Day 1 - Monday, June 12, 2017

7:30
Registration and Continental Breakfast Hosted by

8:15
Co-Chairs’ Opening Remarks
8:30
Policy and Politics of Biosimilars under the New Administration
9:45
Case Study: Reviewing the First 18 Months of Biosimilars and a Look Ahead
10:45
Morning Coffee Break Hosted by

11:00
Demystifying the Demonstration of Interchangeability in View of FDA’s Draft Guidance
12:15
Networking Lunch Hosted By
1:30
Amgen v. Sandoz: Where are we Now?
3:00
Refreshment Break Hosted By

3:15
Patent Portfolio Management in Light of Life Techs. Corp. and Extraterritorial Reach of U.S. Patents
4:00
Untangling the Inner Workings of IPRs for Biosimilars
5:30
Day One Adjourns to Cocktail Reception Hosted by

Day 2 - Tuesday, June 13, 2017

8:00
Continental Breakfast Hosted by

8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
Shall we Dance: Mastering the “Steps” of the BPCIA While Avoiding Common Pitfalls
10:15
Morning Coffee Break Hosted by

10:30
A Biosimilar by Any Other Name. . . Has a Distinguishing Suffix
11:15
Ensuring Labeling Compliance and Assessing Impact of Labeling on Product Liability Litigation
12:15
Networking Lunch Hosted by

1:30
The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars
2:30
The Judges Speak: Inside Perspectives on Biosimilar Litigation
3:45
Afternoon Refreshment Break Hosted by

4:00
Examining the Ethics and Professional Responsibility Concerns for the Biosimilars Industry
5:00
Conference Adjourns

Post-Conference Workshops

A: Product Patentability Workshop: Navigating through § 101 and § 112 Challenges for Biologics

Jun 14, 2017 9:00am – 12:00pm

Speakers

Mercedes Meyer
Partner
Drinker Biddle & Reath LLP

Erica Pascal
Partner
DLA Piper

B: Biosimilars around the World: Examining Challenges and Strategies for Creating an International Biosimilar Portfolio

Jun 14, 2017 2:00pm – 5:00pm

Speakers

Lisa Mueller
Partner, Industry Group Chair, Life Sciences
Michael, Best & Friedrich

James Ogle, Ph.D.
Partner | European Patent Attorney | UK Chartered Patent Attorney
Hoffmann Eitle

Bert Oosting
Advocaat/Attorney
Hogan Lovells International LLP

Day 1 - Monday, June 12, 2017

7:30
Registration and Continental Breakfast Hosted by

8:15
Co-Chairs’ Opening Remarks

Co-Chairs

Kevin Noonan, Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff

Donald Ware
Partner and Chair, Intellectual Property Department
Foley Hoag LLP

8:30
Policy and Politics of Biosimilars under the New Administration

Carlos Angulo
Partner
Zuckerman Spaeder

Erin Ator Thomson
Counsel, Intellectual Property Counseling
Vinson & Elkins LLP (Austin, TX)

Donald Ware
Partner and Chair, Intellectual Property Department
Foley Hoag LLP

Mark Waddell
Chair, Patent Litigation and Counseling
Loeb & Loeb LLP

Five months into the new administration, this session will cover the changes in place and potential changes to come for biosimilars. Our speakers will explore recently passed and pending legislation, new appointees, threats to the Affordable Care Act, and up-to-date challenges for the biosimilars market including the evolving §101 standard, the impact of Bayh-Dole Act on licensing deals and pricing for biologics and biosimilars going forward, and more.

9:45
Case Study: Reviewing the First 18 Months of Biosimilars and a Look Ahead

Aaron Lukas, Ph.D.
Member
Cozen O' Connor

Jenny Johnson
Patent Counsel
Endo Pharmaceuticals Inc

Kevin Noonan, Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff

  • Comparing and contrasting the pathways taken by each of the four approved biosimilars
    • Strategies for working and communicating with FDA during the approval process
    • Examining the data packages for each of the four approved products
  • Evaluating the marketing strategies for each biosimilar that has entered the marketplace
    • Circumventing challenges that arise when bringing a biosimilar to market
  • Reviewing the current U.S. innovator biologics pipeline and choosing the best reference product to target for biosimilar development
  • Eyeing potential partnerships, collaborations, and joint ventures

10:45
Morning Coffee Break Hosted by

11:00
Demystifying the Demonstration of Interchangeability in View of FDA’s Draft Guidance

Bruce Leicher
Senior Vice President & General Counsel
Momenta Pharmaceuticals Inc

Jen Zarutskie Sieczkiewicz, Ph.D., J.D.
Research and Business Development Counsel
Biogen Inc.

Ha Kung Wong
Partner
Fitzpatrick Cella Harper & Scinto

  • Reviewing FDA’s “Considerations in Demonstrating Interchangeability with a Reference Product” Draft Guidance and its impact on the biosimilars market
  • Best practices for maintaining open communication with FDA and ensuring complete understanding of information needed to show interchangeability and product-by-product reasoning
  • Compiling a robust package of evidence supporting interchangeability
    • Best practices for designing and conducting switching studies
    • Supporting a showing that the proposed interchangeable product is expected to produce the same clinical result as the reference products
  • Comparing and contrasting individual state regulations on pharmacy-level substitution
  • Determining eligibility for substitution

12:15
Networking Lunch Hosted By
1:30
Amgen v. Sandoz: Where are we Now?

W. Blake Coblentz
Co-Chair, Hatch-Waxman & Biologics Litigation
Cozen O' Connor

Maureen Bresnahan
Senior Patent Counsel
Eisai Inc

Brendan O’Malley, Ph.D.
Partner
Fitzpatrick Cella Harper & Scinto

Irena Royzman, Ph.D.
Partner
Patterson Belknap Webb & Tyler LLP

Hans Sauer
Deputy General Counsel for Intellectual Property
BIO

At the time of print of this brochure, oral argument is set for April 26th. Following the current schedule, a decision on the merits should come down by the end of June. While it is unlikely that there will be a decision in time for the conference, our panelists will provide an up-to-the-minute review and inside analysis of the arguments presented, the status of the case, predictions for the outcome, and the impacts of alternative outcomes on the industry.

3:00
Refreshment Break Hosted By

3:15
Patent Portfolio Management in Light of Life Techs. Corp. and Extraterritorial Reach of U.S. Patents

Z. Ying Li, Ph.D.
Partner
Steptoe & Johnson

Timothy Worrall
Principal
Polsinelli PC

  • Analysis and impact of the new standards laid out in Life Techs Corp. v. Promega
    • What constitutes a “substantial portion” and how may this be interpreted going forward?
  • Limitations of extraterritorial reach under 271(f)(1)
  • Status of Impression Prod. v. Lexmark pending in the Supreme Court
  • How will this impact the development of biosimilar and innovator products and patent protection for these products?
  • Hypothetical scenarios for how this can impact biologics

4:00
Untangling the Inner Workings of IPRs for Biosimilars

Eli A. Loots, Ph.D.
Partner
Knobbe, Martens, Olson & Bear, LLP

John Josef Molenda, Ph.D.
Partner, Co-Chair, Healthcare & Life Sciences Practice
Steptoe & Johnson

Siegmund Gutman
Partner
Proskauer Rose LLP

Jeremy Lowe
Partner
Axinn Veltrop Harkrider LLP

Gregory Morris, Ph.D.
Partner, Leader Life Sciences Litigation Practice Group
Honigman Miller Schwartz & Cohn LLP

  • Claim drafting post Cuozzo: Balancing the PTAB’s broadest reasonable interpretation (BRI) standard with the District Courts’ Phillips standard
  • Best practices for FTOs and developing an “internal purple book”
  • Examining institution and denial for pharmaceutical petitions in 2016 as compared to 2015 and earlier
    • Exploring the PTAB’s reasoning for issuing denials
  • Mastering the ins and outs of appearing before the PTAB: avoiding procedural pitfalls while strategizing best practices for successful arguments.
  • Introducing § 112 challenges into petition through priority challenges

5:30
Day One Adjourns to Cocktail Reception Hosted by

Day 2 - Tuesday, June 13, 2017

8:00
Continental Breakfast Hosted by

8:30
Co-Chairs’ Opening Remarks and Recap of Day One
8:45
Shall we Dance: Mastering the “Steps” of the BPCIA While Avoiding Common Pitfalls

Christine Willgoos
Special Counsel
Kramer Levin Naftalis & Frankel LLP (New York, NY)

Tara Nealey
Shareholder
Polsinelli PC

Stacie Ropka, Ph.D.
Partner
Axinn Veltrop Harkrider LLP

Chuck Klein
Chair, Complex Commercial Litigation Practice
Winston & Strawn LLP

Andrea Cheek
Partner
Knobbe, Martens, Olson & Bear, LLP (Washington, DC)

Rob Cerwinski
Partner
Goodwin Procter LLP

This interactive session will delve into the decision-making process for each step along the way from decision to go through the BPCIA, to litigation strategies, to product launch and marketing. The audience will divide into small “working groups,” each with a moderator. Topics to be discussed include:

  • Possible impact of Amgen v. Sandoz on the patent dance
    • Pros and cons of taking part in the patent dance
    • Interplay between IPRs and the Patent Dance
  • Strategically timing the filing of a biosimilar application in light of 180-day notice provision
  • Tips for minimizing litigation risks for biosimilars applicants

10:15
Morning Coffee Break Hosted by

10:30
A Biosimilar by Any Other Name. . . Has a Distinguishing Suffix

Thomas Felix, M.D.
Director Regulatory Affairs
Amgen

John Klimek
Senior VP, Standards and Information Technology
National Council for Prescription Drug Programs

  • Strategies for choosing the best suffixes, and ideas for supporting documentation
  • Determining suffix format for interchangeable products
  • Pondering FDA’s implementation process for previously licensed products

11:15
Ensuring Labeling Compliance and Assessing Impact of Labeling on Product Liability Litigation

Jessica Benson Cox
Partner
Faegre Baker Daniels

Jennifer Stevenson
Partner
Shook, Hardy & Bacon LLP

  • Analyzing FDA’s Draft Guidance, “Labeling for Biosimilar Products”
    • Comparing “highly similar” biosimilars to “bioequivalent” small molecule drugs
    • Dissecting product design, manufacture defect, and failure-to-warn claims
  • Evaluating the impact of not including biosimilar-specific data in the label
  • Understanding the impact of biosimilars ability to unilaterally change its label after approval
  • Best practices to market biosimilars to doctors and patients while protecting against liability

12:15
Networking Lunch Hosted by

1:30
The Price is Right: Or is it? Dissecting Pricing and Reimbursement Issues for Biosimilars

Molly Burich
Associate Director Public Policy
Boehringer Ingelheim

Brian P. Carey
Partner
Foley Hoag LLP (Washington, DC)

  • Examining pricing considerations surrounding biologic drugs and how biosimilars may change the game
  • Ascertaining how payors will deal with biosimilars
    • Investigating incentives for government payors
    • Formulary tiering to drive biosimilar uptake without interchangeability
  • Examining how CMS is planning to handle reimbursement for biosimilar products

2:30
The Judges Speak: Inside Perspectives on Biosimilar Litigation

Speakers:

Honorable Garrett E. Brown, Jr. (ret.)
Retired U.S. District Chief Judge
ADR Neutral, Mediator, and Arbitrator

JAMS (New York, NY)

Hon. Lora Green
Lead Administrative Patent Judge, Patent Trial and Appeal Board
US Patent and Trademark Office

Honorable Faith S. Hochberg (ret.)
Retired U.S. District Judge
ADR Neutral, Mediator, and Arbitrator

Hochberg ADR (New York, NY)

Moderator :

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals (Malvern, PA)

This panel offers a unique opportunity to hear comments and inside perspectives from members of the Judiciary on the current biosimilars’ litigations, tips for success, and pitfalls to avoid. The panel will also discuss the interplay between the PTAB, District Courts, and the Federal Circuit for these proceedings.

3:45
Afternoon Refreshment Break Hosted by

4:00
Examining the Ethics and Professional Responsibility Concerns for the Biosimilars Industry

Barbara Fiacco
Partner
Foley Hoag LLP

John Garretson
Partner
Shook, Hardy & Bacon LLP

  • Drawing the line: avoiding conflicts of interest as more and more companies are playing part-innovator, part-biosimilar
    • Reconciling positions taken by outside counsel representing both innovator and biosimilar
  • Deciding to dance and how to avoid confidentiality issues arising with the materials exchange
  • Understanding unique confidentiality issues and potential creation of prior art arising from international submissions and clinical studies

5:00
Conference Adjourns

A: Product Patentability Workshop: Navigating through § 101 and § 112 Challenges for Biologics

Jun 14, 2017 9:00am – 12:00pm

Mercedes Meyer
Partner
Drinker Biddle & Reath LLP

Erica Pascal
Partner
DLA Piper

What is it about?

  • Mapping your way through § 101 jurisprudence
    • How to improve the specific claims in those cases to avoid problems
  • Best practices for drafting claims and specification with structural and functional descriptions in mind
    • Specific functional limitations you want to address including antibody binding affinity, epitope binding, and more
  • Selecting the proper genus and species to include in your application to avoid obviousness-type double patenting
    • Strategically choosing how many embodiments to disclose
    • Differences when protecting a product vs. a basic technology patent
  • Determining the best litigation pathway: utilizing section 101 vs. sections 102 and/or 103
    • Harmonizing written description arguments with 102 and 103 arguments
    • Litigation strategies for asserting 112 and 103 together to “squeeze” your opponent
  • Targeting claims to challenge in litigation
    • Strategies for timing of ilings – filing fast vs. filing complete – what factors to take into account when making this call?

B: Biosimilars around the World: Examining Challenges and Strategies for Creating an International Biosimilar Portfolio

Jun 14, 2017 2:00pm – 5:00pm

Lisa Mueller
Partner, Industry Group Chair, Life Sciences
Michael, Best & Friedrich

James Ogle, Ph.D.
Partner | European Patent Attorney | UK Chartered Patent Attorney
Hoffmann Eitle

Bert Oosting
Advocaat/Attorney
Hogan Lovells International LLP

What is it about?

  • Comparing international regulatory pathways and biosimilar approvals per country
  • Examining emerging markets (e.g. Brazil, Russia, India, China, South Africa)
    • Balancing the short-term challenges with the longer-term benefits
  • Taking into account potential confidentiality issues with filing outside of the United States
    • Inadvertently creating prior art that can be used against you later on
  • Interchangeability on an international level
    • Nor-SWITCH study
  • Best practices for structuring cross-border agreements
  • Envisioning the future: Considering effects of biosimilar entry from outside of the US