8th Annual Paragraph IV Master Symposium - WEB

ACI’s

HatchWaxman SERIES

EARN CLE/ Ethics/Diversity CREDITS

2022 Co-Chairs

8th Annual

Paragraph IV Disputes

MASTER SYMPOSIUM

RYAN M. DANIEL

Chief Patent Counsel, Region North America

Fresenius Kabi USA, LLC

“We’re excited to participate in ACI’s 8th Annual Paragraph IV Master Symposium, here in Chicago and in person for the first time in three years. It’s a very welcome opportunity to connect and engage with colleagues and the judiciary regarding the evolving landscape of Hatch-Waxman law and the pharmaceutical industry.”

September 21–22, 2022 Hyatt Regency McCormick Place, Chicago, IL

Master the skills necessary to rise to the ever-evolving challenges of the pharmaceutical patent endgame

Supporting Sponsors

LINDA FRIEDLIEB

Division Counsel AbbVie

“We can’t wait to gather in Chicago to discuss the key issues at the cutting edge of Hatch-Waxman litigation.

The PIV conference attracts broad participation from key in-house and outside counsel, as well as the Patent Office and judges. It’s an excellent opportunity to cross-pollinate ideas and strategies.”

Associate Sponsors

LOG O

Premium Exhibitor

Sponsored by

AmericanConference.com/PIVDisputesChicago • 888 224 2480

Luncheon Sponsor

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

It’s time to come back to Chicago.

Meet in-person and network with the key influencers shaping the law, policy and proceedings of Paragraph IV litigation at the “original and best’’ event of its kind.

Dear Colleague: We are pleased to be co-chairing ACI’s 8th Annual Paragraph IV Disputes Master Symposium in-person this fall for the first time since the pandemic started. Join us in the center of the Midwest bioscience hub, and take advantage of this opportunity to meet and re-connect with peers from across the country – and even across the globe – as well as learn from leading industry decision-makers, counsel and executives who have been involved in some of the most significant Hatch-Waxman cases decided date.

ACI is proud to present this master symposium each fall as a companion to its flagship Paragraph IV Disputes conference, and is honored to work and interact with this unique group of pharmaceutical professionals and legal thought-leaders.

This conference seeks to capture the nuances of this multifarious area of the law, as well as provide solutions to your most pressing matters. ACI strives to serve the legal and business needs of both branded and generic drug makers by providing our audience with practical information on cutting edge trends that affect both substantive and procedural matters of significance to IP stakeholders.

Over the course of two days, our faculty of esteemed speakers will outline the contours of the current Hatch-Waxman litigation landscape, review the current statutory framework that is designed to balance the competing interests of brands and generics, consider the introduction of several new bills, and more importantly, evaluate their potential impact.

They will also describe the types of matters they encounter citing their own experiences litigating Hatch-Waxman cases, including navigating FDA and FTC regulatory concerns, working with scientific experts, the application of patent law, and the evolution of Paragraph IV litigation strategies.

The time is now to master the skills needed to overcome the next wave of challenges of Paragraph IV disputes.

We look forward to seeing you and your contemporaries for another successful conference!

Sincerely,

Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA, LLC

2 | #ACIPIV #HatchWaxman

Linda Friedlieb Division Counsel AbbVie

twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series

ACI’s

HatchWaxman SERIES

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.

Ryan M. Daniel

Chief Patent Counsel Fresenius Kabi USA, LLC

Stephanie Donahue

James Kellerman

Senior Vice President, Intellectual Property Astellas Pharma US, Inc.

Pearl T. L. Siew

Senior Vice President and Head Intellectual Property Eagle Pharmaceuticals, Inc

Brian Stone

Principal Counsel – Global Patent Litigation, Global IP Department Legal, Ethics & Business Integrity Sanofi-Aventis

James P. Leeds

Assistant General Patent Counsel Eli Lilly & Company

Associate General Counsel, Global Legal-Regulatory Mylan

Serena Farquharson-Torres

Josephine Liu, Ph.D., J.D.

Lars Taavola

Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb

Linda Friedlieb Division Counsel AbbVie

Vice President of IP, North America (ad interim) Sandoz Inc.

Mary Morry

Counsel Merck & Company

Andrea Hutchison Senior Associate General Counsel, IP Litigation Gilead Sciences

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

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

Peter Waibel

Head, US Patent Litigation Novartis Pharmaceuticals Corporation

Kevin Zive

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

Staci Julie

SVP and Chief IP Counsel Teva Pharmaceuticals

EMERITUS MEMBERS Stephen R. Auten

Partner, Chair of Pharmaceutical & Life Sciences Litigation Taft Stettinius & Hollister LLP (Former Vice President, IP, Sandoz, Inc.)

George W. Johnston Counsel Gibbons P.C. (Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

David H. Silverstein, M.S., J.D.

Partner Axinn, Veltrop & Harkrider LLP (Former Senior Director, Intellectual Property, Par Pharmaceutical, Inc)

Meg Snowden

Shareholder Margaret M. Snowden, P.C. (Former Vice President, Intellectual Property, Impax Laboratories)

AmericanConference.com/PIVDisputesChicago • 888 224 2480

Shashank Upadhye

Partner Upadhye Cwik LLP (Former Vice President – Global Intellectual Property, Apotex, Inc.)

Guy Donatiello

Former Senior Vice President, Intellectual Property Endo Pharmaceuticals

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Speaker List DISTINGUISHED CO-CHAIRS Ryan M. Daniel Chief Patent Counsel, Region North America Fresenius Kabi USA, LLC

GOVERNMENT REPRESENTATIVES FROM KEY AGENCIES

Linda Friedlieb Division Counsel AbbVie

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

MEMBERS OF THE JUDICIARY Honorable Colm F. Connolly Chief Judge United States District Court, District of Delaware

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

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

Hon. Christopher J. Burke Magistrate Judge United States District Court, District of Delaware

Hon. Joshua Wolson District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

Mary C. Till Senior Legal Advisor Office of Patent Legal Administration U.S. Patent and Trademark Office Hon. Susan Mitchell Lead Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Hon. Grace Obermann Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Robin Evans Deputy Commissioner for Patents U.S. Patent and Trademark Office

IN-HOUSE COUNSEL Tanzina Chowdhury Senior Corporate Counsel Nostrum Laboratories, Inc.

Linda Friedlieb Division Counsel AbbVie

Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA

Dan Hoang Senior Counsel – Patent Litigation AbbVie

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

Mary J. Morry Counsel, IP Litigation Office of the General Counsel Merck Sharp & Dohme Corp.

Huong Nguyen General Counsel & Compliance Officer Fosun Pharma USA Inc. Brian Stone Associate General Counsel, Global Legal–Regulatory Viatris Andrea Tiglio Associate General Counsel, IP Legal Senior Director IP Astellas Pharma US

LAW FIRMS John L. Abramic Partner Steptoe & Johnson LLP

Anna Brook Partner Culhane Meadows PLLC

David Abramowitz Partner Locke Lord LLP

Dominick A. Conde Partner Venable LLP

Aaron R. Barkoff Shareholder McAndrews, Held & Malloy, Ltd.

Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP

Kevin E. Noonan Partner McDonnell Boehnen Hulbert & Berghoff LLP

Jeremy Lowe Shareholder Leydig, Voit & Mayer, Ltd.

Anil Patel Partner K&L Gates LLP

Jeffrey R. Gargano Partner K&L Gates LLP

Jamie L. Lucia Partner Steptoe & Johnson LLP

John Bennett Partner Allen & Overy LLP

Anne Shea Gaza Partner Young Conaway Stargatt & Taylor, LLP

Andrew Berdon Partner Quinn Emanuel Urquhart & Sullivan LLP

Ted Mathias Partner Axinn, Veltrop & Harkrider LLP

William A. Rakoczy Founding Partner Rakoczy Molino Mazzochi Siwik LLP

Steven J. Horowitz Partner Sidley Austin LLP

Cary Miller Partner Jones Day

Carolyn Blessing Partner Locke Lord LLP

Eric R. Hunt Partner Rakoczy Molino Mazzochi Siwik LLP

Gregory A. Morris Partner Honigman LLP

Caryn Borg-Breen Partner Ballard Spahr

Kurt R. Karst Director Hyman, Phelps & McNamara, P.C.

4 | #ACIPIV #HatchWaxman

Matt Murphy Partner Axinn, Veltrop & Harkrider LLP

Shashank Upadhye Partner Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.) Anita Varma Partner White & Case LLP Scott Weidenfeller Partner Covington & Burling LLP

twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series

Main Conference Day One SEPTEMBER 21, 2022 8:00

Opening Remarks Microphone Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC

Linda Friedlieb, Division Counsel, AbbVie 8:15

LIVE AUDIENCE POLLING

10:15 10:45

The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims Microphone John Bennett, Partner, Allen & Overy LLP

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch-Waxman Reform Measures Microphone Anita Varma, Partner, White & Case LLP Anna Brook, Partner, Culhane Meadows PLLC Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC This opening session will consider current and proposed legislation, as well as other potentially impactful measures which may influence Paragraph IV litigation. Topics of discussion will include: • Pending bipartisan legislation to watch including: » S.2891 (Restoring the American Invents Acts) » S.3772 (Defend American Courts Act) » S.2076 (PASTEUR Act) / S.2209 (VALID Act) • Recent federal and state executive actions and legislative initiatives which may impact biopharmaceutical products patents » Recent selected Hatch-Waxman and BPCIA amendments » Patent listing statutes • “Buy American” policies and executive orders 9:15

SCOTUS WATCH: PENDING PATENT PETITIONS AND THE FUTURE OF SKINNY LABELS, §101 and §112

Skinny Labeling: Forecast on the Future of Carveouts and the Influence of GSK v. Teva on Competition Microphone Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP Gregory A. Morris, Partner, Honigman LLP David Abramowitz, Partner, Locke Lord LLP • Analyzing whether a skinny label alone is enough to preclude induced infringement allegations • Reviewing the implications of recent decisions for induced infringement » Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs • Devising strategic considerations of label language for inducement infringement » What considerations should patent owners keep in mind when labeling drugs?

• Reviewing the approval of generic drug labeling » On what basis will FDA determine the scope of an appropriate carve-out? » Must FDA review the patent to ensure the only information carved out is covered by the patent? » Is the interpretation of the patent claims subject only to a jury’s interpretation?

Networking Coffee Break

Mary C. Till, Senior Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office moderator: William A. Rakoczy, Founding Partner, Rakoczy Molino Mazzochi Siwik LLP As demonstrated by the Federal Circuit’s recent denial of Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc., written description and enablement requirements have perplexed patent practitioners for years. The dissent demonstrates opposing views at the Federal Circuit and among the bar as to §112 and signals that the Supreme Court may grant cert.

• Reviewing Biogen International GMBH v. Mylan Pharmaceuticals Inc. Appeal No. 20-1933, where the Federal Circuit affirmed invalidity of a method of treatment patent for lack of written description • Appreciating the importance of inventor testimony and the impact of post-filing clinical data » When can witness admissions strengthen a written description invalidity defense?

• Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation • Considering the dissent and determining whether the district court erred in applying judicial estoppel • Analyzing litigation insights that inform patent drafting application strategies 11:45

Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v.

Neapco Microphone Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US

John L. Abramic, Partner, Steptoe & Johnson LLP Dominick A. Conde, Partner, Venable LLP This session will review the latest developments and most impactful cases from the last 12 months in 101 jurisprudence. We will also review the Court’s attempt to resolve the “bitter divide” of patent subject matter eligibility.

• Analyzing the unique 101 questions posed by American Axel and assessing its chance of have cert. granted » Understanding the significance of the Court’s invitation to the Solicitor General to file a brief in this case • Considering the Biden administration’s views on patent law and eligibility • Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages

• Assessing the flurry of follow-on cases in the courts

AmericanConference.com/PIVDisputesChicago • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

• Taking stock of the recent 101 cases applying the Supreme Court’s Alice/ Mayo tests before the Federal Circuit » Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020) » Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020) • Deciding whether a new application of an abstract idea is abstract • Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter » Whether there was direction to a natural phenomenon

• Recommending strategies for reducing or eliminating bias » Identifying tests designed to aid in determining where biases exist 4:00

Afternoon Refreshment Break

4:15

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings Microphone Hon. Douglas E. Arpert, Magistrate Judge, United States

• Assessing the competing interests keeping 101 reform at bay

District Court, District of New Jersey

12:45

Hon. Christopher J. Burke, Magistrate Judge, United States District Court, District of Delaware

Networking Luncheon

2:00

VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups Microphone Dan Hoang, Senior Counsel – Patent Litigation, AbbVie Caryn Borg-Breen, Partner, Ballard Spahr With the latest rulings on venue, deciding where to file your case is mission critical. In this session, our panelists will consider the proper venue for HatchWaxman cases and address the unanswered question of what constitutes “actions related to the ANDA submission”. Topics of discussion will include: • Reviewing Celgene Corp. v. Mylan Pharmaceuticals, Inc. 17 F.4th 1111 (Fed. Cir. 2021) » As in Valeant, the question of whether the location where ANDA submissions are sent (i.e., Maryland) might be a proper venue/ where an “act of infringement” occurs, was not addressed by CAFC

moderator: Jeffrey R. Gargano, Partner, K&L Gates LLP This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.

• Understanding when to reduce claims and defenses to a manageable level • How to masterfully manage protective order disputes • Analyzing practical strategies and tactics for effective settlement negotiation 5:15

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings Microphone Honorable Stanley R. Chesler, District Judge, United States District Court, District of New Jersey

Honorable Colm F. Connolly, Chief Judge, United States District Court, District of Delaware

• Determining whether “relevant acts involved in the preparation and submission of an ANDA” limited to submission of the ANDA after Celgene?

Hon. Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)

• Analyzing if Valeant and Celgene have impacted where Hatch-Waxman suits are being filed • Outlining the pros and cons of joint defense groups

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

• Recognizing when to contest venue 3:00

VIEW FROM THE FEDERAL BENCH

DIVERSITY, EQUITY & INCLUSION

Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies Microphone Jamie L. Lucia, Partner, Steptoe & Johnson LLP Robin Evans, Deputy Commissioner for Patents, United States Patent and Trademark Office Implicit bias refers to the unconscious attitudes or stereotypes that affect our understanding, actions, and decisions. In this interactive session, our panelists will introduce the topic of implicit bias in pharmaceutical patent litigation, share bias-reducing strategies, and will invite attendees to share their thoughts and perceptions on implicit bias. Topics of discussion will include:

Distinguished jurists with some of the liveliest Paragraph IV litigation dockets in the country will examine decision-making practices employed by the judicial system and provide sage advice for both patent holders and patent challengers.

6:15

Conference Adjourns to Day Two

Media Partners

• Analyzing both involuntary and voluntary behaviors that hinder diversity, recruiting, and retention efforts in life sciences IP careers • Understanding the economic and other costs of implicit bias, especially in areas of law, science, IP, and innovation

6 | #ACIPIV #HatchWaxman

twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series

Main Conference Day Two SEPTEMBER 22, 2022 8:00

10:45

Opening Remarks

The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review

8:15

REGULATORY THINK TANK

Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation

Microphone Scott Weidenfeller, Partner, Covington & Burling LLP Cary Miller, Partner, Jones Day

Microphone Brian Stone, Associate General Counsel, Global Legal– Regulatory, Viatris

Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C.

• Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard » Weighing the future of parallel proceedings in view of a single standard adoption

• Reconciling Hatch-Waxman exclusivity with CGT exclusivity • Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence HatchWaxman litigation strategies • Exploring branded and generic interests in GDUFA and PDUFA renewals • Examining new attacks on 180-day exclusivity per the propose Blocking Act

• Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective • Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation • Formulating strategies based on type of pharmaceutical patent • Establishing jurisdiction at the PTAB

• Assessing status of FDA activity concerning Hatch-Waxman reform 9:15

THE PTAB LIVE!

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes Microphone Jacqueline Bonilla, Deputy Chief Administrative Patent Judge,

Patent Trial & Appeal Board, U.S. Patent and Trademark Office Hon. Susan Mitchell, Lead Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office Hon. Judge Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office Carolyn Blessing, Partner, Locke Lord LLP

• Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials • Reviewing the latest stats at PTAB, highlighting bio/pharma cases • Outlining the latest developments on pilot programs at PTAB » Legal Experience and Advancement Program (LEAP)

» Special considerations for ex-U.S. parties • Developing sound discovery strategies relative to dual proceedings • Evaluating chances of getting a stay granted in the District Court • Managing experts and use of experts in both forums • Appealing decisions in both forums 12:00

Networking Luncheon

1:00

Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review Microphone Huong Nguyen, General Counsel & Compliance Officer, Fosun Pharma USA Inc.

Andrew Berdon, Partner, Quinn Emanuel Urquhart & Sullivan LLP Anil Patel, Partner, K&L Gates LLP

» Fast-Track Appeals

• Understanding settlement strategies between brands and generics

» Motions to Amend (MTAs) in AIA proceedings

• Structuring agreements and identifying antitrust concerns

• Detailing recent rules at PTAB » New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies) » New rule relating to burdens of persuasion in MTAs • Interpreting PTAB precedent and other information » Newly designated precedent at PTAB » New memorandum regarding indefiniteness approach in AIA proceedings 10:15

Networking Coffee Break

Join Our Email List to Stay Connected SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES AmericanConference.com/join-our-email-list/

» Understanding investigation and liability risks • Highlighting the state legislation directly addressing “reverse payment” patent settlements » Presumption of unlawfulness – California AB 824 • 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

AmericanConference.com/PIVDisputesChicago • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

• Avoiding costly litigation and associated penalties by effectively complying with the law • At-risk Launch considerations 2:00

4:15

Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation Microphone Aaron R. Barkoff, Shareholder, McAndrews, Held & Malloy, Ltd.

INTERNATIONAL

Cross-Border Business Considerations in a HatchWaxman Scenario: The Global Approach to Pharmaceutical Patent Litigation Microphone Kevin Zive, Vice President, General Counsel and Head of Global Intellectual Property, Apotex Inc.

Mary J. Morry, Counsel, IP Litigation, Office of the General Counsel, Merck Sharp & Dohme Corp.

Matt Murphy, Partner, Axinn, Veltrop & Harkrider LLP • Revisiting damages in an at-risk-launch scenario • Exploring questions of royalties, lost profits and exceptional findings • Examining grounds for mitigation • Considering the practical consequences of the Supreme Court’s WesternGeco decision on Hatch-Waxman damages awards » Exploring when U.S. patent owners may recover foreign lost profits tied to domestic acts of infringement under § 271(f)(2)

Dominick A. Conde, Partner, Venable LLP

» Examining cases where the relevant infringing conduct occurred in the United States

Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US When considering cross-border biopharmaceutical patent matters, there are multiple factors in play. It is critical to understand the patent landscape in the relevant countries, the differences in patent laws in various jurisdictions, and the timing of litigation. Topics of discussion will include: • Assessing common international business scenarios encountered by both brand name and generic manufacturers

5:15

Ethical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility Microphone Tanzina Chowdhury, Senior Corporate Counsel, Nostrum Laboratories, Inc.

• Identifying potential safe-harbor concerns related to foreign manufacturers and finishers • Building and managing a winning global litigation team • Understanding the importance of aligning legal and business functions for global patent litigation planning • Managing global pharmaceutical patent litigation • Exploring matters of international trade and impacting the value of pharmaceutical patents 3:00

ETHICS

Shashank Upadhye, Partner, Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.) There is an ethical obligation as well as a fiduciary duty to protect the interest of your client – and Hatch-Waxman litigation has no exception to this general premise. In this interactive session, our leaders will review common ethical challenges faced by Hatch-Waxman practitioners.

Attendees will then reflect critically on hypothetical situations posed by the panelists, discuss in groups, and then review their conclusions.

• Understanding how to maintain candid communication with the USPTO and fulfilling disclosure obligations

Refreshment Break

3:15

OTDP and Patent Terms: Understanding the Interplay Between Obviousness-Type Double Patenting, Pattern Term Extension and Patent Term Adjustment Post-Ex Parte Cellect

• Exploring best practices to avoid inequitable conduct in the pharmaceutical patent litigation arena 6:15

Conference Concludes

Microphone Jeremy Lowe, Shareholder, Leydig, Voit & Mayer, Ltd. Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP Steven J. Horowitz, Partner, Sidley Austin LLP In Ex Parte Cellect, the PTAB considered the appropriateness of an OTDP rejection of two related patents that had different expiration dates due to PTA. The patent whose term had been extended was found invalid – sending shivers down the spine of patent owners everywhere. With a contradictory decision delivered by the CAFC, practitioners are left with two opposing schools of thought. The present case will either expand or contract the Gilead precedent on this issue of first impression, and consider whether the doctrine is statutory or equitable.

8 | #ACIPIV #HatchWaxman

hands-helping BECOME A SPONSOR 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

twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series

Planning Ahead for Live Conferences: C5’s All Secure Safety Plan

As American Conference Institute and our partners plan for in-person events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery. In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or location-specific regulations, and will follow the commitments below.

Attendance Screening

Enhanced Communication

All attendees will need to assert that at the time that they first attend the conference and for the 10 days prior:

y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more.

y Have not experienced any COVID-19 symptoms now or within the last 10 days.

y Education and training for the team to ensure we provide a safe and secure conference experience.

y Have not had close contact with any person with or suspected of having COVID-19 within the last 10 days. y Have not had a positive COVID-19 test within the last 10 days.

y Distribution of local health-resource information in advance of the event.

y Have not been advised by any health authority, government agency or regulatory body, within the last 10 days, to self-isolate due to possible exposure to COVID-19.

y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

Increased Cleaning and Sanitation

We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference.

Reduced Touchpoints

y A conference room layout with planned seating for appropriate physical distancing.

y Reduction of the physical distribution of onsite materials.

y We continue to work closely with our venue partners to ensure the safety of our attendees. Please check back frequently as we monitor and evolve our plan in the weeks ahead.

y Food and beverage options that ensure minimal handling and exposure.

Related Events

ACI’s

HatchWaxman SERIES

AMERICAN CONFERENCE INSTITUTE’S 39th

FDA

BOOT CAMP

September 14–15, 2022 (EST) Virtual Conference

2 Annual Passport to Proficiency on the Essentials of nd

Hatch-Waxman and BPCIA

20

October 2022 Virtual Conference

AmericanConference.com/PIVDisputesChicago • 888 224 2480

th

Anniversary

LIFE SCIENCES IP SUMMIT

17–18 October 2022 Munich

SUMMIT ON

Life Sciences IP Due Diligence November 15–16, 2022 Boston, MA

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

3 Ways to Register 

ONLINE:

AmericanConference.com/PIVDisputesChicago

PRICING



EMAIL:



CustomerService@AmericanConference.com

Register & Pay by July 15, 2022

Register & Pay by August 19, 2022

Register & Pay after August 19, 2022

PHONE:

1-888-224-2480

REGISTRATION CODE:

B00-815-815L23.WEB CONFERENCE CODE:

815L23-CHI

Conference Only – In-House Rate

$1595

Conference Only

$2195

$1795

$1895

$2295

$2395

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.

Bringing a Team?* 3–4

10% Conference Discount

5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

Special Discount

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/

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. * Team/group registrations must be from the same organization/firm and register together in one transaction.

VENUE INFO Hotel:

Hyatt Regency McCormick Place

Address:

2233 S Martin L King Drive. Chicago, IL 60615

WORRY FREE Registration

GUARANTEE

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until September 8.

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 September 8.

EARN CLE/ Ethics/Diversity CREDITS

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.

Questions about CLE credits for your state? Visit our online CLE Help Center at www. americanconference.com/accreditation/cle/

© American Conference Institute, 2022

About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.