Day 1 - Monday, April 27, 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 - Tuesday, April 28, 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
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 - Monday, April 27, 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

An Interview with

Honorable Kathleen M. O’Malley
United States Circuit Judge
U.S. Court of Appeals for the Federal Circuit

by:
Honorable Mary Pat Thynge
Chief Magistrate Judge
District of Delaware

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 - Tuesday, April 28, 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

  • 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

WORKSHOP A: Think Tank on State and Federal Pharmaceutical IP Antitrust Initiatives: Patent Settlements, Reverse Payments, and Emerging Legislation

Apr 29, 2020 8:30am – 11:30am

What is it about?

(Registration starts at 7:30AM – Breakfast will be served)

  • Highlighting the nation’s first state legislation directly addressing purported “reverse payment” patent settlements
  • Reviewing the proper standards of antitrust review and the rising call for a legislative response
    • Analyzing the current legislative and regulatory framework
    • Mergers, acquisitions and exclusive licenses
    • Anticompetitive agreements
    • Abuse of dominance
    • Life cycle management and contracting
    • Pricing strategies
  • Avoiding costly litigation and associated penalties by effectively complying with the law
  • Evaluating the recent FTC reporting findings that detail fewer anticompetitive deals in PIV settlements
  • Reviewing biosimilars in the antitrust context
    • Understanding settlement strategies between innovator biologic companies and biosimilar applicants
    • Whether biologic manufacturers should expect antitrust scrutiny

WORKSHOP B: Working Group on The District Court and IPR Parallel Proceedings: Winning Strategies for Navigating Both Forums

Apr 29, 2020 12:30pm – 4:00pm

What is it about?

(Registration starts at 12:00PM)

  • Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard
    • Weighing the future of parallel proceedings in view of a single standard adoption
  • Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective
  • Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation
  • Formulating strategies based on type of pharmaceutical patent
  • Establishing jurisdiction at the PTAB
  • »» Special considerations for ex-U.S. parties
  • Ensuring all RPIs are properly named
  • Assessing split petition strategies
  • Understanding when requests for joinder can be made and when they should be made
  • Analyzing secondary considerations
  • Developing sound discovery strategies relative to dual proceedings
  • Evaluating chances of getting a stay granted in the District Court
  • Managing experts and use of experts in both forums
  • Best practices for simultaneous trials
  • Appealing decisions in both forums
  • Addressing settlement in both forums
  • Managing desire and expectations of parties to settle despite PTAB’s insistence on moving the petition forward