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8th Annual Paragraph IV Master
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Region North America Fresenius Kabi USA, LLC
EARN Ethics/DiversityCLE/CREDITS LOGO 2022 Co-Chairs HatchWaxman SERIES ACI’s
Master skills necessary to challenges of pharmaceutical patent endgame
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FRIEDLIEBLINDA Counsel DANIELM. Counsel,
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Paragraph Disputes
MASTER SYMPOSIUM 8th Annual September 21–22, 2022 Hyatt Regency McCormick Place, Chicago, IL
“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.”
Chief Patent
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“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.”
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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIESAmericanConference.com/PIVDisputesChicago • 888 224 2480 Supporting Sponsors ExhibitorPremium Sponsored by SponsorLuncheon Associate Sponsors
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AbbVieRYAN
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.
Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA, LLC
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.
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.
Sincerely,
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.
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.
We look forward to seeing you and your contemporaries for another successful conference!
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Linda Friedlieb Division Counsel AbbVie
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.
EMERITUS MEMBERS
Staci Julie
Lars Taavola
Andrea Hutchison
SERIES ACI’s
Fresenius Kabi USA, LLC
Head, US Patent Litigation Novartis CorporationPharmaceuticals
David H. Silverstein, M.S., J.D.
George W. Johnston Counsel
Margaret M. Snowden, P.C. (Former Vice President, Intellectual Property, Impax Laboratories)
Former Senior Vice President, Intellectual Property Endo Pharmaceuticals
Merck & Company
Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
Axinn, Veltrop & Harkrider LLP
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.
VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals
Senior Vice President, Intellectual Property Astellas Pharma US, Inc.
Shashank Upadhye Partner
Guy Donatiello
Principal Counsel – Global Patent Litigation, Global IP Department Legal, Ethics & Business Integrity Sanofi-Aventis
Taft Stettinius & Hollister LLP (Former Vice President, IP, Sandoz, Inc.)
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
James P. Leeds
Josephine Liu, Ph.D., J.D.
Ryan M. Daniel
HatchWaxman
Partner, Chair of Pharmaceutical & Life Sciences Litigation
Stephanie Donahue
Mary Morry Counsel
SerenaFarquharson-Torres
Senior Vice President and Head Intellectual Property Eagle Pharmaceuticals, Inc
Assistant General Patent Counsel Eli Lilly & Company
Peter Waibel
Kevin Zive
Vice President, General Counsel, and Head of Global Intellectual Property Apotex Inc.
Vice President of IP, North America (ad interim) Sandoz Inc.
Pearl T. L. Siew
Partner
SVP and Chief IP Counsel Teva Pharmaceuticals
Gibbons P.C.
Jeffrey N. Myers, Ph.D.
Associate General Counsel, Global Legal-Regulatory Mylan
Stephen R. Auten
(Former Senior Director, Intellectual Property, Par Pharmaceutical, Inc)
(Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)
Vice President & Assistant General Counsel Pfizer Inc
Meg Snowden
Upadhye Cwik LLP
Linda Friedlieb Division Counsel AbbVie
ACI’s Hatch-Waxman Series Advisory Board
Brian Stone
Senior Associate General Counsel, IP Litigation Gilead Sciences
James Kellerman
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Shareholder
Chief Patent Counsel
Fosun Pharma USA Inc.
Ted Mathias Partner
Shashank Upadhye Partner
Ballard Spahr
Caryn Borg-Breen Partner
Jeremy Lowe Shareholder
Cary Miller Partner Jones Day
K&L Gates LLP
Serena Farquharson-Torres
Dan Hoang Senior Counsel – Patent Litigation AbbVie
Culhane Meadows PLLC
United States District Court, District of Delaware
K&L Gates LLP
Honorable Stanley R. Chesler District Judge
Hon. Susan Mitchell
Honigman LLP
District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
Deputy Commissioner for Patents U.S. Patent and Trademark Office
Carolyn Blessing Partner
Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
Allen & Overy LLP
Quinn Emanuel Urquhart & Sullivan LLP
Kurt R. Karst Director
Deputy Chief Administrative Patent Judge,Patent Trial & Appeal Board U.S. Patent and Trademark Office
William A. Rakoczy Founding Partner Rakoczy MazzochiMolinoSiwik LLP
Linda Friedlieb Division Counsel AbbVie
Honorable Colm F. Connolly Chief Judge
GOVERNMENT REPRESENTATIVES FROM KEY AGENCIES
Brian Stone Associate General Counsel, Global Legal–Regulatory Viatris
John L. Abramic Partner
Andrew Berdon Partner
Young StargattConaway&Taylor, LLP
IN-HOUSE COUNSEL
Aaron R. Barkoff Shareholder
Huong Nguyen General Counsel & Compliance Officer
Steptoe & Johnson LLP
Anne Shea Gaza Partner
Sidley Austin LLP
Dominick A. Conde Partner
Axinn, Veltrop & Harkrider LLP
DISTINGUISHED CO-CHAIRS
Leydig, Voit & Mayer, Ltd.
Matt Murphy Partner
MEMBERS OF THE JUDICIARY
McDonnell Boehnen Hulbert & Berghoff LLP
Linda Friedlieb Division Counsel AbbVie
United States District Court, District of New Jersey
Robin Evans
Scott Weidenfeller Partner
Mary J. Morry Counsel, IP Litigation Office of the General Counsel Merck Sharp & Dohme Corp.
Jamie L. Lucia Partner
Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
David Abramowitz Partner
Hon. Joshua Wolson
Jeffrey R. Gargano Partner
Hon. Grace Obermann
Axinn, Veltrop & Harkrider LLP
Axinn, Veltrop & Harkrider LLP
Chief Patent Counsel, Region North America Fresenius Kabi USA, LLC
Chad A. Landmon Partner
Hon. Christopher J. Burke Magistrate Judge
Jacqueline Bonilla
Ryan M. Daniel Chief Patent Counsel Region North America Fresenius Kabi USA
Lead Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
Gregory A. Morris Partner
Covington & Burling LLP
Anil Patel Partner
Upadhye Tang LLP (Former Vice President –Global IP, Apotex, Inc.)
John Bennett Partner
Andrea Tiglio Associate General Counsel, IP Legal Senior Director IP Astellas Pharma US
Hon. Douglas E. Arpert Magistrate Judge
Venable LLP
Speaker List
Steptoe & Johnson LLP
Anita Varma Partner White & Case LLP
United States District Court, District of New Jersey
Steven J. Horowitz Partner
Mary C. Till
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Locke Lord LLP
LAW FIRMS
Senior Legal Advisor Office of Patent Legal Administration U.S. Patent and Trademark Office
Locke Lord LLP
Anna Brook Partner
Kevin E. Noonan Partner
Eric R. Hunt Partner
Ryan M. Daniel
McAndrews, Held & Malloy, Ltd.
Hyman, Phelps & McNamara, P.C.
United States District Court, District of Delaware
Rakoczy MazzochiMolinoSiwik LLP
Tanzina Chowdhury Senior Corporate Counsel Nostrum Laboratories, Inc.
Main Conference Day One
• Considering the Biden administration’s views on patent law and eligibility
Microphone John Bennett, Partner, Allen & Overy LLP
Gregory A. Morris, Partner, Honigman LLP
8:15 LIVE AUDIENCE POLLING 60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch-Waxman Reform Measures
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims
• Recent federal and state executive actions and legislative initiatives which may impact biopharmaceutical products patents
» Understanding the significance of the Court’s invitation to the Solicitor General to file a brief in this case
10:15 Networking Coffee Break
Linda Friedlieb, Division Counsel, AbbVie
• Considering the dissent and determining whether the district court erred in applying judicial estoppel
9:15
• Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages
Dominick A. Conde, Partner, Venable LLP
Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC
• Assessing the flurry of follow-on cases in the courts
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.
• Appreciating the importance of inventor testimony and the impact of post-filing clinical data
SEPTEMBER 21, 2022
8:00
moderator: William A. Rakoczy, Founding Partner, Rakoczy Molino Mazzochi Siwik 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.
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco
AND THE FUTURE OF SKINNY LABELS, §101 and §112
10:45
Microphone Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US
• Reviewing the approval of generic drug labeling
Mary C. Till, Senior Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office
Opening Remarks
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:
Skinny Labeling: Forecast on the Future of Carveouts and the Influence of GSK v. Teva on Competition
» S.2891 (Restoring the American Invents Acts)
• Analyzing litigation insights that inform patent drafting application strategies
• Reviewing the implications of recent decisions for induced infringement
» Is the interpretation of the patent claims subject only to a jury’s interpretation?
• Analyzing the unique 101 questions posed by American Axel and assessing its chance of have cert. granted
David Abramowitz, Partner, Locke Lord LLP
• Pending bipartisan legislation to watch including:
Anna Brook, Partner, Culhane Meadows PLLC
AmericanConference.com/PIVDisputesChicago • 888 224 2480 Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
• Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation
» S.3772 (Defend American Courts Act)
» Must FDA review the patent to ensure the only information carved out is covered by the patent?
John L. Abramic, Partner, Steptoe & Johnson LLP
» Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs
» What considerations should patent owners keep in mind when labeling drugs?
» Patent listing statutes
11:45
SCOTUS WATCH: PENDING PATENT PETITIONS
» S.2076 (PASTEUR Act) / S.2209 (VALID Act)
• Devising strategic considerations of label language for inducement infringement
Microphone Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Microphone Anita Varma, Partner, White & Case LLP
• 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
• “Buy American” policies and executive orders
» On what basis will FDA determine the scope of an appropriate carve-out?
» When can witness admissions strengthen a written description invalidity defense?
Microphone Ryan M. Daniel, Chief Patent Counsel, Region North America, Fresenius Kabi USA, LLC
• Analyzing whether a skinny label alone is enough to preclude induced infringement allegations
» Recent selected Hatch-Waxman and BPCIA amendments
• Reviewing Celgene Corp. v. Mylan Pharmaceuticals, Inc. 17 F.4th 1111 (Fed. Cir. 2021)
» Identifying tests designed to aid in determining where biases exist
» Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
Robin Evans, Deputy Commissioner for Patents, United States Patent and Trademark Office
5:15 VIEW FROM THE FEDERAL BENCH District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings
Microphone Hon. Douglas E. Arpert, Magistrate Judge, United States District Court, District of New Jersey
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:
2:00
• Understanding when to reduce claims and defenses to a manageable level
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 when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter
• Recognizing when to contest venue
4:00 Afternoon Refreshment Break
moderator: Jeffrey R. Gargano, Partner, K&L Gates LLP
Hon. Joshua Wolson, District Judge, United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
• Analyzing practical strategies and tactics for effective settlement negotiation
6:15
» Whether there was direction to a natural phenomenon
» Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020)
3:00 DIVERSITY, EQUITY & INCLUSION Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies
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.
• Recommending strategies for reducing or eliminating bias
Microphone Dan Hoang, Senior Counsel – Patent Litigation, AbbVie Caryn Borg-Breen, Partner, Ballard Spahr
• Understanding the economic and other costs of implicit bias, especially in areas of law, science, IP, and innovation
• Deciding whether a new application of an abstract idea is abstract
• Outlining the pros and cons of joint defense groups
• Determining whether “relevant acts involved in the preparation and submission of an ANDA” limited to submission of the ANDA after Celgene?
Honorable Colm F. Connolly, Chief Judge, United States District Court, District of Delaware
• Taking stock of the recent 101 cases applying the Supreme Court’s Alice/ Mayo tests before the Federal Circuit
4:15 MAGISTRATE TOWN HALL Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings
Microphone Jamie L. Lucia, Partner, Steptoe & Johnson LLP
• Analyzing if Valeant and Celgene have impacted where Hatch-Waxman suits are being filed
» 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
12:45 Networking Luncheon
• Assessing the competing interests keeping 101 reform at bay
Hon. Christopher J. Burke, Magistrate Judge, United States District Court, District of Delaware
This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.
Microphone Honorable Stanley R. Chesler, District Judge, United States District Court, District of New Jersey
moderator: Anne Shea Gaza, Partner, Young Conaway Stargatt & Taylor, LLP
Conference Adjourns to Day Two Media Partners
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VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups
• How to masterfully manage protective order disputes
• Analyzing both involuntary and voluntary behaviors that hinder diversity, recruiting, and retention efforts in life sciences IP careers
• Managing experts and use of experts in both forums
• Highlighting the state legislation directly addressing “reverse payment” patent settlements
» Anticompetitive agreements
12:00 Networking Luncheon
» New rule relating to burdens of persuasion in MTAs
8:15
REGULATORY THINK TANK
10:15 Networking Coffee Break
• Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective
• Assessing status of FDA activity concerning Hatch-Waxman reform
Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C.
• Reconciling Hatch-Waxman exclusivity with CGT exclusivity
• Structuring agreements and identifying antitrust concerns
• Appealing decisions in both forums
Microphone Huong Nguyen, General Counsel & Compliance Officer, Fosun Pharma USA Inc.
• Interpreting PTAB precedent and other information
8:00
» New memorandum regarding indefiniteness approach in AIA proceedings
• Examining new attacks on 180-day exclusivity per the propose Blocking Act
• Outlining the latest developments on pilot programs at PTAB
• Exploring branded and generic interests in GDUFA and PDUFA renewals
» Newly designated precedent 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
» Motions to Amend (MTAs) in AIA proceedings
Cary Miller, Partner, Jones Day
» Analyzing the current legislative and regulatory framework
Hon. Judge Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office
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Opening Remarks
» Legal Experience and Advancement Program (LEAP)
• Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation
1:00
• Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard
Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation
Microphone Brian Stone, Associate General Counsel, Global Legal–Regulatory, Viatris
• Detailing recent rules at PTAB
» Mergers, acquisitions, and exclusive licenses
» Presumption of unlawfulness – California AB 824
Microphone Scott Weidenfeller, Partner, Covington & Burling LLP
» Weighing the future of parallel proceedings in view of a single standard adoption
9:15 THE PTAB LIVE!
• Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence HatchWaxman litigation strategies
The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review
• Understanding settlement strategies between brands and generics
» Abuse of dominance
Anil Patel, Partner, K&L Gates LLP
• Evaluating chances of getting a stay granted in the District Court
• Establishing jurisdiction at the PTAB
» Life cycle management and contracting
» Understanding investigation and liability risks
• Formulating strategies based on type of pharmaceutical patent
• Reviewing the proper standards of antitrust review and the rising call for a legislative response
Carolyn Blessing, Partner, Locke Lord LLP
• Reviewing the latest stats at PTAB, highlighting bio/pharma cases
10:45
» Fast-Track Appeals
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review
Hon. Susan Mitchell, Lead Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office
• Developing sound discovery strategies relative to dual proceedings
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
» Pricing strategies
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Andrew Berdon, Partner, Quinn Emanuel Urquhart & Sullivan LLP
» New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies)
• Considering the practical consequences of the Supreme Court’s WesternGeco decision on Hatch-Waxman damages awards
Microphone Tanzina Chowdhury, Senior Corporate Counsel, Nostrum Laboratories, Inc.
hands-helping BECOME A SPONSOR
• Understanding the importance of aligning legal and business functions for global patent litigation planning
Dominick A. Conde, Partner, Venable LLP
OTDP and Patent Terms: Understanding the Interplay Between Obviousness-Type Double Patenting, Pattern Term Extension and Patent Term Adjustment Post-Ex Parte Cellect
4:15
» Exploring when U.S. patent owners may recover foreign lost profits tied to domestic acts of infringement under § 271(f)(2)
• Exploring best practices to avoid inequitable conduct in the pharmaceutical patent litigation arena
Microphone Aaron R. Barkoff, Shareholder, McAndrews, Held & Malloy, Ltd.
Mary J. Morry, Counsel, IP Litigation, Office of the General Counsel, Merck Sharp & Dohme Corp.
• Examining grounds for mitigation
Shashank Upadhye, Partner, Upadhye Tang LLP (Former Vice President – Global IP, Apotex, Inc.)
• Building and managing a winning global litigation team
3:00 Refreshment Break
• Revisiting damages in an at-risk-launch scenario
» Examining cases where the relevant infringing conduct occurred in the United States
With
• Assessing common international business scenarios encountered by both brand name and generic manufacturers
SponsorInfo@AmericanConference.com
Cross-Border Business Considerations in a HatchWaxman Scenario: The Global Approach to Pharmaceutical Patent Litigation
• Exploring questions of royalties, lost profits and exceptional findings
5:15 ETHICS
2:00 INTERNATIONAL
Ethical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility
• Managing global pharmaceutical patent litigation
Steven J. Horowitz, Partner, Sidley Austin LLP
3:15
Conference Concludes
Microphone Jeremy Lowe, Shareholder, Leydig, Voit & Mayer, Ltd.
Kevin E. Noonan, Partner, McDonnell Boehnen Hulbert & Berghoff LLP
• Avoiding costly litigation and associated penalties by effectively complying with the law
• Understanding how to maintain candid communication with the USPTO and fulfilling disclosure obligations
Microphone Kevin Zive, Vice President, General Counsel and Head of Global Intellectual Property, 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.
• At-risk Launch considerations
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:
• Identifying potential safe-harbor concerns related to foreign manufacturers and finishers
Andrea Tiglio, Associate General Counsel, IP Legal Senior Director IP, Astellas Pharma US
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.
Matt Murphy, Partner, Axinn, Veltrop & Harkrider LLP
6:15
• Exploring matters of international trade and impacting the value of pharmaceutical patents
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Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
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