Paragraph IV Disputes

October 6 – 7, 2020

Agenda

Day 1 - Tuesday, October 6, 2020

7:00	Closed Door Executive Breakfast with ACI’S Hatch-Waxman Series Advisory Board (Limited to 25 Attendees – Application Required for Attendance) Breakfast & Registration
8:00	Co-Chairs’ Opening Remarks
8:15	Paragraph IV State of the Union: Strategic Legal and Economic Guidance in View of Regulatory and Jurisprudential Developments
9:00	The Continuing §101 Saga: Seeking Clarity from the PTO and the Courts on Patent Subject Matter Eligibility
10:00	Extended Networking Coffee Break
10:25	Federal Circuit Fireside Chat
11:10	Assessing the Limitations and Prospects of Obviousness–Type Double Patenting
12:10	Networking Luncheon
1:10	The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on Litigation Strategies
2:10	Extended Afternoon Networking Break
2:40	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 Magistrates Understanding and Harnessing the Nuances of Local Rules
3:30	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 Magistrates Evaluating the Effectiveness of Summary Judgment in Different Venues
4:10	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 Magistrates Appreciating the Magistrate’s Role in Settlement Discussions
5:00	Focus on the PTAB
6:00	Cocktail Reception Sponsored by Loeb & Loeb LLP

Day 2 - Wednesday, October 7, 2020

7:00	Breakfast & Registration
8:00	Co-Chairs’ Opening Remarks
8:15	Morning Roll Call with the District Judges
9:30	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: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Devising Novel Strategies for Proving Infringement and Defending Validity
10:20	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
11:05	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
12:15	Networking Luncheon
1:15	FDA Think Tank on the Latest Regulatory Developments Impacting Hatch-Waxman
2:15	Extended Networking Break
2:45	Orange Book vs. Purple Book: Comparing and Contrasting the Similarities and Differences Driving Efficiencies in PIV and BPCIA Litigation
3:45	INTERACTIVE ETHICS DRILLS: Ethics and New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
4:45	Conference Concludes

Day 1 - Tuesday, October 6, 2020

7:00	Closed Door Executive Breakfast with ACI’S Hatch-Waxman Series Advisory Board (Limited to 25 Attendees – Application Required for Attendance) Breakfast & Registration
8:00	Co-Chairs’ Opening Remarks
8:15	Paragraph IV State of the Union: Strategic Legal and Economic Guidance in View of Regulatory and Jurisprudential Developments Assessing Paragraph IV filing trends and district court decisions impacting the business and practice of ANDA litigation Surveying districts with the most ANDA case filings Analyzing the decline in new patent, PTAB and Paragraph IV filings in the district court and PTAB Comparing 2016 decline and slight 2018 uptick Leveraging precedent for a more effective litigation strategy Reviewing blocking patent developments and §112 advancements Identifying circumstances when settlement is advantageous during an IPR proceeding Assessing the resulting consequences at the District Court level Examining how recent Paragraph IV filings and litigation results i 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 Interpreting the October 2019 USPTO issued guidance on patent eligibility Evaluating the Tillis-Coons Senate bill on patent eligibility, the features of the current draft and the industry reaction Assessing the current state of proposed Hatch-Waxman reform measures affecting Exclusivities Citizens petitions Inter Partes Reviews Competition law Price controls and importation/reimportation
9:00	The Continuing §101 Saga: Seeking Clarity from the PTO and the Courts on Patent Subject Matter Eligibility Understanding the implications of the Supreme Court’s denial of cert. in Vanda, Berkheimer, and Athena Analyzing the recent Federal Circuit decision that sought to provide consistency and predictability under § 101 in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, No. 18-1763 (Fed. Cir. 2019) Evaluating the rationale behind striking down a patent owned by American Axle based on precedent established by the Supreme Court in Alice Revising the drafting practices of patent applications in the aftermath of the Federal Circuit decision Examining the recent USPTO guidance announced in October 2019 that reviews and expounds upon the Revised Patent Subject Matter Eligibility Guidance issued in January of 2019 Understanding why the USPTO will no longer opt for the traditional case-comparison approach when determining whether a claim recited a judicial exception Identifying when a claim recites a practical application for the judicial exception Evaluating when appeals to the PTAB are appropriate under the PEG Anticipating whether Congress will act in light of the Supreme Court’s denial of cert. to resolve these manufactured irregularities that hinder predictable outcomes under § 101 Assessing the probability of true clarification of the patent eligibility standard
10:00	Extended Networking Coffee Break
10:25	Federal Circuit Fireside Chat
11:10	Assessing the Limitations and Prospects of Obviousness–Type Double Patenting Deciphering the judicially created doctrine of ODTP and the policy rationale behind its creation Identifying potential limitations and advantages of ODTP Understanding how Federal Circuit OTDP decisions influence life sciences patent portfolio management Ezra v. Novartis and the relationship between OTDP and patent term extension Novartis v. Breckenridge and the relationship between ODTP and the order of patent expirations Analyzing the expansion of the ODTP doctrine after the Sun Pharma and Gilead line of cases Reviewing strategic direction for defeating ODTP rejections Evaluating how Hatch-Waxman practitioners can avoid terminal disclaimers
12:10	Networking Luncheon
1:10	The Doctrine of Equivalents: Analyzing the Effects of Recent Federal Circuit Decisions on Litigation Strategies Reviewing the efficacy of ensnarement when filing for summary judgment in view of the Janssen and Jang decisions Understanding when prosecution history estoppel bars a claim for infringement under the DOE after the Pharma Tech decision Applying effective advice for constructing a winning case for infringement Learning how to successfully defend against it claims of infringement Employing strategic guidance for narrowing claims at the USPTO Appreciating when the “disclosure-dedication” rule trumps infringement claims under the DOE
2:10	Extended Afternoon Networking Break
2:40	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 Magistrates Understanding and Harnessing the Nuances of Local Rules 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 v. 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
3:30	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 Magistrates Evaluating the Effectiveness of Summary Judgment in Different Venues 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
4:10	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 Magistrates Appreciating the Magistrate’s Role in Settlement Discussions 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	Focus on the PTAB PART I A Matter of Constitutionality: The PTAB Appointment Clause and the Increased Responsibility of AIA Trials Examining agency proceedings that consider the patentability of issued patent claims Analyzing the Federal Circuit opinion in Arthrex which held that the appointment of APJs violates the Appointments Clause of the Constitution Identifying the potential effect of the Arthrex decision on other IPR proceedings and APJ determinations Categorizing which cases must be vacated and remanded in view of the Arthrex decision PART II The APJs Speak on Practice, Policy and Procedure Surveying notable pharmaceutical patent wins and losses Assessing IPR, PGR and CMB filings involving life science patents Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of IPRs Establishing when petitioners may rely on prior art previously considered by the PTAB
6:00	Cocktail Reception Sponsored by Loeb & Loeb LLP

Day 2 - Wednesday, October 7, 2020

7:00	Breakfast & Registration
8:00	Co-Chairs’ Opening Remarks
8:15	Morning Roll Call with the District Judges All rise! Distinguished jurists with some of the liveliest PIV 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.
9:30	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: The Practice of Hatch-Waxman Litigation: Paragraph IV on Trial Devising Novel Strategies for Proving Infringement and Defending Validity 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 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 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
10:20	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 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
11:05	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 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
12:15	Networking Luncheon
1:15	FDA Think Tank on the Latest Regulatory Developments Impacting Hatch-Waxman 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
2:15	Extended Networking Break
2:45	Orange Book vs. Purple Book: Comparing and Contrasting the Similarities and Differences Driving Efficiencies in PIV and BPCIA Litigation Weighing the patent provisions and procedures in the Hatch-Waxman Act and the BPCIA Reviewing the processes for resolving patent disputes Comparing the filing rated for AIA petitions challenging Orange Book patents v. Purple Book patents Analyzing the outcomes to instituted Orange Book-listed or biologic patents Contrasting FDA regulation of large molecule drugs and biological products
3:45	INTERACTIVE ETHICS DRILLS: Ethics and New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena 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

Event Contacts

Partnership Opportunities

Linda Lam

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Speaking Opportunities

Joseph Gallagher

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Sponsorship Opportunities

American Conference Institute

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