Closed Door Executive Breakfast with ACI’S Hatch-Waxman Series Advisory Board (Limited to 25 Attendees – Application Required for Attendance)

Breakfast & Registration

Co-Chairs’ Opening Remarks

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

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

Extended Networking Coffee Break

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

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

Networking Luncheon

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

Extended Afternoon Networking Break

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

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

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

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

Cocktail Reception Sponsored by Loeb & Loeb LLP

Breakfast & Registration

Co-Chairs’ Opening Remarks

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.

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

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

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

FTC KEYNOTE: Antitrust Developments Impacting Brands and Generics

Networking Luncheon

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

Extended Networking Break

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

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

Conference Concludes