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
1:25
Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry
2:25
Afternoon 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 Magistrate Judges
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 Magistrate Judges
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 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
Morning Roll Call with the District Judges
9:15
Morning Coffee Break
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: Devising Strategies for Proving Infringement and Defending Validity
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
Lunch Break
1:15
FDA Think Tank on the Latest Regulatory Developments Impacting Hatch-Waxman
2:15
Extended Afternoon Break
2:45
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

Ryan M. Daniel
Chief Patent Counsel Region North America
Fresenius Kabi USA, LLC

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

Michael Sitzman
Partner
DLA Piper

Adam Perlman
Partner
Latham & Watkins 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
1:25
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

2:25
Afternoon 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 Magistrate Judges
Understanding and Harnessing the Nuances of Local Rules

A
Monitoring Legal Spend and Balancing the Paragraph IV Litigation Budget

Staci Julie
SVP and Chief IP Counsel
Teva Pharmaceuticals

John Molenda
Partner
Steptoe & Johnson LLP

Track Moderator:

Guy Donatiello
SVP, Intellectual Property
Endo Pharmaceuticals Inc.

  • 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

David Abramowitz
Partner
Locke Lord LLP

Hon. Tonianne J. Bongiovanni
Magistrate Judge
District of New Jersey

Track Moderator:

Shashank Upadhye
Partner
Upadhye Cwik LLP

  • 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 Magistrate Judges
Evaluating the Effectiveness of Summary Judgment in Different Venues

A
Effectively Managing Global Pharmaceutical Patent Litigation

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 Moderator:

Guy Donatiello
SVP, Intellectual Property
Endo Pharmaceuticals Inc.

  • 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

Bill Ward
Partner
Boies Schiller Flexner

Hon. Roy Payne
Magistrate Judge
Eastern District of Texas

Track Moderator:

Shashank Upadhye
Partner
Upadhye Cwik LLP

  • 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 Magistrate Judges
Appreciating the Magistrate’s Role in Settlement Discussions

A
Practical Strategies and Tactics for Effective Settlement Negotiation

Neal Dahiya
Assistant General Counsel – Lead for Commercial and Business Development IP
Bristol-Myers Squibb

Lars Taavola
VP, Chief IP Counsel
Mallinckrodt Pharmaceuticals

Track Moderator:

Guy Donatiello
SVP, Intellectual Property
Endo Pharmaceuticals Inc.

  • 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

Alan Clement
Partner
Locke Lord LLP

Hon. Christopher J. Burke
Magistrate Judge
District of Delaware

Track Moderator:

Shashank Upadhye
Partner
Upadhye Cwik LLP

  • 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
8:15
Morning Roll Call with the District Judges

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

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.

9:15
Morning Coffee Break
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: Devising Strategies for Proving Infringement and Defending Validity
Devising Novel Strategies for Proving Infringement and Defending Validity

C
Powerful Portfolio Management: Product Selection, Identifying Targets for Litigation and Monetizing IP Portfolios

Kevin Zive
Vice President, Global IP and Legal Affairs
Apotex Inc.

Deepro R. Mukerjee
Partner & Member, Board of Directors; National Co- Chair, Patent Litigation
Katten Muchin Rosenmann LLP

  • 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

D
Devising Strategies for Proving Infringement and Defending Validity

Noah Leibowitz
Partner
Dechert LLP

Sanjay K. Murthy
Partner
Morgan, Lewis & Bockius LLP

  • 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

10:20

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

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

  • 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

Chad Landmon
Partner
Axinn, Veltrop & Harkrider, LLP

Stephen Rabinowitz
Partner
Dechert LLP

  • 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

Rekha Hanu
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)

  • 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

Vishal Gupta
Partner
Steptoe & Johnson LLP

Melanie Rupert
Partner and Co-Chair, Talent Development
Paul Hastings LLP

Alyson Wooten
Director
Berkeley Research Group LLC

  • 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

12:15
Lunch Break
1:15
FDA Think Tank on the Latest Regulatory Developments Impacting Hatch-Waxman

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

2:15
Extended Afternoon Break
2:45
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

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

Oct 8, 2020 8:30am – 11:30am

What is it about?

Effective January 1, 2020, a new California law was enacted to curb reverse payment settlements by making these agreements more difficult to defend. To complicate matters further, competition authorities at both the state and federal level are engaging in extensive investigations of patent settlements between brand and generic companies, as well as other potentially anticompetitive behaviors.

In response, leading antitrust practitioners will discuss the finer points of federal and state pharmaceutical IP antitrust initiatives in the aftermath of the Supreme Court’s seminal decision in FTC v. Actavis.

This think tank will focus on the considerable consequences that pharmaceutical companies entering into these types of settlement agreements may now incur on the state and federal level. You cannot afford to miss this. Topics of discussion include:

  • Examining California’s Reverse Payment Legislation and understanding how this first state law on this matter may influence other states
  • Understanding how this law law dovetails with the multi-state coalition of state Attorneys General’s price fixing lawsuit against various generic pharmaceutical companies
  • Analyzing plaintiffs and state AG direct and indirect purchaser cases relative to reverse payment settlements
  • Reviewing the proper standards of antitrust review and the rising call for a new legislative response
    • Studying the current legislative and regulatory frameworks
    • Analyzing the call from lawmakers for greater scrutiny of pharmaceutical mergers over antitrust concerns
    • Understanding the implications of patent litigation settlement agreements being deemed presumptively anticompetitive
    • Reviewing abuse of dominance court proceedings in relation to parallel trade of pharmaceuticals
    • Evaluating product introduction strategies to better maintain life cycle management
    • Examining government enforcement trends to better understand 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 IPR Strategies and Parallel Proceedings: Devising Winning Strategies for IPR Best Practices and Navigating Dual Forums in Hatch-Waxman Litigation

Oct 8, 2020 12:30pm – 4:00pm

What is it about?

Parallel litigation in the District Court and PTAB in a Hatch-Waxman proceeding has become a way of life for life sciences patent litigators, adding to the “no-holds barred” atmosphere of this high stakes type of litigation. The art of navigating proceedings between to these two forums has been described as akin to walking a tightrope.

In navigating these dual forums, even the most seasoned of District Court litigators are still learning the evolving art of appearing before the PTAB. In this very interactive session, we will illustrate the “ins and outs” of IPR practice and appearing in dual proceedings in both the District Court and PTAB with a special focus on IPR practice.

  • 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