Understanding new challenges and opportunities for IP protection and litigation under Hatch-Waxman

• Predicting AI’s role in patentability matters, data protection, and its influence on future litigation

TRACK 2 The Practice of PIV Disputes

3:45

Litigation Funding and Transparency in Hatch-Waxman Litigation

microphone-alt Lauren Rabinovic, Principal, GLS capital

Amy Lange Miller, Attorney, Locke Lord LLP

This session will explore the evolving landscape of litigation funding and alternative fee arrangements in Hatch-Waxman litigation, especially considering recent judicial scrutiny on hidden funding sources. Session leaders will discuss how these developments impact Hatch-Waxman litigation strategies and the importance of transparency in funding arrangements.

View from the Bench: Spotlight on Delaware and New Jersey

microphone-alt Honorable Stanley R. Chesler, District Judge, United States District Court, District of New Jersey

Hon. Tonianne J. Bongiovanni, Magistrate Judge, United States District Court, District of New Jersey

Hon. Sherry R. Fallon, Magistrate Judge, United States District Court, District of Delaware

Moderator: Anne Shea Gaza, Partner, Young Conaway Stargatt & Taylor, LLP

District Court Judges are at the forefront of shaping the landscape of pharmaceutical IP law. During this can’t-miss roundtable, distinguished District Court Judges will share their unique perspectives, illuminating the delicate balance between patent holders, generic drug manufacturers, and public interest.

5:45

Cocktail Reception

Sponsored by

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board. ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE

DAY TWO

Friday, April 26, 2024

8:00

Opening Remarks from the Chairs

microphone-alt Andrei Iancu, Partner, Sullivan & Cromwell LLP (Former Director of the USPTO)

Brian Malkin, Associate General Counsel, Teva Pharmaceuticals

Mira Mulvaney, Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company

8:15

Strategic IP Management in Hatch-Waxman Litigation: A Dialogue with Chief IP Counsel

microphone-alt Neema Kumar, VP, IP, North America, Sandoz

Kathryn Jones, VP, Chief Counsel IP, Novo Nordisk

Moderators: Gregory A. Morris, Partner, O’Melveny & Myers LLP

Vishal C. Gupta, Partner, Steptoe LLP

Leading Chief IP counsel from brands and generics will share insights and strategies for navigating the complexities of pharmaceutical intellectual property.

TRACK 1 The Business of PIV Disputes

9:30

Topics of discussion will include:

Brand Perspectives

• Appreciating the importance of patents for innovation

• Understanding the keys to growing a strong portfolio

» Orange Book listing strategies

• Gauging when to expect a Paragraph IV lawsuit

Generic Perspectives

• Determining which patents are ripe to challenge in today’s environment

• What makes one patent more attractive than another?

• Evaluating invalidity and non-infringement for the patent target

• Formulating your ANDA strategy

Considerations for Both Sides

• Deciding when to refer to outside counsel and detailing which matters typically remain in-house

• Taking stock of significantly challenging situations and predicting the challenges in-house lawyers will face in the future

9:15 Morning Break

BREAKOUT TRACKS

TRACK 2 The Practice of PIV Disputes

9:30

GLOBAL IP Risks: Effectively Managing an International Pharmaceutical IP Litigation Strategy

microphone-alt Andrea Tiglio, Executive Director, Assistant General Counsel, IP, Jazz Pharmaceuticals

Kevin Zive, Vice President, Global General Counsel, Head of IP, Apotex, Inc.

Deepro R. Mukerjee, Partner, Katten Muchin Rosenman LLP

This session will equip you with the tools and knowledge needed to navigate the complex landscape of international IP litigation in the HatchWaxman context. Session leaders will share strategies for managing cross-border IP risks, key considerations for global litigation, and aligning your global strategy with business objectives.

TRACK 1 The Business of PIV Disputes

10:25

Navigating Patent Exclusivity and Regulatory Compliance

microphone-alt Raj Gandesha, Partner, White & Case LLP

Nicholas Mitrokostas, Partner, Allen & Overy LLP

Focused on the intersection of pharma IP law and FDA regulations, session leaders will address how to balance patent protection strategies with regulatory compliance.

Best Practices for Utilizing FDA’s Citizen Petition Process: Brand and Generic Recommendations for Achieving Market Access and Petitions for Reconsideration

microphone-alt Brian McCormick, Vice President, Chief Regulatory Counsel, Teva Pharmaceuticals

Maarika L. Kimbrell, Partner, Morgan, Lewis & Bockius LLP

Rob Berlin, Head – US. Regulatory Policy, GSK

This session, designed for both brands and generics, will provide proven strategies to navigate market access challenges. Session leaders will share insights on leveraging citizen petitions for market entry and addressing petitions for reconsideration, while offering practical recommendations to fortify your regulatory strategies.

TRACK 2 The Practice of PIV Disputes

10:25

Jury Trial Preparedness in ANDA Cases

microphone-alt Douglas H. Carsten, Partner, McDermott Will & Emery

Ivan Poullaos, Partner, Winston & Strawn LLP

With an increasing number of Hatch-Waxman disputes being decided by juries, it is crucial for practitioners to master the nuances of presenting complex scientific and legal arguments in a jury-friendly manner. Best practices training is essential for attorneys to effectively communicate the intricacies of pharmaceutical patent cases to a lay audience, ensuring the right balance between technical accuracy and persuasive storytelling.

Brand and Generic Insights on FDA Programs

Impacting Pharmaceutical Patents: Regulatory Initiatives and Recent FDA Litigation Every PIV Practitioner Needs to Know About

microphone-alt

Mary Alice Hiatt, Division Director, Division of Legal and Regulatory Support, Office of Generic Drug Policy, U.S. FDA

Maryll W. Toufanian, Senior Vice President, Regulatory Strategy and Government Affairs, Amneal Pharmaceuticals

Kurt R. Karst, Director, Hyman, Phelps & McNamara PC

For Hatch-Waxman litigators, staying up to date with new FDA regulations impacting Orange Book listed patents is crucial. By monitoring these developments, Hatch-Waxman litigators can adapt their strategies, assess the potential impact on patent validity and infringement disputes, and navigate the evolving landscape of pharmaceutical patent litigation effectively. During this session, our panelists will help you understand the nuances of new regulations and initiatives, empowering you to provide valuable insights, and advocate for your clients’ interests.

12:15 Networking Luncheon

1:15

FTC KEYNOTE: Antitrust Developments Concerning Brands and Generics

microphone-alt Randall Weinsten, Attorney, U.S. Federal Trade Commission

1:45

In re Cellect: Understanding the Implications for Obviousness – Type Double Patenting and Patent Term Adjustments

microphone-alt Mira Mulvaney, Assistant General Patent Counsel, IP Litigation, Eli Lilly & Company

Angie Verrecchio, Senior Counsel, Patent Litigation, Johnson & Johnson

Andrew Cohen, Partner, Patterson Belknap Webb & Tyler LLP

Mark H. Remus, Partner, Crowell & Moring LLP

Moderator: Michael P. Kahn, Partner, Akin Gump Strauss Hauer & Feld LLP

This panel will explore the Federal Circuit’s decision in In re Cellect and its implications for PTA in the context of ODP.

• Analzying how the Federal Circuit’s decision affects the interaction between PTA and ODP

• Outlining measures to audit patent portfolios and employ claim drafting techniques to safeguard against ODP challenges

• Exploring the contrasting treatment of PTA and PTE in the ODP analysis in the Cellect and Novartis decisions

• Emphasizing strategies in drafting claims for first filed and subsequent continuation applications to avoid ODP concerns

• Adapting patent prosecution and litigation strategies

2:45

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes

microphone-alt Honorable Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Linda Horner, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Moderators: Brent Babcock, Partner, Loeb & Loeb LLP

John J. Molenda, Partner, Steptoe LLP

• Surveying notable pharmaceutical patent wins and losses

• Reviewing IPR, PGR and CBM filings involving pharmaceutical patents

• Examining the latest statistics for types of challenges brought and types of patents challenged

• Examining when the PTAB will issue a “good cause” extension of trial

• Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review

• Evaluating when petitioners may rely on prior art previously considered by the PTAB

3:45 Afternoon Break

4:00

One Year of the UP and UPC: Assessing the Impact on Global Pharma Patents

microphone-alt Honorable Rian Kalden, Legally Qualified Judge, Second Chamber of the Court of Appeal, Unified Patent Court

Professor Willem Hoyng, Partner, HOYNG ROKH MONEGIER (Chairman, Advisory Committee of the UPC)

Reflecting on the first year since the launch of the Unitary Patent (UP) and the Unified Patent Court (UPC), this session will examine their profound effects on the global pharma patent landscape. Session leaders will dissect the implications of the UP and UPC, emphasizing how they are reshaping strategies for global patent protection, and enforcement.

• Analyzing how the UP and UPC have transformed pharma patent portfolio management strategies since the UPC opened

• Detailing the cost implications of the UP and UPC, focusing on how they have impacted the financial aspects of patenting and litigation

• Exploring new avenues for enforcing pharma patent rights globally in the wake of the UP and UPC’s establishment

5:00

ETHICS CASE STUDIES: Cybersecurity, Information Security, and the Ethical Protection of Data

microphone-alt Shashank Upadhye, Partner, Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.)

Hon. Teresa Rea, Consultant, Rea Consulting LLC (Former Acting Director of the USPTO)

Kevin E. Noonan, Ph.D, Partner, McDonnell Boehnen Hulbert & Berghoff LLP

Attorneys oversee myriad of sensitive information daily, and confidentiality is a core tenet of the legal profession. Now, more than ever before, cybersecurity must be an ever-present priority for Hatch-Waxman practitioners. This session will offer best practices for protecting your clients’ information, identify the main risks specific to the life sciences and intellectual property, and provide proven strategies on optimizing your firm’s cybersecurity approach that you can immediately implement.

6:00

Conference Concludes

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851 6th Ave, New York, NY 10001

Reservations: 1-866-993-8396

Please note that the guest room block cut-off date is March 25, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book with Confidence!

Register and pay to lock in your early rate and be eligible for a full refund until April 5, 2024

If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by April 5, 2024

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world. Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent.

For more information please contact us at: SponsorInfo@AmericanConference.com

 ONLINE: AmericanConference.com/PIVDisputes EMAIL: CustomerService@AmericanConference.com  PHONE: 1-888-224-2480  CONFERENCE CODE: 896L24-NYC

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/. Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/ All program participants will receive an online link to access the conference materials as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy.

*Team/group registrations must be from the same organization/firm and register together in one transaction.

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.