IV
The
Chicago and in person for the
rise to the ever-evolving
“We can’t wait to gather in Chicago to discuss the key issues at the cutting edge of Hatch-Waxman litigation. 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.”
MASTER SYMPOSIUM 8th Annual September 21–22, 2022 Hyatt Regency McCormick Place, Chicago, IL
FRIEDLIEBLINDA Counsel DANIELM. Counsel,
Chief Patent
the
three
excited
Paragraph Disputes
EARN Ethics/DiversityCLE/CREDITS LOGO 2022 Co-Chairs HatchWaxman SERIES ACI’s
Region North America Fresenius Kabi USA, LLC
the
8th Annual Paragraph IV Master
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here
Part of C5 Group’s LIFE SCIENCES GLOBAL SERIESAmericanConference.com/PIVDisputesChicago • 888 224 2480 Supporting Sponsors ExhibitorPremium Sponsored by SponsorLuncheon Associate Sponsors
engage
AbbVieRYAN
participate
“We’re to in ACI’s Symposium, in first time in years. It’s very welcome opportunity to connect and with colleagues and the judiciary regarding the evolving landscape of Hatch-Waxman law and the pharmaceutical industry.”
Master skills necessary to challenges of pharmaceutical patent endgame
Division
We look forward to seeing you and your contemporaries for another successful conference!
Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA, LLC
2 | #ACIPIV #HatchWaxman twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series
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.
Dear Colleague:
Linda Friedlieb Division Counsel AbbVie
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.
Sincerely,
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.
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.
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.
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.
The time is now to master the skills needed to overcome the next wave of challenges of Paragraph IV disputes.
Vice President of IP, North America (ad interim) Sandoz Inc.
Lars Taavola
Vice President & Assistant General Counsel Pfizer Inc
Fresenius Kabi USA, LLC
Brian Stone
Partner
Stephanie Donahue
Andrea Hutchison
Head, US Patent Litigation Novartis CorporationPharmaceuticals
SVP and Chief IP Counsel Teva Pharmaceuticals
Jeffrey N. Myers, Ph.D.
Gibbons P.C.
Meg Snowden
Merck & Company
Pearl T. L. Siew
Ryan M. Daniel
Assistant General Patent Counsel Eli Lilly & Company
Kevin Zive
George W. Johnston Counsel
Margaret M. Snowden, P.C. (Former Vice President, Intellectual Property, Impax Laboratories)
Principal Counsel – Global Patent Litigation, Global IP Department Legal, Ethics & Business Integrity Sanofi-Aventis
Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
Senior Associate General Counsel, IP Litigation Gilead Sciences
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
David H. Silverstein, M.S., J.D.
VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals
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
Upadhye Cwik LLP
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Senior Vice President and Head Intellectual Property Eagle Pharmaceuticals, Inc
EMERITUS MEMBERS
Senior Vice President, Intellectual Property Astellas Pharma US, Inc.
(Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)
Stephen R. Auten
Linda Friedlieb Division Counsel AbbVie
Shareholder
James P. Leeds
SERIES ACI’s
Shashank Upadhye Partner
Partner, Chair of Pharmaceutical & Life Sciences Litigation
ACI’s Hatch-Waxman Series Advisory Board
Josephine Liu, Ph.D., J.D.
(Former Senior Director, Intellectual Property, Par Pharmaceutical, Inc)
Taft Stettinius & Hollister LLP (Former Vice President, IP, Sandoz, Inc.)
Peter Waibel
Staci Julie
Guy Donatiello
Former Senior Vice President, Intellectual Property Endo Pharmaceuticals
Axinn, Veltrop & Harkrider LLP
SerenaFarquharson-Torres
Chief Patent Counsel
Associate General Counsel, Global Legal-Regulatory Mylan
James Kellerman
Mary Morry Counsel
Anne Shea Gaza Partner
Eric R. Hunt Partner
Linda Friedlieb Division Counsel AbbVie
Hon. Grace Obermann
John Bennett Partner
Honigman LLP
Linda Friedlieb Division Counsel AbbVie
Leydig, Voit & Mayer, Ltd.
Fosun Pharma USA Inc.
Quinn Emanuel Urquhart & Sullivan LLP
Aaron R. Barkoff Shareholder
District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
John L. Abramic Partner
K&L Gates LLP
Robin Evans
Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
Anna Brook Partner
Anil Patel Partner
Jacqueline Bonilla
United States District Court, District of New Jersey
Gregory A. Morris Partner
Mary J. Morry Counsel, IP Litigation Office of the General Counsel Merck Sharp & Dohme Corp.
United States District Court, District of Delaware
Deputy Commissioner for Patents U.S. Patent and Trademark Office
Hyman, Phelps & McNamara, P.C.
Deputy Chief Administrative Patent Judge,Patent Trial & Appeal Board U.S. Patent and Trademark Office
Chief Patent Counsel, Region North America Fresenius Kabi USA, LLC
Andrea Tiglio Associate General Counsel, IP Legal Senior Director IP Astellas Pharma US
Hon. Joshua Wolson
Allen & Overy LLP
Mary C. Till
Carolyn Blessing Partner
Jeremy Lowe Shareholder
Dan Hoang Senior Counsel – Patent Litigation AbbVie
Upadhye Tang LLP (Former Vice President –Global IP, Apotex, Inc.)
Matt Murphy Partner
Cary Miller Partner Jones Day
Steptoe & Johnson LLP
MEMBERS OF THE JUDICIARY
Kevin E. Noonan Partner
Culhane Meadows PLLC
David Abramowitz Partner
Sidley Austin LLP
Jeffrey R. Gargano Partner
William A. Rakoczy Founding Partner Rakoczy MazzochiMolinoSiwik LLP
Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
LAW FIRMS
Honorable Colm F. Connolly Chief Judge
Hon. Douglas E. Arpert Magistrate Judge
Scott Weidenfeller Partner
Kurt R. Karst Director
K&L Gates LLP
Steven J. Horowitz Partner
McAndrews, Held & Malloy, Ltd.
Rakoczy MazzochiMolinoSiwik LLP
Axinn, Veltrop & Harkrider LLP
IN-HOUSE COUNSEL
Chad A. Landmon Partner
Serena Farquharson-Torres
Locke Lord LLP
Ballard Spahr
Jamie L. Lucia Partner
United States District Court, District of New Jersey
Hon. Christopher J. Burke Magistrate Judge
Lead Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
Covington & Burling LLP
Locke Lord LLP
Axinn, Veltrop & Harkrider LLP
United States District Court, District of Delaware
Senior Legal Advisor Office of Patent Legal Administration U.S. Patent and Trademark Office
Huong Nguyen General Counsel & Compliance Officer
Honorable Stanley R. Chesler District Judge
4 | #ACIPIV #HatchWaxman twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series
Steptoe & Johnson LLP
Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA
Ryan M. Daniel
GOVERNMENT REPRESENTATIVES FROM KEY AGENCIES
Young StargattConaway&Taylor, LLP
Ted Mathias Partner
Speaker List
DISTINGUISHED CO-CHAIRS
Tanzina Chowdhury Senior Corporate Counsel Nostrum Laboratories, Inc.
Caryn Borg-Breen Partner
Andrew Berdon Partner
Dominick A. Conde Partner
Axinn, Veltrop & Harkrider LLP
McDonnell Boehnen Hulbert & Berghoff LLP
Brian Stone Associate General Counsel, Global Legal–Regulatory Viatris
Anita Varma Partner White & Case LLP
Hon. Susan Mitchell
Shashank Upadhye Partner
Venable LLP
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
10:45
• “Buy American” policies and executive orders
John L. Abramic, Partner, Steptoe & Johnson LLP
» Must FDA review the patent to ensure the only information carved out is covered by the patent?
Anna Brook, Partner, Culhane Meadows PLLC
Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC
» On what basis will FDA determine the scope of an appropriate carve-out?
» S.3772 (Defend American Courts Act)
» Recent selected Hatch-Waxman and BPCIA amendments
» Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs
8:00
SCOTUS WATCH: PENDING PATENT PETITIONS
moderator: William A. Rakoczy, Founding Partner, Rakoczy Molino Mazzochi Siwik LLP
Dominick A. Conde, Partner, Venable LLP
Mary C. Till, Senior Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office
Microphone Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC
• Assessing the flurry of follow-on cases in the courts
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims
• Considering the dissent and determining whether the district court erred in applying judicial estoppel
• Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation
• 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
Main Conference Day One
SEPTEMBER 21, 2022
• Appreciating the importance of inventor testimony and the impact of post-filing clinical data
Microphone John Bennett, Partner, Allen & Overy LLP
• Pending bipartisan legislation to watch including:
• Reviewing the approval of generic drug labeling
David Abramowitz, Partner, Locke Lord LLP
• Considering the Biden administration’s views on patent law and eligibility
Gregory A. Morris, Partner, Honigman LLP
• Analyzing whether a skinny label alone is enough to preclude induced infringement allegations
» When can witness admissions strengthen a written description invalidity defense?
• 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
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.
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:
9:15
11:45
» S.2076 (PASTEUR Act) / S.2209 (VALID Act)
• Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages
Microphone Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
» Is the interpretation of the patent claims subject only to a jury’s interpretation?
AND THE FUTURE OF SKINNY LABELS, §101 and §112
» What considerations should patent owners keep in mind when labeling drugs?
• Reviewing the implications of recent decisions for induced infringement
• Devising strategic considerations of label language for inducement infringement
Linda Friedlieb, Division Counsel, AbbVie
Microphone Anita Varma, Partner, White & Case LLP
Opening Remarks
• Analyzing litigation insights that inform patent drafting application strategies
8:15 LIVE AUDIENCE POLLING 60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch-Waxman Reform Measures
Microphone Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US
10:15 Networking Coffee Break
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.
» Patent listing statutes
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco
• Recent federal and state executive actions and legislative initiatives which may impact biopharmaceutical products patents
Skinny Labeling: Forecast on the Future of Carveouts and the Influence of GSK v. Teva on Competition
» S.2891 (Restoring the American Invents Acts)
Microphone Honorable Stanley R. Chesler, District Judge, United States District Court, District of New Jersey
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:
• Analyzing both involuntary and voluntary behaviors that hinder diversity, recruiting, and retention efforts in life sciences IP careers
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups
» Whether there was direction to a natural phenomenon
• Recommending strategies for reducing or eliminating bias
moderator: Jeffrey R. Gargano, Partner, K&L Gates LLP
• Analyzing practical strategies and tactics for effective settlement negotiation
This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.
5:15 VIEW FROM THE FEDERAL BENCH District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings
moderator: Anne Shea Gaza, Partner, Young Conaway Stargatt & Taylor, LLP
4:15 MAGISTRATE TOWN HALL Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings
» Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
• Recognizing when to contest venue
• Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter
Hon. Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
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:
12:45 Networking Luncheon
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.
» Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020)
Hon. Christopher J. Burke, Magistrate Judge, United States District Court, District of Delaware
• Deciding whether a new application of an abstract idea is abstract
• Analyzing if Valeant and Celgene have impacted where Hatch-Waxman suits are being filed
Robin Evans, Deputy Commissioner for Patents, United States Patent and Trademark Office
Microphone Hon. Douglas E. Arpert, Magistrate Judge, United States District Court, District of New Jersey
• Assessing the competing interests keeping 101 reform at bay
6:15
6 | #ACIPIV #HatchWaxman twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series
2:00
3:00 DIVERSITY, EQUITY & INCLUSION Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies
• Determining whether “relevant acts involved in the preparation and submission of an ANDA” limited to submission of the ANDA after Celgene?
• Understanding when to reduce claims and defenses to a manageable level
Conference Adjourns to Day Two Media Partners
» Identifying tests designed to aid in determining where biases exist
Microphone Dan Hoang, Senior Counsel – Patent Litigation, AbbVie Caryn Borg-Breen, Partner, Ballard Spahr
• Outlining the pros and cons of joint defense groups
» 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
Microphone Jamie L. Lucia, Partner, Steptoe & Johnson LLP
• Understanding the economic and other costs of implicit bias, especially in areas of law, science, IP, and innovation
• Reviewing Celgene Corp. v. Mylan Pharmaceuticals, Inc. 17 F.4th 1111 (Fed. Cir. 2021)
Honorable Colm F. Connolly, Chief Judge, United States District Court, District of Delaware
• How to masterfully manage protective order disputes
• Taking stock of the recent 101 cases applying the Supreme Court’s Alice/ Mayo tests before the Federal Circuit
4:00 Afternoon Refreshment Break
8:15
Hon. Susan Mitchell, Lead Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office
The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
• Appealing decisions in both forums
Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation
» Legal Experience and Advancement Program (LEAP)
Cary Miller, Partner, Jones Day
» Fast-Track Appeals
1:00
Andrew Berdon, Partner, Quinn Emanuel Urquhart & Sullivan LLP
» Abuse of dominance
» Understanding investigation and liability risks
• Understanding settlement strategies between brands and generics
» Pricing strategies
Carolyn Blessing, Partner, Locke Lord LLP
• Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence HatchWaxman litigation strategies
• Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective
The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review
Opening Remarks
• Highlighting the state legislation directly addressing “reverse payment” patent settlements
• Reviewing the proper standards of antitrust review and the rising call for a legislative response
» New memorandum regarding indefiniteness approach in AIA proceedings
» Weighing the future of parallel proceedings in view of a single standard adoption
Hon. Judge Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office
• Developing sound discovery strategies relative to dual proceedings
9:15 THE PTAB LIVE!
» Anticompetitive agreements
Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C.
» Life cycle management and contracting
• Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard
» New rule relating to burdens of persuasion in MTAs
Anil Patel, Partner, K&L Gates LLP
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review
• Structuring agreements and identifying antitrust concerns
• Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation
REGULATORY THINK TANK
Microphone Huong Nguyen, General Counsel & Compliance Officer, Fosun Pharma USA Inc.
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
• Outlining the latest developments on pilot programs at PTAB
• Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials
» Special considerations for ex-U.S. parties
» Newly designated precedent at PTAB
» Motions to Amend (MTAs) in AIA proceedings
10:15 Networking Coffee Break
Microphone Scott Weidenfeller, Partner, Covington & Burling LLP
Microphone Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office
• Examining new attacks on 180-day exclusivity per the propose Blocking Act
8:00
• Managing experts and use of experts in both forums
• Evaluating chances of getting a stay granted in the District Court
10:45
» Analyzing the current legislative and regulatory framework
• Interpreting PTAB precedent and other information
» Mergers, acquisitions, and exclusive licenses
12:00 Networking Luncheon
Join Our Email List to Stay Connected SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES AmericanConference.com/join-our-email-list/ Main Conference Day Two SEPTEMBER 22, 2022
• Exploring branded and generic interests in GDUFA and PDUFA renewals
» New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies)
• Reconciling Hatch-Waxman exclusivity with CGT exclusivity
• Assessing status of FDA activity concerning Hatch-Waxman reform
• Detailing recent rules at PTAB
• Establishing jurisdiction at the PTAB
» Presumption of unlawfulness – California AB 824
• Formulating strategies based on type of pharmaceutical patent
Microphone Brian Stone, Associate General Counsel, Global Legal–Regulatory, Viatris
• Reviewing the latest stats at PTAB, highlighting bio/pharma cases
• At-risk Launch considerations
• 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)
Microphone Tanzina Chowdhury, Senior Corporate Counsel, Nostrum Laboratories, Inc.
• Understanding how to maintain candid communication with the USPTO and fulfilling disclosure obligations
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.
3:00 Refreshment Break
• Exploring questions of royalties, lost profits and exceptional findings
• Exploring best practices to avoid inequitable conduct in the pharmaceutical patent litigation arena
Don’t at:
miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us
Cross-Border Business Considerations in a HatchWaxman Scenario: The Global Approach to Pharmaceutical Patent Litigation
hands-helping BECOME A SPONSOR
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:
• Avoiding costly litigation and associated penalties by effectively complying with the law
• Examining grounds for mitigation
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.
Microphone Kevin Zive, Vice President, General Counsel and Head of Global Intellectual Property, Apotex Inc.
8 | #ACIPIV #HatchWaxman twitter: @ACI_Conferences linkedin: ACI’s Hatch-Waxman Series
Dominick A. Conde, Partner, Venable LLP
4:15
• Revisiting damages in an at-risk-launch scenario
6:15
Conference Concludes
With
• Understanding the importance of aligning legal and business functions for global patent litigation planning
3:15
SponsorInfo@AmericanConference.com
Shashank Upadhye, Partner, Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.)
Matt Murphy, Partner, Axinn, Veltrop & Harkrider LLP
Mary J. Morry, Counsel, IP Litigation, Office of the General Counsel, Merck Sharp & Dohme Corp.
• Building and managing a winning global litigation team
OTDP and Patent Terms: Understanding the Interplay Between Obviousness-Type Double Patenting, Pattern Term Extension and Patent Term Adjustment Post-Ex Parte Cellect
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.
5:15 ETHICS
Ethical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility
Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US
Steven J. Horowitz, Partner, Sidley Austin LLP
Microphone Aaron R. Barkoff, Shareholder, McAndrews, Held & Malloy, Ltd.
Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP
2:00 INTERNATIONAL
• Identifying potential safe-harbor concerns related to foreign manufacturers and finishers
• Assessing common international business scenarios encountered by both brand name and generic manufacturers
» Examining cases where the relevant infringing conduct occurred in the United States
Microphone Jeremy Lowe, Shareholder, Leydig, Voit & Mayer, Ltd.
Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
• Managing global pharmaceutical patent litigation
• Exploring matters of international trade and impacting the value of pharmaceutical patents
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
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y Have not had close contact with any person with or suspected of having COVID-19 within the last 10 days.
Planning Ahead for Live Conferences: C5’s All Secure Safety Plan
Enhanced Communication
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.
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Attendance Screening
y Food and beverage options that ensure minimal handling and exposure.
y Have not had a positive COVID-19 test within the last 10 days.
Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html
y A conference room layout with planned seating for appropriate physical distancing.
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.
y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference.
Reduced Touchpoints
Related Events HatchWaxman ACI’s Hatch-WaxmanandBPCIA 2nd Annual Passport to Proficiency on the Essentials of October 2022 Virtual Conference FDA BOOT CAMP AMERICAN CONFERENCE INSTITUTE’S 39th September 14–15, 2022 (EST) Virtual Conference Life Sciences IP Due Diligence November 15–16, 2022 Boston, MA LIFE SCIENCES IP SUMMIT 20 Anniversary th 17–18 October 2022 Munich
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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.
y Have not experienced any COVID-19 symptoms now or within the last 10 days.
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.
All attendees will need to assert that at the time that they first attend the conference and for the 10 days prior:
y Distribution of local health-resource information in advance of the event.
Safety and Physical Distancing
© American Conference Institute, 2022 Looking to Register? Contact our Customer Service Representatives: Dan Manganiello American Conference Institute 1D.Manganiello@AmericanConference.com2123523220x5464 Use Registration Code: B00-999-DMO23 Mark Parrish American Conference Institute 1M.Parrish@AmericanConference.com2123523220x7207 Use Registration Code: B00-999-MPH23 Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. CONFERENCE CODE: 815L23-CHI PRICING Register & Pay by July 15, 2022 Register & Pay by August 19, 2022 Register & Pay after August 19, 2022 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. Conference Only Conference Only In-House Rate $2195 $1795$2295 $1895$2395$1595 Bringing a Team?* 3–4 10% Conference Discount 5–6 15% Conference Discount 7 20% Conference Discount 8+ Call 888-224-2480 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 Questionsrequest. about CLE credits for your state? Visit our online CLE Help Center at www. americanconference.com/accreditation/cle/ 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. WORRY FREE Registration GUARANTEE EARN CREDITSEthics/DiversityCLE/ VENUE INFO Hotel: Hyatt Regency McCormick Place Address: 2233 S Martin L King Drive. Chicago, IL 60615 About us: The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence Forcompany.over35 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.
