Paragraph IV Disputes

April 26 – 27, 2021 (Eastern Daylight Time)

Agenda (Eastern Daylight Time)

Day 1 - Tuesday, October 6, 2020

8:00	Co-Chairs’ Opening Remarks
8:15	Paragraph IV State of the Union: Developing a New Game Plan for the New Normal: Assessing Legal, Regulatory, and Jurisprudential Developments in the Era of COVID-19
9:00	The Continuing §101 Saga: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies
10:00	Extended Morning Break
10:25	And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge
11:10	The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies
12:25	Lunch Break
1:10	Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry
2:10	Afternoon Break
2:25	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Understanding and Harnessing the Nuances of Local Rules
4:15	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Effectively Managing Global Pharmaceutical Patent Litigation TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Evaluating the Effectiveness of Summary Judgment in Different Venues
4:20	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Practical Strategies and Tactics for Effective Settlement Negotiation TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Appreciating the Magistrate’s Role in Settlement Discussions
5:00	PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers
6:00	End of Day One – Conference Adjourns

Day 2 - Wednesday, October 7, 2020

8:00	Co-Chairs’ Opening Remarks
8:15	Fireside Chat with The Hon. Stanley R. Chesler
9:15	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios TRACK D: Devising Strategies for Proving Infringement and Defending Validity Devising Novel Strategies for Proving Infringement and Defending Validity
10:35	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely
11:25	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation
11:55	FTC KEYNOTE: Antitrust Developments Impacting Brands and Generics
1:00	Lunch Break
1:30	FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities
2:30	Extended Afternoon Break
3:00	New Studies in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations
3:45	ETHICS DRILLS: Ethics and New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
4:45	Conference Concludes

Day 1 - Tuesday, October 6, 2020

8:00	Co-Chairs’ Opening Remarks Stephanie Donahue Principal Counsel, Patent Litigation Sanofi- Aventis Pearl T. L. Siew Senior Vice President and Head, Intellectual Property Eagle Pharmaceuticals, Inc.
8:15	Paragraph IV State of the Union: Developing a New Game Plan for the New Normal: Assessing Legal, Regulatory, and Jurisprudential Developments in the Era of COVID-19 Colman Ragan Vice President & General Counsel, North America IP Teva Pharmaceuticals Ryan Hagglund Senior Counsel Loeb & Loeb LLP Evan Diamond Partner King & Spalding LLP Assessing Paragraph IV filing trends and district court decisions impacting the business and practice of ANDA litigation Understanding the effect of the global pandemic on the business and practice of Hatch-Waxman litigation Understanding the potential long-term impact the coronavirus could have on supply chain disruption Evaluating the impact of the conservation of resources on future investment in research and development Reconciling court docket delays and Hatch-Waxman Act 30-month stays Assessing the threat of compulsory licensing and march-in rights Examining how recent Paragraph IV filings and litigation results have influenced business judgments including mergers and acquisitions, research and development initiatives, and licensing decisions Analyzing the nexus between PIV legislative proposals and the evolving drug pricing debate Assessing the current state of proposed Hatch-Waxman reform measures
9:00	The Continuing §101 Saga: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies Maureen Bresnahan Assistant General Counsel, Legal Department Eisai, Inc. Jeffrey R. Gargano Partner Morgan, Lewis & Bockius LLP Jeanna M. Wacker Partner Kirkland & Ellis LLP Exploring the latest 101 jurisprudence relative to Hatch-Waxman Understanding how the Supreme Court’s denial of cert. in Vanda has impacted Hatch-Waxman and Paragraph IV Examining Federal Circuit’s ruling in Vanda relative to secondary patents Mallinckrodt v. Praxair (Fed. Cir. 2019) Analyzing the PTO’s Revised Patent Subject Matter Eligibility Guidance and how it applies to Hatch-Waxman patents Assessing faults in claim construction relative to a 101 denial How does a claim need to be written in order to satisfy 101? Evaluating proof and proffers which can uphold or defeat 101 assertions Predicting R&D trends in pharmaceuticals relative to the 101 conundrum
10:00	Extended Morning Break
10:25	And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge Honorable Leonard P. Stark Chief Judge District of Delaware Honorable Mary Pat Thynge Chief Magistrate Judge District of Delaware Interviewed by: Pilar G. Kraman Partner Young Conaway Stargatt & Taylor, LLP
11:10	The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on ANDA Litigation Strategies Mary Morry Counsel Merck & Company Steven Maslowski Partner Akin Gump Strauss Hauer & Feld LLP Adam Perlman Partner Latham & Watkins LLP Susan Krumplitsch Partner DLA Piper LLP Examining the significance of recent series of ANDA cases before the Federal Circuit finding infringement through the Doctrine of Equivalents Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019) Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020) Analyzing the role of the DOE’s sister doctrine, prosecution history estoppel relative to this line of cases Tangential relationship test Exploring how this new line of DOE and PHE cases will influence findings of infringement in future ANDA cases Anticipating whether the Supreme Court will grant cert.
12:25	Lunch Break
1:10	Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry Karen E. Brown Senior Vice President, Intellectual Property and Legal Affairs Obsidian Therapeutics, Inc. Huong Nguyen General Counsel Fosun Pharma USA Inc. Gerald Flattmann Partner King & Spalding John Bennett Partner Goodwin Procter LLP Understanding how the Federal Circuit’s decision in Biogen Int’l GmbH v. Banner Life Scis. LLC (Fe. Cir. 2020) may influence the future application of patent term extension Exploring the Federal Circuit’s as well as the District of Delaware’s reasoning as the scope and limitation of PTE rights as being specific to “the active ingredient of… a new drug… including any salt or ester of the active ingredient.” Examining the Biogen decision as part of developing PTE jurisprudence Assessing how this case may impact the Hatch-Waxman realm
2:10	Afternoon Break
2:25	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Understanding and Harnessing the Nuances of Local Rules Track A Staci Julie SVP and Chief IP Counsel Teva Pharmaceuticals John J. Molenda Partner Steptoe & Johnson LLP Track A Moderator Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals Track B David B. Abramowitz Partner Locke Lord LLP Honorable Tonianne J. Bongiovanni Magistrate Judge District of New Jersey Track B Moderator Shashank Upadhye Partner Upadhye Cwik LLP A Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget Implementing practices to minimize surprises and increase predictability Forecasting the budget by phase and quarter Knowing when to reevaluate use of task codes Deciding what components go into the budget Vendors Experts Appeals Costs vs. fees Understanding the source of error when surprises and overages occur Evaluating the appropriateness of alternative fee arrangements Considering license deals as a means to save litigation spend and remain within budget B Understanding and Harnessing the Nuances of Local Rules Evaluating the “go to” jurisdictions for patent litigation by comparing adopted local patents rules meant to expedite and streamline patent litigation Comparing jurisdictions that have specified processes for limiting contention amendments and claim construction hearings Understandings the considerations to make when deciding on the best venue for your case Identifying which jurisdictions require the alleged infringer to produce contentions, document and claims charts first
4:15	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Effectively Managing Global Pharmaceutical Patent Litigation TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Evaluating the Effectiveness of Summary Judgment in Different Venues Track A Takanori Abe Founder Abe & Partners Henry Gu Vice President, Chief IP Counsel Akebia Therapeutics Thomas L. Irving Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Track A Moderator Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals Track B Bill Ward Partner Boies Schiller Flexner Honorable Roy Payne Magistrate Judge Eastern District of Texas Track B Moderator Shashank Upadhye Partner Upadhye Cwik LLP A Effectively Managing Global Pharmaceutical Patent Litigation Understanding the importance of aligning legal and business functions Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers Building a winning global litigation team Selecting the right foreign counsel Coordinating multi-jurisdictional proceedings Assessing the impact and dangers of applicable international treaties on the PIV landscape B Evaluating the Effectiveness of Summary Judgment in Different Venues Reviewing novel strategies for utilizing venue in Hatch-Waxman litigation Appreciating the increased importance of venue in view of the varying practice considerations for different jurisdictions Analyzing which courts have added additional hurdles for litigants to file for summary judgment Highlighting summary judgment practice in Delaware and New Jersey Key takeaways and strategic concerns under §101 Assessing venue implications and success rates of dispositive motions
4:20	BREAKOUT SESSIONS (CHOOSE A OR B) TRACK A: The Solution Room with ACI’s Hatch-Waxman Series Advisory Board Members Practical Strategies and Tactics for Effective Settlement Negotiation TRACK B: Litigation War Room: The Practice of Paragraph IV with the Magistrate Judges Appreciating the Magistrate’s Role in Settlement Discussions Track A Neal Dahiya Assistant General Counsel – Patents Bristol-Myers Squibb Lars Taavola VP, Chief Intellectual Property Counsel Mallinckrodt Pharmaceuticals Track A Moderator Guy Donatiello Senior Vice President, Intellectual Property Endo Pharmaceuticals Track B Alan B. Clement Partner Locke Lord LLP Honorable Christopher J. Burke Magistrate Judge District of Delaware Track B Moderator Shashank Upadhye Partner Upadhye Cwik LLP A Practical Strategies and Tactics for Effective Settlement Negotiation Developing timelines for business and legal milestones relative to the terms of the settlement Understanding the application of antitrust law’s “rule of reason” on pharmaceutical patent settlement practice Examining recent decisions concerning pharmaceutical patent settlements in the PIV context Analyzing practical strategies and tactics for effective settlement negotiation B Appreciating the Magistrate’s Role in Settlement Discussions Investigating recent judicial efforts to promote settlements Understanding the limits of judicial settlement authority Evaluating the dissemination of settlement-oriented innovations Adjusting to the magistrate’s role in the settlement process Viewing the magistrate’s role in promoting settlement as a tool to manage your own dispute and avoid the uncertainties and limitations of fully litigates cases
5:00	PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers Honorable Jacqueline Wright Bonilla Vice Chief, Administrative Patent Judge Honorable Michelle N. Ankenbrand Lead Administrative Patent Judge Honorable Kristi Rupert Sawert Administrative Patent Judge Moderator: Gregory A. Morris Partner Honigman LLP Surveying the types and numbers of life sciences patent cases brought before the PTAB in the last year Comparing and contrasting the number of small vs. large molecule cases in IPRs and PGRs Understanding the significance of the Federal Circuit’s denial of rehearing in Arthrex Inc. v. Smith & Nephew (Fed. Cir. 2020) and what it means for the future of IPRs as well as the PTAB under the Appointments clause Anticipating Supreme Court and/or Congressional review Examining the nexus between injury and standing to appeal an IPR Argentum v. Novartis (Fed. Cir. 2020) Analyzing how the Supreme Court in Thryv, Inc. v. Click-to-Call Technologies, LP, et al. (Supreme Court 2020) essentially expanded the powers of the PTAB through its ruling that the time bar cannot be appealed
6:00	End of Day One – Conference Adjourns

Day 2 - Wednesday, October 7, 2020

8:00	Co-Chairs’ Opening Remarks Stephanie Donahue Principal Counsel, Patent Litigation Sanofi- Aventis Pearl T. L. Siew Senior Vice President and Head, Intellectual Property Eagle Pharmaceuticals, Inc.
8:15	Fireside Chat with The Hon. Stanley R. Chesler Honorable Stanley R. Chesler District Judge District of New Jersey Interviewed by: Bruce M. Wexler Partner and Global Co-Chair of IP Paul Hastings LLP
9:15	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios TRACK D: Devising Strategies for Proving Infringement and Defending Validity Devising Novel Strategies for Proving Infringement and Defending Validity Track C Kevin Zive Vice President – Global Intellectual Property and Legal Affairs Apotex Inc. Deepro R. Mukerjee Partner & Member, Board of Directors; National Co- Chair, Patent Litigation Katten Muchin Rosenman LLP Track D Noah M. Leibowitz Partner Dechert LLP Sanjay K. Murthy Partner Morgan, Lewis & Bockius LLP Track C Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios Appreciating the importance of global portfolio planning Developing techniques for an accurate assessment of the current value of your portfolio Analyzing trends within your portfolio Evaluating the strength of your patents in your current portfolio and how to monetize them Recognizing potential portfolio targets and vulnerabilities Identifying “good” targets and how they “complete” portfolio development Utilizing business functions to advance product portfolio planning Identifying team members from operations, business development and life cycle management Making adequate preparations for negotiations as well as litigation Track D Devising Strategies for Proving Infringement and Defending Validity Understanding that the battle for validity/invalidity and infringement/non-infringement begins during the prosecution history Devising tactics for drafting a high-quality patent that can be enforced and withstand close scrutiny Examining patent challenges and defenses in ANDA proceedings under new 112 jurisprudence Nalpropion Pharmaceuticals, Inc. v. Actavis Labs. FL, Inc., (Fed Cir. 2019) Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc., (Fed. Cir. 2019) Developing strategies to follow when the validity opinion is written by in-house counsel, a patent agent or an engineer Identifying circumstances constituting willful infringement and thus, treble damages Proving that the product or process infringes your patent Ensuring acts of infringement are easily detected Identifying patent vulnerabilities giving rise to claims of invalidity or non-infringement, thus forming the basis of a Paragraph IV Certification
10:35	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely Track C Stephanie Donahue Principal Counsel, Patent Litigation Sanofi- Aventis David Silverstein Partner Axinn, Veltrop & Harkrider LLP Andrew J. Allen Senior Director, Legal Counsel – IP Dr. Reddy’s Track D Chad Landmon Partner Axinn, Veltrop & Harkrider, LLP Stephen S. Rabinowitz Partner Dechert LLP C How the IP Team Can Present a Unified Front: Mastering Intradepartmental Communication Communicating a cohesive story with consistency across all IP stakeholder groups and levels of engagement Devising a central message digestible by C-level leadership, corporate communications, finance, legal/compliance, manufacturing, operations, etc. Establishing the desired level of commitment amongst teams based on availability and responsiveness Succinctly focusing on shared, pragmatic business goals D Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely Drafting well-constructed claims with diverse scope Ensuring that all counts are plead with specificity Avoiding Rule 11 sanctions Devising strategies for situations with multiple ANDA filers Understanding when to reduce claims and defenses to a manageable level Analyzing how to masterfully manage protective order disputes Choosing your defenses with prudence Understanding the advantages of not pleading every defense Knowing which patents to ask to delist Assessing allegations of improper Orange Book listing
11:25	BREAKOUT SESSIONS (CHOOSE C OR D) TRACK C: In-House Perspectives on The Future of IP Teams and Working with Outside Counsel Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team TRACK D: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation Track C Rekha Hanu, Ph.D, J.D Executive Director, Chief IP Counsel Akorn Pharmaceuticals Jonathan S. Caplan Partner, Co-Chair, Intellectual Property Kramer Levin Naftalis & Frankel LLP Honorable Teresa Rea Partner Crowell & Moring LLP Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office Track D Vishal Gupta Partner Steptoe & Johnson LLP Melanie R. Rupert Partner and Co-Chair, Talent Development Paul Hastings LLP Alyson Wooten Director Berkeley Research Group LLC C Diversity and Inclusion, Incorporation and Implementation: A Guide for Creating a Successful IP Team Understanding what specific evidence of diversity pharmaceutical companies, and IP departments in particular, are seeking from their law firm counterparts Implementing policies and practices that will effect change and promote a diverse workplace Identifying best practices for evaluating your outside firm’s efforts in promoting diversity Reviewing firm statistics on women, minorities, sexual orientation, etc. Sharing data-driven strategies to address current diversity challenges in STEM D Selecting and Effectively Using Expert Witnesses in Pharmaceutical Patent Litigation Finding, vetting, retaining, and disclosing expert witnesses in PTAB and District Court proceedings Understanding the limitations and exclusion of testimony as evidenced by cases where judges enter Daubert orders
11:55	FTC KEYNOTE: Antitrust Developments Impacting Brands and Generics Markus H. Meier Assistant Director, Health Care Division, Bureau of Competition U.S. Federal Trade Commission
1:00	Lunch Break
1:30	FDA THINK TANK: Update on Select Drug Competition Action Plan (DCAP) Activities Brian Stone Vice President Assistant Global General Counsel Regulatory Mylan Kurt Karst Director Hyman, Phelps & McNamara PC Grail Sipes Deputy Center Director for Regulatory Policy, CDER Maryll Toufanian Director, Office of Generic Drug Policy, CDER U.S. Food & Drug Administration Identifying brand and generic perspectives on the latest FDA initiatives impacting pharmaceutical patents Reviewing emerging projects influencing drug access and litigation trends Understanding the efforts to improve transparency and predictability for generic drug applicants Understanding the Drug Competition Action Plan Learning how the efforts aim to increase access to lower cost generic drugs Evaluating Competitive Generic Therapy (CGT) Establishing what may be designated as CGT Reviewing designation eligibility, mechanics, exclusivity Interpreting the interplay between Hatch-Waxman and CGT Analyzing the Off-Patent and Off-Exclusivity List Overview of the intentions of the list, what is included and how often it is updated Assessing the PIV Patent Certifications List Analyzing the June 2019 revised PIV Patent Certifications List
2:30	Extended Afternoon Break
3:00	New Studies in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations Matthew Pearson Partner Akin Gump Strauss Hauer & Feld LLP Donna Meuth Associate General Counsel, IP Eisai Kathleen B. Carr Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Is it so Obvious to be Inherent? New Developments in the Inherency Defense and its Implications for ANDA Litigation Assessing whether inherency exists in obviousness Evaluating offensive and defensive strategies Determining whether inherency demonstrates obviousness Understanding the importance of Hospira v. Fresenius (Fed. Cir. 2020) relative to future findings of obviousness in inherency Under this decision when can the inherency defense be raised Determining the necessity of prior art disclosures Structural Obviousness Implications for Secondary Patents Understanding the significance of findings of structural obviousness and lead compound analysis obviousness as illustrated in: Valeant Pharmaceuticals Int’l, Inc. v. Mylan Pharmaceuticals Inc., No. 2018-2097 (Fed. Cir. April 8, 2020) Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019) Assessing the impact of these cases on formulation and method patents in the Hatch-Waxman arena Obviousness-Type Double Patenting Review Analyzing the latest Federal Circuit and District Court trends related to OTDP Examining District Court decisions and subsequent Federal Circuit activity on OTDP as it applies to PTA Evaluating circumstances in which a terminal disclaimer must be made New Considerations in Secondary Considerations Understanding the implications of Fox Factory, Inc. v. SRAM, LLC (Fed. Cir. 2019) for findings of non-obviousness due to secondary considerations Re-examining requirements to meet the nexus presumption Assessing applicability of Fox Factory to secondary considerations raised in ANDA obviousness challenges
3:45	ETHICS DRILLS: Ethics and New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena David G. Conlin Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Reviewing the sufficiency of your notice letter Establishing standards for determining when attorneys and/or firms should be disqualified for conflicts Determining who is a client based on actual representation Considering joint defense arrangements in the Hatch-Waxman setting and possible ethical predicaments
4:45	Conference Concludes

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